Congress Hearing Explores Medicare Advantage Routines That Deny, Delay Needed Care

Maybe this is why they are starting to refer to this as Medicare-C – because there is no advantages

Congress Hearing Explores Medicare Advantage Routines That Deny, Delay Needed Care

https://www.medpagetoday.com/publichealthpolicy/medicare/104569

 

A screenshot of Richard Blumenthal speaking during this hearing.

WASHINGTON — A 79-year-old man with prostate cancer needed a PET scan, but his Medicare Advantage (MA) plan refused to pay for it. Another MA plan denied approval for a wheelchair for a patient with multiple sclerosis and a tibia fracture. Still another enrollee recovering from a stroke found he was ineligible for coverage for physical therapy.

The neurosurgeon treating a fourth patient, the late University of Connecticut physics professor and melanoma patient Gary Bent, PhD, referred him for acute rehab after removing a lesion from his brain. But Bent’s MA plan intermediary refused, putting him and his wife, Gloria, through a lengthy ordeal They were told he “couldn’t withstand intense therapy,” she said.

He was eventually admitted to a skilled nursing facility, but was discharged from there after about 5 weeks because his MA plan discontinued payment, even though it turned out he had bacterial meningitis, she said.

Those were among many examples of how MA plans have routinely denied coverage for medical services — despite their doctors’ orders and despite Medicare policy that they should be covered — presented Wednesday during a hearing of the Senate Homeland Security and Governmental Affairs Permanent Subcommittee on Investigations.

Lawmakers have collected many examples in which MA plans are failing beneficiaries, “denying or delaying care,” said committee chair Sen. Richard Blumenthal (D-Conn.) at the start of the hearing. They “face denials in the middle of major medical crises, forcing them and their loved ones to fight even as they are fighting for their lives.”

Algorithms Decide

“Perhaps most troubling of all,” Blumenthal continued, “there is growing evidence that insurance companies are relying on algorithms rather than doctors or other clinicians to make decisions to deny patient care.”

Sen. Roger Marshall, MD (R-Kan.), an ob/gyn, listed many examples of denials, including the examples above.

He said a huge culprit is prior authorization, in which MA companies — to avoid waste and reduce costs — require doctors to get many kinds of medical care pre-approved. A few years ago, an MA plan canceled Marshall’s patient’s next-day surgery because Marshall was required to talk with a plan representative first. Prior authorization has “become a tool to delay care — hoping the patient dies so they don’t have to give any more care, I guess.”

One focus during the hearing was on the MA plans’ frequency of incorrectly denying care. Of 35 million prior authorization requests submitted to MA plans in 2021, 6% or two million were denied, said Jean Fuglesten Biniek, PhD, associate director of Medicare policy for the Kaiser Family Foundation here. Of those, only 11% were appealed and when they were, 80% of the denials were overturned, suggesting that many denials should have been initially approved.

These denials burden providers’ staff resources and impose delays for enrollees “during a point in their lives when they’re potentially in very poor health,” she said.

Why such a low rate of appeals? Biniek was asked. “People may not know how to appeal; they may not believe they have a case to appeal. And people are often very ill … and if they don’t have a caregiver or somebody to assist them or access to legal services, going through that process can be difficult,” she replied.

A key problem with MA plans is their refusal to pay for skilled nursing facility stays or approve coverage for lengths of stays that doctors say their patients need, said Christine Huberty, an attorney with the Greater Wisconsin Agency on Aging Resources, which provides free legal services for seniors.

For a patient who has undergone hip replacement surgery in a hospital, for example, she said, “their doctor generally recommends several weeks in a skilled nursing facility until they’re ready to safely go home.”

In regular Medicare, that patient would be covered for up to 100 days of skilled nursing facility care after a 3-day hospitalization. But although MA plans are supposed to provide the same coverage, Huberty said, too often they don’t.

Dizzying Red Tape

Instead, a senior “can expect to receive a denial well before their doctor even says they’re ready to go home … they’re thrown into a maze of red tape that is dizzying, even to our experienced legal team,” fighting a denial that is made by “a third-party contractor using an algorithm,” Huberty said.

