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ADHD drug maker suing DEA over ‘effectively shutting down’ manufacturing
Posted on November 15, 2023 by Pharmaciststeve
ADHD drug maker suing DEA over ‘effectively shutting down’ manufacturing
OMAHA, Neb. (WOWT) – During an ongoing national shortage for drugs used to treat attention-deficit-hyperactivity disorder (ADHD), one manufacturer is suing the federal government.
A New York-based law firm representing Ascent Pharmaceuticals, Inc. said the Drug Enforcement Administration is keeping its client from manufacturing generic prescriptions to treat ADHD.
“At the very time that there is a federal government-recognized scarcity of ADHD medications, the government has elected to effectively shut down the company that was making 20 percent of the generic forms,” said Jim Walden, managing partner at Walden, Macht and Haran.
Walden said the DEA’s basis for the move is over alleged record-keeping violations by Ascent—assertions Walden said are wrong.
Hanging in the balance was Ascent’s application for a production quota.
“They were supposed to decide Ascent’s quota for manufacturing in July of ‘22,” Walden said. “Over the course of the last year-and-a-half, DEA has been conducting this audit of Ascent’s record keeping, and Ascent has cooperated. It provided all the documents when DEA expressed some concerns about documents.”
He said over that year-and-a-half, Ascent had been falling back on its stockpile of raw materials for making ADHD drugs, but that it has since run out.
He said the DEA finally denied Ascent’s quota application only after the company asked a judge to speed up the agency’s decision on it in late September.
“We had been strung along, believing that we were going to get approved any day. After we filed that lawsuit, DEA filed its final denial two days after.”
So Walden has filed an emergency motion to restore Ascent’s ADHD drug manufacturing.
This comes during a time when prescriptions used to treat ADHD have been in short supply, which local pharmacies have been feeling.
It started with Adderall, then expanded to other medications like Focalin, Ritalin, Concerta, and Vyvanse.
Because of that, Walden said it’s a bad time for the government to put a muzzle on Ascent Pharmaceuticals’ manufacturing efforts.
“It used to make roughly 47 million pills that were used for ADHD treatments,” he said. By August of this year, it was only producing about 100,000 of them. Now, it’s producing none.”
6 News reached out to the DEA for comment but has not heard back.
The agency has said pharmaceutical companies have more than enough raw ingredients to make ADHD drugs.
Walden said he wouldn’t be surprised if the U.S. Court of Appeals for the Second Circuit makes a decision on Ascent’s lawsuit in the next couple of weeks.
42 USC 1395: Prohibition against any Federal interference
https://uscode.house.gov/view.xhtml
From Title 42-THE PUBLIC HEALTH AND WELFARE CHAPTER 7-SOCIAL SECURITY SUBCHAPTER XVIII-HEALTH INSURANCE FOR AGED AND DISABLED
§1395. Prohibition against any Federal interference
Nothing in this sub chapter shall be construed to authorize any Federal officer or employee to exercise any supervision or control over the practice of medicine or the manner in which medical services are provided, or over the selection, tenure, or compensation of any officer or employee of any institution, agency, or person providing health services; or to exercise any supervision or control over the administration or operation of any such institution, agency, or person.
(Aug. 14, 1935, ch. 531, title XVIII, §1801, as added Pub. L. 89–97, title I, §102(a), July 30, 1965, 79 Stat. 291 .)
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Clinical Context of Suicide Following Opioid Transitions
Posted on November 13, 2023 by Pharmaciststeve
Clinical Context of Suicide Following Opioid Transitions
CSI:OPIOIDs (Clinical Context of Suicide Following Opioid Transitions) is a scientific research study to closely examine suicides that happen after prescription opioid dose reductions in patients with long-term pain. Beginning as a pilot study supported by UAB Heersink School of Medicine’s Department of Medicine, today it’s supported by a Veterans Administration grant under the title “CSI:OPIOIDs-V“. The study’s purpose is to increase knowledge of the demographic, societal, and clinical factors that have led and may lead patients with pain to die by suicide after opioid reduction or stoppage.
Our work was inspired by the attention and tracking of Ms. Anne Fuqua, who noticed that many suicides of pain patients were reported by families online, but not followed up by health authorities or policymakers.
Results from the CSI:OPIOIDs study will help families, clinicians, and policymakers understand when and why patients with pain die by suicide after opioid reduction or stoppage. The results will help identify ways to improve health care and assure positive outcomes for patients with pain.
