American ingenuity and free markets can solve the problem of rising drug prices… if we allow it.

A couple of major threats to the health of the prescription drug supply chain are finally getting some long overdue attention.

  1. We are over-reliant on foreign production.

More than 90 percent of our prescription drugs are either manufactured in China or contain key ingredients that come from China, and China isn’t our best friend. Drugs on this Chinese-sourced list include antibiotics, birth control pills, cancer treatments, anti-depressants, statins (for high cholesterol), and HIV/AIDS drugs.

Why in the world are we outsourcing this mission-critical aspect of American medicine to countries hostile to our nation? (Not to mention the fact that countries like China are stoking the opioid epidemic by exporting deadly illicit Fentanyl to our shores).

Steve Jobs famously took the Obama administration to task over the main reason Apple had 700,000 factory workers employed in China, instead of the U.S:  D.C. is not business-friendly and it is impossible to build a factory in the United States due to regulations and unnecessary costs.

https://www.businessinsider.com/president-obamas-lack-of-resolve-frustrated-steve-jobs-2011-10

Unfortunately instead of cutting the red tape, Sen. Elizabeth Warren and colleagues are proposing exactly the wrong solution to bringing drug production back to the US of A. Instead of unleashing the market forces that built America into the #1 economy in the world, Warren hopes to import the same policies that sank behemoths like the U.S.S.R. and helped ignite the dumpster fires consuming Venezuela and Cuba: nationalized takeover of production.

Even the most profitable industries are not immune to the destruction that government-run production can bring. Case and point: Nationalization has driven Venezuela from oil powerhouse into the poorhouse:

So let’s look for proven solutions instead of dooming the drug industry to a fate of greater drug shortages, stagnation, and even higher prices.

Yes, there is already a sea of red tape and failed policies standing between American patients and inexpensive drugs. Thankfully, unlike Senator Warren, the Trump administration’s FDA Commissioner Scott Gottlieb MD and HHS Secretary Alex Azar seem truly interested in getting to work cutting through it by unleashing competition not warmed over communism.

Which brings us to the second major threat to the supply chain that is getting some overdue sunshine:

2) Kickbacks to Group Purchasing Organization and Pharmacy Benefit Manager Middlemen.

According to nomiddlemen.org:

GPOs and PBMs are perpetrating “a dangerous and unethical game of ‘pay-to-play.’ It’s the dirty little secret behind the outrageous cost of medications and the shortages of many drug and medical supplies. Unfortunately, a law was passed that allows these medical market “middlemen” to accept kickback payments from drug and medical supply companies in exchange for exclusive sales contracts! It created a government-sanctioned system of racketeering that would be illegal in any other industry.

 

The FDA along with HHS have signaled a willingness to end the kickbacks. And since the beginning of 2019 Senator Susan Collins and the new Chair of the Senate Finance Committee, Chuck Grassley have also stated they are going to take a close look at these shameful business practices

https://www.collins.senate.gov/newsroom/senator-collins-urges-administration-prioritize-reducing-drug-prices

https://www.grassley.senate.gov/news/commentary/grassley-top-priority-reducing-health-care-costs

Bottom line? American ingenuity can solve the problem of rising drug prices. If we will let it.

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Take Action by Jan 11: Eliminate the #GPO #PBM Middlemen #Safeharbor Creating Drug Shortages and High Prices

“Drug shortages are pretty much a daily disaster right now for most hospitals,” reported Pharmacy Times on December 10. Meanwhile, “The US Food and Drug Administration (FDA) is not just seeing an increase in drug shortages but also a spike in the intensity and duration of shortages,” writes Zachary Brennan, summarizing conclusions from an FDA event last month.

This summer FDA Commissioner Scott Gottlieb, MD convened a Drug Shortage Task Force “to seek root causes of drug shortages and potential enduring solutions.”

The Task Force has issued a request for public comment as it prepares a report to Congress, and the deadline to submit solutions is January 11. Please help us, your colleagues, and your patients, take advantage of this opportunity to share a few key ideas with the Task Force.

