PBM: Unmask the Villains of Healthcare’s High Costs

https://practicingphysician.org/pbm-unmask-the-villains-of-healthcares-high-costs/

Would you like to lower healthcare costs, restore quality and improve choice? Yes? Then you MUST learn about Pharmacy Benefit Managers (PBMs).

If you look on the Fortune 500 top 12 companies, you will find three companies who own PBM. Dig deeper, and you’ll discover these companies are CVS  health, who owns the PBM CVS Caremark, United Healthcare who owns the PBM Optum Rx, and Cigna, who owns the PBM Express Scripts. These three PBM control 85% of the prescription drug market, and are the biggest revenue generators for their parent companies. 

For example, when the insurance company Cigna, purchased Express Scripts in 2019, their revenues tripled. Take a peek under the hood of CVS Health, and you will discover that CVS’s  PBM CVS Caremark is, to put it frankly, its prize cash cow, its biggest source of revenue.  Moo.  

Until recently, many Americans had no idea what a PBM was, and blamed insurance and pharma and physicians for the high cost of care. The truth is much more complicated, and those making the money don’t want you to pull the mask off the villain of high healthcare costs.  They aim to prevent  the Scooby Doo denouement and keep Americans from discovering the biggest, richest, most devious villains in the healthcare space are the PBM.

Some really important clues to why we should suspect that the PBM are villainous profiteers:

–    The PBM and insurance companies now own one another, and some, like the CVS Health empire, also own pharmacy chains

–    The PBM controls the pharmaceutical companies, by creating the formularies, aka the list of medications that the insurance companies will “cover”. Physicians play no part, nor have any say in  this choice.

–    The PBM can collect legalized kickbacks, called ‘rebates’ from pharmaceutical companies because the PBM were granted an exemption from the anti-kickback statute in 2003 by GW Bush’s HHS secretary. This anti-kickback exemption allows pharmaceutical companies to simply pay for placement on the formulary.  Americans are not necessarily getting the best medication, but the best med a legal bribe can buy.

–    There is no transparency for these kickbacks (aka rebates) but sources have revealed that in 2020, the total amount of kickbacks approached $200 BILLION (yes with a B).

–    PBM like CVS Caremark are now facing charges of preventing elderly Medicare patients, including those with End Stage Kidney Failure from access to affordable life sparing medications.

–    In multiple states, PBM have been found to be helping themselves to Medicaid money… not a small helping, either: In Ohio alone, the PBM subsidiary of Centene as well as CVS and Optum were pocketing $244million per year.

–    The big PBM that own pharmacies, like CVS are utilizing shady practices to put trusted Mom and Pop pharmacies out of business.    

–    In an NBC News exclusive with Cynthia McFadden, the PBM mail order pharmacies were found to be delivering ineffective medications.  One young pediatric patient with cystic fibrosis was hospitalized after wasting away because of medications delivered by PBM giant Express Scripts, whose agent pooh poohed the concerns of the patient’s mother.

Do you need to hear more? 

Yes, you need to understand who is granting more favors to the behemoth companies responsible for the maleficent behavior noted above.

Let’s look at several recent congressional bills in chronological order of passage. 

The Affordable Insulin Now Act was passed by the House and Lingers in the senate

Although those who support the bill  claim to have lowered the cost of insulin, Lloyd Dogget, a Texas Democrat correctly stated that the bill does not lower the cost of insulin by even a penny.  He’s correct.  It lowers the co-pay, but the uninsured, and those who pay insurance ( whether they be employer or independent purchaser)  will continue to pay the full bloated cost of insulin, 80% of which is flowing to the PBM via kickbacks and fees.  In other words, this bill simply ensures that the taxpayers keep paying the PBM in the form of kickbacks.

Worse yet, the bill grants a delay of the rebate rule for PBM.  The rebate rule was an Executive Order introduced in 2020 and demanded that the kickbacks (aka rebates) would flow to the patient at the point of sale and not the PBM and the insurers.  PBMs are continually telling Americans that they pass on the rebates, yet when the rebate rule was suggested, they have threatened to increase Medicare premiums as soon as the rule is enacted. 

Congress has discovered they can pull the entirely disingenuous accounting sleight of hand of delaying the rebate rule (in other words, allowing the PBM to keep collecting their kickbacks and not forcing them to pass on to patients) and thereby claiming that they are saving money by preventing Medicare premium increases. To put another way, the PBM’s and Insurers are playing Chicken with the rebate rule by threatening Medicare premium increases, and the Congress-people that delay the rebate rule are taking the bait.  I suppose that makes them lower than chickens in the game.  Perhaps they are simply chicken….. oh, never mind. Maybe they simply don’t understand.