The length of that patient’s stay is determined by a computer based on millions of “past beneficiary data points, not the patient’s plan of care or the advice of their doctors,” she continued. If the patient chooses to fight, denials at each level are upheld by a quality improvement organization, often with little to no explanation, she said.

Megan Tinker, chief of staff of the Office of Inspector General (OIG) for the Department of Health and Human Services (HHS), noted that Medicare pays MA plans a capitated rate per beneficiary, and thus have “a potential incentive” to deny access to services they should cover.

For example, she said, a plan denied payment for a computed tomography scan, medically necessary to rule out a life-threatening aneurysm, referencing a rule that beneficiaries are supposed to first get a less-expensive x-ray. “But Medicare has no such requirement,” Tinker said.

Prior authorization is being used to deny care that, in 13% of the cases investigated, traditional Medicare would have paid, Tinker told lawmakers. “Plans make more money by providing fewer services.”

Although OIG has reported on this problem, its oversight abilities are limited by resources. The agency receives 2¢ to oversee every $100 HHS spends, and each year turns down between 300 and 400 “viable criminal and civil healthcare fraud cases,” leading to the “potential for patients to be put in harm’s way, including individuals enrolled in Medicare Advantage,” Tinker said.

They Didn’t Choose

It’s not as if the cost savings that MA plans were designed to achieve are happening, Biniek said. In its report, the Medicare Payment Advisory Commission projectedopens in a new tab or window that in 2023, the trust fund will pay $27 billion more for MA enrollees, or 6% more, than similar patients with traditional Medicare.

One witness at the hearing, Lisa Grabert, MPH, a visiting research professor at Marquette University’s College of Nursing in Milwaukee and a former staff member of the House Ways & Means Committee, praised MA plans, saying that both of her parents are enrolled in them.

She said beneficiaries are choosing MA plans for their comprehensive benefit packages and “improved financial protections” and “choice simplicity,” and that beneficiaries are willing to accept the trade-offopens in a new tab or window of using a provider network with some utilization review requirements such as prior authorization.

“It is our expectation that a Medicare beneficiary has a basic understanding of this when they elect their choice of coverage,” she said. “However, it may not be clear to beneficiaries what they are agreeing to when it comes to prior authorization.”

Later in the hearing, Blumenthal referenced Bent’s case, and whether he had an informed choice to buy an MA plan.

“Actually,” his widow replied, “Gary was a retired state employee whose benefits were determined by the Office of the State Comptroller … Someone else made the decision for us that we would be on Medicare Advantage.” Her husband died in March after developing an infection.

Blumenthal summarized as he adjourned the hearing: MA plans’ denials and delays of care “deeply impact people, impoverishes them financially but also spiritually when they have to be on the battlefield at the same time their loved ones are fighting for their lives,” he said.

“The fact of the matter is [an MA plan] works until you need it,” he said. “It’s fine, so long as you don’t need it for the big stuff, like melanoma, like long term care, like certain kinds of injections, and other needs that everyday Americans have.”

How Congress should fix the problem remains unclear. But, Blumenthal said, “This investigation will continue. There’s a lot here that needs to be known.”

21st century testing to help chronic pain pts justify needing higher doses

If you are reading this, YOU NEED TO SHARE THIS – not just LIKE IT… unless you feel that there is no one in your circle of family & friends who are dealing with chronic health issues, that could possibly benefit & enjoy improving their QOL. If you are a intractable chronic pain pt, this could give your prescriber HARD JUSTIFICATION why you need a higher dose.

For years, those who follow and read my blog… Have heard me routinely talk about pharmacogenomics (PGx). “back in the day”, I was a hard-charging, card carrying, type-A workaholic.  Now in my 8th decade on this earth, those words no longer really applies to me. I could not, in good conscience , pull back from supporting those in  the chronic pain community, to try and get up to speed with PGx. So I started looking around to find a Pharmacist that has this PGx stuff down pat. Must have been my GOOD KARMA day. I found Cari A. Lalande, PharmD, RPh
Owner | Clinical Genetic Pharmacist.

