I am not recommending this and/or condemning this. According to this study, the warning level of a daily dose was 4Gm ( 4000mg) That would entail taking > 3 capsules daily of the typical strength for 1200 mg of omega-3 per capsule.  This study does not state that those pts taking < 4 Gm of omega-3 is safe of developing A-FIB.

https://www.medscape.com/viewarticle/997348

In its September meeting, the safety committee (Pharmacovigilance Risk Assessment Committee [PRAC]) of the European Medicines Agency (EMA) confirmed that atrial fibrillation will now be included as a common side effect in the Summary of Product Characteristics for medicinal products containing omega-3-acid ethyl esters.

Should atrial fibrillation develop, intake of the medication must be stopped permanently.

Omega-3-acid ethyl esters are used to treat hypertriglyceridemia if lifestyle changes, particularly those related to nutrition, have not been sufficient to lower the blood triglyceride level. Hypertriglyceridemia is a risk factor for coronary heart disease.

During a Periodic Safety Update Single Assessment Procedure, the EMA safety committee analyzed systematic overviews and meta-analyses of randomized, controlled clinical studies. Experts found a dose-dependent increase in the risk for atrial fibrillation in patients with cardiovascular diseases or cardiovascular risk factors who were being treated with omega-3-acid ethyl esters compared with those treated with placebo.

The observed risk was at its highest at a dose of 4 g/d.

The PRAC will recommend an update to the Summary of Product Characteristics for preparations that contain omega-3-acid ethyl esters. The aim is to inform physicians, pharmacists, and patients of the risk for atrial fibrillation. A notification (direct healthcare professional communication) will be sent to healthcare professionals soon to inform them of further details.

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Pfizer to price COVID treatment Paxlovid at $1,390 per course

https://www.reuters.com/business/healthcare-pharmaceuticals/pfizer-price-covid-19-drug-paxlovid-1400-five-day-course-wsj-2023-10-18/

Oct 18 (Reuters) – Pfizer on Wednesday (PFE.N) said it will set the U.S. price for its COVID-19 antiviral treatment Paxlovid at nearly $1,400 per five-day course when it moves to commercial sales after government stocks run out, more than double what the government currently pays for it.

The new list price, which does not include rebates and other discounts to insurers and pharmacy benefit managers, is $1,390 per course, Pfizer said in an emailed statement. The U.S. government paid around $530 per course for Paxlovid it has made available to Americans at no cost.

Paxlovid, the most commonly prescribed at home treatment for COVID-19 in the U.S., will remain available for free to patients there until the end of the year, Pfizer said.

Under an agreement with the government, the drug will also stay free of charge for patients insured under the Medicare and Medicaid programs through the end of 2024, and to uninsured and underinsured patients through 2028.

In Pfizer’s clinical trial, Paxlovid was shown to reduce hospitalizations and death by around 90% for unvaccinated people at risk for serious disease. In another trial, Pfizer was not able to show benefit for those considered at standard risk, including vaccinated patients.

Influential U.S. drug pricing watchdog the Institute for Clinical and Economic Review (ICER) said last year that its suggested price range for Paxlovid based on the benefits and value to patients was between $563 to $906 per course.

The United States purchased around 24 million courses of the oral two-drug treatment from Pfizer, and still had a large supply, but arranged to return 7.9 million courses last week. The company also slashed its full-year revenue forecast due to lower-than-expected sales of its COVID-19 products.

Under that deal, a credit for the returned Paxlovid doses will pay for the supply to Medicare, Medicaid, underinsured and uninsured patients.

Demand for the drug has fallen since last year. In 2022, patients were given around 7 million courses of the drug, according to U.S. government data. Through Oct. 1, around 3.4 million courses had been administered in 2023.

The new list price was first reported by the Wall Street Journal.

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The PBM industry started in 1970 and initially, IMO..their reimbursements was pretty much on line with the “going rate” that community pharmacies charged and gross profit that they made. “back in the day”, wholesale prices was almost stagnate, but in the mid-late 80’s.. wholesaler prices of Rx meds started to increase dramatically. Little did those in pharmacy knew what was causing these dramatic wholesale price increases.  Looking back now, it was apparent as the PBM’s gained more and more control over the Rx meds, the PBM industry – where there was no financial clarity in how they made their money – was apparently implementing their ability to demand kickbacks, rebates, and discount for the pharmas for having their meds on the PBM’s approved formulary.  This was probably were the PBM industry was controlling > 50% of all prescriptions.