The insulin Bill was not the first time Congress  delayed the rebate rule.  Apparently they did it in the infrastructure bill, too.  Howard Dean, a physician and former presidential candidate called them on it in Newsweek, even pointing out that the rebate rule was solid, and potentially the best thing to come from the Trump Presidency. 

Based on the above, we ought to let that insulin bill die and come up with a real way to lower insulin costs.

The recent Gun Bill Passed by the Senate and House and signed into law sneaked in a gift to PBMs.

Why on earth would a bill on guns contain another delay in the rebate rule, yet another gift to the PBM industry?  The same faulty accounting gimmick of using the rebate rule delay as a pay for.  Unbelievable.  Senators Chris Murphy, D-CT and John Cornyn, R-Tx are mum about who put the PBM poison pork into the gun bill.  Interestingly, Murphy’s top donor is the law firm that helps CVS negotiate mergers.  And Cornyn is a top taker from Vizient, a hospital Middleman Group Purchasing Organization.

Good news at last!  PBM reform in the Mental Health Package

Thankfully, some good news exists. .  Some colossally INCREDIBLE news:

HR 7666, the bipartisan mental health bill introduced by Frank Pallone, D-NJ, and Cathy McMorris Rogers –R, Wa passed the house this week with 400 yay votes.

Some of us were really yelling ‘Yay’ when we discovered splendid section 602, quietly added by Rep Michael Burgess (R-Tx), mandating   big time TRANSPARENCY for big PBM/Insurers with shocking penalties of $10K per day for non-compliance.

Requiring  PBM transparency will save $2BILLION/10 years, paying for the bill.  Billion with a ‘B’.  As Mental health and substance abuse medications are largely overpriced due to PBM kickbacks, this provision absolutely belongs in the bill.

Americans will receive  some wonderful services  with this bill for Mental Health and Substance Use Disorders. Full detail can be found in the bill,  but here is a screenshot of some of the high points

WE CANNOT STOP… we must make sure the mental health bill passes in the senate WITH PBM reform Intact. 

Please CALL and EMAIL  both of your US Senators ASAP, (find their numbers and email contact links  here ) and tell them to PASS  the Senate version of HR 7666 with the Burgess amendment to bring PBM transparency and accountability intact.  Ask  your friends to call.  Ask your neighbors to call. Ask everyone in your circle and beyond. Tell YOUR Senators you now know the PBMs are behind the ever increasing healthcare costs and it’s time for Congress  to listen to we the people and not the profiteering villainous Pharmacy Benefit Managers! 

Drs. Mass and Dewey are proud to be pediatricians for over 20 years each and fierce advocates for patients and physicians!

Dr. Mass, graduated from Duke Medical School and trained at Northwestern. She has practiced in the Philadelphia area. She’s a cofounder of Practicing Physicians of America And leadership in Free To Care .

Dr. Dewey attended Loyola University Stritch School of Medicine . She did a year of surgery internship then two years of pediatric surgery research before training in Pediatrics at University of Minnesota. She is founder and CEO of Peds Mama Doc and has published in multiple outlets

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Medicare plans to stop posting some hospital safety data

https://www.statnews.com/2022/07/01/medicare-wants-to-stop-publishing-some-hospital-safety-data-next-year/

After Ann MacDonald’s 82-year-old mother, Betty (above left), died in a Rhode Island hospital after developing sepsis after surgery, she has wondered about hospital safety. She turns to Care Compare, a federal government website that compiles hospital quality data in a user-friendly format, to look at its star ratings whenever she or a loved one needs hospital services. But Care Compare shrank during the pandemic, and Medicare, the federal agency that maintains the website, wants to trim even more of the measures from the data it’ll release next year.

Medicare proposes to keep under wraps a composite score made of 10 metrics of patient safety and adverse events, including pressure ulcers, hip fractures, and sepsis after surgery, the condition that killed MacDonald’s mother. Patient safety groups aren’t buying the agency’s argument that the change is fair given hospitals’ pandemic strain. STAT’s Tara Bannow explores.

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Just have someone (bureaucrat) with some degree of political power that has a family member that ends up abusing some potentially addictive substance and they will exercise any and all power/influence they can muster up to solve this problem – never mind that the particular family member has some undiagnosed/untreated mental health issues… they really will not publicly admit that fact.  Most will blame the SUBSTANCE that their relative is abusing/involved with.  So, even if there is a valid medical use for certain substances/medications…  the bureaucrat will attempt to eliminate/restrict EVERYONE’S access to this/these substance(s), even those who have a valid medical necessity to help optimize the person’s quality of life.

