what’s your story ?

A chronic pain pt asked if I would share their story…

So I am not only going to share this pt’ story,  I have created a NEW TAB on the first page of my blog and will put links to pt’s stories who share in the future

If you have a story you want shared sent it to steve@steveariens.com

HELP — HELP — HELP

Every week, sometimes multiple of times a day… I get emails, FB messages, phone calls from chronic pain pts that are being denied care and their medically necessary medication… sometimes from a prescriber, some from a pharmacy/pharmacist, insurance/PBM.

I am about to take on the task of being CFO for the non profit American Pain & Disability Foundation, so there is going to be one more alligator in my swamp…and I am getting tired/bored with giving out the same/similar advise over and over… hopefully after I finish this post they will read it first and/or if they don’t read it first..  I can just answer their question with referring them to this post first with a hyperlink.

FIRST THE PHARMACY/PHARMACIST

I often get some cryptic message about them being denied their medication – and I am suppose to fill in the blanks and come up with a recommendation.  Often, I am just replying with the same/similar words that I have routinely typed to other pts.

If the pt is going to a chain store… and you have been getting your meds without problem for months or years and all of sudden they are getting stonewalled.. Most likely, there has been a change in the staffing in the Rx dept of that store or they have encountered  a “floating pharmacist” that is working there for a day or week… covering a sick employee, a vacation, a pregnancy leave.  Often these Pharmacists don’t know your prescriber, don’t know you and won’t bother to look at your Rx records at the store…  JUST SAY NO…

They know that the pt calls HQ, they will be told that they stand behind their pharmacist’s decisions – can’t make a pharmacist to fill a Rx… probably get the same answer from the board of pharmacy.  They could ask the Pharmacist to provide the clinical information that they made their decision on… but.. that would create a virtually Tsunami of paperwork.

Another “reason” … “I’m not comfortable”… maybe the pt should ask the pharmacist what clinical information that he/she is not comfortable about ? – IMO “I’m not comfortable” is an EXCUSE not based on few if any FACTS.

Then there is a “we are out of stock”… what the Pharmacist hopes that the pt doesn’t know that the DEA requires that every pharmacy keep a hard copy PERPETUAL INVENTORY… Maybe the pt should document the date/time of being told that the pharmacy is out of stock and send a request to the pharmacy board to ask the pharmacy to provide a copy of the perpetual inventory sheet for the particular medication/strength for the particular day/time…  Does the Board of Pharmacy consider LYING TO PTS UNPROFESSIONAL CONDUCT ?  If the Board won’t go as far as getting this information – then they apparently don’t.

The pt will probably be told that the Pharmacist has a “corresponding responsibility” which is in the control substance act of 1970…  Just have to make sure that the medication is being prescribed for valid medical reason…  IMO, corresponding responsibility should be a “two way street” … make sure that medication does not get into the hands of someone that really doesn’t have a valid medical necessity and make sure that the medication gets in the hands of someone that does have a valid medical necessity..  But Pharmacists don’t have access to the pt’s medical records – other than the Rxs they have filled at the store and/or pulled a state PDMP report…  Pharmacists don’t have the legal right, nor training, nor physical space,  nor time to do a physical exam…  If they have not called and talked to the prescriber.. the information that the Pharmacist has is fairly limited… so many use the term “corresponding responsibility” to JUST SAY NO. They turn this term into a ONE WAY STREET TO JUST SAY NO !!!

Other than the state of Alaska, I know of no pharmacists that have experienced any bad consequences for JUST SAYING NO !!

Perhaps, a pt – being denied their medication… share this chart with the Pharmacist… this chart shows the comorbidity complication of under/untreated pain and if a pt is intentionally thrown into cold turkey withdrawal those complications will come on very quickly and probably very intensively…  Think hypertensive crisis, stroke, death… how would that affect the pharmacist’s license ?

The quickest path for a pt to get their medication is to find a independent pharmacy … where the pt will be dealing with the Pharmacist/owner who tend to be less judgemental.. here is a website to locate one by zip code https://ncpa.org/pharmacy-locator

DENIAL FROM A PRESCRIBER

More and more prescribers are no longer in a private practice. Their practice has been sold to large hospital system and they are just an employee of that corporation and what they will/won’t prescribe is more likely being dictated by their corporate employer.

It is best if chronic pain pts are proactive when they are first told that they are going to participate in a involuntary forced reduction in their meds.  IMO… waiting until you are way down the path of reducing their doses… it is probably too late to back things up  Here is a post that I did a few months ago that should give the pt some direction of actions that they may be able to take http://www.pharmaciststeve.com/?p=35002

Insurance/ PBM problems/denials

Many insurance company will hire a PBM ( Prescription Benefit Manager) to handle the adjudication of Rx claims… they provide you the “drug card”. There are a handful of PBM’s that control the lion’s share of the market place.

If your insurance is thru your employer.. abt 50% of large employers are self insured that is referred to as an ERISA prgm – over seen by the Fed Labor Dept and insurance company is just an administrator to pay out your employer’s money for health claims for their employees and their families.  If you have this sort of “insurance” and you get denied…someone at your employer can just call up the insurance company and tell them to pay for your medications as your prescriber wrote for… after all it is your employer’s money that they are paying out.

