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$21B opioid settlement is ‘disrupting patient care,’ APhA CEO says

https://www.beckershospitalreview.com/pharmacy/21b-opioid-settlement-is-disrupting-patient-care-apha-ceo-says.html

A $21 billion settlement between 46 attorneys general and three pharmaceutical distributors — AmerisourceBergen, Cardinal Health and McKesson — may be leading to more drug supply issues, The New York Times reported March 13. 

The settlement was intended to tweak former allowances and diminish the nation’s pile of unnecessary prescription painkillers, which helped fuel the opioid epidemic. This tighter leash didn’t just corral opioids, though: Some anxiety, attention-deficit/hyperactivity disorder and addiction medications are now harder to access, according to the Times. 

Because the agreement included multiple controlled substances that could become addictive, including muscle relaxants and Xanax, tens of thousands of drug orders have been canceled. 

As part of the settlement, these distributors have to set monthly caps to some controlled substances, meaning pharmacies cannot order more of these drugs if their supplier already reached its limit — even if patients come in needing a refill. 

Ilisa Bernstein, PharmD, interim CEO of the American Pharmacists Association, told the Times that the new rules, which took effect in July, have led to “havoc” in some pharmacies.

“They have patients coming in to get medication, and they can’t have it,” Dr. Bernstein said. “It’s disrupting patient care.”

Cardinal Health and McKesson did not respond to the outlet’s requests for comment, but AmerisourceBergen told the Times it is waiting on guidance from the government to block misuse of “these drugs without interfering with good-faith clinical decisions made by doctors.”

Why this Pennsylvania city called the proposed $21B opioid settlement ‘unacceptable’

How many times can the bureaucrats “take” profits from companies that are selling legal products ?  Remember the Tobacco settlement in 1999 +/- ?  that only involved the manufacturers of tobacco products… with this settlement 46 states are “confiscating” the profits of the three major USA wholesalers.

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FOR IMMEDIATE RELEASE
April 5, 2023

Contact: CMS Media Relations
CMS Media Inquiries

HHS Finalizes Rule to Strengthen Medicare, Improve Access to Affordable Prescription Drug Coverage, and Hold Private Insurance Companies Accountable to Delivering Quality Health Care for America’s Seniors and People with Disabilities

Thanks to President Biden’s new law to lower prescription drug costs, the final rule will also improve access to affordable prescription drug coverage for an estimated 300,000 low-income individuals

Today, the U.S. Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS), is finalizing a rule to put people with Medicare first and put strong protections in place so that Medicare Advantage (MA) works for them. This final rule will strengthen Medicare Advantage and hold health insurance companies to higher standards for America’s seniors and people with disabilities by cracking down on misleading marketing schemes by Medicare Advantage plans, Part D plans and their downstream entities; removing barriers to care created by complex coverage criteria and utilization management; and expanding access to behavioral health care. The new rule will also promote health equity, and implement a key provision of the Inflation Reduction Act—President Biden’s new law to lower prescription drug costs—that will improve access to affordable prescription drug coverage for an estimated 300,000 low-income individuals.

The Biden-Harris Administration is committed to protecting and strengthening Medicare for the 65 million people with Medicare today and for future generations. In the past few months, the Department has taken a series of actions to ensure the Medicare Advantage program works for people with Medicare and that private insurance companies are held accountable for providing quality coverage and care:

In February, CMS finalized a rule to start recovering improper payments made to Medicare Advantage plans through audits for the first time since 2007. Recovering these improper payments and returning this money to the Medicare Trust Funds will protect the fiscal sustainability of Medicare and allow the program to better serve seniors and people with disabilities, today and in the future.
Last week, CMS finalized policies in the 2024 Medicare Advantage and Part D Rate Announcement to improve payment accuracy and ensure taxpayer dollars are appropriately safeguarded and well-spent.

“At HHS, we put seniors and people with disabilities first,” said HHS Secretary Xavier Becerra. “That is exactly what we are doing today. In our latest effort to strengthen Medicare and hold insurance companies accountable, we are putting protections in place so that Medicare Advantage works for beneficiaries and they get the quality care they deserve. We will continue our efforts to deliver on the President’s vision to strengthen this program for the millions of people with Medicare and for future generations to come.”

