Medicare open enrollment now thru Dec 7th

See the source image

https://www.medicare.gov/plan-compare/#/?lang=en&year=2021

Everyone needs to look at the Part D plan… many will not have to change their plan but others may be forced to change.

What I found was that some of the Part D policies is that they are currently not listing prices of individual medications.

When comparing prgms for us… I was offered one policy from Anthem and when comparing Barb’s … she was not offered that same Anthem Part D policy, but a different Anthem policy with a higher monthly premium, but lower copay… in reality looking at premium and deductible… she would be paying $100 more per year than would I.  I talked to a licensed agent for Anthem and he stated that Barb should have been offered the same policy as was offered me.

Some policies are stating that they are NO LONGER PAYING FOR  some Medication – like Alprazolam (Xanax), Methocarbamol (Robaxin ) and others.

Everyone need to pay attention to the prices listed for each medication. I saw a few where the price in the deductible period is the same as after the deductible is met… since suggests to me that the particular medication is basically the pt will be paying the “full rack rate” for the entire year for the particular medication.

There could be some software issues with this program – like no prices listed – or not offering a particular policy for some odd reason.

If you are not happy with your current Part D Policy… it is important to look at your options, but … given the errors that I ran into … it might be advisable to not commit to a specific policy until towards the end of the open enrollment period — and hopefully any software issues have been corrected.

Of course, if you want to keep the policy that you have now… you NEED TO DO NOTHING… you will automatically be re-enrolled into that policy

 

 

Court tosses $7M judgment awarded to patient paralyzed after spine injection at ASC

Court tosses $7M judgment awarded to patient paralyzed after spine injection at ASC

https://www.beckersasc.com/asc-news/court-tosses-7m-judgment-awarded-to-patient-paralyzed-after-spine-injection-at-asc.html

The Colorado Court of Appeals reversed a $7 million judgment against Surgery Center at Lone Tree (Colo.) on Oct. 15, saying the ASC should not have been held vicariously liable for a spine surgeon’s alleged malpractice.

Plaintiff Robbin Smith lost all feeling in her lower extremities after receiving “a bilateral S1 L1-L2 transforaminal steroid injection using the particulate corticosteroid Kenalog” at Surgery Center at Lone Tree, according to court documents. Ms. Smith was later diagnosed with bilateral lower extremity paraplegia secondary to spinal infarct/ischemia and is permanently paralyzed below the waist.

She and her husband, Doyle Edward Smith Jr., filed a lawsuit against three defendants: the spine surgeon who performed the epidural, SpineOne Spine & Sport Medical Clinic, and Surgery Center at Lone Tree, where the injection took place.

However, only the claims against the ASC proceeded to trial. Claims against the spine surgeon were settled before trial, and claims against Lone Tree-based SpineOne Spine & Sport Medical Clinic, which is the surgeon’s employer, were dismissed.

During trial, the plaintiffs alleged Surgery Center at Lone Tree had an obligation to either prevent its surgeon’s off-label use of Kenalog, which they believe contributed to Ms. Smith’s paralysis, or ensure Ms. Smith had given her informed consent to its off-label use.

After an eight-day trial, a jury ruled in favor of the Smiths and awarded them $14.9 million in damages. The trial court reduced the amount of the verdict to roughly $7 million. The ASC appealed the jury’s ruling, and the Smiths cross-appealed the reduction in damages.

Citing Colorado’s corporate practice of medicine doctrine, which “prohibits healthcare facilities from controlling a physician’s independent professional judgment regarding the practice of medicine, diagnosis or treatment,” the Colorado Court of Appeals reversed the trial court’s judgment and remanded the case for judgment in favor of Surgery Center at Lone Tree.

“We conclude that the trial court should have dismissed the corporate negligence and uninformed consent claims against [Surgery Center at Lone Tree] as a matter of law because, under the corporate practice of medicine doctrine, [Surgery Center at Lone Tree] was not vicariously liable for any malpractice” by the operating surgeon, nor was the ASC obligated to assume any medical responsibilities the surgeon failed to fulfill, the Colorado Court of Appeals said.