FULL DISCLOSURE: I won’t get the first penny for being a conduit in connecting Cari, with someone in the community who wants to see if PGx/NGx could help improve their overall health/QOL.  This is Cari’s professional business/practice, and she does charge for her services and will bill insurance, if it is covered. I think that it would be best, if any/all pts asked their practitioner if they will use/believe in PGx testing. There are some practitioners that are still working with 20th century knowledge and skill sets.

Last, but not least, Cari has agreed to become a contributor to my blog. Sharing stories about pts she has helped using PGx & NGx and the positive QOL outcomes she has been able to accomplished for these pts.

Health By Genetics™ is a unique pharmacist owned genetic lab designed to conduct comprehensive pharmacogenomic (PGx), nutrigenomic (NGx) molecular testing. Our wholistic approach to patient-centered care empowers individuals to live life abundantly, on their terms.

Utilizing genetics as the basis, we work with both the patient and their providers to determine the best medication choice for each thereby reducing the occurrence of side effects, polypharmacy, and increase awareness of better lifestyle choices. 

Our goal is to solve for challenges most patients face when multiple providers are involved in prescribing various

medications without communicating with each other thereby increasing the risk of adverse side effects and related events.

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Click here to schedule a meeting: https://calendly.com/health-by-genetics

Nutrigenomics is a field of study that investigates the relationship between nutrition and an individual’s genes. It explores how genetic variations influence the body’s response to different nutrients and how diet can affect gene expression and function.

The core concept behind nutrigenomics is that each person’s genetic makeup influences how they process and metabolize nutrients from the food they consume. Genetic variations can affect the absorption, metabolism, and utilization of specific nutrients, as well as impact an individual’s susceptibility to certain diseases or conditions.

By studying the interactions between genes and nutrients, nutrigenomics aims to understand how personalized nutrition can optimize health, prevent disease, and improve overall well-being. This field combines principles from genomics, molecular biology, biochemistry, and nutrition to provide insights into the intricate relationship between diet and genetics.

Nutrigenomics research involves analyzing an individual’s genetic profile to identify specific genetic variations related to nutrient metabolism. This information can then be used to tailor personalized dietary recommendations and interventions. For example, certain individuals may have genetic variations that affect their ability to metabolize certain vitamins or minerals efficiently. Understanding these genetic variations can help in designing dietary plans that compensate for these limitations and promote optimal nutrient utilization.

Overall, nutrigenomics offers the potential for more precise and personalized dietary recommendations based on an individual’s genetic profile. However, it’s important to note that this field is still evolving, and more research is needed to fully understand the complex interactions between genetics and nutrition.


Pharmacogenomics is a field of study that combines pharmacology (the study of how drugs work) and genomics (the study of an individual’s genes and their functions) to understand how genetic variations influence an individual’s response to medications. It examines the relationship between an individual’s genetic makeup and their response to specific drugs, including how they metabolize, process, and respond to medications.

Pharmacogenomics aims to develop personalized medicine approaches by using genetic information to guide drug therapy decisions. By understanding how genetic variations can affect drug response, healthcare providers can tailor medication choices and dosages to individual patients, maximizing efficacy and minimizing adverse reactions.

Genetic variations can influence drug efficacy, safety, and tolerability. Certain genetic variants can affect how quickly a drug is metabolized in the body, leading to differences in drug levels and potentially impacting its effectiveness or causing adverse effects. Additionally, variations in genes involved in drug targets or drug transporters can affect how a person responds to a particular medication.

Pharmacogenomic testing involves analyzing an individual’s genetic information to identify specific genetic variations that may impact drug response. This information can help guide treatment decisions, such as selecting the most appropriate medication or adjusting the dosage to optimize therapeutic outcomes.