It would seem by this article that those Oregon bureaucrats want just about any/all state bureaucrats to have total access to the state’s PDMP.  Forget that this database contains a “boat load” of HIPPA PERSONAL PRIVATE HEALTH INFORMATION. To quote President Reagan, when your neighbor loses their job, we are in a recession, when you lose your job, we are in a depression .

State fails to enact majority of recommendations aimed to stem opioid misuse, audit says

A Secretary of State report says the state needs to do more to identify excessive prescribers and patients who “doctor shop”

https://oregoncapitalchronicle.com/2022/06/29/state-fails-to-enact-majority-of-recommendations-aimed-to-stem-opioid-misuse-audit-says/

As a deadly drug epidemic continues to rage in Oregon, state officials have only made a few changes recommended by the Secretary of State’s Office nearly four years ago to curb opioid misuse.

That was the overarching finding of an audit released Wednesday of the state’s Prescription Drug Monitoring Program, which tracks prescriptions of controlled substances, including painkillers, stimulants and tranquilizers. 

The report reviewed changes the state has made since the Audits Division of the Secretary of State’s Office first audited the program in December 2018. 

Over that time, the drug epidemic has worsened, and today poses a major threat to adolescents.

Secretary of State Shemia Fagan said during an online news conference that her mother became addicted and ended up homeless. Addiction, for her, is deeply personal, she said.

“These are people’s parents and kids and uncles and brothers and siblings and friends,” Fagan said. “Five Oregonians die a week from opioid related overdoses.”

When the 2018 audit was released, Oregon had the highest rate of seniors hospitalized for opioid overdoses, abuse and dependence. It had the sixth-highest percentage of teenage drug users.

Today, Oregon has the highest rate of misuse of prescription opioids in the country, the Secretary of State’s Office said in a statement.

“Although Oregon is dispensing fewer opioid prescriptions, it is still prescribing at a higher rate than the national average,” auditors wrote. “Additionally, there has been a steady increase in prescription stimulants.”

A practice of excessive prescribing of opioids dates to the 1995 federal approval of OxyContin and aggressive marketing by Purdue Pharma. In the more than two decades since, thousands of people have died across the country. Deaths in Oregon from overdoses and poisoning jumped from about 600 in 2018 to 700 in 2019 and 900 in 2020, Oregon Health Authority data show. 

While prescription opioids have contributed to the epidemic, the state is also grappling with a flood of fake fentanyl pills that are easily accessible on the streets.

In the 2000s, amid an opioid epidemic fueled by overprescriptions, various states created databases to track them as a way of limiting excessive prescribing of opioids. Fifty states now have a monitoring program but many have tighter rules than Oregon and they don’t have a drug problem as severe as Oregon, said Kip Mennott, the Secretary of State’s audit director. Tightening the program’s requirements will help stem the problem but it’s not the only answer, he said.

“This is not the entire drug epidemic – this is one part of it,” Mennott said.

Program’s requirements

The program requires pharmacies to file information about prescriptions of controlled substances. Prescribers are supposed to register so state officials can identify excessive prescribers. Prescribers also search the database to identify patients who “doctor shopped” to obtain more prescriptions than they need.

But Oregon providers are not required to check the database when they prescribe controlled substances, the latest audit said. This is something auditors recommended in 2018 and is common in other states.

The audit identified patients with opioid prescriptions from “excessive numbers of prescribers” and “dangerous prescription drug combinations,” which includes mixing opioids such as OxyContin with sedatives, like Xanax.

It also said that state laws prevent the database from being shared with health licensing boards and law enforcement to monitor and address questionable prescription activity, another area of concern. 

“Questionable prescribing habits seen within the data, even those that are egregious, cannot be elevated to any regulatory or enforcement entities to directly look into those situations,” the 2018 audit said.

Memmott, whose youngest brother has struggled with a lifelong drug addiction, said many of the changes needed are up to the Legislature. But he said the Oregon Health Authority has not taken an aggressive role in pursuing those changes.

“They feel like they’re limited, and they have other legislative priorities as well,” Memmott said. 

As a result, the Secretary of State’s Office is taking “a more active role” in lobbying lawmakers, including presenting the audit to the Legislature, Fagan said. She called on state lawmakers to pass the remaining changes recommended by the audit.

“We have to take full advantage of it,” Fagan said, referring to the program.

The health authority said in a statement that it values the state’s prescription monitoring program, noting it has reduced overprescribing.

“The agency is pleased with the performance of the (program) in ensuring appropriate use of prescription drugs, and helping people work with their health care providers and pharmacists to determine what medications are best for them,” the statement said.