The court also dismissed the Smiths’ claim for negligence per se, on the grounds that state licensing and federal Medicare regulations weren’t enacted primarily for public safety reasons.

Today I turned in my resignation as a certified pharmacy technician with CVS

Leaving the bench

Today I turned in my resignation as a certified pharmacy technician with CVS.

I’ve been working as a tech for the last 18 years and the changes that come down on us are getting worse and worse. I’ve lost hope that our patients will be taken care of. Last week was the worst shift of them all. A flood of people coming in for flu shots, phone lines lighting up, people piling up at the register, and stacks of prescriptions waiting to be filled. We were drowning with no relief in sight. As I looked at my overtaxed pharmacist all I could see was a mistake waiting to happen. She’s being pulled in no less than 5 different directions, while the flu shots are piling up and she’s suiting up for the task, the narcotic waiter she still has to count and verify is 40 minutes past the promised time. While the patient was extremely understanding after watching us for the last hour, it’s not fair to him or any of our patients to have our attention pulled away in different directions constantly. I went home after my shift, defeated, and really thought about why I was still working here. It most certainly wasn’t because of the money, I could make more working at a coffee shop or as a cashier at a grocery store, shoot a lot of them even got hazard pay during this time. No raises since my pharmacy was bought out 5 years prior and most likely none in the future even with minimum wage creeping up in my state. No hazard pay, no thank you for coming in, nothing but headaches and chest pains. Our patients are no longer patients but are treated as customers who should be up sold at every interaction. Do you need this or that, how about we call your doctors for refills you don’t need, what about auto filling, what about any of these 3-5 vaccines, do you have a rewards card…. Looking back over the years the best thing to happen to me was NOT going to pharmacy school where I would have been saddled with a mortgage in student loan debt and in a job market that’s over saturated. 12 hour shifts, no time for a bathroom break, let alone trying to have a lunch break and many working extra hours before and after their shifts uncompensated just to clear the work for their colleagues. It was bittersweet turning in my 2 week notice, I feel awful for the team I’m leaving behind but I’m glad the abuse will be over. I did not join the pharmacy team to become a used car salesman but that is what CVS has turned it into, minus the commission of course. It’s time to let go and focus on myself, my son has been counting down the days to my last pharmacy shift so he came have some more mommy time… life is too short.

Isn’t INTENTIONALLY throwing a pt into cold turkey withdrawal and inflict a torturous level of pain — a human rights violation ?

My state drivers license was suspended unknown to me, to make matters worse my great-grandson took nana’s d.l. for the picture of nana long story short he lost it. We were in the hectic throws of covid, dept of Licensing closed. I went and got veteran’s affairs outreach office to make me a copy of that Driver’s license also included my social security. Card. My pharmacist at took the copy for months (7) now they are refusing unless I have a original drivers license. Because of covid I don’t have a chance of getting a new one. I paid my fines but the drivers license dept is telling me because of covid they have to send it out of state using the picture off my old dl.picture.this will take 6 weeks. I am disabled on social security. My pain meds I have been on for 10 years. I cannot just stop. Pain is constant and I can function with my meds . I have implants that have gone wrong. I need to have surgery, I also have nerve damages, spinal stenosis, nerve damage in my back, Deep vein th. Thyroid disease. Have gone thru therapy, exercises, non-opiod meds. Nothing help. My dr. Had me classified as completely disabled, no Hope’s of going back to my job of 15 years. But also let me tell you when I became aware of my lost of license I did what I could to correct it. Can you advise me? My meds are due 10-19-20. I am afraid of what will happen if I cant find a way to get this copy to be accepted the GOVERNMENT gave me a copy of the original. My script has my photo on it I have my photo on my copy. What more can I do?? Please respond, thank you

Twitter & Facebook has banned this story

Inside Hunter Biden’s murky history of business dealings in China

https://nypost.com/2020/10/14/inside-hunter-bidens-murky-history-of-business-dealings-in-china/

An expose of Hunter Biden’s emails published by The Post on Wednesday showed the oft-troubled son leveraging access to his then-vice president father and introducing him to an executive of a Ukrainian gas company that was under scrutiny at the time.