Overall, pharmacogenomics holds great promise for improving the safety and effectiveness of drug therapy by tailoring treatments to an individual’s genetic profile, leading to more personalized and precise healthcare.


A holistic approach to patient-centered care is a comprehensive approach that considers the physical, emotional, mental, social, and spiritual aspects of an individual’s well-being. It recognizes that each person is a unique and complex whole, and aims to address their health needs in a way that empowers them to live a fulfilling and abundant life.

In a holistic approach, healthcare providers not only focus on treating the symptoms or diseases but also strive to understand the underlying causes and factors that contribute to a person’s health. They take into account the individual’s lifestyle, environment, relationships, and personal beliefs when developing a care plan.

Empowerment is a key aspect of holistic patient-centered care. It involves actively involving the patient in their own healthcare decisions and treatment options, respecting their autonomy and preferences. Healthcare providers encourage patients to take responsibility for their health and well-being, providing them with education and tools to make informed choices and actively participate in their care.

This approach recognizes that health is not merely the absence of disease but a state of overall well-being. It promotes the concept of abundance by focusing on enhancing the quality of life and promoting wellness in all areas of a person’s life. It seeks to promote balance and harmony in physical, emotional, and spiritual dimensions, aiming for optimal health and vitality.

Overall, a holistic approach to patient-centered care values the whole person, recognizes their unique needs and preferences, and empowers them to actively participate in their healthcare journey. It aims to foster well-being, self-care, and a sense of abundance in individuals’ lives.

 

chuckle of the day 05/19/2023

May be a meme of newspaper, magazine and text

New chronic pain cases occur more frequently than other conditions, and often persist

Chronic Pain Incidence Is High in the U.S.

https://www.medpagetoday.com/neurology/painmanagement/104558

New cases of chronic pain — defined as pain experienced on most days or every day over 3 months — occurred more frequently than new cases of other common chronic conditions, U.S. survey data showed.

Chronic pain incidence was 52.4 cases per 1,000 person-years, reported Richard Nahin, MPH, PhD, of the NIH in Bethesda, Maryland, and co-authors.

This was higher than the incidence of diabetes (7.1 cases/1,000 person-years), depression (15.9 cases), and hypertension (45.3 cases), the researchers said in JAMA Network Openopens in a new tab or window.

Moreover, chronic pain was persistent: nearly two-thirds (61.4%) of adults with chronic pain in 2019 continued to have it in 2020.

The findings come from National Health Interview Survey (NHISopens in a new tab or window) data and are the first nationwide estimates of chronic pain incidence.

Recent NHIS data showed the prevalence of chronic painopens in a new tab or window in the U.S. was about 21%, affecting an estimated 51.6 million adults. High-impact chronic pain — pain severe enough to restrict daily activities — affected 17.1 million people.

“Understanding incidence, beyond overall prevalence, is critical to understanding how chronic pain manifests and evolves over time,” Nahin said in a statement. “These data on pain progression stress the need for increased use of multimodal, multidisciplinary interventions able to change the course of pain and improve outcomes for people.”

The NHIS is a cross-sectional poll conducted annually by the National Center for Health Statistics. Nahin and co-authors evaluated 10,415 adults who participated in both the 2019 and 2020 surveys. Participants with chronic pain during both periods were considered to have persistent chronic pain.

The sample included 51.7% women. More than half of the study population — 54% — were ages 18 to 49. Most participants (72.6%) were white; 16.5% were Hispanic and 12.2% were Black. Most (70.5%) were not college graduates.

At baseline (2019), 40.3% of participants reported no pain, 38.9% reported non-chronic pain, and 20.8% reported chronic pain.

Of those without pain in 2019, the rate of incident chronic pain was 52.4/1,000 cases (95% CI 44.9-59.9). The rate of incident high-impact chronic pain was 12.0 (95% CI 8.2-15.8). Lower educational attainment and older age were associated with higher rates of chronic pain in 2020, regardless of pain status in 2019.

In 2020, rates of persistent chronic pain and persistent high-impact chronic pain were 462.0 and 361.2 cases per 1,000 person-years, respectively.

