What is it with bureaucrats, they seem to like to “play games” with people’s lives.  Congress screws around with passing annual budgets and this year.. LAST MINUTE that passed a 45 day continued resolution to post pone the job that they knew was due since everyone claim to office. There was the threat of many of the 2 million people who work for the Fed bureaucracy – would not get paid – but just like all the other times that Congress did this.. they could come around after the “financial crisis” was over and pay all the employees the paid that they were due, and got nothing more/less than a extra paid vacation.

Now here we are again with the DEA playing with pt’s quality of life issues and just putting ANOTHER BANDAID on the issue. Practitioners and staff can’t budget long term, pts never knows when the DEA is going to take some sort of action and turn their Quality of Life issues upside down.

Here is a blog post from the first of 2023 the DEA told Newsweek it’s not responsible for pts inability to get prescriptions

I don’t know what is worse, the DEA can say that with a straight face -or – the media believes such statements as FACT !!

DEA again extends telemedicine flexibilities

https://www.cnn.com/2023/10/10/health/dea-extends-controlled-medication-telehealth-flexibilities-wellness/index.html

With a November cutoff looming, the United States Drug Enforcement Administration has for a second time extended temporary rules allowing prescription of controlled medications via telehealth.

These rules, established during the Covid-19 pandemic, are an exception to the conditions of a law known as the Ryan Haight Act, which require at least one in-person medical examination before a doctor can prescribe a controlled medicine, including stimulant medications for attention-deficit hyperactivity disorder, benzodiazepines for anxiety, and drugs for opioid use disorder, sleep or pain, said Dr. Shabana Khan, chair of the American Psychiatric Association’s Committee on Telepsychiatry, in a previous interview with CNN.

As the pandemic public health emergency that allowed for the exception neared its May 11 end date, the DEA received more than 38,000 public comments on two proposals designed to keep some flexibility in the telehealth framework moving forward, Khan said. The proposals would allow telehealth practitioners to prescribe one 30-day supply of buprenorphine — a medication for opioid use disorder — or Schedule III-V non-narcotic controlled medications, without doing an in-person exam first. A patient would have to do an in-person exam before the second prescription of either type of medication, according to those proposals.

The DEA and the Substance Abuse and Mental Health Services Administration announced May 9 that the temporary rules would be extended through November 11, while the DEA and HHS considered the public comments and any revisions to the proposals — buying more time for telehealth patients who might have otherwise experienced a disruption in care.

Now, after holding two days of public listening sessions on the rules in September, the DEA and HHS have further extended the flexibilities through December 31, 2024.

Some medical organizations have praised the decision.

American Medical Association president Dr. Jesse M. Ehrenfeld said in a news release that the organization is “grateful the DEA recognizes patients being treated with these medications … often have challenges securing and traveling to in-person appointments, and that the agency is committed to avoiding lapses in their care.”

The latest extension also applies to all patient-practitioner relationships conducted over telehealth, not just those started before, or on, November 11.

“We are thrilled that the DEA is taking such a thoughtful and thorough approach to creating the right rules around the prescription of controlled substances,” said Kyle Zebley, senior vice president of public policy at the American Telemedicine Association, in a news release. “This is a critical issue for millions of individuals and their families, as well as clinicians wanting to provide care to their patients, wherever and whenever they need it.”

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I don’t know if they do it any more, but one of the large chains use to give people a “gift card” when they “pitched a fit” – while waiting in line to get their Rx filled or their Rx(s) where not ready WHEN THEY THOUGHT THAT THEY SHOULD BE.  Guess what the other people waiting in the Rx line to get their Rx(s) filled learned?  Pts who “pitch a fit” may get enough on a “gift card” to pay for the copay(s) on their prescriptions.

Be sure to read this survey from 2022 about the concerns of pharmacy workers  https://www.pharmacist.com/About/Newsroom/apha-and-naspa-release-initial-findings-from-the-2022-national-pharmacy-workplace-survey

Why Walgreens pharmacy workers are walking off the job

https://www.kxly.com/news/money/why-walgreens-pharmacy-workers-are-walking-off-the-job/article_c2bf2d16-7703-500a-9749-d2c1e69e53c0.html

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Bled Tanoe, PharmD, Founder at #PizzaIsNotWorking

Dear Public, the pharmacy world is on fire right now and you might wonder why.