Here’s how you can help! Continue reading

Click and Comment to End Killer GPO/PBM Kickbacks

Co-Founder of Physicians Against Drug Shortages, Bob Campbell, writes:

Go to this site and click on the right button “Comment Now”
https://www.regulations.gov/comment?D=HHSIG-2018-0002-0001

There are already a bunch of comments from PADS members and you are able to read them first for inspiration. Those representing organizations should also submit a comment on behalf of their organization’s membership.

I wrote the passage below and then added an attachment GPO/PBM Facts which is added here as an attachment. There are some great WSJ comments below too which may be an inspiration. I hope this makes it easy. Say who you are why you care and then cut and paste to your heart’s delight. Also you can just compose from the heart.

During our October 22 White House meeting I hope to have a “large number” of comments to get rid of the Middlemen Kickbacks. I will personally deliver a “click count” to the White House so lets aim to impress.

Best
Bob Campbell

Suggestions for Comments:

In my 29 year career in medicine I have witnessed the emergence of middlemen GPO/PBM Kickbacks. What began as a nuisance has become the largest cost driver in healthcare. HHS should formally recommend repeal of the GPO/PBM Safe Harbor. It is a policy that is long overdue. Independent analyses demonstrate 35%-47% of the consumer cost of drugs is used to fund kickbacks. These GPO and PBM contracts are highly guarded and kept secret for a reason. Repeal the Safe Harbor. Reduce costs and end deadly drug shortages.

Repeal the Group Purchasing Organization (GPO) Kickback Safe Harbor {42 CFR § 1001.952(j)} and make the American healthcare system great again.

The GPO/PBM Middleman is the cartel responsible for spiraling healthcare costs, They are responsible for the unprecedented drug price spikes and dangerous, even fatal shortages that began in 2006. The GPO executives and there enablers are growing immeasurably rich in the process. Meanwhile the American people are facing escalating hospital costs. Americans can no longer afford health insurance or medications.
HHS OIG, the Department of Justice, and the Federal Trade Commission are failing to intervene to restore a competitive healthcare supply chain. Congress has failed to confront the powerful businessmen who have criminalized the healthcare supply chain.
Eliminating kickbacks in the healthcare supply chain will save $30b-$90B per year based upon empiric published analyses.

What can saving these billions of dollars do?

Restore the drug marketplace so that inexpensive and available generic medications are once again available to patients.

Rejuvenate the moribund generic drug manufacturing industry in the United States with the creation of hundreds of new plants and tens of thousands of new high paying jobs for American workers.

Allow savings to the Medicare and Medicaid programs totaling $11.1B-$33.3B that would occur immediately with no reduction in health care delivery.

Restore competition in the purchasing of all healthcare supplies. Kickbacks create high prices and low supply. Competition creates low prices and abundant supply. Competition lowers prices and improves quality. Cartels inflate prices and diminish quality.

End dangerous drug shortages that sometimes hurt and sometimes kill patients
Ending the healthcare supply chain kickbacks are a required component of any remedy for the rising cost of healthcare. It is also a necessary step if we are to continue to improve the quality of healthcare in any and all healthcare delivery institutions across the country. The intersection of law, economics, and medicine is where the next chapter in improving patient safety and extending high quality health care to all citizens begins.

The anticompetitive healthcare supply chain should be replaced by one that omits the market allocation fees and vendor access kickbacks. It is a necessary and inevitable event. There is no pathway to affordable high quality healthcare until Medicine’s Mobster Middlemen are vanquished.

Letters to WSJ:

Drug Rebates Help Many, but Not Patients

Pharmacy-benefit managers that are middlemen to middlemen, two orders of magnitude between the consumer and producer.

