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.

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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.

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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 ?

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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

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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.”

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Americans Have No Right to Healthcare

— It’s high time we change that

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

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.

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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    

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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.

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EU Says Novavax COVID Shot Must Carry Heart Side Effect Warning

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

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https://www.pharmaciststeve.com/supreme-court-hearing-for-the-doctors-xiulu-ruan-md-and-shakeel-kahn-md/

https://www.pharmaciststeve.com/dea-policy-reversal-on-allowed-prescription-annotations-for-schedule-ii-prescriptions/

If you listened to the above video and heard the retired pharmacist/chronic pain pt stating that all of his correspondence with bureaucrats/politicians seems to have “fallen on deft ears”.

Over 5 decades ago,  the feds/DEA declared that marijuana had NO VALID MEDICAL VALUE… yet 40 +/- states have legalized MJ in some form or another and Chuck Schumer (an attorney) is starting a “discussion” within Congress to get MJ taken off of the controlled substance act. https://nypost.com/2021/07/14/schumer-drafts-pot-legalization-bill-despite-biden-opposition/  but – of course – they are going to tax the crap out of every level in MJ distribution system from growing to sales…   but many states that had legalized MJ and taxed the crap out of it, have found that they have created a “good market” for the drug cartels to produce and sell non-approved MJ  https://nypost.com/2022/07/26/chuck-schumers-over-taxed-marijuana-bill-would-only-aid-illegal-dealers

Likewise, decades ago the FEDS/DEA declared that Psychedelic drugs had not valid medical necessity but now there is https://psychedelicspotlight.com/5-psychedelic-clinical-trials-2022-maps-mdma-psilocybin-ketamine-lsd-dmt/      No one has to look far to see how serious a mental health problem our country has.  Has this reality caused the FEDS/DEA to pull back on their “no valid medical use” on psychedelic drugs and remove it from being a C-I on the DEA’s controlled substance list.

Different states have passed and/or proposed some sort of tax on pharma Rx opiates  like NY, NJ, Delaware. & Minnesota.  In some states, as NY , which exempted Morphine, Methadone & buprenorphine from the tax.  Pts are finding pharmacies that no longer stock their opiate medications,  wholesalers not longer shipping opiates into NY and some manufacturers are no long shipping opiates into NY.  https://www.usnews.com/news/best-states/articles/2020-11-17/patients-struggle-to-find-prescription-opioids-after-new-york-tax-drives-out-suppliers  Senator Manchin has tried on several occasions to get a federal tax law on opiates passed and each time they have failed.

Will opiates eventually go down the same path as alcohol, tobacco, gambling… all having some potential for addiction, will become acceptable when the bureaucrats can find a way to put a excise/sin tax on opiates will make them socially acceptable and everyone will turn a blind eye/deft ear to whatever problems that results within our society ?

When is the chronic pain community figure it out that writing letters/emails and making phone calls to your member of Congress only to get – if you get a response  – that may or may not have anything to do with what you contacted your representative about ?  Lobbying Congress is probably not a viable idea, because collectively the lobbying industry spends 9+ million a day to lobby the 535 member of Congress to something that the businesses that hires lobbyists wants to be done.

If anyone notices, when any of the states are unhappy with what the Feds do, they end up filing a lawsuit. It is claimed that typically 40% of Congress is attorneys and the DEA is part of the DOJ – again with wall to wall attorneys.  If/when the CDC published the final document of their 2022 opiate dosing guidelines and many entities see the 50 MME lists dozens of times in the 211 page document and start implementing that as a new “standard of care and best practices” that all prescribers should follow on all chronic pain pts.  What is the community going to do… more letters/emails/phone calls to their member of Congress ?

Einstein defined insanity years ago… doing the same thing over and over and expecting a different outcome….

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