Why It Matters
Since 2012, many doctors have been reducing or stopping opioid medications in their patients with pain. While some patients have tolerated this change in medication, others have been harmed gravely, with suicidal events found in several research papers and news reports. Right now, no one fully understand what personal factors or life circumstances differentiate patients who tolerate change in their opioid medications well from those who are harmed by that change. Until we look closely at the individual tragedies, we cannot expect the kind of systematic changes in healthcare that will reduce negative outcomes for similar patients in the future.
What Will This Study Do
The CSI:OPIOIDs team will:
- Compile a registry of individuals who have died by suicide following a reduction or stoppage in their opioid medication
- Perform in-depth, one on one interviews with survivors of individuals who have died by suicide after opioid transition to understand what led their loved-one to commit suicide
- Identify factors common to these individuals prior to their death and suggest ways to reduce likelihood that future patients will commit suicide under similar circumstances
There are many reasons that no other team has attempted to study these deaths closely. But one is that any form of research that reaches out to members of the public who have suffered such a loss is hard to do. A research team must surmount logistical challenges and establish trust across communities of patients, families, experts and policy makers. See our briefing on Youtube to learn more.
Research Team
The CSI:OPIOIDs research team is led by Dr. Stefan Kertesz, Professor of Medicine at UAB Heersink School of Medicine and physician at the Birmingham VA Medical Center. See Our Team for more information.
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10 Ways MedPAC Commissioners Think Regulators Should Fix Medicare Advantage Plans
Posted on November 13, 2023 by Pharmaciststeve
10 Ways MedPAC Commissioners Think Regulators Should Fix Medicare Advantage Plans
https://www.medpagetoday.com/special-reports/features/107253
Improvements needed in network accuracy and transparency regarding denial rates, they say
Medicare Payment Advisory Commission (MedPAC) members wrestled last week with how to prevent a range of frustrations they say providers and patients are encountering with Medicare Advantage (MA) plans.
Although the commissioners were just discussing ideas and didn’t make any formal recommendations, MedPAC staff will analyze the commissioners’ remarks for possible inclusion in an upcoming report to Congress — a report that will suggest regulatory changes to help the plans work better for patients and providers.
This year, the number of Medicare beneficiaries enrolled in MA plans toppedopens in a new tab or window 50% of 65.7 million eligible, and as MedPAC chair and Harvard health policy professor Michael Chernew, PhD, noted, the program is only going to get “bigger and bigger.”
These meetings give commissioners “a broad range of freedom to say whatever they want, and make a number of suggestions about problems and solutions,” Chernew told Medpage Today in a phone interview.
But getting to an actual recommendation requires lengthy and complex staff analyses to understand possible unintended consequences, he said. Implementation may take years, and will only come after approval by the Centers for Medicare & Medicaid Services (CMS).
That said, here are some of the problems commissioners want the agency to address:
1. Pave a way for unhappy MA enrollees with “reasonable buyer’s remorse” to leave their MA plans and have a “special election period” to buy a supplemental plan that picks up traditional Medicare’s 20% Part B co-pays and hospitalization deductibles.
Beneficiaries have limited periods in which they can buy a supplemental plan without medical underwriting. Those periods are generally limited to their first 6 months of eligibility or, if they leave traditional Medicare later for an MA plan, they have a one-time 12-month period in which they can go back to traditional Medicare and get their supplemental plan back if it is still available.
“I’m in a state that does not have guaranteed issue rights to supplement outside of very restricted periods,” said Gina Upchurch, RPh, MPH, founder and executive director of Senior PharmAssist, a nonprofit in Durham, North Carolina. “We see a lot of people that really cannot make the selection to go back” to traditional Medicare with a supplement plan because they would have to undergo medical underwriting, she said.
“If a member attests to a reasonable buyer’s remorse, they [should] have guaranteed issue to go back to traditional Medicare” with a supplemental plan. “That’s ideal from a public policy [standpoint],” said Scott Sarran, MD, MBA, consultant and principal at Triple Aim Geriatrics.
“People need to understand if someone is in MA, and for whatever reason doesn’t like the prior authorization or the networks … You really don’t know what’s going to happen to you. So switching back [to traditional Medicare] would be important,” said Larry Casalino, MD, former health policy chief at Weill Cornell Medical School’s Department of Population Heath Sciences.
2. Require MA plans to maintain up-to-date directories of providers, including clinicians, that are not only in network, but available to see new patients. CMS should step up efforts to audit those listings, the commissioners said.
“Provider directories are a problem. It’s sort of ridiculous to enroll in a plan and have the provider directory be out of date. It’s unbelievable we are having this discussion in 2023,” said Brian Miller, MD, MPH, an assistant professor of medicine at Johns Hopkins University.