The family’s dealings in Ukraine are the subject of several congressional probes and even led to the impeachment of President Trump who was eventually cleared in the Senate of the charge that he pressured Ukraine’s leader to dig up dirt on Joe Biden.

Hunter Biden’s dealings in China, however, have earned a lot less scrutiny — including over a $1 billion windfall for his business venture just days after visiting Beijing with his influential father.

In 2009, Hunter Biden and Christopher Heinz, the stepson of former secretary of state John Kerry, founded Rosemont Seneca Partners, a billion-dollar private equity firm.

Still at the helm of the firm, Hunter flew aboard Air Force Two to China in December 2013, accompanying his then-veep father on an official visit where Joe Biden reportedly met with Hunter’s Chinese partners.

Ten days later, Hunter’s company inked a deal with the state-owned Bank of China and created the $1 billion investment fund called Bohai Harvest RST (BHR), according to reporting by Peter Schweizer, president of the Government Accountability Institute and the best-selling author of “Secret Empires: How the American Political Class Hides Corruption and Enriches Family and Friends.”

A representative for BHR told The New Yorker in July 2019 that Hunter Biden introduced his father to Chinese private equity executive Jonathan Li during the trip. Li later became the CEO of BHR.

Hunter Biden was forced to step down from the BHR board in October 2019 following blistering call outs from President Trump.

A spokesman for Biden’s family denied any wrongdoing or that there was a connection between the vice president’s visit and BHR’s wild fundraising success.

However, Schweizer found what he described as “a troubling pattern” of Biden and Heinz both seeming to benefit from their fathers’ positions in the Obama administration.

“Over the next seven years, as both Joe Biden and John Kerry negotiated sensitive and high-stakes deals with foreign governments, Rosemont entities secured a series of exclusive deals often with those same foreign governments,” Schweizer wrote in his book.

In another May 2017 incident, Hunter met with Chinese tycoon Ye Jianming, the chairman of energy company CEFC, in a Miami hotel room and the pair discussed American infrastructure and energy deals, according to a 2018 report by the New York Times.

After the meeting, Ye sent Hunter a 2.8-carat diamond and a “thank you” note and the ex-veep’s son began negotiating a deal for CEFC to invest $40 million dollars in a natural gas project on Louisiana’s Monkey Island.

Six months later, a CEFC executive was arrested in New York on unrelated bribery charges, and his first call was to Hunter Biden’s uncle, James Biden. According to the Times report, James believed the call was for Hunter.

“There is nothing else I have to say,” James Biden told the publication. “I don’t want to be dragged into this anymore.”

 

Cancer pts: 2013 to 2017, the national opioid prescribing rate declined by 20.7% among oncologists and 22.8% among non-oncologists

Opioid Prescribing for Cancer Care Drops

https://www.drugtopics.com/view/opioid-prescribing-for-cancer-care-drops

The rate of prescribing opioids among both oncologists and non-oncologists has dropped significantly in the past few years, raising concerns for patient care, according to a recent study.

In the wake of the US opioid epidemic, there have been major efforts to curb opioid prescribing. Researchers at Yale University School of Medicine set out to discover whether the efforts have affected prescribing among oncologists, whose patients often require opioids for symptom management.

Their findings, recently published in the Journal of the National Cancer Institute, showed that, from 2013 to 2017, the national opioid prescribing rate declined by 20.7% among oncologists and 22.8% among non-oncologists.1

During the 5-year period, 43 states reported a decrease in opioid prescribing among oncologists. In 5 states, opioid prescribing decreased more among oncologists than non-oncologists, according to the study.

From 2013 to 2017, prescribing of gabapentin increased by 5.9% among oncologists and 23.1% among oncologists and non-oncologists, respectively. Among palliative care providers, opioid prescribing increased by 15.3%.

“Given similar declines in opioid prescribing among oncologists and non-oncologists, there is concern that opioid prescribing guidelines intended for the non-cancer population are being applied inappropriately to patients with cancer and survivors,” wrote Vikram Jairam, MD, with the department of therapeutic radiology at Yale University School of Medicine.