Of those reporting non-chronic pain in 2019, 14.9% had progressed to chronic pain at follow-up. Of those reporting chronic pain in 2019, 10.4% had fully recovered (were pain-free) in 2020.

“Although chronic pain is sometimes assumed to persist indefinitely, our finding that 10.4% of adults with chronic pain experienced improvement over time is consistent with previous evidence from studies in Denmark, Norway, Sweden, and the U.K., which revealed rates ranging from 5.4% to 8.7%,” the researchers noted.

The study did not include information about the underlying causes of pain and survey data were collected only twice across 2 years of follow-up, Nahin and co-authors acknowledged. It’s possible that people experiencing new or persistent chronic pain or high-impact chronic pain were less likely to participate in the 2020 follow-up survey, which may have led to rates being underestimated.

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Dr. Jay K Joshi: Open Letter to DEA Administrator Milgram

Open Letter to DEA Administrator Milgram

Directly oversee the investigation of your DEA agents

https://www.daily-remedy.com/open-letter-to-dea-administrator-milgram/

Dear Administrator Anne Milgram,

I hope this letter finds you well.

I request you to oversee the investigation into the misconduct of DEA agents in my case. I initially filed a complaint with the Office of Inspector General which has been transferred to the Drug Enforcement Agency Office of Professional Responsibility.

The DEA has shown a lack of willingness and an inability to uphold it standards of conduct. Oversight agencies have consistently shown repeated incidents of misconduct by DEA agents, with only a few receiving much, if any, accountability.

I understand you are trying to reform the DEA and to enact much-needed reform. I thank you for listening to the public and for delaying the implementation of restrictive telehealth policies. Now I ask you to review the misconduct by DEA agents who targeted me in 2017 and manipulated evidence in my case that led to an indictment in 2018.

These agents solicited perjured statements from former employees who were forging prescriptions using my DEA license. They materially altered evidence in my case, including falsifying a police report and submitting an affidavit with false claims that were known to be untrue at the time of submission.

How they did this was quite clever. They would tamper with evidence and then obtain perjured statements to corroborate the tampering. Let me provide an example. Look at the police report I filed against the employee who was forging scripts under my name. You will see the report claims I reported her brother for threatening me, but somehow did not report her forgeries. How could I report one but not the other? Her brother threatened me because I planned to report her to the police.

This fraud was then complemented by perjured statements taken during the grand jury testimony. The same employee was asked by federal prosecutors whether she had forged scripts under my name – to which that employee answered no with no pushback from either DEA agents or federal prosecutors. This is all the more curious, since both DEA agents and federal prosecutors had many forged prescriptions in their hand.

The misconduct is easy to discern when you parse through the evidence in this way. But it makes the efforts to distort evidence in this case all the more concerning. And it’s precisely why you must directly intervene in this investigation.

I have written a book that details the misconduct by the DEA in this case. I also compiled all legal documents in this case and plan to share them with investigative journalists and criminal justice reform organizations. These efforts are intended to raise awareness of the misconduct in my case. I plan to involve all interested parties in the review of DEA misconduct. Thank you in advance for your time and effort.

 

Respectfully,

Dr. Jay K Joshi

After all the problems with SCS:FDA OKs SCS Devices for Chronic Back Pain

FDA OKs Spinal Cord Stimulation Devices for Chronic Back Pain

https://www.medscape.com/viewarticle/992053

The US Food and Drug Administration (FDA) has expanded the indication for Abbott Laboratories’ spinal cord stimulation (SCS) devices to include treatment of chronic back pain in patients who have not had, or are not eligible for, back surgery, the company has announced.

The new indication spans all of Abbott’s SCS devices in the US, which include the recharge-free Proclaim SCS family and the rechargeable Eterna SCS platform.

The devices feature the company’s proprietary, low-energy BurstDR stimulation waveform, a form of stimulation therapy that uses bursts of mild electrical energy without causing an abnormal tingling sensation to help disrupt pain signals before they can reach the brain, the company explains.