If you are on Medicare or Medicaid… then you are probably dealing with a Part D Rx prgm… they have a three level appeal process.. they don’t have to tell you about the process unless you ask and then they have to give you the process in writing- today that is probably a website.  Be sure to meet the time limits of making the appeals… expect to get denied the first time because the same system/people that already denied it … is the one handling the appeal.. because a fair percent of pts getting denied will give up… after three denials there is a Administrative Law Judge (ALJ) again they have to tell you the process is writing… the very fact that you KNOW ABOUT the ALJ appeal level… may be enough to get them to cave… because they know that at least 50% get to this level will get approved.  Doesn’t cost the pt anything, and now a days… it is probably a ZOOM type meeting..  the pt doesn’t need an attorney… just needs to state way they need what was denied … it is a pretty straight forward process.

It is also good if the pt calls 800-MEDICARE or www.cms.gov and file a complaint against any provider for denying you care.

Any other kind of health insurance… you just have to ask what their appeal process is and if they don’t offer… ask for the details in writing… the more times you appeal … the more likely the pt will get a YES/APPROVED.

 

 

 

 

 

I reserve the right of editorial censorship

It looks like the political “mud slinging” has already started – IMO – worse than the national election two years ago… I am taking a stand – in particular – against “slanderous name calling”  directed toward specific politicians, particular political parties and/or specific people.  I don’t mind political debate – based on FACTS… when the debate drifts off the road based on FACTOIDS, FAKE NEWS, opinions stated as FACTS.. is where I am going to draw the “line in the sand” and delete comments that go down that path.

While personally, I am not a big fan of our political/bureaucratic system.. IMO.. it is too self serving… Admittedly, politically I tend to lean to the POLITICAL RIGHT but that is because the Libertarian party is seemingly always kept in their place by our dominating “two party system”.

I have belonged to a national pharmacy association for 35 yrs… that promotes the saying “get into politics … or get out of pharmacy ..” If you don’t attempt to influence politicians… someone else will…. and IMO this saying applies to those in the chronic pain community and/or pts who are dealing with subjective diseases.  Legislatures, bureaucrats are doing things that are adversely effecting the quality of life of those pts.  As long as those being affected continue to lack unity and/or a large segment chooses to stand on the sidelines, whoever is successfully “bending the ear” of these politicians … they will continue to do so because they have  little/no concern about the consequences and/or collateral damage that they cause to those suffering and dealing with subjective diseases.

I am sure that the vast majority of my readers will understand and cooperate…those who try to challenge this policy…  It is THREE STRIKES and you are out/banned… and WORDPRESS gives me your IP ADDRESS attached to your comment(s)… Once banned, just posting under a different name – WILL NOT WORK !  Everyone needs to “play nice “

Lastly, please do not post anything promoting a particular vendor or any entity or person selling a product/particular service. Because some may perceive/believe that they have my endorsement which may or may not be the case. Anyone posting a link to a professional selling a product/service will be edited out

While pts can’t get their Rxs in a timely manner at CVS ..this is how they help upper management unwind at DISNEY WORLD

The most recent quarter CVS reported abt a 3 BILLION net profit (pretax)… the above apparently is from a recent “upper echelon management” is REWARDED for helping CVS generate all those $$ in profits…

from the twitter post  The private John Legend concert CVS Health hosted (despite restrictive formularies, non-medical switching & denying patients medication access due to cost) was just the icing on the cake CVS leaders enjoyed this week in Orlando. Let’s take a peek at good times on patient dime…

study provided a clear picture of pain medication: to assist pharmacists in targeting deprescribing efforts geared at both patients and providers

Pain Management in Breast Cancer Outpatients

https://www.uspharmacist.com/article/pain-management-in-breast-cancer-outpatients

Pain is reported by 25% to 89% of breast cancer (BC) patients during the disease process. This pain, which may be due to disease progression, surgery, or drug treatment, can range from mild to severe and can be of short or long duration. Little is known about how this pain is managed in the outpatient setting.

A retrospective, administrative claims data study utilizing information from the National Ambulatory Medical Care Survey (NAMCS), which is a national probability cross-sectional sample survey of office-based medical care services, was conducted to examine pain management practices and the factors associated with the prescription of pain medications, especially opioids, in women with BC. The study analyzed NAMCS data obtained between 2011 to 2016.

Women aged 18 and older years were included in the study if—based on either International Classification of Disease-9 (ICD-9) or ICD-10 codes—BC was their primary diagnosis. The medications were classified using the American Hospital Formulary Service (AHFS) classification and included opioids, nonopioids (e.g., nonsteroidal anti-inflammatory agents, acetaminophen, salicylates), and combinations of both drug classes. Adjuvant analgesics included the anticonvulsants (e.g., barbiturates), antidepressants (e.g., selective serotonin reuptake inhibitors, serotonin norepinephrine reuptake inhibitors, tricyclic antidepressants), and corticosteroids.

Between 2011 and 2016, 23.95 million office visits were made by women with a primary diagnosis of BC. Of this group, over one-half (50.81%) were aged 40 to 64 years. One-third (32.81%) of visits occurred in the Northeast region, with almost all (95.65%) occurring in metropolitan areas. The vast majority of patients (83.7%) were identified as White. Most of these patients (84.93%) were seen in general and family practice settings. Depression and diabetes were the most common comorbidities.