You see, for more than a decade, working conditions at your local CVS Health ,Walgreens , RITEAID PHARMACY and others have been unsafe. But with COVID, what was once a house on fire , became an entire neighborhood or even city on fire! Community Chain Pharmacists, Technicians and Pharmacy Students were tasked with the great honor to vaccinate the entire country. We took, this call with pride, because we were and are still are the very heart of public health and what we do for the public at large, can NOT be explained in one post !

We are the most accessible individuals. We are often the first person you see before headed to your doctor. And the last person . While everything was shutting down, we were present. We held you in the moments of the lonely quarantine. We celebrated with you. We mourned with you . And we did all of that while still expected to continue to fill prescriptions, meet company profits driven goals among other things.

And yet, our burdens were not matched with the proper physical, emotional and even financial support. But we did it. We burned ourselves to the ground because we chose this profession. Meanwhile, companies like those big corporations, pocketed the revenues and made no attempt to meet simple requests such as less demands on us, better staffing, patients centered values or even better pay for our technicians who were and are still very much underpaid.

We have come to work with fear in our hearts because every prescription we touched, felt like an error! We became sick, physically and emotionally. Some turned to substances and other things just to make it through. We became the pilot with no flight attendants and yet still being asked to handle bags, drinks and snacks while flying the plane .

And today, it is still happening. This is very much alive in your Walgreens, CVS and others.

Now do you understand why we are on fire? We do not feel safe for you! The very people we took an oath to protect… your life is being endangered by those corporations and they do not care about you and us.

So no, we are not asking for more money like they say in the news. There is not a shortage of us. They are lying so much, it is like breathing air for them.

What we want is safety for you! What we want is to take care of you. What we want is to know your name and take time to know you.For them, you are just a prescription number. To us, you are so much more!!

We don’t want to pass snacks and drinks.
We want to fly you to safety!

We have always seen you.
But now, do you see us? Do you see why many are walking out in protest? Do you see why they are putting their reputation And livehood on the line ?

Patient Safety should be the number goal of any healthcare system. It is ours as Pharmacists, Technicians and Pharmacy Students. We strive for it! But to them, those giants… it is NOT!

Disclaimer: those thoughts are my own.

Right now, Pharmacy, Pharmacists & Pharmacy technicians are in a crisis. This did not happen over night, but the COVID-19 pandemic did accelerate a crisis that was already building.

What man-hours were added to a Rx dept during the COVID-19 vaccines and testing… as soon as the demand for COVID-19 vaccines, it was just as as Flu vaccines “season” was just starting and most/all the chains cut back on the man-hours in the various Rx depts. This was seemingly the “straw” and I know many chain pharmacies around us, were experiencing Rx dept staff – calling in sick and/or just “giving notice”

Here is a recent blog post, that maybe the direct/indirect outcome of the under staffed, over worked Rx depts.  https://www.pharmaciststeve.com/it-is-claimed-that-third-largest-cause-of-all-premature-deaths-is-from-medical-errors/

I suggest you read the above post and pay particular attention to the response of the attorney representing CVS, questioning why the chain was being fined $10,000.  They apparently accept no responsibility of the BAD OUTCOME(S) of under staffing.

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https://www.8newsnow.com/investigators/cvs-abortion-medication-mixup-ends-las-vegas-womans-pregnancy-dreams-all-i-got-was-a-sorry/

LAS VEGAS (KLAS) — Timika Thomas does not come from a large family. So, as an adult, she decided to make one and had four lovely, healthy children. She and her husband, in 2019, decided to have one more.

Progressing into her thirties, Thomas was having trouble getting pregnant. She had two ectopic pregnancies, which led to Thomas having her fallopian tubes removed. And even though they weren’t insured for the costs they would endure, they decided to pay for invitro fertilization – IVF.

Doctors sedated Thomas, inserted two eggs inside her body and sent her home with prescriptions, one of which would trick her body into producing enough hormones to kickstart her pregnancy.