The expanded indication was supported by results from the DISTINCT study, which enrolled 270 adults suffering from severe, disabling chronic back pain for an average of more than 12 years and who were not eligible for surgery.

The study showed that significantly more patients who were treated with SCS achieved significant improvements in back pain, function, quality of life, and psychological status than peers treated with conservative medical management.
“To date, we have struggled with how to treat people who weren’t considered a good surgical candidate because we didn’t have clear, data-driven treatment options for non-surgical back pain,” Timothy Deer, MD, president and CEO of the Spine and Nerve Centers of the Virginias in Charleston, West Virginia, said in a news release.

“This new indication for Abbott’s SCS devices, together with BurstDR stimulation, allows physicians the ability to identify and treat a new group of people, providing them with relief from chronic back pain,” Deer adds.

CVS closes $10.6B acquisition of Oak Street Health to expand primary care footprint

CVS Health is expanding its vertical integration into providing healthcare. Besides the nearly 10,000 community pharmacies, they have specialty pharmacies, mail order pharmacies, Aetna insurance, the PBM Caremark, Silver Scripts Medicare Part D now part of Aetna and a Medicare -C (Advantage) prgms, and in many of their community pharmacies they have MINUTE CLINICS and this acquisition  of was < 60 days since acquiring  CVS closed $8B deal for health services company Signify Health

Those pts who have their medical care provided by CVS Health are pretty familiar with the restricted networks that entities like CVS force pts to use. It is much like when a fish bites down on a “baited hook” …  there is no getting off the hook.

CVS closes $10.6B acquisition of Oak Street Health to expand primary care footprint

https://www.fiercehealthcare.com/providers/cvs-closes-106b-acquisition-oak-street-health-expand-primary-care-footprint

front of Oak Street Health clinic in Philadelphia

CVS Health has sealed the deal on its acquisition of Oak Street Health, picking up about 169 medical centers in 21 states.

The acquisition will broaden CVS Health’s value-based primary care platform and significantly benefit patients’ long-term health by improving outcomes and reducing costs – particularly for those in underserved communities, according to the company in a press release Tuesday.

The acquisition cleared a major regulatory hurdle back in late March when the Department of Justice and the Federal Trade Commission allowed the antitrust waiting period to run out on without taking action to halt the deal. Sen. Elizabeth Warren, D-Massachusetts, had urged the FTC to take a closer look at the deal and challenge any M&A activity in healthcare that could lead to higher prices, less competition and lower care quality.

The retail pharmacy giant announced the deal on February 8 as an all-cash transaction for $39 per share, representing an enterprise value of approximately $10.6 billion. The company financed the transaction with borrowings of $5.0 billion from a term loan agreement entered into on May 1, 2023 and existing cash and available resources.

Oak Street Health will continue to operate as a multipayer primary care provider as part of CVS Health.

Oak Street CEO Mike Pykosz will continue to lead the Medicare-focused primary care company when the deal closes, CVS said, and the provider would be folded into its newly created healthcare delivery arm.

Closing the Oak Street deal follows closely on the heels of CVS finalizing its $8 billion acquisition of home health and technology company Signify Health.

 

 

 

 

 

Homeless vets are being booted from NY hotels to make room for migrants: advocates

https://nypost.com/2023/05/12/homeless-vets-are-being-booted-from-ny-hotels-to-make-room-for-migrants-advocates/amp/

Nearly two dozen struggling homeless veterans have been booted from upstate hotels to make room for migrants, says a nonprofit group that works with the vets.

The ex-military — including a 24-year-old man in desperate need of help after serving in Afghanistan — were told by the hotels at the beginning of the week that their temporary housing was getting pulled out from under them at the establishments and that they’d have to move on to another spot, according to the group and a sickened local pol.

“Our veterans have been placed in another hotel due to what’s going on with the immigrants,’’ said Sharon Toney-Finch, the CEO of the Yerik Israel Toney Foundation.