Numerous CMS reports over the years have documented high rates of inaccuracies in those directories, with clinicians going off contract or not accepting new patients during the plan year. CMS could verify through claims data to determine “to what extent the listed providers in the directory are actually seeing patients for a plan,” Casalino suggested.
“Having out-of-date directories is completely unacceptable when we think about the fact that people will pick plans based on the coverage of their providers,” said Stacie Dusetzina, PhD, professor of health policy at Vanderbilt University Medical Center in Nashville.
3. Study Medicare’s rules for assuring that MA plan enrollees can get in-network coverage for medically necessary care with out-of-network specialists when the plan has no appropriate in-network specialists that can meet the patients’ needs. “Who monitors that, and do we see that a lot?” Upchurch asked.
4. Mandate that beneficiaries have a reliable way to compare plans in terms of prior authorization review and compliance with various rules, perhaps requiring that such information be displayed on the Medicare Plan Finder, said Sarran.
“It should be clear to a prospective member making a buying decision how Plan X compares to Plan Y and their percent of denials, percent of overturns, maybe any corrective actions that have been taken against the plan, [and] enforcement actions by CMS,” he said.
5. Prohibit plans from restricting first-choice access to Part B cancer drugs that are listed in the National Cancer Center Network compendia, or requiring the patient to try other drugs first. “There should be no requirement for a ‘step’ to get to anything that’s in that category,” Sarran said.
6. Require that each plan disclose on the Medicare Plan Finder whether it allows enrollees to get care at comprehensive or National Cancer Institute-designated cancer centers in network — or with discounted co-pays at out-of-network facilities — and to specify which ones.
“Prior research has suggested that there are some problems with network coverage of any of those levels of more specialized care,” Dusetzina said.
A patient who needs specialty cancer care but can’t get it in network might pay full price for that care, or leave MA for traditional Medicare without a supplement, thus paying 20% of all cancer care costs, “which is unaffordable,” Dusetzina said.
Rather than having plans specify which specialty providers they include, perhaps requiring them to “highlight exclusions from their network might be an interesting approach,” said Sarran. “And you could require listed exclusions on [the Medicare] Plan Finder of cancer centers, of teaching hospitals, of major hospital systems with large market shares. Again, we want an informed consumer. Industry can’t reasonably argue against an informed consumer making good, informed decisions, so how do we enable that?”
7. Revamp MA plan star ratings metrics to reflect the stability and consistency of a plan’s provider network in a way that would include each plan’s prior authorization denial rate, and indicate how much enrollees can rely on their providers staying in-network.
“You know, we figure out how to pay people. So it feels like we should be able to tie these things together in a way that makes it really clear who is available, who’s accepting patients,” Dusetzina said.
8. Find ways to make sure beneficiaries know what they are giving up when they enroll in an MA plan with respect to being constrained to narrow provider networks and accepting delays or denials of care because of prior authorization.
“Anything we do that helps people understand what they’re giving up and what they’re getting I think is an absolutely central principle,” said Betty Rambur, PhD, RN, professor of nursing at the University of Rhode Island.
“It’s important that Medicare beneficiaries know what their trade-offs are; those trade-offs are often not clear,” Miller said.
9. Require that MA plans list behavioral health plans in their directories by provider name rather than just giving patients a company to call.
Patients often don’t really want to go see a psychiatrist, but if a doctor recommends it, “you want them to see someone good that you know, and that they would be happy with,” and get feedback from that visit, said Casalino. Currently, doctors sometimes just have an 800 number to give the patient and no idea who the patient would end up seeing.
“It would be hard to exaggerate the discontent of a physician who has to do that,” he said.
10. Improve the user-friendliness of the appeals process for both enrollees and providers. “The more we make that an easy remedy, the more plans will back away from unnecessary denials on the front end,” suggested Sarran.
Chernew stressed that MA plans were designed to reduce unnecessary care and use the savings from that to add other benefits and reduce premiums.
“But that doesn’t mean there aren’t situations in which care is denied that shouldn’t be denied, or that the quality in the plan is worse than it would be in fee-for-service,” he said. Getting the balance between getting to efficient delivery systems, “versus the potential for [MA plans] to be overly aggressive is a challenging thing for CMS.”
Chernew also emphasized that everyone agrees beneficiaries need to be better informed about the things they give up by choosing MA over fee-for-service, but given the complexities of the plans, “that is a daunting task.”