It is reasonable to assume that the steep drop in opioid prescribing rates among oncologists is related to the “seismic shifts in prescribing regulations and attitudes toward opioids,” wrote Andrea C. Enzinger, MD, and Alexi A. Wright, MD, MPH, both with the Dana-Farber Cancer Institute in Boston, Massachusetts , in a companion editorial.

“The period studied overlaps with the rapid expansion of state opioid legislation establishing prescription drug monitoring programs (PDMPs), mandating provider education, and requiring patient identification and pharmacist verification prior to opioid dispensing,” they wrote. “Prescription drug plans also began imposing limits on the quantity, dose, or duration of opioid prescriptions, further reducing prescribing.”

Writing an opioid prescription has become a complex process that involves signing controlled substance agreements, checking PDMPs, filling prior authorization paperwork, communicating with pharmacists, and “even rewriting prescriptions to comply with seemingly arbitrary and sometimes conflicting rules set by states, insurers, and pharmacies,” Enzinger and Wright wrote.

“These burdens likely disincentivized oncologists from prescribing, potentially shifting this responsibility to palliative care — as evidenced by the 15% increase in opioid prescribing observed among palliative care physicians,” they wrote. “To protect cancer patients’ access, it is critical for policy solutions to lessen — rather than add to — oncology providers’ workload.”

Pharma files for bankruptcy because of various opiate crisis lawsuits

Mallinckrodt files for Chapter 11 bankruptcy

https://www.beckershospitalreview.com/pharmacy/mallinckrodt-files-for-chapter-11-bankruptcy.html

Mallinckrodt has filed for Chapter 11 bankruptcy for all of its U.S. subsidiaries and some international subsidiaries, the company said Oct. 12. 

The bankruptcy restructuring will reduce the company’s total debt by about $1.3 billion and resolve opioid-related claims and litigation involving its drug Acthar.

“After many months of deliberation, negotiation and consideration of alternatives, Mallinckrodt’s management and board of directors determined that implementing a Chapter 11 restructuring provides the best opportunity to maximize the value of the enterprise and position the company for the future in light of the current challenges it faces,” said Mark Trudeau, Mallinckrodt’s CEO. 

Opioid claims against the company are to be channeled into one or more trusts which would receive $1.6 billion in structured payments. The company also agreed to pay $260 million over seven years to settle claims it knowingly underpaid Medicaid for Acthar. 

In the bankruptcy filing, Mallinckrodt listed both assets and liabilities in the range of $1 billion to $10 billion. 

The company will continue to operate as normal as it restructures for bankruptcy. 

Mallinckrodt had said in February that it would put its U.S. generics business in bankruptcy as part of a proposed opioid settlement. In August, the company said it was considering bankruptcy for the parent company and most of its subsidiaries. 

In early March, the U.S. sued Mallinckrodt, alleging it knowingly underpaid Medicaid hundreds of millions of dollars in rebates for Acthar. The U.S. Justice Department said the company had calculated its rebate payments to Medicaid based on the drug’s price in 2013, but it has raised the drug’s price by 20 percent since then. The company was ordered to pay $650 million to CMS. 

As part of its bankruptcy filing, Mallinckrodt said it would reset Acthar’s Medicaid rebate calculation as of July 1, and that state Medicaid programs will receive 100 percent rebates on Acthar Medicaid sales. The company said it will dismiss its appeal of the Justice Department’s ruling in the case. 

Read Mallinckrodt’s full news release here.

Fewer people dying during the COVID-19 pandemic than two previous years ?

In the USA – on average 7500 people die EVERY DAY… according to this. According to this, total USA deaths for 2020 is projected to be the LOWEST IN THREE YEARS and this number must include the reported 200,000+ COVID-19 deaths.

Makes one wonder before the pandemic… reportedly we had a death crisis of opiate OD’s and vaping deaths.

 

US Blood Pressure Validated Device Listing

US Blood Pressure Validated Device Listing

https://www.validatebp.org/

Blood pressure measurement devices that have been validated for clinical accuracy as determined through an independent review process.

Uncontrolled high blood pressure (“BP”) is the leading risk factor for death and disability. The accurate measurement of BP is essential for the diagnosis and management of hypertension. One important aspect of accurate measurement is whether the BP measurement device has been validated for clinical accuracy.