During these visits, over one-quarter (27.12%, or about 6.5 million women) received pain medications. Among the total study population, 15.16% received opioids, 17.13% were prescribed nonopioid analgesics, and 22.7% received adjuvant therapies. Over one-tenth (10.27%) of patients received combination analgesics. Tramadol and oxycodone were the most prescribed opioids (3.75% and 1.57%, respectively). Ibuprofen, followed by naproxen, were the most prescribed nonsteroidal anti-inflammatory agents (3.73% and 1.27%, respectively). Benzodiazepines, followed by glucocorticoids, were the frequently prescribed adjunctive therapies (7.61% and 6.98%, respectively).

Factors significantly associated with the decreased prescribing of analgesics included residing in the Northeast as opposed to the West (odds ratio [OR] = 0.31, 95% CI -0.10 to 0.99), being White as opposed to Black (OR = 0.5, 95% CI 0.3-0.85) and being seen by nonprimary care physicians rather than primary care physicians (OR = 0.37, 95% CI 0.15-0.94). Being on Medicaid or other state-based payment programs as opposed to having private insurance (OR = 2.38, 95% CI 1.15-4.93), being prescribed adjuvant medications versus not receiving these agents (OR = 4.74, 95% CI 3.10-7.24), and visiting general or family practice specialties compared with other specialties (OR = 3.18, 95% CI 1.22-8.29) were associated with increased prescribing of pain medications.

The only two factors that were significantly associated with opioid prescribing were geography and medical specialty. Women living in the Northeast, Midwest, and South were 94-fold (OR = 0.06, 95% CI 0.01-0.29), 85-fold (OR = 0.15, 95% CI -0.04 to 0.62) and 76-fold (OR = 0.24, 95% CI 0.06-0.92) less likely to receive opioids than those residing in the West. General and family practice clinicians were significantly more likely to prescribe opioids compared with other disciplines (OR = 6.76, 95% CI 1.71-26.70).

This study provided a clear picture of pain medication usage among women with BC and can assist pharmacists in targeting deprescribing efforts geared at both patients and providers.

The content contained in this article is for informational purposes only. The content is not intended to be a substitute for professional advice. Reliance on any information provided in this article is solely at your own risk.

HHS, DOJ Issue Guidance to Eliminate Telehealth Discrimination

HHS, DOJ Issue Guidance to Eliminate Telehealth Discrimination

https://mhealthintelligence.com/news/hhs-doj-issue-guidance-to-eliminate-telehealth-discrimination

The federal agencies’ guidance provides examples of discrimination during telehealth visits and actions to ensure virtual care remains accessible to all.

 In honor of the Americans with Disabilities Act (ADA) anniversary, the US Department of Health and Human Services (HHS) worked with the US Department of Justice (DOJ) to publish new guidance that seeks to eliminate discrimination in the telehealth arena.

The COVID-19 pandemic has been accompanied by rapid expansions in healthcare access, particularly through the use of telehealth. Although telehealth is a valuable resource, discrimination does exist, leading to barriers to care. For example, research has shown that racial minorities, older age groups, and those living in rural areas use telehealth less frequently than their counterparts, and the digital divide further exacerbates disparities in virtual care access.

As 2022 marks 32 years since the introduction of the ADA, HHS and DOJ released guidance focused on federal nondiscrimination laws, including the ADA Section 504 of the Rehabilitation Act of 1973, Title VI of the Civil Rights Act of 1964, and Section 1557 of the Patient Protection and Affordable Care Act, and actions healthcare providers can take to ensure they are in compliance with these laws.

The guidance aims to ensure equitable care for those with disabilities, including people who are blind, deaf, or do not speak English proficiently. Blind people who seek out telehealth solutions may find that the modality does not contain screen reader software, and deaf people may have trouble engaging with an interpreter over telehealth. Those who are not fluent in English may struggle to seek and schedule an appointment. 

To curb discrimination, providers can take several actions, including making changes to their policies and practices to provide additional support for disabled people who wish to have a virtual visit, such as implementing sign language interpretation and language assistance services.

“It is critical to ensure that telehealth care is accessible to all, including patients with disabilities, those with limited English proficiency, and people of all races and national origins,” said Assistant Attorney General Kristen Clarke of the Justice Department’s Civil Rights Division, in a press release. “Federal civil rights laws protect patients from discrimination whether they receive health care online or at the doctor’s office. The Department of Justice will vigorously enforce the ADA and other civil rights laws to ensure that health care providers offering telehealth services are doing so free from discrimination.”

HHS and DOJ also said that people can file complaints if they feel they are a victim of telehealth discrimination.

Complaints related to ADA violations are common and can occur when treating various conditions.

In May, AIDS Alabama and CHLPI claimed that Alabama Medicaid did not provide hepatitis C treatment for those struggling with substance use disorders. While filing the complaint, the organizations defended their argument by pointing out that Alabama Medicaid is in violation of the ADA.