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multiple agendas attempting to reduce the overall available of controlled meds
Posted on November 12, 2023 by Pharmaciststeve
The common denominator on all these attacks on the availability of control meds is our JUDICIAL SYSTEM. Starting when 41 state Attorney Generals, that sued the 3 major drug wholesalers, and got them to agree: to pay billions in fines – didn’t even go to court – AND agreed to REDUCE the controls that they sell to ALL PHARMACIES. Here is a synopsis of the nearly 600 page agreement: AGREEMENT via the “grapevine”, this agreement was signed in April 2022 and was not suppose to see the light of day, but someone leaked it in early 2023. The “grapevine” also states that those same AGs got the major pharmacy chains to pay billions in fines and agreed to reduce the controlled Rxs filled, but that agreement has not seen the light of day yet. There was also some sort of agreement with Kroger and some sort of fine being paid, but another agreement that may not have seen the light of day.
DEA revokes the DEA license of Shreveport, Louisiana-based Morris & Dickson, the nation’s fourth-largest wholesale drug distributor, with $4 billion a year in revenue and nearly 600 employees serving pharmacies and hospitals in 29 states. https://www.usnews.com/news/best-states/louisiana/articles/2023-05-26/after-yearslong-delay-dea-revokes-license-of-wholesale-drug-distributor-over-opioid-crisis-failures What is going to happen to the allocation of the controlled meds that this wholesaler had? Will they JUST DISAPPEAR?
Then we have Rite Aid filing for bankruptcy and closing 100+ stores and both CVS & Walgreen is scheduled to close 100+ stores each over the coming years. https://www.pharmaciststeve.com/drugstore-closures-could-make-pharmacy-deserts-even-worse/ If history repeats itself, these chains will just transfer the Rx files to one of their nearby store, but happens to the controlled meds allocated to these closed stores? Again, will they just disappear?
Is the current DEA proposal for reducing pharma opioid production quotas, just a “smoke screen” for what various parts of our judicial system has already enacted or is in the process of enacting? https://www.pharmaciststeve.com/dea-proposed-reduction-in-pharma-controlled-med-production-quotas/
Earlier this year, the DEA stated that <1% of pharmas’ opioids are diverted. Historically, the estimated number of chronic pain pts in the USA as a percentage of our population…has remained fairly constant. However, during the 2010-2020 decade our population grew at about 11%, the same\similar time frame that the vast majority of opioid/controlled med pharma production quotas were reduced somewhere in the 50% range.
Is this some sort of WARPED covert genocide? Getting chronic pain pts to die prematurely from under/untreated pain and or end up committing suicide?
Opioid Litigation Affects All of Pharmacy
https://www.daily-remedy.com/opioid-litigation-affects-all-of-pharmacy/
Opioid litigation has had a significant impact on the number of pharmacies operating within the United States. This has occurred due to several reasons.
Firstly, opioid litigation involves lawsuits and legal actions against pharmaceutical companies, distributors, and even pharmacies themselves, holding them accountable for their role in the opioid crisis. These litigations have resulted in substantial financial penalties and settlements for the defendants, often in the billions of dollars. As a consequence, many pharmacies have faced financial strain and even bankruptcy, leading to a reduction in the overall number of pharmacies.
Secondly, the legal actions and subsequent reforms brought about by opioid litigation have significantly strengthened regulatory oversight of pharmacies. Government agencies such as the Drug Enforcement Administration (DEA) and state regulatory bodies have implemented stricter regulations and monitoring systems to combat the over-prescription and misuse of opioids. These regulations often require pharmacies to implement more comprehensive prescribing and dispensing practices, which can be costly and burdensome for smaller or less compliant pharmacies. As a result, some pharmacies have found it economically unviable to continue operating, leading to a decrease in the number of pharmacies.
Additionally, opioid litigation has resulted in heightened public awareness and scrutiny surrounding the role of pharmacies in the opioid crisis. This increased awareness has caused some individuals and communities to seek alternatives for pain management, leading to a decrease in demand for opioids and consequently reducing the need for pharmacies to dispense these medications. This shift in consumer behavior has further contributed to a decline in the number of pharmacies specializing in opioids.
Moreover, opioid litigation has brought about changes in the attitudes and practices of healthcare providers. Many physicians and healthcare professionals have become more cautious and vigilant when prescribing opioids, resulting in decreased prescription rates. As a consequence, pharmacies that solely relied on opioid prescriptions for their business may have faced a decline in demand, making it financially unsustainable for them to continue operating.
Lastly, the negative publicity and social stigma surrounding opioids have influenced consumer perceptions and choices concerning pharmacies. As the opioid crisis garners significant media attention, consumers have become more discerning about where they fill their prescriptions. Some individuals may actively seek out pharmacies that are not involved in legal actions or that focus on alternative pain management options. This consumer shift in preference has created a disadvantage for pharmacies with a history of opioid-related litigation, leading to a decrease in their customer base and overall viability.