Joseph Antos and James C. Capretta write in support of pharmacy-benefit managers (PBM) that are middlemen to middlemen, two orders of magnitude between the consumer and producer, with market discipline totally absent (“Drug Rebates Aren’t ‘Kickbacks’” (op-ed, Sept. 17). Certainly, in today’s electronic age pharmaceutical manufacturers could have websites for consumers to purchase their products after an electronic prescription is received. Alternatively, for a known additional amount, a pharmacist could advise and dispense. Americans with health accounts could pay directly for most drugs, especially generics. Insurance could supplement the individual’s payment to purchase the newer, more expensive items. Reforms of the drug-approval process to lower costs would be beneficial.

Kenneth A. Fisher, M.D.
Kalamazoo, Mich.

The entire PBM industry is all about kickbacks and market manipulation. The more rent takers, the more forced manipulation of consumers and the less transparency there are, the less free any market can be. Oligopsony is the antithesis of a free market and directly leads to increased consumer prices. The safe harbor allowing kickbacks and market manipulation for PBMs needs to be rescinded.

Howard C. Mandel, M.D., FACOG
Los Angeles

Rebates create an environment where higher-list-price drugs are favored, providing zero incentive for pharma companies to introduce lower-priced medicines in competitive therapeutic classes. Over the last five years, according to the Department of Health and Human Services, pharmaceutical spending has increased by 38% while the average individual health-insurance premium has increased by 107%. During the same period, rebates, discounts and fees paid by the biopharmaceutical industry to insurers and PBMs have risen from $74 billion to $153 billion—an increase of 107%. Rebates, discounts and fees haven’t slowed precipitous premium increases.

Because PBMs retain a portion of negotiated rebates and other price concessions as compensation for their services, list prices are rising rapidly even as net prices have held steady. Unsurprisingly, manufacturers are willing to raise prices and transfer the greatest list-price-based rebate value to middlemen to secure preferred formulary position at the expense of real free-market competition, while also limiting the therapeutic options of physicians and patients.

Most rebates are generated from the medicines needed by the sickest patients, including those with cancer, autoimmune disorders and HIV. These patients pay 10 times more out of pocket than healthy patients and are forced to try cheaper or more rebate-rich drugs before getting medicines that work best. Faced with higher out-of-pocket costs and barriers to access, people are more likely to stop their treatment, getting sicker and more expensive to treat.

Rebates targeting the most vulnerable Americans aren’t just kickbacks, they are discriminatory and deadly measures as well.

Peter J. Pitts, Robert Goldberg
Center for Medicine in the Public Interest
New York

Legalized kickbacks for an industry that is controlling the prescription market? This has turned the pharmaceutical market into a pay-to-play operation as manufacturers can pay an increasing kickback for a coveted place on the formulary. Euphemistically calling them rebates is simply a way to keep the money flow of health care hidden from the unsuspecting public.

Marion Mass, M.D.
Perkasie, Pa.

You are either FOR Killer GPO PBM Kickbacks or Against Them

Bob Campbell, MD, co-founder of Physicians Against Drug Shortages writes:

Want to introduce an element of competition into healthcare? Ending the GPO/PBM kickbacks is the best place to start. Low hanging fruit and no room for compromise. You are either FOR sole source pay to play inflationary kickbacks or against.

So far since Trumps rumored new introduction of barriers to the kickbacks have been “rumored” to be “possibly written for possible introduction “ as new HHS rules Sen Warren and Hatch and Congressman Walden have emerged to keep the kickbacks in place and unfettered by HHS. They have not seen the rumored rules but if the rules might interfere with the essential kickbacks then the rules must never be enforced. Not good for America. Senators Toomey and Casey of Pennsylvania are both long time defenders of pay to play kickbacks. Pennsylvania Senate campaigns are very expensive and the PBM GPO cartels are very generous to supporters. Remember Trump can only erect barriers to access to the safe harbor. Congress made kickbacks and racketeering legal for GPOs and PBMs with the safe harbor law. Only Congress can make pay to play payola illegal again. That is an enduring solution. Trump cannot do that. Congress can.