7 healthcare takeaways from Senate Democrats’ newly passed $739B landmark bill

7 healthcare takeaways from Senate Democrats’ newly passed $739B landmark bill

https://www.beckershospitalreview.com/finance/7-healthcare-takeaways-from-senate-democrats-newly-passed-739b-landmark-bill.html

With a 51-50 vote, Senate Democrats passed a sweeping $739 billion bill Aug. 7 that furthers some of the largest changes to healthcare in years.

Titled the Inflation Reduction Act, the bill touches energy, tax reform and healthcare. The House is expected to take it up Aug. 12, with Democrats aiming to approve it and send it to President Joe Biden’s desk.  

Here are seven healthcare takeaways from the 755-page bill

Drug pricing

1. For the first time, Medicare would be allowed to negotiate the price of prescription medicines with manufacturers. Negotiation powers will apply to the price of a limited number of drugs that incrementally increases over the next seven years. Ten drugs will be eligible for negotiations beginning in 2026; eligibility expands to 15 drugs in 2027 and 20 by 2029. 

2. The HHS secretary will provide manufacturers of selected drugs with a written initial offer that contains HHS’ proposal for the maximum fair price of the drug and reasoning used to calculate that offer. Manufacturers will have 30 days to either accept HHS’ offer or propose a counteroffer.  

3. Members of Medicare Part D prescription drug plan would see their out-of-pocket costs for prescription drugs capped at $2,000 per year, with the option to break that amount into monthly payments, beginning in 2025.

4. Democrats lost on a provision to place a $35 cap on insulin for Americans covered by private health plans. The provision to cap insulin at $35 dollars for Medicare enrollees passed by a of 57-43. 

5. Drug companies will be required to rebate back price differences to Medicare if they raise prices higher than the rate of inflation, coined an “inflation rebate.”

6. The legislation makes all vaccines covered under Medicare Part D free to beneficiaries with no deductibles, co-insurance or cost-sharing, starting in 2023. 

Tax subsidies 

7. The legislation extends the Affordable Care Act’s federal health insurance subsidies, now set to expire at the end of the year, through 2025. Democrats say the extension will prevent an estimated 3.4 million Americans from losing health coverage.

This can be a slippery slope to what Congress can control… Did they only mandate $35/month price limit ONLY ON INSULIN PAID FOR BY Medicare Part D and part  C, maybe because it would be a bad political move – and possibly unconstitutional – to tell private insurance companies and the three pharmas that produce insulin… in what they can charge for a product.

The PBM industry claims that they “negotiate” with pharmacies on what they will be paid to fill prescriptions and that industry controls about 90%+ of the FOUR BILLION Rxs that are filled in the USA.  Their action of  “negotiating ” with pharmacies is actually a “take it or leave it” contract. In the end the pharmacy is told to sign/take the contract offered or we will make sure that most of your pts will end up having their Rxs filled at one or more of your competitors.

The play a similar game with the Pharmas,  the pharmas are told if you want your brand name med on their approved formulary, you will pay the PBM a certain percent – claimed to be up to 75% of the AWP (Average Wholesale Price) otherwise the PBM will be require that to get their med paid for will require a PA (prior authorization) and everyone knows that the PBM will suggest to the prescriber a therapeutic alternative that doesn’t require a PA for the pt to get some medication for their health/medical needs.

This year, I ran into a problem with Humana Part D that they would only pay for a particular generic pharma med, even though on their website, they state that the generic is “covered”, HOWEVER, paying CASH for the med was $15.00 LESS than my copay would have been unless a particular pharma’s generic was dispensed.  Where was that extra $15.00 going ?… Probably into Humana’s bottom line, because the rebate/discount/kickback to Humana from the pharma was greater than the generic that my pharmacy stocked and wanted to fill and bill Humana.

If Congress can dictate what a manufacturer can charge for this particular product (Insulin) what will prevent Congress – other than a lot of lawsuits – from telling untold number of manufacturers, retailers and others are allowed to charge for their products and/or how much gross/net profit  a business could legally allowed to make.  Are we on a path for Congress to attempt to nationalize many large businesses…the next step towards socialism ?

 

Minnesota is among the first states to address the unintended consequence of CDC opioid guidance from 2016


 

Minnesota is among the first states to address the unintended consequence of CDC opioid guidance from 2016

https://www.kare11.com/article/news/local/breaking-the-news/law-could-be-life-saving-for-chronic-pain-patients/89-b22f2aba-667d-42cb-877d-20c3eb70efd3

LAKEVILLE, Minn. — On August 1, a change to a Minnesota state statute regarding opioid prescribing quietly ushered in a change that could be life-saving for people who suffer of severe, chronic pain. 

The change addresses issues that arose from the 2016 CDC Guideline for Prescribing Opioids for Chronic Pain. While the guideline was “intended to improve communication between providers and patients,” it had an unintended consequence for sufferers of intractable pain. It led to dosing restrictions and tapering of the only medication that worked for them.

“This is severe, unrelenting, incurable pain, where other medications have not worked as well or don’t work at all,” said Cammie LaValle, who suffers from complex regional pain syndrome. “It is an incurable, rare disease, rare condition. It is systemic, and at one point I was using a wheelchair, I was begging for amputation of my arm and my leg, because the pain is that severe.”