In conclusion, opioid litigation has caused a decline in the number of pharmacies due to financial pressures, increased regulatory oversight, decreased demand for opioids, changes in prescribing practices, and consumer preferences. These combined factors have significantly impacted the pharmacy landscape within the United States, leading to a reduction in the overall number of operating pharmacies.
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DEA PROPOSED reduction in pharma controlled med production quotas
Posted on November 10, 2023 by Pharmaciststeve
Proposed Aggregate Production Quota 2024 (2023-24282) DEA1228
https://www.regulations.gov/commenton/DEA-2023-0150-0001
Synopsis of the 3 major drug wholesalers agreement to reduce the controls sold to all pharmacies
I just wonder if the proposed reduction in pharma production quotas is just the DEA’s followup of the agreed upon reduction by the 3 major drug wholesaler – synopsis of agreement link above
That agreement, that was reportedly signed in April, 2022, was suppose to see the light of day, but was leaked in 2023. I did not see in the nearly 600 page agreed if there was a specific reduction mentioned… just the wholesalers agreed to REDUCE controls sold to all pharmacies. Could the DEA know what that percentage is going to be?
We have already heard of widespread lack of availability of control meds at local pharmacies. Is this the DEA CYAing the 3 major drug wholesalers, who agreed to reduce the number of controlled Rx meds they sell to pharmacies. Which in the end that reduction would have denied some disabled pts their medically necessary controlled medication.
Here is a post from last year – that some believe that the DEA is violating a federal law, by interfering with the availability of controlled meds by pts that a valid medical necessity and without them, their QOL will be compromised.
Is how the DEA enforces the CSA… in violation of this federal law ?
Of course, the entity that is in charge of enforcing our disability laws and civil rights law is our Federal Attorney General and the same entity is also the OVERSIGHT ENTITY of the DEA.
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THE EXTREME PERSECUTION OF DR. SHIVE AKULA, MD., ADJUDICATED GUILTY FACING YEARS OF WRONGFULL IMPRISONMENT
Posted on November 10, 2023 by Norman Clement
Dr. Shiva Akula’s lawsuit details the conspiracy method and how the criminal indictment is purposed to eliminate Dr. Akula from the American healthcare market to permit his competitors to seize his business and personal assets.
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Drugstore closures could make pharmacy deserts even worse
Posted on November 10, 2023 by Pharmaciststeve
Drugstore closures could make pharmacy deserts even worse
https://www.cnn.com/2023/11/06/business/drugstore-closures-pharmacy-deserts/index.html
New York CNN —
With hundreds of pharmacies closing their doors this year alone, experts fear that more vulnerable Americans could be left without access to the medications they need.
Pharmacy closures have been a problem for years. CVS closed 244 stores between 2018 and 2020 and said in 2021 that it would close another 900 locations through 2024. In 2019, Walgreens said it would close 200 stores. This year, it announced an additional 150 closures. And Rite Aid recently filed for bankruptcy and announced that it would shutter about 100 of its roughly 2,200 stores as part of its restructuring efforts, with more closures to come. Brick and mortar pharmacies are facing a number of challenges: more competition, a tough few years stemming from the pandemic, and squeezed margins as reimbursement rates for prescription medications fall, due in part to how the business has changed.
When drugstores disappear, patients suffer, said Jenny Guadamuz, assistant professor at the UC Berkeley School of Public Health, Division of Health Policy and Management. “You can think of a closure as a disruption of care,” she said. “You had a routine: You would go to a pharmacy that was geographically accessible — ideally affordable — was probably preferred for your health insurance plan. And then that pharmacy is no longer there.”
A long way to go
When pharmacies close, some patients have to travel farther to get the medications they need. That extra distance and time often means they won’t pick up their medicine at all, Guadamuz said.
Melvin Thompson, now a healthcare consultant, was previously executive director of the Endelo Institute, a nonprofit organization devoted to health, education and community development on the South Side of Chicago, where he lives. Thompson said that since 2016, four or five major drugstores have closed in his area, and new ones haven’t opened to fill in the gap.
“To lose that first pharmacy was really a shock to the system,” he said. Some people have lost relationships with trusted pharmacists, or a nearby place to buy groceries. He’s noticed that because of the closures, people are traveling farther to get to drugstores. “We’re driving out of our communities to pharmacies miles away.” During the Covid pandemic, Endelo organized transportation to get seniors to pharmacies for vaccinations, he said.