But the agency will not play a major role in pursuing legislative changes.

“OHA appreciates that the Secretary of State auditors identified additional areas of improvement. However, many of the recommendations fall outside of the scope of OHA and require additional legislative changes,” the statement said. “The agency looks forward to working with the Oregon Legislature as potential statutory changes are considered in future sessions. The Legislature established the (the program) as a means for improving provider collaboration and patient outcomes, but the program is not a law enforcement, regulatory or insurance tool.”

The audit said five recommendations have not been implemented and three others 

• Develop a way for officials involved with Medicaid to query the database to allow them to monitor patient prescriptions for controlled substances statute
• Ask the Legislature to adopt a change in statute ensuring that prescribers register with the program as required and that pharmacies submit corrected data. 
• Ensure providers justify questionable prescribing practices and share potential signs of abuse, misuse or diversion of controlled substances with licensing boards and law enforcement. The health authority said it is “actively using appropriate channels” to recommend legislative changes.
• Expand the list of professional and state entities that can access the database. The health authority said it is “actively” involved in making this legislative change.
• Require prescribers to check the database before prescribing a controlled substance and require pharmacies to do the same before filling a prescription and periodically while the patient is on these medications. OHA staff said it is in the process of recommending that the Legislature make this change.

The three recommendations that have been partially implemented include expanding information that the database collects.

“We need more transparency,” Mennott said.

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PBM faces suit over alleged ‘refill pill mill’ scheme

https://ncpa.org/newsroom/qam/2022/06/29/pbm-faces-suit-over-alleged-refill-pill-mill-scheme

Express Scripts is facing a lawsuit under the False Claims Act on charges that it delivered pointless prescribed drugs to military personnel, bilking the federal authorities and distributors out of billions of dollars. A whistleblower claims the company’s software was allegedly set up to refill 90-day prescriptions on day 60, which means that

Tricare beneficiary obtained 73 percent more tablets than prescribed over the course of 12 months.

The suit was filed in a California federal courtroom in mid-2019 and unsealed earlier this month. Express Scripts inflated drug prices for payers and patients via its “refill pill mill” that systematically overcharged the Tricare program for treatment from October 2009 to March 2018, the suit alleges. NCPA has spoken out for years against mail-order pharmacy for many reasons, not the least of which is the waste it produces. Here’s a link to our Waste Not, Want Not document showing examples of this needless waste. If you have a photo to add, send it to Michael Rule.

According to  https://en.wikipedia.org/wiki/Express_Scripts  One of Express Scripts largest clients is the United States Department of Defense‘s Tricare program. and On March 7, 2018, it was announced that Cigna would buy Express Scripts in a $67 billion deal. The deal closed on December 20, 2018 at $54 billion, allowing Cigna to start offering new Express Scripts products to its corporate health insurance customers in 2019.

Maybe Cigna’s due diligence in looking into buying Express Scripts, exposed this “little systematic overcharging” of Tricare/Feds caused it to come to a end, because Cigna’s did not have anything to do with the financial liability tail attached to the Express Scripts deal.

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Not everyone can see the “few degrees of separation” for different things that our Federal government does and how it will/could affect what other parts of the Federal government can be able to do and/or could be challenged in our courts that they can no longer go forward with “business as usual”. Recent decisions by the SCOTUS can affect the DEA and how they function.  This one with the EPA,  has been doing much the same actions as the DEA has been routinely over the years creating rules/regulations. So that they can “create some new low hanging fruit” that they can go after.

Then there was this recent SCOTUS decision about DOJ/DEA  using questionable processes going after prescribers https://www.pharmaciststeve.com/supreme-court-rules-for-doctors-on-pill-mill-prosecution-proof-9-to-0-in-favor-of-practitioners/

and is this the response to the SCOTUS by some within the DOJ ? https://www.justice.gov/opa/pr/justice-department-s-criminal-division-creates-new-england-prescription-opioid-strike-force

Knowing that anyone challenging this new “prescriber round up”  could easily take up to SEVEN YEARS to get a legal challenge thru our court system and get this using questionable processes to shut down prescribers… how many chronic pain pts could end up without any pain management.

And could this SCOTUS ruling on subjective mental health RED FLAGS and the confiscation of a person’s guns, could be used as the basis of challenging all the DEA RED FLAGS that they have created that the DEA has no such authority granted the DEA  in the Controlled Substance Act to create/enforce such RED FLAGS.

BREAKING: SCOTUS Reins in the Power of the EPA

https://pjmedia.com/news-and-politics/stacey-lennox/2022/06/30/breaking-scotus-reigns-in-the-power-of-the-epa-n1607295

On Thursday the Supreme Court handed down a ruling that will significantly curtail the power of executive agencies to control entire sectors of the economy through promulgating rules.