In this article, it is stated that Medicare-C (Advantage) prgms are going to be covering > 50% of Medicare population. Is all of these large Healthcare corporations walking away from Medicare-C contracts, the beginning of these prgms trying to increase their profits, by limiting/denying expensive care?  It looking at some of the offering for 2024 – especially for those people having Medicare & Medicaid – additional benefits and/or perks that MAY have less to do with verifiable health benefits.

Hospitals sour on Medicare Advantage: 8 things to know

https://www.beckershospitalreview.com/finance/hospitals-sour-on-medicare-advantage-8-things-to-know.html?origin=BHRE&oly_enc_id=5923F2659290B3Z

With the Medicare open enrollment period underway, some seniors may have fewer provider choices in their respective regions as hospitals and health systems across the country increasingly cut ties with the Medicare Advantage program. 

Eight things to know about this trend:

1. Becker’s has previously reported on hospitals or health systems across the country that have recently ended some or all Medicare Advantage contracts. Those organizations include San Diego-based Scripps Health; Bend, Ore.-based St. Charles Health System; Louisville, Ky.-based Baptist Health Medical Group; and Corvallis, Ore.-based Samaritan Health Services.

2. The reasons behind Medicare Advantage contract terminations vary by system and by payer offering the plan. Some systems have cited steep losses amid excessive prior authorization denial rates and slow payments from insurers. Others have noted that most MA carriers have faced allegations of billing fraud from the federal government and are being probed by lawmakers over their high denial rates.
3. The Medicare Advantage landscape is constantly changing, with some health systems dropping only certain MA carriers and maintaining relations with others due to renegotiated contracts. For example, Brunswick-based Southeast Georgia Health System will terminate its contract with Centene’s WellCare Medicare Advantage plan in December but will remain in network with Aetna, Anthem, Humana and UnitedHealthcare MA plans. 

4. Medicare Advantage contract negotiations between payers and providers have become more public over the last year. According to data shared with Becker’s by FTI Consulting, among the 64 contract disputes reported in the media this year through Sept. 30, 37 involved MA plans, and 10 disputes exclusively involved MA plans. In the third quarter alone, 15 disputes involved MA plans, compared to seven in the third quarter of 2022, or a 115% increase year over year.

5. Rural hospitals especially have expressed concern with the growth rate of Medicare Advantage enrollment in non-urban areas and the effect on their financial sustainability as more seniors move away from traditional Medicare. From 2010 to 2023, Medicare Advantage enrollment grew faster in rural and micropolitan areas than in metropolitan areas.
6. Though some health systems are moving away from Medicare Advantage, others are partnering with payers, grocers or other systems to launch their own MA plans for 2024.
7. CMS issued a final rule in April that aims to streamline Medicare Advantage and Part D prior authorizations, including ensuring consistency with traditional Medicare national and local coverage guidelines. The agency has proposed another rule that would require MA carriers to approve urgent prior authorizations within 72 hours, and within seven days for standard requests. The proposed rule also would require payers to publicly report prior authorization denial rates and provide specific reasoning for denied requests.
8. Despite tensions with some health systems, the Medicare Advantage program has bipartisan support in Congress and a 95% quality satisfaction rating among enrolled members in 2023. MA total enrollment is expected to be 33.8 million in 2024, representing more than half of the total Medicare population. There are nearly 4,000 MA plans being offered this year nationwide, and MA members spend an average of $2,434 less on out-of-pocket costs and premiums per year compared to traditional Medicare members.

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This video and the class action that is being discussed between independent pharmacies and one or more PBM’s. The attorney (on the right) mentioned the one word “TYING”, what he is referring to is the part of the Sherman Antitrust Act https://en.wikipedia.org/wiki/Tying_(commerce) Tying (informally, product tying) is the practice of selling one product or service as a mandatory addition to the purchase of a different product or service. In legal terms, a tying sale makes the sale of one good (the tying good) to the de facto customer (or de jure customer) conditional on the purchase of a second distinctive good (the tied good).

TYING could also be involved with pain docs (needle jockeys) mandating that a pt get Epidural Spinal Injections (ESI) in order to get a prescription for oral opiates.  Secondly, if the pt has been getting little/no positive outcomes, then the ESI are not medically necessary and the billing of a ESI to insurance would be insurance fraud, besides violating the TYPING part of Sherman Antitrust.