Thompson, who himself lives close to a pharmacy in the South Side, said there is now more pressure on remaining locations. There are “lines for seniors out the door for prescriptions… and it’s the result of people now all going to the same pharmacy,” he said.
As major chains close their doors, the number of independent pharmacies in the United States has stayed pretty steady over the past three years, according to data from the National Community Pharmacists Association, which represents the interests of independent pharmacists. But chain closures aren’t likely to lead to more business for independents, which face challenges apart from competition from national chains.
The negative impact of this trend is most pronounced for minority groups. A USC study co-authored by Guadamuz that was published in 2021 found that Black and Latino neighborhoods in 30 US cities had fewer pharmacies than White and diverse neighborhoods from 2007 to 2015.
“If you’re located in a low-income neighborhood, and effectively in a Black and Latinx neighborhood, having any pharmacy is less common. And having a pharmacy that meets your needs is much less common,” she said.
In some areas, pharmacies do more than just fill medications. They “play a crucial role in the community,” said Omolola Adepoju, a health services researcher and clinical associate professor at the University of Houston’s Tilman J. Fertitta Family College of Medicine. “You don’t need an appointment to talk to a pharmacist,” she added. Patients can just walk in to get medications, vaccinations and answers to their questions, making pharmacies an “integral access point for primary care services for many underserved communities.”
In theory, Amazon or mail-order services could fill in the gap, delivering prescriptions directly to patients. But online pharmacies can’t administer vaccines, and not every medication can be shipped.
Plus, some patients may not have access to the internet. Even if they do, they might not trust online providers, fearing that a medication may have been exposed to extreme heat or otherwise compromised during delivery.
In some sectors, chain closures can open the door for more competition from local businesses. But market conditions in the pharmacy sector make it unlikely that independent pharmacies will be able to thrive.
Drugstore economics
Drugstores like Rite Aid and others have suffered from increased competition from online pharmacies and big box stores like Walmart and Target, which also fill prescriptions.
But some say that the major challenge to pharmacies has come from pharmacy benefit managers, or PBMs, which work as middlemen between different parts of the healthcare business, including insurance providers, drug companies and retailers.
PBMs are “a very, very powerful entity,” said Douglas Hoey, CEO of the National Community Pharmacists Association. “They control drug pricing, they control prescription drug reimbursement,” he said, adding that the groups also negotiate rebates and charge administrative fees. PBMs originally started in the 1960s as insurance claims managers and have evolved over time to manage more parts of the health care business.
The costs of doing business through a PBM can squeeze margins and sometimes put pharmacies in the red, Hoey said. And the impact on independents has been outsized because a higher percentage of their business comes from prescription drugs compared to national chains, he added.
Pharmacy benefit managers argue that they help keep drug prices down by negotiating with drug makers.
In September, the House Committee on Oversight and Accountability held a hearing about benefits managers, listening to testimony from those saying that the groups are driving prices up. During the hearing, JC Scott, president and CEO of Pharmaceutical Care Management Association, the trade group representing PBMs, said that “health plan sponsors, including employers, voluntarily hire PCMA’s member organizations to secure savings and provide choice and specialized expertise on pharmacy benefit design, coverage, and delivery.” He added that PBMs work with insurers to “secure lower costs for prescription drugs and achieve better health outcomes.”
But elected officials are skeptical: Legislation has been introduced to curb the power of PBMs, which lawmakers say are making drugs more expensive for customers.
These dynamics mean that reduced competition in the space is unlikely to benefit independents, said Hoey. What it might do, he said, is burden already overloaded pharmacists with new customers.
“I think we’ll see more… unacceptable experiences at the pharmacy,” Hoey said.
Recently, pharmacy workers have been staging walkouts over working conditions they say put patients at risk. Some have said that a focus on vaccination puts them behind on filling prescriptions, creating a stressful environment for workers and negatively impacting patients who need medication.
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54 surgeries in 14 yrs of being on this planet
Posted on November 8, 2023 by Pharmaciststeve
Most of us in healthcare have heard of RARE DISEASES, often that refers to so few a pts have been diagnosed with, that no pharma can afford to do the research to discover a medication to treat the particular health issue. Often Congress will pass laws to give a pharma generous tax incentives to find a medication to treat and/or manage the RARE DISEASE.
Poor little Emmalyn has been cursed with having been diagnosed collectively with several different difficult to treat health issues.
Emmalyn has been accepted at a clinic in Arkansas that specializes in treating pts like her, but she needs to raise $55,000. American Pain and Disability Foundation helped raise the $2,500 DOWN PAYMENT and if she can manage to raise enough – total of $55,000. She will start treatment in this clinic early next year.