Toney-Finch, a disabled military veteran, created YIT to raise awareness of premature births, as well as helping the homeless and low-income military service veterans in need of living assistance.

“One of the vets called me on Sunday,’’ she said.

“He told me he had to leave because the hotel said the extended stay is not available. Then I got another call.

“We didn’t waste any time,’’ the advocate said.

“That’s when we started on Monday to organize when and where to move them all.

“I am glad you called me today,’’ she told The Post.

“Last night, I was crying.”

Toney-Finch said 15 of the veterans got the heave-ho from the Crossroads Hotel in Newburgh about 60 miles north of New York City in Orange County — a new epicenter of Big Apple’s migrant crisis since Mayor Eric Adams began bussing Gotham’s overflow there against local officials’ wishes.

The other five displaced veterans were split between two other local facilities — the Super 8 and Hampton Inn & Suites in Middletown, Toney-Finch said.

The Middletown hotels are not believed to have migrants yet but were reportedly on the city’s shortlist to take some.

She said the hotels didn’t explicitly say the vets had to move because of the migrants but that it was clear to her that was the case, given the timing.

All 20 of the booted veterans have ended up at a Hudson Valley hotel about 20 minutes away, said Toney-Finch, who asked that The Post not name the site.

The Crossroads, Super 8 and the hotel where the vets are now staying had no comment when contacted by The Post on Friday.

Hampton Inn did not immediately respond to a message left on voicemail.

Toney-Finch said the veterans had originally been set to temporarily stay at the three hotels for up to four weeks, till permanent housing for them could be found.

The vets were about two weeks into their hotel stays when they got the boot, she said.

“Now we have to work from ground zero. We just lost that trust [with the vets],” the organizer said.

“A lot of them are Vietnam veterans. We do help them on a constant basis to get them benefits and help them find a place in society.”

State Assemblyman Brian Maher, a Republican who helps rep Orange County, said, “Shining a light on this is important because we need to make sure these hotels know how important it is to respect the service of our veterans before they kick [them] out of hotels to make room.”

“They really ought to think about the impact on these people already going through a traumatic time,’’ he told The Post.

“Whether you agree with asylum-seekers being here or not, we can’t just ignore these veterans that are in our charge that we are supposed to protect: the New Yorkers and Americans.”

“We need to put them first.”

Toney-Finch said she believes it all comes down to money.

“They want to get paid’’ more, she said of the hotels, referring to what her group shells out to get the vets housing compared to what the city is paying for each migrant.

“That’s so unfair, because at the end of the day, we are a small nonprofit, and we do pay $88 a day for a veteran to be there,” she said.

While it’s unclear what the city is paying upstate, various reported deals between the Big Apple and Manhattan hotels have called for payments such as $190 a night — part of an estimated $4.3 billion migrant price tag for taxpayers through spring 2024.

Adams began bussing migrants flooding the city to The Crossroads on Thursday — hours before a key federal immigration-rule change was set to take effect and feared to increase the influx even more.

Hizzoner’s move spurred a vicious war of words between Adams and officials in Orange and neighboring Rockland County, where the mayor also has threatened to bus migrants — till a lawsuit at least temporarily blocked the move.

Maher said it’s outrageous that veterans are getting caught in the crossfire of the migrant crisis.

“For these people only being there a few weeks, then to be told after having a level of trust developed, ‘Hey, you have to get out,’ That’s not right,’’ he said.

“One thing I’m doing today is my staff and I are putting together care packages to let them know: ‘Listen, we are embarrassed by this.’

“We put a bunch of things in the care package as well as cards for the veterans to say, ‘Thank you.’ ”

And does anyone wonder why our military is having trouble meeting their recruitment goals ?