This class action with the PBM industry could uncover one or more issues of how they are violating numerous laws involving especially pain pts in the limiting or denying appropriate prescribed medications.  If they are violating laws with community pharmacies, what other groups are they violating laws with?  The PBM industry has never been very financially transparent in how they function.

Over the last five years, the top five PBMs are now owned by the top five insurance companies. For a long time, PBMs have been licensed insurance companies. Those top five PBMs control 90%-95% of all prescriptions, with CVS Health/Caremark controlling about 33% alone.

I am seeing an increasing number of large Healthcare/Hospital corporations dropping contracts with various Medicare-C (Advantage) prgms, mostly over slow/low reimbursement and a draconian amount of prior authorizations and “red tape” getting a PA approved.

This may be just the first “wave” of healthcare providers pulling away from Medicare-C prgms. This is third time that the FEDS has tried to get a similar program like the current Medicare – C prgm.  The first  – back in 1970’s – was called Medicare HMO.. It failed after both providers & pts started pulling out and premiums, co-pays & deductibles started going up.  It was placed later with a Medicare-C prgm and followed a similar path and failed.

Maybe this version of Medicare-C in starting down the same path.

What will the community do if one or more chain pharmacies and/or Medicare Part D/Medicare-C decide that they are no longer going to dispense and/or prescribe opioids/controls?  I see a bunch of “keyboard warriors” on many private FB pages, will they use their efforts to reach out to some class action law firms or law firms that focus on civil rights to attempt to get a class action started.  All it takes is 1-2 lead plaintiffs to get one started. If everyone in the community just curls up in the “fetal position” and accepts no pain management as “their fate”… suicides and premature deaths will just skyrocket.

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United Healthcare is endorsed by AARP and Humana was just bought/merged with United Health.. for the last few years, we have had Humana Part D and for 2024 – if we keep Humana – our premiums will be UP 84% and the estimated cost of my medication will be UP JUST 400%. and this is what AARP – who is supposed to be supportive of Seniors- ENDORSES?

This year, I am seeing large healthcare corporations DROPPING OUT OF Medicare-C also known as Medicare Advantage prgms, seemingly over poor reimbursement rates and draconian prior approval processes. Is this year just the beginning of a trend of  Medicare-C having fewer and fewer providers in their network?

Is this more a issue of MANAGED PROFITS and MANGLED CARE?

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The 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.

“THE FLIP IS ON,” HOW LOUISIANA STATE OFFICIAL MANEUVERED TO WRESTLE CONTROL OF CANON HOSPICE FROM A SUCCESSFUL INDIAN BUSINESS OWNER, DR. SHIVA AKULA, MD., (HERO OF COVID-19 & KATRINA) IN A PAYROLL SCHEME AND COVERING UP THEIR EMBEZZLEMENT DEBACLE!!!

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Here is a hyperlink https://www.hpso.com/getmedia/261a3590-6368-41e6-857c-f2bf9dbdf6ea/CNA_CLS_PHARM_072823_CF_PROD_SEC-(1).pdf  listing the claims that involve Board of Pharmacy (BOP). It suggests that only 30% of complaints to the state BOP results in no action and dismissed. Does this mean that a Pharmacist denying to fill a Rx for undisclosed clinical reasons, would the BOP consider this unprofessional conduct?

The cost of defending a pharmacist license grew 43% in 5 years

https://www.beckershospitalreview.com/pharmacy/the-cost-of-defending-a-pharmacist-license-grew-43-in-5-years.html

Liability claims and incidents involving pharmacists have risen in individual cost, according to a new industry report.

The Healthcare Providers Service Organization worked with the American Pharmacists Association and the Institute for Safe Medication Practices to compile data on pharmacist malpractice claims and license defense cases.

When pharmacists are defending an alleged infraction to their state pharmacy board, the average cost is $7,650 — which is a 43% increase from 2018, and more than twice as expensive as the average expense in 2013, the report found.

The top five most common allegations that cause a pharmacist’s license to be in jeopardy are wrong drug, wrong dose or strength, wrong patient, failing to consult with a practitioner about a concern, and an error in calculation or preparation.

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Medicare Part B premiums to rise by 6 percent in 2024

https://thehill.com/homenews/4253377-medicare-part-b-premiums-rise-by-6-percent-in-2024/

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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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