A bill that is written, reviewed polished, and ready to go for any courageous Member of Congress. One version for the House and one for the Senate. President Trump says not one person in Congress is capable enough to take action on this matter. Is anyone willing to take him up on his challenge? All we need is a Healthcare Hero.  How about 100 new generic medication manufacturing plants with 200 jobs at each plant all in the state that leads the way. High paying clean manufacturing jobs that will stay busy throughout economic boom and bust cycles. Hundreds more just like it across the country, but the state of the Member of Congress who will introduce the bill gets first dibs.

A capital investment frenzy occurs if this bill passes. We need chemotherapy, saline, potassium chloride, potassium phosphate calcium carbonate, calcium chloride, sodium bicarbonate, epinephrine,ephedrine, norepinephrine, dopamine dobutamine, glucose, nitroglycerin, cardiac surgical drugs, antibiotics, obstetric medications, pediatric seizure medications and hundreds more.

I need drugs to paralyze people and unparalyze them. I need drugs to increase blood pressure and increase heart rates when they are too low. I need drugs to decrease blood pressure that is too high and slow down heart rates that are too high. Right now using smoke and mirrors. We should postpone all cardiac surgery until the Unsafe Safe Harbor is repealed. Right now we have Fake Anesthesia.

Trust me that is way more dangerous than Fake News. No more Fake Solutions from politicians for explosive healthcare costs and drug shortages. Exclusive Pay to Play Market Allocation Contracts is all that is keeping American companies from lowering costs for drugs and ending drug shortages. All contracts are written by an unnecessary extra layer of Middlemen inserted into the healthcare supply chain with a uniquely powerful ability to demand kickbacks from manufacturers to permit them to make lifesaving medications and medical devices for Americans who need healthcare. Drug Shortages never had to happen and can be ended. Healthcare Kickbacks never had to happen and can be ended.

Can a Former Pharma Insider Solve Sky High Rx Costs?

HHS Secretary Alex Azar talked a good game in a Rose Garden ceremony and subsequent press conference—held Friday, May 11—on Trump Administration efforts to lower prescription drug costs for American patients.

Azar is, of course, a former executive of Eli Lilly. Can he be trusted to champion the interests of everyday Americans?

We will soon find out.  President Trump stated that Sec. Azar’s insider knowledge about the complex schemes to raise prices, perpetrated by industry middlemen, is exactly what makes him the right person for the job.

Watch the video of the Rose Garden Ceremony:

Although groups like Physicians Against Drug Shortages have been sounding the alarm for years, industry-led smoke and mirrors have, until recently, largely flown under the radar of the main-stream-media. Thankfully, respected outlets like the Wall Street Journal and Washington Times are now beginning to shine needed light on this malfeasance.

As these articles explain, a safe harbor to Medicare anti-kickback law is the major policy failure enabling the bad actors to line their pockets by driving up costs. The safe harbor legalizes kickbacks paid by manufacturers to Pharmacy Benefit Managers (PBMs) and their cousins-in-crime Group Purchasing Organizations (GPOs).

TownHall.com reports: Repealing the GPO/PBM safe harbor to Medicare anti-kickback law “would open the drug and medical supply segment of healthcare to free market competition and foster innovation. In addition, it would result in cost reductions estimated at $100 billion [actually more like $200 billion], including savings for the Medicare and Medicaid programs.”

Congress initially enacted the GPO safe harbor in 1986. Then in 1987 Congress reaffirmed the measure, instructed HHS to implant the the safe harbor into regulation, and granted HHS authority to create additional safe harbors. In 2003 HHS OIG issued guidance clearing the way for PBMs to piggyback on the GPO safe harbor. Such guidance could theoretically be revised or rescinded by the HHS Secretary, without needing action by Congress.

And in their remarks today, both Trump and Azar mentioned that they will be looking at reining in such abusive practices.

Later in the press room, Azar explained that there are perverse incentives at play: “These big price increases are actually a good deal for pharmacy benefit managers, who are supposed to keep prices down.”