“You have to make yourself think it’s pregnant,” Thomas told the 8 News Now Investigators. “We’re taking a lot of supplements to make our bodies think it’s pregnant.”

In previous attempts, Thomas had taken a shot to her buttocks in order to trigger that hormone inside of her, but injecting herself was emotionally trying and she wanted to give her “butt cheek a rest,” she said.

Her doctor prescribed a vaginal suppository in place of the injections. Thomas went to her CVS branch at W. Craig Road and Camino Al Norte in North Las Vegas. She took two of her required doses and knew something was wrong.

“I started cramping really bad,” Thomas said.

No stranger to the IVF process, she expected cramping, but this was not the pain she anticipated.

“My cramping went beyond that,” she said. “It was extreme. It was painful.”

Thomas checked the bottle, looked up the name of the prescription on the label, and the results of her internet search began a yearslong process of mourning.

“The first thing I read is it’s used for abortions,” Thomas said.

Documents obtained by the 8 News Now Investigators outline how two technicians and two pharmacists made a series of errors that led to Thomas being given the wrong medication, which essentially terminated her budding pregnancy on the spot.

“They just killed my baby,” she said to herself at the time. “Both my babies, because I transferred two embryos.”

Among the series of mistakes, those documents say one technician – incorrectly believing she knew the generic name for the brand prescribed by the doctor – entered the wrong name into the prescription. One pharmacist did not catch the error, and another pharmacist failed to counsel Thomas when she came to pick up her medication.

“It [the error] would have been caught because then they would have had to have the medicine in their hand,” Thomas said. “And they would have said, ‘Oh, this is Misoprostol or Cytotek, have you taken this before?’ And I would have said ‘no.’ ”

Thomas lodged a complaint with the Nevada State Board of Pharmacy, which met in September. After she gave heartbreaking testimony about her horrifying experience, the two pharmacists were fined and had their licenses suspended provisionally. If both pharmacists avoid disciplinary action over the next 12 months, pay fines and take continuing education credits, their licenses will be reinstated, according to pharmacy board documents.

CVS, in response to inquiries from the 8 News Now Investigators, provided the following statement:

“We’ve apologized to our patient for the prescription incident that occurred in 2019 and have cooperated with the Nevada Board of Pharmacy in this matter. The health and well-being of our patients is our number one priority and we have comprehensive policies and procedures in place to support prescription safety.  Prescription errors are very rare, but if one does occur, we take steps to learn from it in order to continuously improve quality and patient safety.”

The pharmacy board fined CVS the maximum amount allowed by statute — $10,000.00 – for its vicarious liability of the pharmacists’ errors.

At the hearing, the attorney for the retail behemoth distanced his client from its one-time employees.

“To suspend or take action against a pharmacy license when they really didn’t do anything wrong [it] wasn’t pled they did anything wrong,” the attorney said prior to the board imposing the fine. “The only allegation is that they had these pharmacists.”

Thomas was insulted.

“I felt like that was not okay because he should have took initiative for the company as a whole.”

Both pharmacists apologized.

“It’s a human error,” one pharmacist testified, in between heaving sobs. “It was just a human error and I’m so sorry.”

But sorry barely softens any of the heartache or sorrow Thomas feels even some four years later.

“All I got was a sorry,” she said. “It will never be good enough.”

I hope a lot of chain Pharmacists read the comment from the attorney representing CVS before the NV Board of Pharmacy.  The chains don’t have their back.  In reality,  most/all chains have something in their policies & procedures manuals that all employee must follow/obey any/all Fed/State laws, rules & regulations. The fact that Rx dept staff makes a Rx mis-fill , which is a violation of the State’s Pharmacy Practice Act and thus the chain can claim that the employee(s) violated the chain’s policies & procedures… thus the chain has no responsibility – financial liability for the employees’ actions.

While the attorney representing CVS at the NVBOP meeting .. did not state the employees violated the chain’s policies and procedures…but… The pharmacy board fined CVS the maximum amount allowed by statute — $10,000.00 – for its vicarious liability of the pharmacists’ errors.

At the hearing, the attorney for the retail behemoth distanced his client from its one-time employees.