FDA Mulling Trial Design Issues for Long-Term Opioids in Chronic Pain

 

 

 

 

 

 

The perceived prevalence of OIH in clinical practice is a relatively rare phenomenon

Opioid Induced Hyperalgesia—Exploring Myth and Reality

FDA Mulling Trial Design Issues for Long-Term Opioids in Chronic Pain

https://www.medpagetoday.com/painmanagement/opioids/104064

To evaluate the long-term efficacy and tolerability of a representative extended-release (ER)/long-acting (LA) opioid in a 12-month placebo-controlled trial, FDA staff are considering an enriched enrollment randomized withdrawal (EERW) study design, they noted in a briefing documentopens in a new tab or window ahead of an advisory committee meeting.

On Wednesdayopens in a new tab or window, the Anesthetic and Analgesic Drug Products Advisory Committee will consider the advantages and limitations of using an EERW design to evaluate morphine sulfate ER in a phase IV trial — part of a postmarketing requirement — among patients with chronic non-cancer pain who had initial tolerability to the ER opioid.

The committee will also discuss looking at the incidence of opioid-induced hyperalgesia (OIH), a condition in which a patient’s increase in pain can be attributed to the treatment with an opioid, among other objectives, such as changes in physical function and in levels of anxiety and depression.

FDA staff said the EERW study protocol might be the best available design amid the many challenges of conducting placebo-controlled clinical trials for chronic pain over an extended time period.

“Due to the unique clinical considerations regarding patients with chronic pain appropriate for long-term opioid therapy, the design of the clinical trials intended to evaluate the treatment effect of analgesics in this patient population poses certain challenges,” they wrote. “There are different options with respect to clinical trial designs, each with their own advantages and disadvantages.”

“There are also challenges in selecting appropriate patients, controls, and endpoints, as well as to retain enough patients to generate interpretable data,” they added.

To address these concerns, FDA staff wrote that the EERW design “varies from the conventional clinical trial design in the timing of randomization and dichotomization to two treatment groups, opioid or placebo,” noting that this design uses “a long prerandomization period and a relatively short period where patients will be on double-blind drug.”

“The EERW design, while not ideal, appears to offer the best compromise to answer this public health question,” they wrote.

In addition, the EERW study design “may inform the incidence of OIH provided that the protocol includes appropriate OIH surveillance and a prospective definition of OIH,” they added.

The advisory committee will also be asked to discuss the likelihood of maintaining a sufficient number of study participants using the study design, specifically considering the acceptable degree of dropout related to its effects on the interpretation of outcomes.

FDA staff noted that dropout during a 12-month trial could be the most challenging aspect of evaluating the long-term efficacy of opioids. “Our prior experience suggests a substantial dropout rate even over the 12 weeks of prior randomized trials (in the 40-50% range), and therefore raises the real concern that a dropout rate in a 52-week duration trial would be higher, undermining the robustness of the between-group comparison at the trial primary timepoint,” they wrote.

Other factors, such as the adequacy of the length of the study (38 to 52 weeks) and secondary endpoints, including time-to-treatment failure, pain scores, and a proposed tapering scheme to mitigate concerns over unblinding the participants, will also be discussed.

Finally, the advisory committee will be asked to consider other potential study designs that could be used in the assessment of long-term use of opioids.

“With respect to the parallel-group, placebo-controlled randomized controlled study, this approach poses the challenges of recruiting patients into a long duration placebo-controlled study — in patients who have severe pain intensity having failed other treatments,” FDA staff wrote. “The prior study included a long-term placebo-controlled period and failed due to recruitment issues.”

After the original postmarketing requirement was issued in 2013, the Opioid Postmarketing Requirements Consortium (OPC) started a 26-week study in patients with high opioid requirements in 2016, but decided to end the study in 2018 due to several factors, including challenges with patients and changes to opioid prescribing requirements. The OPC submitted an updated protocol for a 52-week trial in January 2020. With guidance from FDA staff, the EERW protocol was refined and submitted for consideration.

Last week, the FDA issued several updatesopens in a new tab or window to the prescribing information and labeling for immediate-release (IR) and ER/LA opioids that will make the increased risk of overdose with increased doses more clear. The changes will also highlight the risk of OIH.

While the FDA typically follows the advice of its advisory committees, isn’t required to do so.