“The Biden-Harris Administration has made exceptionally clear that one of its top priorities is protecting and strengthening Medicare,” said CMS Administrator Chiquita Brooks-LaSure. “With this final rule, CMS is putting in place new safeguards that make it easier for people with Medicare to access the benefits and services they are entitled to, while also strengthening the Medicare Advantage and Part D programs.”

“People with Medicare deserve to have access to accurate information when making coverage choices, and to be able to get the care they need without excessive burden or delays,” said Dr. Meena Seshamani, CMS Deputy Administrator and Director of the Center for Medicare. “The commonsense policies in this rule further our goals to advance health equity, improve access to care, and drive high-quality, whole-person care.”

Cracking Down on Misleading Marketing Schemes

The final rule includes changes to protect people exploring Medicare Advantage and Part D coverage from confusing and potentially misleading marketing practices. Ads will be prohibited if they do not mention a specific plan name, or if they use the Medicare name, CMS logo, and products or information issued by the Federal Government, including the Medicare card, in a misleading way. Further, the final rule strengthens accountability for plans to monitor agent and broker activity.

Removing Barriers to Care Created by Complex Prior Authorization and Utilization Management

CMS is also providing important protections regarding utilization management policies and coverage criteria that ensure that Medicare Advantage enrollees receive the same access to medically necessary care that they would receive in Traditional Medicare. The rule streamlines prior authorization requirements and reduces disruption for enrollees by requiring that a granted prior authorization approval remains valid for as long as medically necessary to avoid disruptions in care, requiring Medicare Advantage plans to annually review utilization management policies, and requiring denials of coverage based on medical necessity be reviewed by health care professionals with relevant expertise before a denial can be issued. These policies complement proposals in CMS’ Advancing Interoperability and Improving Prior Authorization Processes Proposed Rule (CMS-0057-P).

Expanding Access to Behavioral Health Care

CMS remains committed to emphasizing the critical role that access to behavioral health plays in whole person care. In line with CMS’ Behavioral Health Strategy and the Administration’s strategy to address the national mental health crisis, CMS is strengthening behavioral health network adequacy in Medicare Advantage by adding clinical psychologists and licensed clinical social workers to the list of evaluated specialties. CMS is also finalizing wait time standards for behavioral health and primary care services and more specific notice requirements from plans to patients when these providers are dropped from their networks. In addition, CMS is requiring most types of Medicare Advantage plans to include behavioral health services in care coordination programs, ensuring that behavioral health care is a core part of person-centered care planning.

Promoting More Equitable Care

Additionally, CMS is advancing health equity and driving quality in health coverage by establishing a health equity index in the Star Ratings program that will reward Medicare Advantage and Medicare Part D plans that provide excellent care for underserved populations. Plans will also be required to provide culturally competent care to an expanded list of populations and to improve equitable access to care for those with limited English proficiency, through newly expanded requirements for providing materials in alternate formats and languages. The final rule balances patient experience/complaints measures, access measures, and health outcomes measures in the Star Ratings program to more effectively focus both on patient-centric care and on improving clinical outcomes.

Implementing President Biden’s New Prescription Drug Law

The final rule also implements a key provision of the Inflation Reduction Act that improves access to affordable prescription drug coverage for approximately 300,000 low-income individuals. As outlined in President Biden’s new prescription drug law, CMS is expanding eligibility for the full low-income subsidy benefit (also known as “Extra Help”) to individuals with incomes up to 150% of the federal poverty level who meet eligibility criteria. Beginning January 1, 2024, this change will provide the full low-income subsidy to those who would currently qualify for the partial low-income subsidy. As a result of this change, eligible enrollees will have no deductible, no premiums (if enrolled in a “benchmark” plan), and fixed, lowered copayments for certain medications under Medicare Part D.

View a fact sheet on the final rule.

The final rule can be accessed from the Federal Register at: https://www.federalregister.gov/public-inspection/2023-07115/medicare-program-contract-year-2024-policy-and-technical-changes-to-the-medicare-advantage-program.