“To suspend or take action against a pharmacy license when they really didn’t do anything wrong [it] wasn’t pled they did anything wrong,” the attorney said prior to the board imposing the fine. “The only allegation is that they had these pharmacists.”

I hope that all chain Pharmacists, understand that they really need to personally have their own professional liability insurance, because the chains really don’t have their back and will use situations – such as this – they will try to dodge any lawsuits over the damages caused by their employees in the Rx dept.

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Some 25-30 yrs ago, we were “traveling” and before satellite radio, when I was always searching for some radio channel that was playing a musical genre that I wanted to listen to.  I listen to a report on UK/England  – and their national healthcare system – and they had a pilot program that trying to develop that would predict when a person was admitted to a hospital – IF THEY WOULD BE DISCHARGED ! Fortunately, the system proved to be ONLY 90% ACCURATE.  The goal of the program was the computer to predict when a pt was admitted to the hospital that no matter what healthcare was provided the pt, the pt would DIE. So if a pt was predicted NOT TO BE DISCHARGED, the pt would only be provided supportive care – something like HOSPICE CARE, because the computer had determined that the pt was going to die in the hospital and NOT BE DISCHARGED.

Is this the path that United Health is on ? With this: UnitedHealthcare (UHC) — the nation’s largest health insurance company, which provides Sullivan’s Medicare Advantage plan — doesn’t have a crystal ball. It does have naviHealth, a care management company it bought in 2020, and one of several businesses that use computers to help insurance companies make coverage decisions.

When the “managed healthcare” programs started in the 1970’s… after a few years… some were referring to those programs as “mangled care”. The pts that were the “most satisfied” with the HMO programs were those people who needed little care.

Feds Rein in Predictive Software That Limits Care for Medicare Advantage Patients

— A computer program isn’t always a crystal ball for care

https://www.medpagetoday.com/special-reports/features/106668

Judith Sullivan was recovering from major surgery at a Connecticut nursing home in March when she got surprising news from her Medicare Advantage plan: It would no longer pay for her care because she was well enough to go home.

At the time, she could not walk more than a few feet, even with assistance — let alone manage the stairs to her front door, she said. She still needed help using a colostomy bag following major surgery.

“How could they make a decision like that without ever coming and seeing me?” said Sullivan, 76. “I still couldn’t walk without one physical therapist behind me and another next to me. Were they all coming home with me?”

UnitedHealthcare (UHC) — the nation’s largest health insurance company, which provides Sullivan’s Medicare Advantage plan — doesn’t have a crystal ball. It does have naviHealth, a care management company it bought in 2020, and one of several businesses that use computers to help insurance companies make coverage decisions.

Its proprietary “nH Predict” tool sifts through millions of medical records to match patients with similar diagnoses and characteristics, including age, preexisting health conditions, and other factors. Based on these comparisons, an algorithm anticipates what kind of care a specific patient will need and for how long.

But patients, providers, and patient advocates in several states said they have noticed a suspicious coincidence: The tool often predicts a patient’s date of discharge, which coincides with the date their insurer cuts off coverage, even if the patient needs further treatment that government-run Medicare would provide.

“When an algorithm does not fully consider a patient’s needs, there’s a glaring mismatch,” said Rajeev Kumar, MBBS, the president-elect of the Society for Post-Acute and Long-Term Care Medicine, which represents long-term care practitioners. “That’s where human intervention comes in.”

The federal government will try to even the playing field next year, when the Centers for Medicare & Medicaid Services (CMS) begins restricting how Medicare Advantage plans use predictive technology tools to make some coverage decisions.

Medicare Advantage plans, an alternative to the government-run, original Medicare program, are operated by private insurance companies. About half the people eligible for full Medicare benefits are enrolled in the private plans, attracted by their lower costs and enhanced benefitsopens in a new tab or window like dental care, hearing aids, and a host of nonmedical extras like transportation and home-delivered meals.

Insurers receive a monthly payment from the federal government for each enrollee, regardless of how much care they need. According to the Department of Health and Human Services’ inspector general, this arrangement raises “the potential incentive for insurers to deny access to services and payment in an attempt to increase profits.” Nursing home care has been among the most frequently deniedopens in a new tab or window services by the private plans — something original Medicare likely would cover, investigators found.