To address this challenge, the American Medical Association (AMA) enlisted the National Opinion Research Center at the University of Chicago (NORC) to assist in the design and management of an independent process to determine which BP devices available in the U.S. meet the AMA’s established criteria to validate clinical accuracy (the “Validated Device Listing (VDL) Criteria”). An Independent Review Committee comprised of physician experts in the BP field assesses whether a BP device satisfies the VDL Criteria for validation of clinical accuracy. This independent review process results in a formal list of BP devices that have been validated for clinical accuracy (the “US Blood Pressure Validated Device Listing” or “VDL”).

More information regarding the VDL Criteria, governance structure, and requirements for BP device manufacturers to submit device documentation to the Independent Review Committee can be found on the Validation page.

  • Photograph of 10 Series® Wireless

    Omron

    10 Series® Wireless

    BP7450

    Alt names: HEM-7320

    Sizes: Adult (22-42 cm)

    Validation Protocol(s): ANSI/AAMI/ISO 81060-2: 2009

     

  • Photograph of 3 Series®

    Omron

    3 Series®

    BP7100

    Alt names: HEM-7311

    Sizes: Adult (22-42 cm)

    Validation Protocol(s): ANSI/AAMI/ISO 81060-2: 2009

     

  • Photograph of 5 Series®

    Omron

    5 Series®

    BP7200

    Alt names: HEM-7311

    Sizes: Adult (22-42 cm)

    Validation Protocol(s): ANSI/AAMI/ISO 81060-2: 2009

     

 

  • Photograph of 5 Series® Wireless

    Omron

    5 Series® Wireless

    BP7250

    Alt names: HEM-7311

    Sizes: Adult (22-42 cm)

    Validation Protocol(s): ANSI/AAMI/ISO 81060-2: 2009

     

  • Photograph of 7 Series® Wireless

    Omron

    7 Series® Wireless

    BP7350

    Alt names: HEM-7320

    Sizes: Adult (22-42 cm)

    Validation Protocol(s): ANSI/AAMI/ISO 81060-2: 2009

     

 

  • Photograph of Advanced Manual Inflate Blood Pressure Monitor

    A&D Medical

    Advanced Manual Inflate Blood Pressure Monitor

    UA-705

    Alt names: UA-705V, UA-704

    Sizes: Medium (23.8-36 cm), Large (36-45 cm)

    Validation Protocol(s): BHS Revised Protocol: 1993 *

  • Photograph of Bronze Upper Arm

    Omron

    Bronze Upper Arm

    BP5100

    Alt names: HEM-7311

    Sizes: Adult (22-42 cm)

    Validation Protocol(s): ANSI/AAMI/ISO 81060-2: 2009

     

 

 

 

 

 

  • Photograph of Complete™ Wireless

    Omron

    Complete™ Wireless

    BP7900

    Alt names: HEM-7311

    Sizes: Adult (22-42 cm)

    Validation Protocol(s): ANSI/AAMI/ISO 81060-2: 2009

     

 

  • Photograph of Gold Upper Arm

    Omron

    Gold Upper Arm

    BP5350

    Alt names: HEM-7311

    Sizes: Adult (22-42 cm)

    Validation Protocol(s): ANSI/AAMI/ISO 81060-2: 2009

     

 

  • Photograph of Platinum Upper Arm

    Omron

    Platinum Upper Arm

    BP5450

    Alt names: HEM-7311

    Sizes: Adult (22-42 cm)

    Validation Protocol(s): ANSI/AAMI/ISO 81060-2: 2009

     

 

 

  • Photograph of Silver Wireless

    Omron

    Silver Wireless

    BP5250

    Alt names: HEM-7320

    Sizes: Adult (22-42 cm)

    Validation Protocol(s): ANSI/AAMI/ISO 81060-2: 2009

     

 

  • Photograph of Talking+ Blood Pressure Monitor

    A&D Medical

    Talking+ Blood Pressure Monitor

    UA-1030T

    Alt names: UA-1020

    Sizes: Small (16-24 cm), Medium (23-37 cm), Large (31-45 cm), Smooth Fit (23-37 cm)