While some commentators view this decision narrowly as a determination of the Environmental Protection Agency’s (EPA) ability to promulgate regulations to address climate change, in practice, it sets a precedent that will limit the ability of all executive agencies to make regulations that shift entire industries without specific congressional authority to do so.

According to legal expert Jonathan Turley, “it will be much more difficult for President Biden to order sweeping environmental changes without congressional approval” in the wake of this decision.

The case, West Virginia v. Environmental Protection Agency, originated during the Obama administration. It challenged the EPA’s Clean Power Plan, a set of regulations that required all energy producers to transition coal-fired power plants to natural gas. The Obama EPA relied on its powers under the Clean Air Act to make the mandate.

A group of states led by West Virginia and coal industry associations sought a stay on the Clean Power Plan in 2015. The plaintiffs argued the plan exceeded the EPA’s mandate under the Clean Air Act and violated states’ rights to regulate electrical power. The D.C. Circuit Court of Appeals denied the plaintiffs a stay in January 2016. When the plaintiffs appealed the issue to the Supreme Court, the justices issued the stay, pending the outcome of all litigation.

This stay on implementing regulations was the first granted by SCOTUS before a review by the federal court of appeals. Many SCOTUS watchers felt this ruling signaled that the court might be interested in rolling back Chevron deference or narrowing the power of executive agencies through the major rules doctrine.

Chevron deference is SCOTUS’s legal test to determine when the court should defer to an executive agency’s answer or interpretation of the law when authoring regulation. This deference was appropriate when the agency’s response was reasonable and Congress had not spoken directly to the precise issue in question. Applying the major rules doctrine would require Congress to speak on substantive issues through legislation before an administrative agency could act. The current court used this reasoning twice during COVID, ending the CDC’s eviction moratorium and preventing Biden’s vaccine mandate for private employers.

Related: Biden White House Counsel Jumps Ship

Other commenters thought it was a sign the court would be willing to prevent agency overreach until litigation settled all legal questions. Regulations can do significant damage while parties argue a case when an administration begs for forgiveness in the courts after knowingly sidestepping Congress. The Obama administration lost more lawsuits with a 9-0 majority at the Supreme Court than any modern president.

The issues in the case remained unresolved when President Trump took office in January of 2017. As part of easing regulations on the energy industry, Trump’s EPA repealed the Clean Power Plan and implemented the Affordable Clean Energy rule. The new rule required coal-fired plants to upgrade their equipment to burn coal more efficiently. On the evening of January 20, 2021, the D.C. Court of Appeals struck down the Trump EPA regulation. It said the EPA’s revocation of the Obama plan was invalid based on a misinterpretation of the Clean Air Act. Joe Biden was inaugurated the next day.

Instead of quickly implementing the Obama-era regulation, Biden’s EPA decided to try its hand at writing a new rule. The plaintiffs weren’t waiting to resolve the issue. West Virginia v. Environmental Protection Agency asked SCOTUS to overturn the D.C. Circuit’s ruling on the Trump-era plan. Specifically, it urged SCOTUS to review whether a regulation that is so substantial it affects an entire industry violates the major questions doctrine. It also asked the court to rule on provisions of the Clean Air that may violate the nondelegation clause of the Constitution.

In the decision, the majority found the court had the jurisdiction to decide the case without a new rule from the Biden administration. The plaintiffs’ claim asked SCOTUS to issue what some, including Justice Elena Kagan in the dissent, see as an advisory ruling. The court made an advisory opinion when it ruled in favor of the plaintiffs seeking an injunction against New York’s gathering limits on religious services. When SCOTUS issued the decision, the restrictions no longer applied to the religious organizations that filed the suit. SCOTUS took a similar advisory approach here.

The majority opinion, authored by Chief justice John Roberts, concludes (emphasis added):

Capping carbon dioxide emissions at a level that will force a nationwide transition away from the use of coal to generate electricity may be a sensible “solution to the crisis of the day.” New York v. United States, 505 U. S. 144, 187 (1992). But it is not plausible that Congress gave EPA the authority to adopt on its own such a regulatory scheme in Section 111(d). A decision of such magnitude and consequence rests with Congress itself, or an agency acting pursuant to a clear delegation from that representative body. The judgment of the Court of Appeals for the District of Columbia Circuit is reversed, and the cases are remanded for further proceedings consistent with this opinion.

This wording appears to be a significant blow to the Chevron deference and a nod to the major questions doctrine. It will impact cases that allege executive overreach and may be the first of many steps the court will take to make the legislative branch of government do its job.