After UHC cut off her nursing home coverage, Sullivan’s medical team agreed with her that she wasn’t ready to go home and provided an additional 18 days of treatment. Her bill came to $10,406.36.

Beyond her mobility problems, “she also had a surgical wound that needed daily dressing changes” when UHC stopped paying for her nursing home care, said Debra Samorajczyk, a registered nurse and the administrator at the Bishop Wicke Health and Rehabilitation Center in Shelton, Connecticut, the facility that treated Sullivan.

Sullivan’s coverage denial notice and nH Predict report did not mention wound care or her inability to climb stairs. Original Medicare would have most likely covered her continued care, said Samorajczyk.

Sullivan appealed twice but lost. Her next appeal was heard by an administrative law judge, who holds a courtroom-style hearing usually by phone or video link, in which all sides can provide testimony. UHC declined to send a representative, but the judge nonetheless sided with the company. Sullivan is considering whether to appeal to the next level, the Medicare Appeals Council, and the last stepopens in a new tab or window before the case can be heard in federal court.

Sullivan’s experience is not unique. In February, Ken Drost’s Medicare Advantage plan, provided by Security Health Plan of Wisconsin, wanted to cut his coverage at a Wisconsin nursing home after 16 days, the same number of days naviHealth predicted was necessary. But Drost, 87, who was recovering from hip surgery, needed help getting out of bed and walking. He stayed at the nursing home for an additional week, at a cost of $2,624.

After he appealed twice and lost, his hearing on his third appeal was about to begin when his insurer agreed to pay his bill, said his lawyer, Christine Huberty, supervising attorney at the Greater Wisconsin Agency on Aging Resources Elder Law & Advocacy Center in Madison.

“Advantage plans routinely cut patients’ stays short in nursing homes,” she said, including Humana, Aetna, Security Health Plan, and UHC. “In all cases, we see their treating medical providers disagree with the denials.”

UHC and naviHealth declined requests for interviews and did not answer detailed questions about why Sullivan’s nursing home coverage was cut short over the objections of her medical team.

Aaron Albright, a naviHealth spokesperson, said in a statement that the nH Predict algorithm is not used to make coverage decisions and instead is intended “to help the member and facility develop personalized post-acute care discharge planning.” Length-of-stay predictions “are estimates only.”

However, naviHealth’s website boasts about saving plans money by restricting care. The company’s “predictive technology and decision support platform” ensures that “patients can enjoy more days at home, and healthcare providers and health plans can significantly reduce costs specific to unnecessary care and readmissions.”

New federal rulesopens in a new tab or window for Medicare Advantage plans beginning in January will rein in their use of algorithms in coverage decisions. Insurance companies using such tools will be expected to “ensure that they are making medical necessity determinations based on the circumstances of the specific individual,” the requirements say, “as opposed to using an algorithm or software that doesn’t account for an individual’s circumstances.”

The CMS-required notices nursing home residents receive now when a plan cuts short their coverage can be oddly similar while lacking details about a particular resident. Sullivan’s notice from UHC contains some identical text to the one Drost received from his Wisconsin plan. Both say, for example, that the plan’s medical director reviewed their cases, without providing the director’s name or medical specialty. Both omit any mention of their health conditions that make managing at home difficult, if not impossible.

The tools must still follow Medicare coverage criteria and cannot deny benefits that original Medicare covers. If insurers believe the criteria are too vague, plans can base algorithms on their own criteria, as long as they disclose the medical evidence supporting the algorithms.

And before denying coverage considered not medically necessary, another change requires that a coverage denial “must be reviewed by a physician or other appropriate health care professional with expertise in the field of medicine or health care that is appropriate for the service at issue.”

Jennifer Kochiss, a social worker at Bishop Wicke who helps residents file insurance appeals, said patients and providers have no say in whether the doctor reviewing a case has experience with the client’s diagnosis. The new requirement will close “a big hole,” she said.

The leading Medicare Advantage plans oppose the changes in comments submitted to CMS. Tim Noel, UHC’s CEO for Medicare and Retirement, said Advantage plans’ ability to manage beneficiaries’ care is necessary “to ensure access to high-quality safe care and maintain high member satisfaction while appropriately managing costs.”