Medicare Advantage Value-Based Insurance Design Model Extension

Additionally, today CMS is also releasing more information about the extension of the Center for Medicare and Medicaid Innovation’s Medicare Advantage Value-Based Insurance Design (VBID) Model from 2025 through 2030. This extension will introduce changes intended to more fully address the health-related social needs of patients, advance health equity, and improve care coordination for patients with serious illness. View the fact sheet, and more information, on the model webpage.

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Get CMS news at cms.gov/newsroom, sign up for CMS news via email and follow CMS on Twitter @CMSGov

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Dr. Ruan Requests Support For Another Writ

https://www.daily-remedy.com/dr-ruan-requests-support-for-another-writ/

Xiulu Ruan, MD; 66857019

F.C.I. Oakdale 1, Eva 2

P.O. Box 5000, Oakdale, LA 71463

Re: Request for Amicus Brief for Our Upcoming Petition for Writ of Certiorari (Case Number: to be assigned soon)

March 18, 2023

Jane M. Orient, MD, Executive Director Association of American Physicians and Surgeons

1601 N. Tucson Blvd. Suite 9, Tucson AZ 85716-3450

Dear Dr. Orient:

Dr. Couch and I need your help! Pain physicians need your help! Millions of people living in pain need your help!

On June 27, 2022, in a 9:0 decision, the Supreme Court handed down Xiulu Ruan v. U.S., 142 S. Ct. 2730 (“Ruan II”). Ruling in my favor the Court vacated and remanded my case back to the Eleventh Circuit. The Court, however, did not expressly invalidate its earlier precedent, U.S. v. Moore, 423 U.S. 122 (1975). This is problematic.

For close to five decades, Moore (1975) has been the Court’s seminal case law in prosecuting clinicians as drug traffickers under the Controlled Substances Act (CSA) Section 841. The Moore Court, unfortunately, erred when it ruled: “Registered physicians can be prosecuted under the Section 841, when, as here, their activities fell ‘outside the usual course of professional practice’ [‘OUCPP’].”  Based on today’s standard in Ruan II, the above OUCPP Ruling was plain error because it failed to consider the guilty intention or “mens rea” respecting OUCPP (discussed in detail in the attached essay).

Moore (1975) is also self-contradictory: While the Court implicitly authorized the Moore’s Jury Instruction, which contained the phrase “other than in good faith” that served as the requisite “mens rea” at Dr. Moore’s trial, the Court’s OUCPP Ruling, however, mentioned no “mens rea,” thus negating the “mens rea” it had endorsed in Moore’s Jury Instruction. Consequently, Moore (1975) violated the Law of Non-Contradiction, which dictates that the two opposing propositions cannot be both true at the same time in the same sense. (The two premises, “A is B” and “A is not B,” are mutually exclusive and collectively exhaustive and therefore cannot be both true at the same time.)

On my direct appeal, I cited Moore to support my “good faith” or the lack of “mens rea.” The Eleventh Circuit rejected it, citing Moore’s OUCPP Ruling:”This rule reflects the Supreme Court’s decision in U.S. v. Moore, 423 U.S.122 (1975), the first case by the Supreme Court establishing that physicians can be prosecuted for violating the Controlled Substances Act ‘when their activities fall outside the usual course of professional practice.’ Id. at 124″ (U.S. v. Ruan, 966 F.3d 1101, 1166-67) (11th Cir. 2020). This predicament is caused by the Moore Court’s simultaneously embracing two opposing propositions.

In addition, Moore (1975) erroneously acquiesced to a novel prosecution model, the prototype of prosecuting physicians as drug traffickers under Section 841, namely by combining the CSA 841(a) statute with 21 C.F.R. Section 1306.04(a), together with Moore (1975). Today, this compound criminal liability standard has the following appearance:

“It is generally ‘unlawful for any person knowingly or intentionally … to manufacture, distribute, or dispense, or posses with intent to manufacture, distribute, or dispense, a controlled substance.’ 21 U.S.C. Section 841(a). A medical professional’s prescription of a controlled substance is lawful only if ‘issued for a legitimate medical purpose by an individual practitioner acting in the usual course of professional practice.’ 21 C.F.R. Section 1306.04; See also United States v. Moore, 423 U.S. 122,

124” (U.S. v. Lague, 971 F.3d 1093 (9th Cir. 2020)).