“It is considered one of the suicide pains,” said Dr. Todd Hess, who has worked in pain management for more than 30 years. “It is very difficult to treat, and it’s what I specialize in.”

Technically, Dr. Todd Hess is recently retired from that specialty, and says it’s a direct result of the impact the CDC guideline had on his ability to treat patients.

 “It felt like I couldn’t do my job any more,” Dr. Hess said. “The 2016 CDC guideline had good intentions, I believe, at the start, but it was not meant to be anything more than a guideline.”

The guideline featured specific numeric thresholds for opioid prescribing, which were later adopted widely and used in regulations and state laws to police opioid prescribing.

“Pain doctors were literally being investigated,” Dr. Hess said. “I mean, I’ve been investigated numerous times and luckily they’ve all come out in my favor because we’ve done the right thing, and that has sent a chilling effect to the medical community.”

And that left Cammie and many other patients out in the cold.

During a hearing in the Minnesota Senate this spring, Laura Johnson, a chronic pain patient, provided emotional testimony of her own struggles.

“I have suffered with chronic pain for over 20 years. I have MS and a deformed spine,” Johnson said. “I can no longer sit, I can’t sleep and I can’t walk. I don’t have a pain doctor anymore. I got dumped because he was so afraid of the fear of the DEA and the guidelines.”

Johnson said she represented just one of many patients who were no longer able to share their stories.

“Many have turned to the streets out of desperation,” she said. “Many more have ended their lives.” 

Both the Minnesota Medical Association and American Medical Association backed up that patient testimony, sending letters in support of the bill.

“For too many years, patients with pain have suffered because of inflexible, numeric thresholds on opioid therapy,” wrote Dr. James Madera, CEO of the AMA.

But thanks to the advocacy, led by Cammie, there is finally hope. The revised statute changes Minnesota law in several ways:

Provides new or updated definitions for intractable pain, drug diversion, palliative care, rare disease and establishes criteria for the evaluation and treatment of intractable pain when treating non-terminal and terminal patients.

  • No physician, advanced practice registered nurse, or physician assistant shall be subject to disciplinary action by the Board of Medical Practice or Board of Nursing for appropriately prescribing or administering a controlled substance in Schedules II to V of section 152.02 in the course of treatment of a patient for intractable pain, provided the physician, advanced practice registered nurse, or physician assistant keeps accurate records of the purpose, use, prescription, and disposal of controlled substances, writes accurate prescriptions, and prescribes medications in conformance with chapter 147 or 148 or in accordance with the current standard of care.
  • No physician, advanced practice registered nurse, or physician assistant, acting in good faith and based on the needs of the patient, shall be subject to disenrollment or termination by the commissioner of health solely for prescribing a dosage that equates to an upward deviation from morphine milligram equivalent dosage recommendations or thresholds specified in state or federal opioid prescribing guidelines or policies, including but not limited to the Guideline for Prescribing Opioids for Chronic Pain issued by the Centers for Disease Control and Prevention and Minnesota Opioid Prescribing Guidelines.
  • Prohibits a prescriber from tapering a patient’s medication dosage solely to meet a predetermined dosage recommendation or threshold if the patient is stable; is experiencing no serious harm from the level of medication prescribed, and is in compliance with treatment plan and patient-provider agreement.
  • No pharmacist, health plan company or pharmacy benefit manager shall refuse to fill a prescription for an opiate issued by a licensed practitioner authorized to prescribe opiates solely based on the prescription exceeding a predetermined morphine milligram equivalent dosage recommendation or threshold.
  • Requires the prescriber and patient to enter into an agreement that includes the patient’s and prescriber’s expectations, responsibilities, and rights according to the best practices and current standard of care with agreement to be signed by the patient and the prescriber, and a copy of the agreement included with the patient’s medical record and a copy to the patient, to be reviewed at least annually and when there are any changes to treatment plan.
  • Absent clear evidence of drug diversion, nonadherence with the agreement must not be used as the sole reason to stop a patient’s treatment with scheduled drugs.

“Opioids are not for everybody, and this is not a pro-opioid bill at all,” Dr. Hess said. “It’s a doctor/patient relationship bill, where patients and doctors and nurse practitioners and PA’s will have a safe zone to do it properly. We know this is dangerous, but we also know not treating pain is dangerous too.”

“It will hopefully protect patients like me, and worse off than me,” Cammie said. “There are people actively dying right now that don’t have access to medications because their oncologist are afraid to prescribe.”

I did a word search of this text for “DEA” and it only appeared ONCE…  “It will hopefully protect patients like me, and worse off than me,” Cammie said. “There are people actively dying right now that don’t have access to medications because their oncologist are afraid to prescribe.”

Does this mean, that if any entity – like the DEA or VA system – decides to impose some daily MME system limit as to a pt’s daily dose.. will this law back the prescriber’s belief as to what the pt’s valid medical needs are. Could a insurance/PBM company does not impose a limit, just refuses to pay for a particular med or category of meds or refuse to pay for any Rx above a certain MME.