Restricting “utilization management tools would markedly deviate from Congress’ intent in creating Medicare managed care because they substantially limit MA [Medicare Advantage] plans’ ability to actually manage care,” he said.

In a statement, UHC spokesperson Heather Soule said the company’s current practices are “consistent” with the new rules. “Medical directors or other appropriate clinical personnel, not technology tools, make all final adverse medical necessity determinations” before coverage is denied or cut short. However, these medical professionals work for UHC and usually do not examine patients. Other insurance companies follow the same practice.

David Lipschutz, JD, associate director of the Center for Medicare Advocacy, is concerned about how CMS will enforce the rules since it doesn’t mention specific penalties for violations.

CMS’ deputy administrator and director of the Medicare program, Meena Seshamani, MD, PhD, said that the agency will conduct audits to verify compliance with the new requirements, and “will consider issuing an enforcement action, such as a civil money penalty or an enrollment suspension, for the non-compliance.”

Although Sullivan stayed at Bishop Wicke after UHC stopped paying, she said another resident went home when her Medicare Advantage plan wouldn’t pay anymore. After 2 days at home, the woman fell, and an ambulance took her to the hospital, Sullivan said. “She was back in the nursing home again because they put her out before she was ready.”

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Recall alert: Blood pressure medication recalled after oxycodone pill found on production line

This sounds like some sort of sabotage by a disgruntled employee.  Sort of reminds me of situation abt 40 yrs ago https://www.history.com/news/extra-strength-tylenol-poisonings-1982, where someone took some Tylenol Extra Strength from a store and tampered capsules of Extra-Strength Tylenol. Someone had opened the capsules and replaced the pain-relieving medicine with deadly doses of potassium cyanide.  They then proceeded to put the bottles of Tylenol Extra Strength back on the retail shelf they took them from, killing seven people.

While Oxycodone 5 mg taken by someone who it was not prescribed to, probably may not cause any personal harm … unless the person is severely allergic to Oxycodone and/or opioids in general.  However, the finding of any Oxycodone 5 mg in a few bottles of betaxolol, will cost the pharma KVK-Tech, Inc a untold amount of $$ in doing a recall to one or more lot numbers of the medication.

KVK-Tech, Inc. is voluntarily recalling a single lot of 10-milligram betaxolol tablets “as a precautionary measure” after a single oxycodone hydrochloride tablet was found on the same production line, according to the U.S. Food and Drug Administration.

Betaxolol is a drug used to combat high blood pressure. Oxycodone hydrochloride is a drug used for pain relief and is a narcotic that’s a “popular drug of abuse,” per the U.S. Drug Enforcement Administration.

The 10-mg betaxolol pills are white, round and film-coated, with one side displaying a “K” and the number “13.” The pills were packaged in white plastic bottles, each filled with 100 tablets, and distributed to wholesalers and retailers nationwide. Bottles in the affected lot — Batch Number: 17853A — have an expiration date of June 2027.

According to the FDA, the company found a single, five-milligram oxycodone hydrochloride tablet on the packaging line during line clearance — the process of making sure equipment is free of materials — after the recalled betaxolol batch was packaged.

“The betaxolol package insert warns about slowing in the heart rate in elderly patients which is likely to be exacerbated by inadvertent opioid administration,” the FDA release warns. “Additionally, some patients prescribed low-dose betaxolol might have compromised heart and lung function that is also likely to be exacerbated by an opioid.”

“Therefore, inadvertent exposure to a controlled substance, such as oxycodone, in that patient population is likely to result in significant slowing in breathing, known as respiratory depression, which is a serious health risk,” the release reads.

The FDA notes that betaxolol and oxycodone hydrochloride tablets look similar. KVK has not received any reports of foreign tablets in bottles of betaxolol tablets.

According to the FDA release, if you received pills from the recalled lot, stop using them and immediately return them to KVK-Tech. The company will reimburse you for the cost of purchasing the medication, the release states.

You can contact KVK-Tech at 215-579-1842, Ext: 6002, or by email at customerservice@kvktech.com.

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