Video of White House Press Conference With Sec. Azar:

What is HHS going to do? They put out a 44-page blueprint of their plan:

https://www.hhs.gov/sites/default/files/AmericanPatientsFirst.pdf

One step HHS announced it will implement immediately is a prohibition of Part D gag clauses, “preventing pharmacists’ telling patients when they could pay less out-of-pocket by not using insurance.”

Great words but let’s hope HHS doesn’t stop there. The blueprint is less clear about other action HHS will take related to PBMs, although it states HHS is considering:  “Measures to restrict the use of rebates, including revisiting the safe harbor under the Anti-Kickback statute for drug rebate.”

Rebates? Why does CMS use that euphemism? They are not rebates, they are legalized kickbacks.  Furthermore, rebates do not go to the patients, they flow to the PBM and insurance companies.

Unfortunately, HHS has a poor track record when it comes to using it’s existing authority to stop PBM abuse. The Government Accountability Office reports: “since 2004, [HHS] has not routinely exercised its authority to request and review disclosures” that PBMs are required to make available to comply with the safe harbor.

HHS promises there will be an opportunity for the public to comment through a “Request for Information.”

HHS appears to be asking the right questions, including:

“Do PBM rebates and fees based on the percentage of the list price create an incentive to favor higher list prices (and the potential for higher rebates) rather than lower prices?”

and

“Should PBMs be obligated to act solely in the interest of the entity for whom they are managing pharmaceutical benefits? Should PBMs be forbidden from receiving any payment or remuneration from manufacturers, and should PBM contracts be forbidden from including rebates or fees calculated as a percentage of list prices? What effect would imposing this fiduciary duty on PBMs on behalf of the ultimate payer (i.e.,
consumers) have on PBMs’ ability to negotiate drug prices?”

When details become available about the comment opportunity we will ask that all patients and doctors demand that HHS take strong action to stop the PBM and GPO kickbacks.

Ultimately, as Trump stated in his comments, Congress will need to do it’s part in concert with administration actions.  One priority for Congress must be to repeal the GPO/PBM safe harbor and end legalized kickbacks.

In the meantime HHS can lead the way to educate Americans on how such repeal will save $200 billion dollars/year and prevent dangerous drug shortages.

Americans are depending on you to do the right thing, Secretary Azar.

The Ho$pice Hu$tle?

What’s going on with the recent flurry of acquisitions and divestment in the Hospice industry. IP4P asked HIT-industry veteran Barbara Duck (@MedicalQuack) to weigh in:

“Optum certainly kept this very quiet when they sold their hospice facilities to Compassus; however, they are not out of the business, they want to manage it instead, just as they manage surgeons and physicians with Surgical Care Affiliates and OptumCare doctors.  The worst nightmare for those in hospice has come true, the thought of Optum utilization managers running around Compassus Hospice facilities as they intend now to use Optum Hospice Services to manage them.  Hospice care by the algorithms is what we are looking at here with even more undue and not proven analytical scoring of patients taking place at their last days of their lives.  I think the screen from the PowerPoint presentation on the revenue growth here tells the story of what this company’s (Compassus) goals are, revenue and not patient care being the first priority. Continue reading

PBMs Invade Medical Records and Cash-Pay RX Discount Cards

We wrap up 2017 with a guest post from friend of IP4PI Barbara Duck (@MedicalQuack):

This should not really come as a big surprise as what hasn’t the pharmacy benefit managment business touched?  So what is OptimizeRX?  Most have probably not heard of this software but it is a connect to EMRs that will send your prescription right to the pharmacy.  Oh, now you say, well imagethe PBMs do that and they do but what they have been missing is a way to collect data on patients who are not using their PBM prescription card or those who do not have one.  It’s all about getting more data about you to “score” and of course sell those scores to insurers and other interested parties.  Once the pharmacy has the transaction, it does not fall under HIPAA rules as it’s a prescription, linked to an EMR to provide a transaction.  As we all know, your medications in an EHR are protected but again, I’ll repeat this for those who still think HIPAA is covered at the pharmacy, it is not.  It’s been a sore spot for years with privacy. Continue reading