    Validation Protocol(s): BHS Revised Protocol: 1993 *

     

  • Photograph of ULTRACONNECT Wireless Blood Pressure Monitor

    A&D Medical

    ULTRACONNECT Wireless Blood Pressure Monitor

    UA-1200BLE

    Sizes: Integrated (22-42 cm)

    Validation Protocol(s): ANSI/AAMI/ISO 81060-2: 2009

     

 

 

  • Photograph of Welch Allyn Home® Blood Pressure Monitor, 1700 Series

    Hillrom-Welch Allyn

    Welch Allyn Home® Blood Pressure Monitor, 1700 Series

    H-BP100SBP

    Sizes: XS (15-24 cm), Standard (22-42 cm), XL (40-54 cm)

FDA flags 428 spinal cord stimulator patient deaths, urges more tests before implant

FDA flags 428 spinal cord stimulator patient deaths, urges more tests before implant

https://www.medtechdive.com/news/fda-flags-428-spinal-cord-stimulator-patient-deaths-urges-more-tests-befor/584714/

  • FDA on Thursday published a letter to healthcare providers outlining hundreds of reports of deaths and thousands of injuries and malfunctions with spinal cord stimulators, reminding physicians to follow product labels calling for a simulation in patients prior to permanently implanting the SCS devices.
  • Healthcare providers are supposed to trial the estimated 50,000 devices implanted each year from companies such as Abbott, Boston Scientific, Medtronic and Nevro to ensure they adequately relieve a patient’s pain. An agency review of 107,728 adverse event reports submitted in the last four years found 30,321 reports of unsatisfactory pain relief.
  • The warning comes after a June report from Public Citizen called for FDA to tighten how it regulates the devices, including requiring original PMA submissions for all new models and reassessing whether any approved devices should be removed from the market. Device Events is also among the organizations that have highlighted dangers with spinal cord stimulators. 

Dive Insight:

The labels on spinal cord stimulators are clear on the need for trial simulation periods: Materials from Abbott, Boston Scientific, Medtronic and Nevro state their devices are only for use in patients who received effective pain relief during trial stimulation. The companies also provide information on how to carry out these trial periods. Nevro, for example, provides pages of information for physicians on two different approaches to trial-phase implantation.  

Yet, FDA is concerned about compliance with the trial-phase requirement. After its dive into the data found 28% of MDRs cite “pain relief, inadequate” as a problem, FDA said the review “highlights the need for patients to undergo and demonstrate an adequate trial.” The next two most frequently cited Patient Problem Codes — “pain” and “therapeutic effects, unexpected” — also point to the possibility that some physicians may be implanting SCSs without performing trial periods. 

FDA also looked at the most frequently reported Device Problem Codes but appeared less concerned by the findings. “Charging problems” was the most commonly reported code, leading FDA to state the reports “are consistent with those expected with battery-powered stimulation devices intended for longer-term implantation and therapy.”

The 107,728 MDRs received by FDA in the four-year period following July 27, 2016, include reports of 428 individual deaths of patients implanted with SCSs between 2005 and 2020. Almost one-third of cases where times to event were available happened in the 30 days after implantation. Many of the patients had comorbidities and the average age was 69 years. FDA said MDRs often lack “enough information to establish a causal relationship between the device and the reported event.”

For now, FDA has limited its response to the data to a reminder of the need to trial SCS implants and recommendations for physicians about discussing the risks with patients and creating individualized follow-up plans for each recipient of a device. It also said it continues to evaluate the devices via mandated postmarket studies, medical literature and other sources.

But FDA’s steps don’t meet critics’ demands. Public Citizen’s June report detailed what it called FDA’s “dangerously lax oversight of high-risk implantable medical devices.” Public Citizen accused FDA of granting premarket approval to SCSs on the strength of studies of other devices, rather than prospective clinical trials of the implants being submitted for review.

In light of that evidence, Public Citizen called for FDA to move SCSs devices to a higher risk class. The Public Citizen report did not specifically mention the potential for harm due to a failure to follow the requirements on trial periods.