This compound criminal standard contains multiple fatal flaws . I will briefly mention one here: The violation of Section 1306.04 is akin to a civil infringement, not a felony offense. There is no rational connection between violating Section 1306.04 and violating Section 841 (discussed in detail in the attached essay).

Indeed in U.S. v. Howen, 2022 U.S. Dist. LEXIS 236721 (E.D. Ca. 2022), the Government filed a civil suit against defendant pharmacist Howen and defendant pharmacies for knowingly violating Section 1306.04. The court opined: “Section 1306.04(a) explicitly subjects pharmacists to CIVIL PENALTIES if they ‘knowingly’ fill an invalid prescription [.]’ See 21 C.F.R. Section 1306.04(a)” (2022 U.S. Dist. LEXIS 14) (emphasis added).

Further, the term “OUCPP” in the context of Section 1306.04 differs in meaning from “OUCPP” in the context of Moore (1975). The former contemplates a civil infringement such as in Howen, while the latter represents a felonious offense per Moore’s OUCPP Ruling. Through the equivocal usage of the term “OUCPP” introduced by Moore (1975), a false causal connection between the two was established even though there was no rational connection between them. Thus innocuous conduct such as OUCPP in violation of Section 1306.04 became notorious felonious offense under Section 841.

For close to five decades innumerable clinicians including physicians, surgeons, licensed nurse practitioners and physician assistants, podiatrists, dentists, pharmacists, etc., have been prosecuted under this erroneous criminal standard as well as under Moore’s OUCPP Ruling. (Moore’s other serious errors were discussed in detail in the attached essay.)

Congress designed separate CSA provisions (Section 841, 842, and 843) for different purposes. Indeed the District of Columbia Circuit reasoned that the “broad outline strongly suggests that Congress intended to deal with registrants primarily through a system of administrative controls … and reserving the severe penalties provided in Section 841 for those seeking to avoid regulation entirely by not registering.” (U.S. v. Moore, 505 F.2d 426, 430 (D.C. Cir. 1974))

Following Moore (1975), almost all clinicians charged with “overprescribing” were prosecuted under Section 841, as though Section 842 and 843 had never existed. This practice violated the basic interpretive canon admonished by the Court in Rubin (138 S. Ct. 816) for it rendered 842 and 843 provisions nonsensical and superfluous, thus at odds with Congress’s intention.

Although the Howen Court in California treated the violation of Section 1306.04 as a civil infringement, the Eleventh Circuit, however, pushed it all the way to the other end, treating it like an act of “drug dealing.” For example, in U.S. v. Mencia, 2021 U.S. App. LEXIS 17160 (11th Cir. 2021), the Eleventh Circuit elaborated: “When does a physician stop acting as a doctor and start acting as a “drug pusher[?]” The answer under the Act is when he prescribes controlled substances outside the course of his professional practice or without a legitimate medical purpose.” (2021 U.S. App. LEXIS 40-41)

Shocking, isn’t it? That’s how pliable and insidious 21 C.F.R. Section 1306.04 could be. Its interpretation depends entirely on the caprice of the courts. A violation of it, a civil infringement per a federal court in California, can become a felonious offense of drug trafficking per the Court of Appeals for the Eleventh Circuit in Atlanta. Does this make any sense at all?

In the past two years, tons of illicitly manufactured fentanyl have been smuggled in across the open southern border with minimal government intervention. By contrast, Dr. Couch and I, in our capacity as fellowship-trained, multi-board certified interventional pain specialists, received sentencing enhancement for collectively prescribing FORTY GRAMS of fentanyl -­ during four and half years in treating our patients at Physicians’ Pain Specialists of Alabama, a tertiary interventional pain clinic that had been in practice for 17 years with more than 8,000 active patients (when the Government shut it down in 2015).

In a recent article, “The Misinformed & Misguided Prescription Abuse Prevention Act: A Response to Delfino,” by Robert Capodilupo and Jacob James Rich, published in “Yale Law and Policy Review” — Inter Alia (Spring 2023), the authors pointed out that, while opioid prescribing has declined over the past decade, total opioid deaths have skyrocketed because of a spike in illicit opioid overdoses. They cautioned that the proposed Prescription Abuse Prevention Act by Delfino may create a harmful “chilling effect,” further deterring physicians from prescribing needed pain medicines to treat patients.