DEA Policy Reversal on Allowed Prescription Annotations for Schedule II Prescriptions

here is a post I did recently and I am not sure what the DEA is up to with information contained in the letter in this post,  but I suspect that it has something to do with prescribers sending out controlled med Rxs that is missing a “i” being dotted and/or a “t” being crossed.  Could the DEA start collecting data on such prescribers and could they determine that a particular prescriber is sending out controlled med Rx and track data on such prescribers and could they look to such a prescriber as providing “illegal Rxs” because of those “i’s” not dotted or “t’s” not crossed.  Here is a post : Supreme Court hearing for the Doctors Xiulu Ruan, MD and Shakeel Kahn, MD

Where the SCOTUS with a 9-0 vote decided that the DEA had been using OBJECTIVE CRITERIA to judge prescribers treating pts dealing with SUBJECTIVE DISEASES and it was ILLEGAL for the DEA to do so… Could this be what the DEA is going to use as “go around” to what they have used in the past to “take prescribers down” ?  Only time will tell, but this SCOTUS decision maybe a good example the path the chronic pain community needs take to get some better pain management… and that would mean using law firms.

Insurance denies pt’s therapy: because the insurance company guidelines are out-of-date

AITA for Pointing Out to the Insurance Company That I’m the Expert on My Patient?

https://www.medscape.com/viewarticle/976690

I (48, F) had to do one of those “peer-to-peer” calls with an insurance physician (undisclosed-age, M). I know, it’s a commonplace task now, what’s the big deal, etc., but let me explain.

From the start of the conversation, tons of red flags. First of all, he won’t tell me what specialty he is. And I’m like, “Okay, that’s kind of weird, but can you at least tell me if you’re an oncologist?” Then he asks, “Why does that matter?” So I say, “It matters a lot because I’m an oncologist and this is about a person with cancer. It’s literally a matter of life and death because your insurance company denied their cancer treatment.”

He finally says, “No,” he’s not an oncologist.

“So then, what’s your specialty?” I ask.

He clears his throat and says he isn’t allowed to say. Then he reminds me that this call is being recorded for quality assurance purposes.

“Excellent,” I say. “Then it’s being recorded that you’re the one obstructing my patient’s access to lifesaving treatment.”

Then he says there’s no reason to be rude and calls me “Miss.” I ask him to please refer to me by my title of “Dr,” and he drops the “Miss” but instead starts using my first name as if we’re old friends or something.

At this point, I’m not making any progress in getting my patient’s medication approved, so I let the first name/untitling go and ask him to explain why the insurance company denied the medication (let’s call it X).

I hear him shuffling papers, and then he says it’s because we didn’t try medication Y yet.

I tell him it’s correct that medication Y used to be the standard-of-care first-line therapy, but as of 6 months ago, the FDA approved medication X as the more effective therapy. I explain to him the insurance company guidelines are out-of-date. Any board-certified oncologist would know this. Which he, inconveniently, is not.

Then he tells me there’s often a lengthy delay in updates to company guidelines, which he can’t control. To which I respond, “That’s why I, as the patient’s doctor, should be in charge of what treatment is approved,” not him or the insurance company.

He says he doesn’t disagree with me, but it’s not in his power to approve it. Because the company hasn’t updated its guidelines, I’ll have to talk to an oncologist at the insurance company to get an override.

It seems obvious to me it would have made more sense to do that in the first place, but in the interest of time, I keep this comment to myself and tell him, “Fine, please transfer me to their oncologist.”

Then he says, “Oh no, I can’t do that. You’ll have to set up another phone call.”

At this point, I’ve had another patient in an exam room waiting for over 15 minutes so I ask him to please hurry and set that up.

I hear papers shuffling again, and he says they can set me up for that phone call at 4:42 AM the next day.

When I ask for a more reasonable time, he says because they’re in a different time zone, that’s all they can offer, and if I don’t take that time, then my patient’s case will be closed, and I’ll have to start all over with the appeal from the beginning — which means talking to someone like him again.

Because there’s no real choice, I take the offered time. The following morning, the insurance oncologist immediately approves medication X.

So AITA for pointing out that if the insurance company had trusted that I, as a board-certified oncologist, was doing the right thing for my patient from the get-go, we could have saved everyone a lot of time and frustration (and sleep)?

Their response? “This call is being recorded for quality assurance purposes.”

Americans Have No Right to Healthcare

Americans Have No Right to Healthcare

— It’s high time we change that

https://www.medpagetoday.com/opinion/second-opinions/96938

A photo of a woman outdoors with a sign which reads: Healthcare is a human right
The United Nations’ Universal Declaration of Human Rights, signed in 1948, set up the framework that healthcare is a human right. Article 25 of the document stated that, “everyone has a right to standard of living adequate for the health and well-being of himself and his family including…medical care and necessary social services, and the right to security in the event of unemployment, sickness, disability, widowhood, old age or other lack of livelihood in circumstances beyond his control.”

President Franklin D. Roosevelt previewed these sentiments in his State of the Union Address where he described the four freedoms. The first two, freedom of speech and freedom of religion, are codified in our First Amendment. But the third and fourth, freedom from fear and freedom from want, remain nebulous in our view. And nowhere in our nation’s founding documents does it explicitly state that Americans are entitled to have access to a physician or any form of medical treatment.

Some people might interpret the values espoused in the Declaration of Independence, with its notion of inalienable rights to “Life, Liberty, and the pursuit of happiness,” as denoting that “life” equals an explicit right to healthcare. This is simply not a reality in America.