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erin@erinhouchin.com

Ms Houchin,

Could you please share your position on the war on drugs and all the illegal fentanyl coming across our SW border from China & Mexico cartels and 70K-75K/yr dying from illegal opiate poisoning ? There is a estimated 100+ million people dealing with chronic pain and that could suggests that in Indiana 9th district has some 200K-250K and the DEA is raiding prescriber’s practices apparently based on (illegal) data mining of states’ PDMP’s and charging prescribers of violating some undefined standard of care and best practices and red flags that the SCOTUS recently declared were UNCONSTITUTIONAL in regards to being used to confiscate guns https://www.pharmaciststeve.com/breaking-supreme-court-rules-red-flag-gun-laws-unconstitutional-should-red-flags-used-by-dea-be-unconstitutional/ and the results of the 2016 CDC opiate dosing guidelines have caused many dealing with chronic pain to have their medically necessary pain management to be reduced and patient’s quality of life is being greatly compromised https://www.pharmaciststeve.com/new-data-on-opioid-dose-reduction-implications-for-patient-safety/

Thanks in Advance

 
This person (Erin Houchen) is running for Congress as the candidate for the 9th Indiana district House seat. She was the Senator representing the 47th Indiana district for 8 years, ending in 2022. A few years back, I attended a political action day at the Indianapolis state house organized by the Indiana Pharmacist Assoc, which I am a member.  Part of that day was the typical “chicken meal” and speakers addressing the couple of hundred Pharmacists, Pharmacy students and technicians.  There was three speakers, two pharmacists, one in the House & one in the Senate and Senator Houchin.

As I remember, Senator Houchin was pretty much “gun-ho” about fighting the war on drugs, you know.. all opiates are bad and everyone who takes opiates get addicted.  So, on June 15th, 2022, I sent the above question to her, via the email on her campaign webpage.  She is a little younger than our Daughter, maybe I should have sent it via Face Book or text since she is part of GenX like our Daughter.

According her wikipedia page https://en.wikipedia.org/wiki/Erin_Houchin#Early_life_and_education  She has a Bachelor of Arts degree in psychology and a Master of Arts political management . which would suggest that she lacks a depth of knowledge in regards to addiction vs dependence and the understanding that the illegal Fentanyl that last year killed/poisoned some 70K- 75K of our citizens and that according to wikipedia there is some 400 different KNOWN Fentanyl analogs and only one is approved for by the FDA for human use and the FDA approved Fentanyl analog that is commercially available is not available in a solid oral dosage form.  Here I am 2+ weeks after sending that email and I have only heard

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Retailers’ websites show the emergency contraceptive in short supply after Supreme Court’s abortion decision

https://www.wsj.com/articles/cvs-walmart-limit-purchases-of-plan-b-pills-after-surge-in-demand-11656358819

Some of the nation’s biggest retailers are rationing over-the-counter emergency contraceptive pills as demand spikes following the Supreme Court ruling overturning a constitutional right to abortion.

CVS Health Corp., CVS -1.42%▼ Walmart Inc. WMT -1.41%▼ and Rite Aid Corp. RAD -5.15%▼ were limiting purchases of the pills, which were in short supply or out of stock on major retailer websites. CVS and Rite Aid were limiting purchases to three, while Walmart was limiting orders to 10.

Plan B pills are different from medication abortion, also known as plan C, which requires a prescription and involves the administration of different pills to terminate a pregnancy. In the U.S., medication abortion has been approved by the Food and Drug Administration for up to 10 weeks of pregnancy. Two medications—mifepristone and misoprostol—are typically used in a

Several companies make versions of Plan B that range in cost from $10 to more than $50. On Monday, the cheapest option available from major retailers’ websites was a pill for $35. There are three types of emergency contraceptive pills: progestin-only pills like levonorgestrel (sold under the brand name Plan B, among others), ulipristal (brand name Ella) and combined emergency contraception pills that consist of ethinyl estradiol and levonorgestrel. The latter two types require prescriptions.

Plan B One-Step, the top-selling emergency contraceptive, is owned by a pair of private-equity firms, Kelso & Co. and Juggernaut Capital Partners. Teva Pharmaceutical Industries Ltd. sold the brand in 2017 to the investors as part of a move to shed its women’s health business. Representatives from the firms didn’t respond to requests for comment.

In the days following Friday’s court decision, social media filled with comments either encouraging or dissuading people to stock up on the contraceptive. Some users posted that they were buying as many as possible; others argued against stockpiling for fear it would cut off access to people with an immediate need.