This clinic has pts come to it FROM ALL OVER THE WORLD. I am told that Emmalyn’s family has to raise this money because her health insurance is provided by the state of Arkansas and because of limited openings at the clinic and all the step therapy and prior authorizations requirements of her insurance, dovetailing the two together is nearly impossible.
https://www.acmcrn.org/emmalyn-freeze
Emmalyn’s story begins with a diagnosis of Chiari Malformation with syringomyelia in 2012 at the age of 3 after a Chiari Decompression surgery to help drain the two syringes, one in her thoracic and a smaller one in her cervical region. Unfortunately, the surgery wasn’t successful, and Emmalyn went onto suffer many surgeries and procedures. It started with chemical meningitis, then being diagnosed with occult tethered cord in 2013, which led to the first of four detethering surgeries.
Emmalyn continued to suffer from headaches and leg pain for the next two years, which brought the third and final decompression surgery. Her thoracic syrinx had grown bigger, and they hoped to reduce its size. Her third decompression surgery happened in Nov of 2015. The decompression surgery seemed to have gone fine until December of 2015 when her grandma discovered a large bump on the back of her head that was squishy. She was diagnosed with a pseudomeningocele and that’s when things really went downhill due to the damage to her dura (lining of the spinal cord) which unleashed a series of devastating events.
Since Emmalyn’s original surgery in July of 2012, she has since endured three Chiari Decompression surgeries, a plate in her head to treat the Craniocervical Instability (CCI) brought on by a botched Chiari Decompression surgery, spinal fusion surgery throughout her cervical region, spinal fusion hardware removal, numerous infections, shunts, 6 CT Myelograms, 1 Cisternogram, several lumbar punctures, numerous MRI’s, blood patches, a fibrin patch, ICP bolts, anti-siphoning devices, EVD drains, numerous spinal fluid leaks from the back of her head to her lumbar, and because of her diagnosis of Ehlers Danlos Syndrome dural patches with muscle flaps and harvesting her own tissue, and this isn’t a complete list of all the procedures she has gone through.
Here’s Emmalyn’s story as told by her mother, Stephanie Freeze:
Currently, Emmalyn has four shunts installed and continues to have serious spinal pressure issues and serious side effects from the massive scar tissue in her spine. Emmalyn deals with 10/10 lower back pain, 10/10 back of the head pain every day of her life at the age of 13 and does not have full use of her left leg due to a tremor that developed and has to walk with a cane.
If all of this wasn’t enough, Emmalyn was diagnosed on November 15th, 2021, with Adhesive Arachnoiditis by an astute neurosurgeon in Rhode Island. The neurosurgeon let us know that she has serious cauda tethering with a syrinx present and massive scarring. She also has an arachnoid cyst in her lumbar area and also explained that the terrible tremor she has in her left leg, which requires her to use a cane, is most likely due to AA.
In June of 2022, her main neurosurgeon, made the decision that Emmalyn needed to undergo one more CT myelogram as leak symptoms were still on the rise. When the Myelogram was performed, they let us know there is an empty sac appearance to the distal thecal sac likely due to adhesions of the nerve roots. At this point the decisions were made that nothing should be done in the lumbar area unless absolutely necessary and that is when I started my research on Adhesive Arachnoiditis. When researching I realized how much had been done to Emmalyn’s spine that could have been avoided. I joined all the groups on Facebook and met wonderful people, including ACMCRN.org, that have been able to guide me through what this grueling and terrifying disorder that my 13-year-old daughter is facing.
I got in touch with the Tennant Foundation and started reading all the bulletins. I reached out to Dr. Tennant to see what his thoughts were, and he put me in touch with a doctor that could try and help Emmalyn. We have started medications to help her and have found out that she has intestinal malabsorption with opioids and that is why the meds were not helping her pain. The doctor put Emmalyn on Troque’s for medications so that they would help. We had MRI’s 2 months after being on the meds. The pain hasn’t really improved yet, but on the MRI’s the adhesions are improving and headed in the right direction that gives me hope.
Emmalyn has been through 51 brain and spine surgeries in her life. More than any person should have to go through and unfortunately is not doing well at this point. Our next steps are driving to California from Illinois on February 4th to see Dr. Schievink. We have to drive as Emmalyn cannot take the 5-hour flight, as it causes her too much pain. She will undergo a MR Myelogram of the full spine and MRI of the brain with and without contrast and seeing Dr. Schievink the same day on February 9th. We believe Emmalyn has another leak or too many CSF diversions as she currently has 4 shunts. We absolutely have to get these pressure problems under control, and I believe things will head in the right direction.