The preamble to the Constitution mentions providing for the “general welfare.” Could this be recognition enough that healthcare is a right for the individual? No, for one’s individual welfare does not necessarily equate to the general welfare. Although there have been Constitutional Amendments proposed in the past — most recently by Rep. Betty McCollum (D.-Minn.) — as yet, there is no enumerated U.S. right to healthcare.

But, you may ask, doesn’t a pregnant woman have the right to choose whether or not to have an abortion? Isn’t that a right to healthcare? Yes, the Roe v. Wade decision determined that this form of healthcare is legal. However, the Supreme Court based their decision on an individual’s right to privacy in their medical decision making. It did not stem from a right to healthcare.

But, others may say, the emergency department is open to all — doesn’t that mean Americans have a right to healthcare? Unfortunately, the 1986 Emergency Medical Treatment and Labor Act (EMTALA), which made access to emergency care a right for all Americans, is exceedingly limited in scope. It only guarantees treatment for life and limb threatening conditions and treatment of women in labor. It does not guarantee treatment for chronic conditions such as high blood pressure or heart disease. It does not cover cancer care. Moreover, one must ask if a single, limited law could be construed as a right.

Senior citizens have a right to healthcare once they age into the Medicare program. More recently, Americans with specific diseases, such as end stage renal disease and Lou Gehrig’s disease have this right to healthcare extended to them. But as simple laws, the right to emergency care, to care for seniors, and for those with certain deadly conditions could easily be ripped away. A future Congress could repeal these laws if it chose to do so.

It wouldn’t be the first time. We have seen that health laws, such as the Medicare Catastrophic Coverage Act of the late 1980s, can easily be repealed. Other laws, like the Affordable Care Act, show that a single law can be sabotaged whenever a political party has control of both Congress and the White House. And the will of the people can be ignored by dithering politicians who intransigently refuse to implement lawful extensions of healthcare. As just one example, this occurred in Maine in 2018, when the former Governor failed to execute a Medicaid expansion ballot initiative approved by the state’s citizens.

All our patients desire is a chance to be healthy and to keep their families healthy. Should they not be allowed to do this without squandering their life’s savings or risking bankruptcy? Since the 1940s, following the defeat of Nazi Germany, our country has made bold steps towards securing this human right to healthcare and making Americans free from want.

If nothing else, this last year showed us that moving toward the right to healthcare for all is possible. With the federal government ensuring access to COVID-19 testing and vaccinations, everyone in this country had a right to the most aggressively developed medical care the world has ever seen. The pandemic has shown us what we can do when we recognize that an individual’s welfare actually is dependent upon the general welfare. So, although an explicit right to healthcare does not formally exist in the U.S. for all people regardless of age or medical condition, the past 2 years have revealed why every American should be assured of that right.

America must make the healthcare of its citizens a protected right. As difficult as it may be in these polarized times, the U.S. needs a Constitutional Amendment to guarantee healthcare as a right. Anything less would fall short of the needs of everyday Americans. Until then, in America, healthcare is not a right. But its high time we change that.

Democrats’ New Drug Pricing Bill Will Jack Up Prices For Americans, CBO Finds

Democrats’ New Drug Pricing Bill Will Jack Up Prices For Americans, CBO Finds


below is a graphic of where the majority of the $$$ paid at the pharmacy register goes and here is what Congress has negotiated on the NUMBER OF MEDICATIONS that price negotiations can be done on  The number of negotiated drugs would be limited to 10 Part D drugs in 2026, 15 Part D drugs in 2027, 15 Part B and Part D drugs in 2028, and 20 Part B and Part D drugs in 2029 and later years.   More information is available in this hyperlink  https://dailycaller.com/2022/08/05/democrats-drug-pricing-cap-bill-cbo-manchin-sinema-schumer-medicare/     and NO ONE will see any savings for over THREE YEARS from now, and reaching a total of 20 meds AT THE END OF THE DECADE.  Since all Medicare meds are covered under Part D and/or Medicare-C and those are provided by FOR PROFIT insurance companies and these major insurance companies also own various PBM entities. Barb has been on Medicare Part D since it started in Jan 2006. So many promises over the years as to what was going to happen and never came to fruition, kind of reminds me of Charlie Brown and Lucy    

Democrats’ landmark new drug pricing legislation could actually result in an initial increase in drug prices, according to information released Thursday by the Congressional Budget Office (CBO).

The non-partisan CBO reported that the legislation, which places a cap on price increases so they cannot go up faster than inflation, could lead drug companies to raise launch prices of new drugs to make up the difference. The CBO also said that allowing Medicare to negotiate certain drug prices directly would contribute, albeit not as much, to higher prices.

 

The possibility that pharmaceutical companies will counteract the inflation-linked price cap by simply raising starting prices will undercut some messaging in favor of the bill, which Democrats argue will rein in major corporations allegedly price-gouging Americans for necessary medicine. (RELATED: ‘This Is An American Bill’: Joe Manchin Defends New Reconciliation Package)

The price cap provision of the bill has garnered bipartisan support in the past. The Medicare price negotiation is a far more contested aspect of the overall policy. Democrats are including the drug pricing reforms in the major reconciliation package slated to hit President Joe Biden’s desk in early August after it goes before the Senate on Saturday. The package also includes provisions aimed at addressing climate change and out-of-control inflation that has dogged the Biden administration and Democrats for months.