Capodilupo and Rich also explained that the drastically increased opioid mortality over the past a few years was mostly due to illicitly manufactured fentanyl, not prescription fentanyl, noting that, by August 2017, the CDC had formally removed fentanyl from the definition of prescription opioid mortality. They predicted that further reduction in opioid prescribing may exacerbate opioid overdoses by orienting pain patients and recreational users to illicit alternatives such as heroin and illicit fentanyl.

The Court should use this petition to re-examine the fatally flawed criminal standard presented, which, for decades, has resulted in enormous harm to clinicians, patients, and our society — a tragedy and disgrace never intended by Congress .

Thank you wholeheartedly in advance for your attention and kind help. We look forward to seeing your Brief of Amicus Curiae in connection with our certiorari.

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How Reliable Are Your Generic Drugs From India?

https://www.peoplespharmacy.com/articles/how-reliable-are-your-generic-drugs-from-india

FDA warning letters to Indian drug companies have increased dramatically in recent years.

Are you taking generic drugs from one of these manufacturers?

For decades the FDA has told Americans that generic drugs are absolutely identical to brand name medicines. Physicians, pharmacists and insurance companies reassure patients that a $4 generic prescription is the same as a brand name medicine that costs over $150 for the same number of pills.

The only problem is that some generic drugs are now skyrocketing in price for lack of competition.

It is puzzling why so many generic drug manufacturers have stopped making certain products. It is almost as if the industry has divvied up the market.

The results are appalling. This is how we ended up with Martin Shkreli at Turing Pharmaceutical jacking up the price of one drug 5,000%. But he isn’t the only one. Other companies are also abusing the American public by raising generic drug prices into the stratosphere. Read more about this scandal at this link.

Give Us More Generic Drugs!

Congress is anxious to see the FDA approve more generic drugs faster. Our legislators want to save money on medicines. After all, federal programs like Medicare, Medicaid and the Veterans Administration spend a lot on prescription drugs.

Private and nonprofit hospitals also want to spend less on medicine. And of course insurance companies are desperate to get people taking cheaper generic medicine.

No one seems to be concerned about quality.

Heck, we didn’t worry about quality either. Starting with our first book, The People’s Pharmacy (published in 1976), we told people that very same thing. For over 25 years we believed that the FDA was totally on top of both the approval and monitoring of generic drugs. We never even stopped to think about manufacturing problems. Of course in those days most generic drugs were made in the U.S.A That all has changed.

Where Your Generic Drugs Come From:

Now that 88 percent of all prescriptions are dispensed as generic medications, the quality of such drugs is more important than ever.

But the vast majority of them now come from abroad, where FDA oversight has historically been dismal.

The active pharmaceutical ingredients (APIs) and the so-called inactive ingredients now come primarily from all over the world: Brazil, China, India, Mexico, Slovakia, Thailand, Turkey and goodness knows where else.

Historically, the FDA hasn’t even known where all the chemicals in your medicine originated. There is no requirement to put country of origin on the drug label.

What the FDA has Found in India:

In the last few years, though, FDA inspectors have been active in India, where so many inexpensive generic drugs are manufactured for the American market. What they have found is frightening.

In just the last few weeks, the FDA reprimanded the Indian drug manufacturer Wockhardt for hiding unwelcome test results and deleting data. This is not the first time Wockhardt has run into trouble. Since April of last year the company has recalled hundreds of millions of tablets and capsules. They included popular blood pressure medicines such as amlodipine and lisinopril as well as the antibiotic azithromycin and the sleeping pill zolpidem.

Wockhardt is not the only Indian pharmaceutical firm to run afoul of the FDA. Other Indian companies that have received warning letters over the last several months include Aurobindo, Dr. Reddy’s Laboratories, IPCA and Sun Pharmaceutical Industries.

Ranbaxy Laboratories, one of the largest of the Indian generic pharmaceutical firms, has had multiple run-ins with the U.S. Food and Drug Administration. A few years ago this company pleaded guilty to felony charges after being accused of falsifying data. The company paid $500 million in fines.