I have come to terms that my daughter has so many disorders that don’t have a cure and have met so many fighting this same battle. I advocate to other parents to please research, get all your questions asked and get many opinions. I am including Emmalyn’s published story, which she has endured 11 more surgeries since I wrote that story, and I am currently working to bring her story up to date. I am always here for anyone that has questions or may need to talk as this road is too long and hard to do alone.
Please read more of her story: The Emmalyn Freeze Story – A Chiari Warrior’s Journey (Updated) – Chiari Bridges.
Like many patients and parents of rare disease patients, Emmalyn and her family have traveled tens of thousands of miles in order to get answers and treatments for Emmalyn. They have flown on planes, which Emmalyn is no longer able to do, so now they drive in a car. They have had to incur the costs of hotels, food and drink, gas, and other incidentals. The cost of this is overwhelming for their family and they have had to rely on the generosity of friends and family. Would you consider giving a donation to the Sweet Emmalyn GoFundMe. Gift Cards can be sent to sfreeze02@gmail.com, along with any questions or comments you might have. The family does accept money orders and cashier checks.
Update to Emmalyn’s Story:
In the beginning of 2023, Emmalyn’s leg pain escalated, prompting Stephanie to seek solutions. She journeyed from Chicago to California for a specialized MRI and consultation with Dr. Tennant, an adhesive arachnoiditis specialist. The MRI unveiled a sizable growth in Emmalyn’s cyst, necessitating fenestration. This discovery led to another trip, this time to Durham, embarked upon on March 5th. On March 9, 2023, Emmalyn underwent a marathon 6-hour surgery. The procedure aimed to fenestrate the cyst, secure a shunt, and detether her lumbar spinal cord to alleviate leg pain. While it did alleviate lower back pain, the persisting symptoms included positional headaches and vomiting.
An infection on April 6th extended their stay, and although Emmalyn was discharged on April 11th, they didn’t return home until April 13th, amounting to a total of 37 days away. What was initially planned as a two-week endeavor was significantly prolonged due to circumstances.
Emmalyn’s health struggles persisted into April, prompting a return to Durham on April 22nd to consult her hematologist, followed by another trip on April 30th. Regrettably, her head pain endured. This led to a further trip to Durham on May 14th, as Hematology necessitated an additional appointment and referred her to Immunology. Neurosurgery aimed to address her severe head and neck pain.
An update on May 22nd from Emmalyn’s mom, Stephanie, indicated the need to reset Emmalyn’s shunt due to worsening pain. After weeks of unsuccessful attempts to adjust the shunt correctly, Dr. Grant sought consultation with the shunt manufacturers for a solution. Further trips were planned to Rhode Island and North Carolina for EDS pain management and comprehensive MRI scans of the brain and spine.
Despite their tireless efforts, Emmalyn’s condition did not improve. Dr. Grant’s consultations led to a high-stakes decision for a risky surgery on June 13th, with the goal of addressing tethering and cerebrospinal fluid blockage. This intricate procedure lasted around six hours. Complications necessitated an extended stay in North Carolina, beyond their initial expectations.
On August 10th, another procedure, a lumbar puncture, was conducted in a bid to uncover the cause of Emmalyn’s persistent head pain. Unfortunately, this procedure did not yield the desired results, prompting a MR Myelogram that revealed a significant spinal fluid leak. Surgical options are being investigated now.
Emmalyn’s relentless journey weighed heavily on her family, burdened by copays, medical bills, lodging, and travel costs. Throughout these trials, their spirits remained resilient as they yearned for Emmalyn’s recovery and her eventual return home, a goal they fervently hoped to achieve by the end of August.
If you find yourself moved by Emmalyn’s courageous battle and her family’s unwavering determination, consider sharing her story. Spreading awareness not only shines a light on the challenges faced by rare disease patients like Emmalyn but also offers a ray of hope in garnering support, both emotional and financial, during this challenging period. Your willingness to share her journey could make a meaningful difference and provide the essential aid that Emmalyn and her family need
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the “unholy alliance” between Vertex Pharmaceuticals, US Pain Foundation and lawmakers
Posted on November 7, 2023 by Pharmaciststeve
This video is about the “unholy alliance” between Vertex Pharmaceuticals, US Pain Foundation and lawmakers; how they work together within the public, private – partnerships to create an illusion for the public in an effort to gain support. It is reminiscent of a theater act. In this video, I will show what happened behind the scenes, outside the public purview, examining all the strings that were pulled years before resulting in the changes in the healthcare system we are seeing today.
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