The bill had been stalled until Democratic West Virginia Sen. Joe Manchin recently gave his endorsement to move forward.

Vanderbilt should lose Magnet status over RaDonda Vaught’s treatment, nurses say

Vanderbilt should lose Magnet status over RaDonda Vaught’s treatment, nurses say

https://www.beckershospitalreview.com/nursing/vanderbilt-should-lose-magnet-status-over-radonda-vaught-s-treatment-nurses-say.html

Some nurses are urging the American Nurses Credentialing Center not to renew Vanderbilt University Medical Center’s Magnet designation, arguing that the hospital’s response to RaDonda Vaught’s fatal medication error and conviction do not align with the program’s mission to create an environment where nurses flourish.

Nashville, Tenn.-based Vanderbilt University Medical Center is applying for redesignation of its Magnet designation for Vanderbilt University Hospital’s adult enterprise and must undergo a site evaluation this month, according to a public notice posted on the organization’s website.

The credentialing center’s Magnet recognition program commends hospitals for their excellence in nursing services. Vanderbilt has received the designation in 2006, 2012 and 2017.

In 2017, Ms. Vaught made a fatal medication error while working as a nurse at Vanderbilt, for which she was sentenced to three years of probation in May after being found guilty of criminally negligent homicide and abuse of an impaired adult. 

Ms. Vaught immediately took responsibility for the error, which occurred after she overrode a medication cabinet, but contends that other factors and working conditions for nurses at the medical center contributed to the mistake. For example, she said that Vanderbilt directed nurses to use overrides to overcome cabinet delays and regular technical issues caused by an ongoing overhaul of the hospital’s EHR system. Vanderbilt fired Ms. Vaught in January 2018, and the Tennessee Board of Nursing stripped her of her license in 2021.

“So many things had to line up incorrectly for this error to have happened, and my actions were not alone in that,” Ms. Vaught told ABC News in May. In 2018, Vanderbilt shared a plan of correction with CMS to address deficiencies identified in a federal investigation after the fatal error.

Ms. Vaught’s case has spurred an outcry from nurses across the country, many of whom have expressed concerns about the likelihood of similar mistakes under increasingly difficult working conditions. 

Now, nurses from across the U.S. are penning letters to the credentialing center ahead of Vanderbilt’s site visit, saying the organization should not allow the hospital to keep its Magnet designation. 

“The mission of the Magnet Recognition Program is to ‘continually elevate patient care around the world in an environment where nurses flourish,'” Jenna Lukis, BSN, RN, wrote in emailed comments to the credentialing center, which she shared Aug. 2 in the Nurses March for RaDonda’s Law Facebook group. “With their actions in 2017 and their inaction in 2022, VUMC has demonstrated to the entire country that their hospital does not align with this mission.”

Ms. Lukis’ post garnered more than 30 comments, many from nurses who said they had also sent letters to the credentialing center about Vanderbilt’s Magnet status. The deadline to submit comments is Aug. 6. 

Vanderbilt did not immediately respond to Becker’s request for comment.

EU Says Novavax COVID Shot Must Carry Heart Side Effect Warning

EU Says Novavax COVID Shot Must Carry Heart Side Effect Warning

https://www.medscape.com/viewarticle/978527

LONDON (Reuters) -The European Medicines Agency (EMA) is recommending Novavax’s COVID-19 vaccine carry a warning of the possibility of two types of heart inflammation, an added burden for a shot that has so far failed to win wide uptake.

The heart conditions – myocarditis and pericarditis – should be listed as new side effects in the product information for the vaccine, Nuvaxovid, based on a small number of reported cases, the EMA said on Wednesday.

Novavax said no concerns about heart inflammations were raised during the clinical trials of Nuvaxovid and that more data would be gathered, adding that the most common cause of myocarditis is viral infections.

“We will work with the relevant regulators to assure our product information is consistent with our common interpretation of the incoming data,” U.S. vaccine developer Novavax added.

In June, the U.S. Food and Drug Administration flagged a risk of heart inflammation from the Novavax vaccine.

Myocarditis and pericarditis were previously identified as rare side effects, mostly seen in young men, from groundbreaking messenger RNA (mRNA) vaccines made by Moderna and the Pfizer and BioNTech alliance, with the vast majority of those affected recovering fully.

The EMA said on Wednesday it had asked Novavax to provide additional data on the risk of these side effects.

Last month, the EU agency identified severe allergic reactions as potential side effects of the vaccine.

Novavax was hoping that people who have opted not to take Pfizer and Moderna’s vaccines would favour its shot because it relies on technology that has been used for decades to combat diseases including hepatitis B and influenza.

However, only around 250,000 doses of Nuvaxovid have been administered in Europe since its launch in December, according to the European Centre for Disease Prevention and Control.

(Reporting by Natalie Grover in London and Ludwig Burger in Frankfurt, additional reporting by Michael Erman in New York; editing by Jason Neely, Emelia Sithole-Matarise and Alexander Smith)

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