Planned Parenthood on Monday advised against stockpiling emergency contraceptives as they have limited shelf life and because hoarding supplies could limit access for women who have an immediate need.

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Lawmakers Pummel Biden’s Drug Policy Czar at House Hearing

— GOP and Democratic members raise issues with border control, medication-assisted treatment

https://www.medpagetoday.com/psychiatry/opioids/99473

WASHINGTON — Rahul Gupta, MD, MPH, director of the White House Office of National Drug Control Policy, got hit from all sides Monday at a House Committee on Oversight and Reform hearing on the federal response to the overdose crisis.

As often happens during a congressional discussion of substance use disorders, committee Republicans focused on the issue of border control. “One [outstanding question] is how President Biden’s border crisis and this administration’s open border policies have aided and abetted trafficking of illicit drugs, such as fentanyl, in our country,” said Rep. James Comer (R-Ky.), the committee’s ranking member. “Fentanyl is being smuggled across the southwest border at unprecedented rates … We must act now to secure our southern border to stem the flow of illicit fentanyl.”

Rep. Pat Fallon (R-Texas) also pressed the issue. When Gupta, in response to a question, said that the southern border of the U.S. was secure but the administration is continuing to work with Mexico on the drug issue, Fallon called that response “shockingly inadequate” adding “it shows just gross negligence … the Mexican drug cartels are controlling the southern border, not the federal government. It’s a gross dereliction of duty that’s putting Americans at risk.”

Medication-Assisted Treatment Questioned

But Republicans weren’t the only ones showing their displeasure. Rep. Stephen Lynch (D-Mass.) decried the use of medication-assisted treatment as a strategy for helping those with substance use disorder. “We allow doctors to have hundreds of patients and just give them Suboxone [buprenorphine/naloxone] and not really deliver any behavioral health services that would get at the underlying addictive activity,” he said. “We’ve got a couple of clinics that hand out Suboxone — the patients go out the door and then they either trade that or they buy fentanyl or methamphetamines, which is even a worse problem. They can’t get high with the Suboxone, so they’re going to harder drugs,” which leads to more stabbings and other violence.

“We’re actually seeing much more violent activity because an individual on methamphetamines might be up for days, and we’re seeing a lot of stabbings,” he said. Gupta noted that “people have different ways of getting at the treatment … Some may do OK cold turkey, while others may need medication for varying amounts of time … We’ve got to help people when they need it and where they need it.”

Lynch seemed unimpressed with that answer. “It’s not working where I am,” he said. “I’ve got tent cities, hundreds and hundreds and hundreds of people all together, right next to a methadone clinic, that are shooting up … I think we’re pushing more of this stuff out, and it’s not helping. So I think we’ve got to reassess.”

Should Cannabis Be Reclassified?

Rep. Ro Khanna (D-Calif.) wanted to know why cannabis — which he said could sometimes be a useful alternative to opioids for pain management — was classified by the Drug Enforcement Administration (DEA) as a Schedule I drug — a class with the most restrictions — while opioids were classified as Schedule II. Classifying cannabis as Schedule I also means that researchers are barred from conducting rigorous, large-scale studies on it, he added. “Do you see this as a contradiction that needs to be resolved?” Khanna asked.

Gupta agreed that “it’s important for us to continue to look at this from a research perspective, from a medical use perspective. Clearly, the policies that we’ve had in this country with regard to marijuana have not worked, and the president has said so.” Khanna reminded Gupta that “the president has the executive authority to direct DEA, HHS, and FDA to consider administratively rescheduling marijuana, which would facilitate research, which would facilitate patient access … At least make sure it’s rescheduled so it’s not more restricted than opioids themselves.”

Congresswoman Eleanor Holmes Norton (D-D.C.) said that she was “extremely disappointed that the Biden administration’s two budgets have proposed maintaining the rider that prohibits the District of Columbia from spending its local funds on commercializing recreational marijuana.” Gupta responded that “in the matter of the D.C. rider, I understand it’s with Congress, and I’ll leave it at that. And having said that, the president has been very clear that he supports decisions regarding legalization of marijuana to be left up to individual states, but at the federal level, he has supported decriminalization of marijuana use and automatic expungement of records.”

An Equity Lens

Norton wasn’t entirely negative about the administration’s response to the issue so far, however. “Since assuming office, the Biden administration has shown a robust commitment to advancing equity and centering recovery over punishment in federal response to the overdose crisis,” she noted, and gave Gupta a chance to further explain the administration’s policy in this area.