An interesting note on the Ranbaxy mess: Sun Pharmaceuticals of India acquired Ranbaxy for $3.2 billion last year, making Sun Pharma India’s biggest drug company. Sun has itself come under FDA scrutiny. A Bloomberg report noted that Sun Pharma employees had faked test results.

How Many Companies Have Run Into Trouble?

Over the last five years the FDA has banned products from 44 different Indian drug-making facilities.

That should give insurance companies some cause for alarm when they insist that their customers must use generic rather than brand name drugs.

What About China?

India is not the only place that is coming under increased scrutiny by the FDA. For years, the agency only had a few inspectors on the ground in China. Now that there are more, they are discovering shortcomings in Chinese plants too.

Warning letters have been sent to a number of companies in recent months. Even brand name companies have been tainted. Pfizer’s Chinese partner, Zhejiang Hisun, was accused of systemic problems associated with “data manipulation.”

That is a sanitized way of saying employees were cooking the books and violating the rules of good manufacturing practices. Customers had been complaining about drugs not measuring up to standards between 2012 and 2014.

What Should You Do?

Patients are the ultimate customers of foreign-made pharmaceuticals.

We have been receiving complaints about generic drugs that do not work as well as their brand name counterparts for more than a decade:

Problems with Generic Prilosec for Reflux:

We have been hearing about this particular problem for years:

Kathi in Milwaukee:

“I became so ill after my pharmacy plan switched me to generic omeprazole that my MD ordered an endoscopy to make sure I did not have esophageal cancer. I was sick for almost 3 months, and am still having issues almost a year later.”

Linda in Los Angeles:

“I have been taking Prilosec by AstraZenca for 20 years and have had no GERD problems at all. As of November 1, 2015, I was advised by my pharmacy that I would now have to take a generic. I have taken a generic omeprazole (20mg) for 40 days now, and it is NOT the same. I am burping all the time and have reflux and choking, something I never had with the brand name Prilosec. I am fortunate that my insurance has paid 80% of the cost (over $200 month).”

Men on Flomax for Frequent Urination:

Men who have to get up at night to go to the bathroom know pretty quickly how well their medicine is working:

Henry in Nevada:

“My first generic flomax (tamsulosin) was barely tolerable. In the second prescription the pharmacy changed manufacturers and this generic was far worse and not as effective. If the FDA is not directly monitoring these drugs then they are unlikely to have the necessary ingredients to be effective.”

BK on other ingredients in tamsulosin:

“My husband has been taking Flomax for a few years, when just last month, a generic form came to the market. Due to the inert ingredients, he ended in the hospital with gastritis. My insurance company will not pay for Flomax, only the generic tamsulosin. We cannot afford the high price of Flomax.

“I asked them to make a one-time exception to override the cost for a one-month supply of Flomax, just to wean him off the alpha blocker as needed due to severe side effects, but was denied.

“I could not believe the inert ingredients are so different. Drug companies should be aware of up coming law suits they are causing!”

Just think of the extra cost of hospitalization because of the generic substitution. How short-sighted of the insurance company in our humble opinion.

How to Report Generic Drug Problems to the FDA:

The FDA is starting to pay attention to our frequent messages of generic manufacturing problems. Anyone who would like to report a drug problem may do so at www.FDA.gov/MedWatch.

Patients can also share their experiences below in the comment section. Please try to find the name of the generic drug manufacturer on the label of the bottle so we can let the FDA know which companies have frequent customer complaints.

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Mulready Files Action Against CVS/Caremark

https://www.oid.ok.gov/release_040323/

OKLAHOMA CITY – Oklahoma Insurance Commissioner Glen Mulready announced today the filing of an administrative action against CVS/Caremark that outlines alleged violations of the Patient’s Right to Pharmacy Choice Act. The filing targets the practice of “steering patients” to CVS pharmacies and prescription mail-order services and seeks to censure, suspend, place on probation or revoke the Pharmacy Benefit Manager (PBM) license of CVS/Caremark. In addition, the Oklahoma Insurance Department (Department) will seek restitution and/or levy fines for each alleged violation.

“I am convinced that CVS/Caremark does not want to follow Oklahoma law and wants to find every opportunity to skirt their responsibility,” Mulready said. “I am extremely frustrated with the misinformation and confusion presented to Oklahoma consumers.”