Gupta said that with his office’s recently released drug control strategy, “one of the things we are doing is looking at all of the metrics that are available to us … We were able to put forward a state model for nonviolent crimes; if someone has a mental health disorder, or addiction, let’s get the person help; let’s get them treatment; let’s get them housing — instead of incarcerating them. It’s not only a good thing to do and prevents recidivism, but it’s also cost-effective for the communities. It is these types of things that the strategy looks at, figuring out how to solve problems at a community level and making sure that we’re doing that with the lens of equity.”

Rep. Debbie Wasserman Schultz (D-Fla.) was also supportive of Gupta, praising his understanding of the issue. She saved her wrath for Florida Governor Ron DeSantis (R) and other Republican governors who are opposed to expanding Medicaid in their states. “Research shows that overdose rates are lower in states that expanded Medicaid coverage under the Affordable Care Act,” she said. “In fact, states that expanded Medicaid coverage experienced at least 10% fewer overdoses involving synthetic opioids like fentanyl, and 11% fewer overdoses involving heroin, when compared against states that haven’t expanded Medicaid.”

“Sadly, because Governor DeSantis is immune to facts, science, and even the shame that families must endure because of his callous inaction, he is not likely to be moved to act,” Wasserman Schultz concluded. “But that doesn’t mean we stop calling out his and other Republican governors’ cruel indifference and how it compounds this crisis and adds to the pain that millions of American families will suffer.”

This is a image I first posted in 2014, probably data from 2013 or 2012… so while the deaths from the two drugs, Alcohol & Nicotine use/abuse has not changed much in the intervening 8 to 10 yrs, but drug/opiate overdoses are up around SEVEN TIMES. From a White House administration perspective, the problem has been BIPARTISAN perspective over the up to last decade of time.  There is enough blame to go all around for both political parties.

Could it be time for the chronic pain community to align with those protesting “my body, my choice”, “healthcare is a RIGHT”, “I don’t what some politician/bureaucrat to decide what I do with my body”..  SCOTUS unanimously decided last week that the DOJ/DEA were applying undefined standard of care and best practices – objective standards – to determine if prescribers were not meeting those objective standards when treating pts dealing with subjective diseases Supreme Court Rules for Doctors on ‘Pill Mill’ Prosecution Proof: 9 to 0 in favor of practitioners

The pro-abortion groups seems to have a fairly large number of supporters and a LOT OF ENTHUSIASM.. and the chronic pain community represents a MASSIVE NUMBER OF VOTES.  After all 435 members of the House and 33-34 Senators will up for election/re-election in Nov 2022.  Could a coalition of those two very large groups – AND VOTERS – could that cause politicians to listen to their constituents. ?

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The illegal Fentanyl from China is killing more American EACH YEAR… than all the soldier killed in ALL THE YEARS of the Vietnam war, everyone killed at the attack on Pearl Harbor and all the people killed at 911  TOGETHER…

Now that the SCOTUS has declared that DOJ/DEA is incorrectly/illegally charging many prescribers of prescribing control meds without meeting a UNDEFINED standard of care and best practices Supreme Court Rules for Doctors on ‘Pill Mill’ Prosecution Proof: 9 to 0 in favor of practitioners

Who believes that the DEA will start to focus on their original charge back in 1973 to deal with illegal controlled substances being sold – mostly on our streets.

Here is graphic I have from 2014 – EIGHT YEARS AGO…  16K OD’s per year. the number of deaths from use/abuse of alcohol & tobacco hasn’t changed much BUT, the number of OD drug deaths is up ALMOST SEVEN TIMES.

There is substantial evidence that most/all of this illegal Fentanyl analog is made in China and shipped to Mexico, who turns the raw illegal Fentanyl powder and using their tablet presses, produces  millions and millions of fake tablets that looks like legal prescription tablets/doses.  Recently the DEA or CDC stated that 60% of the illegal Fentanyl tablets contain a LETHAL AMOUNT OF THE ILLEGAL FENTANYL.

That is like playing Russian Roulette with a 5 shot gun with only 2 chambers EMPTY.

If another nation or two is contributing to the deaths of > 100,000 of our citizens EVERY YEAR … are we at WAR ?   All it took to declare war against Japan when they attacked Pearl Harbor and killed about 3000 … All it took was the 911 attack on the twin towers in NY and killed about 3000 to declare war on the Bin Laden and his followers.   Of course, those deaths all happened in a SINGLE DAY… and since the OD deaths from illegal Fentanyl is abt 300/day… a number not significant enough for us to act ?  We don’t have to attack another country… we could start by CLOSING OUR SOUTHERN BORDER and initiate other efforts to stop the tsunami of illegal drugs coming into our country. There is – on average 7700 people that die in our country VERY DAY… maybe 4% are being killed by illegal drug coming into our country is not significant enough to worry about ?

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