The Department sent a letter in February providing notice to CVS/Caremark that administrative action would be taken if they did not immediately correct their communication that went out to consumers related to the CVS/Caremark Maintenance Choice Program.

In response to the Department’s February formal notice, CVS/Caremark took corrective action but has since communicated to their large client employers that filling 90-day prescriptions is now prohibited. CVS/Caremark has used untruthful and harmful statements to explain the reasoning behind this impactful business decision that continues to restrict pharmacy choice conditions.

“I expect PBM licensees to follow the law, not operate on the fringes of regulatory compliance,” Mulready said. “This is especially egregious because this is the first time that any PBM previously sanctioned by the Department has publicly committed the same violation a second time. This is unacceptable, and we will hold them accountable.”

The administrative hearing is scheduled for May 25, 2023.Click here to view the Notice of Hearing and Order to Show Cause.

For more insurance information, please contact the Oklahoma Insurance Department at 1-800-522-0071 or visit our website at www.oid.ok.gov.

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Must watch & please give a retweet!

The trans 'Hero' in Matt Walsh's documentary 'What is a woman' silences an entire room of reporters in a live press conference about 'medically transitioning children!"@AlissaWalsh21 @ladykennington @againstgrmrs @OfficialAbelG @catcattinson… pic.twitter.com/qnGUaqGS18

— Scott Newgent-Trans Regretters (@NotScottNewgent) March 11, 2023

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98% of US hospital websites share patient data with third-parties

https://www.beckershospitalreview.com/healthcare-information-technology/98-of-us-hospital-websites-share-patient-data-with-third-parties.html

Almost all U.S. hospital websites are sending patient data to third-party companies such as Alphabet, Meta and Adobe, SC Media reported April 3. 

The report cited an April 3 study published in Health Affairs in which researchers analyzed 6,162 U.S. hospital and health system websites, including 3,747 identified non-federal acute care hospitals with websites, and found that 98.6 percent of them sent sensitive health information to third parties. 

Alphabet, the parent company of Google, received 98.5 percent of patient data transfers, followed by Meta which received 55.6 percent of all third-party transfers. 

Adobe Systems also received 31.4 percent of third-party data transfers and AT&T received 24.6 percent of all data transfers. 

The researchers also found that 69 percent of all U.S. hospital homepages transferred data to third parties. 

U.S. hospital and health system homepages had a median of 16 third-party data transfers.

The transfers were the highest among medium-sized hospitals, nonprofit hospitals, urban hospitals and health system-affiliated hospitals. 

This comes as 14 hospitals and health systems across the U.S. are facing lawsuits that allege that their websites have embedded pixel tracking tools that send patient information to Meta, Facebook and Google.

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Now I understand how the DEA is able to state with a “straight face” that they don’t control/ration controlled meds and interfere with pt’s access in getting them.  I have read a couple of comments about the Walgreen, CVS, Walmart lawsuit by 50 state AG’s , native American groups and others that those three chain pharmacy chains agreed to “reduce opioid Rx dispensed”.   So here was have 50 state Attorney Generals, hiring law firms on a contingency basis – so that the states are not putting any tax payer monies at risk.  If the win, the states get a windfall of money from the lawsuit as does the law firms involved.  Whatever is contained in the final settlement, like reduce opioid Rx dispensing… the DEA can claim that they didn’t cause that.  Just like the DEA & VA had no input in the CDC 2016 opioid dosing guidelines?

This could be the “final straw”, in proving that the major drug wholesalers and major chain drug stores are complicit in discriminating against a segment of the population (disabled) and are being intentionally denying medically necessary medication, which is most likely a civil rights violation under the Americans with Disability Act. Unless these settlements are “sealed” and not available for public view, it would appear that discriminating against disabled pts.  Could the community need to sue whatever corporate executive(s) that signed the agreement.  I suspect that each of those large corporations have something in their policies and procedure manuals that if an employee breaks/violates the law, the corporation is not responsible for their actions.

Xanax and Adderall Access Is Being Blocked by Secret Drug Limits

https://www.bloomberg.com/news/articles/2023-04-03/adderall-shortages-are-made-worse-by-the-opioid-crisis?srnd=premium

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NSAID Use Remains Complex

Review leads to recommendations and warnings on the use of NSAIDs for pain.

https://www.practicalpainmanagement.com/news/nsaid-use-remains-complex

Aspirin, the first nonsteroidal anti-inflammatory drug or NSAID, was developed in 1897. It was not until the 1950s that non-aspirin NSAIDs became available and forever changed the treatment of pain.

As a class of drugs, NSAIDs can reduce pain, fever, and inflammation, leading some to view them as miracle drugs. Yet, from the start, their use has raised safety concerns. Specifically, NSAIDs reduce the production of prostaglandins by inhibiting cyclo-oxygenase (COX) enzymes. COX-1 inhibitors have the unfortunate effect of lowering the production of the prostaglandin that protects the lining of the GI tract, which can lead to gastrointestinal problems. COX-2 inhibitors, also known as coxibs, get around this problem because they do not interfere with the production of prostaglandin that protects the stomach. However, all NSAIDS increase the risk of a wide range of cardiovascular events, including heart attack, stroke, and other cardiovascular woes.

Nonetheless, NSAIDs, available over the counter and by prescription, are among the most commonly used medications in the world. Their high level of use is, in part, because they are especially useful as alternatives to opioids as treatments for chronic pain, particularly pain with underlying inflammation. However, using them in clinical practice requires a thoughtful and cautious approach. Balancing the benefit versus the risk of treatment is always a consideration.

“Every therapeutic decision we make in medicine has benefits and risks,” said Kevin Byram, MD, assistant professor of medicine in the division of rheumatology and immunology and associate director of the rheumatology training program at the Vanderbilt University Medical Center. “The decision not to use an NSAID has risks and benefits, too,” he said. Among the risks of eschewing NSAIDs is, of course, the need for opioids in their place. However, Dr. Byram points out other risks as well. For example, the patient might not be as mobile, and that could cause them to lose the cardio-protective effects of exercise. All of this makes the use of NSAIDs complex and, at times, confusing.

Drawing on decades of research on NSAIDs, a team of researchers from the University of Michigan and the Cleveland Clinic examined the history of this class of drugs, their risks and benefits, and offered suggestions to clinicians for prescribing these drugs to treat pain and inflammation. Their recommendations were published this February in Rheumatic Disease Clinics.¹

The research team’s findings suggest that all NSAIDs pose an increased risk of adverse cardiovascular events, a fact many clinicians are not aware of, said Deeba Minhas, MD, a rheumatologist and assistant professor of medicine at the Institute for Healthcare Policy and Innovation at the University of Michigan and first author on the study. She added that nuances in side effects based on COX profiles remain widely understood.

“Because we do not know ahead of time how patients may respond to NSAIDs,” the reviewers wrote, “it may be important to monitor patients closely after initiating an NSAID.” For example, they suggested monitoring blood pressure and asking about symptoms after 1 week of use. At 2 to 4 weeks, they recommended checking blood work for potential side effects and adjusting the dose if necessary. They also pointed out that emerging factors, such as biomarkers of COX inhibition, could aid clinicians in selecting the appropriate NSAID and its proper dose for a given patient.

Other recommendations included:

• using the lowest possible dose for the shortest possible time
• considering topical NSAIDs when appropriate
• engaging in shared decision-making with patients when making the risk-benefit calculation
• creating a pain toolkit for patients that includes non-pharmacologic therapies such as TENS, physical therapy, occupational therapy, myofascial release, and mindfulness.

They also suggested asking the patient to keep a pain- and side-effect diary, or the equivalent app, and reviewing this at routine follow-up visits.

Regarding specific drug choices, Minhas et al suggested starting with ibuprofen plus a proton pump inhibitor (PPI) or naproxen plus PPI. Celecoxib might be a good alternative, although they advised against doses higher than 200 mg or twice daily regimens. In individuals taking aspirin, they recommended either naproxen plus PPI, taken two hours after the aspirin, or 200 mg of celecoxib plus PPI.

Additionally, they recommended that diclofenac be avoided in patients with cardiovascular risk factors. “Overall, it does not seem that there is a benefit to using diclofenac, though I think it is still highly prescribed,” said Dr. Minhas.

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