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

Coming soon to an EHR near you: Downtime and Missing Patient Data

Electronic Health Records are often full of bloat and incorrect data, except when they are not accessible at all and/or relevant patient data isn’t even entered into the system. Here’s a frightening note from management sent to “providers” in one health system earlier this week:

Subject: Downtime Message to Providers
To the Health Network Medical Staffs :

On December 12 from approximately 7:30-10 AM the entire network experienced a EHR unplanned outage. It was due to a server issue in Kansas City and affected several customers. The Issue was identified quickly and remedied. We were back up in under 2 hours.

We identified the fact that data from the EHR had not transferred since Nov 16th. We failed to actively monitor that transaction so did not know that data transfer had failed. The data transfer issue has been fixed by our EHR vendor and we are putting a process in place to assure that the monitoring of the transmission of data happens without fail.

Your IS team understands that this impacted your workflow and we apologize. We continue to work toward no disruption in information flow at all times.

Chief Medical Information Officer

10 Reasons to ‘Refuse to Enroll’ in Obamacare

From our friends at Citizen’s Council for Health Freedom:

OPEN ENROLLMENT 2018: 10 Reasons to ‘Refuse to Enroll’ in Obamacare

‘Command and Control,’ ‘Claw Backs,’ ‘Narrow Networks’ and More Are Reasons to Stay Out of an Expensive, Privacy-Compromising Gov’t Plan.

Just a few days remain in the open enrollment period for the Affordable Care Act (ACA), and for those still on the fence, Citizens’ Council for Health Freedom (CCHF) is sharing the top 10 reasons to “Refuse to Enroll.”

“For more than eight years, the Affordable Care Act has been changing America’s health care landscape—and not for the better,” said CCHF president and co-founder Twila Brase. “Costs have skyrocketed because younger, healthier Americans wisely chose not to enroll, unlike the Obamacare architects thought they would. Health plans that were already making money hand over fist received bailouts for insuring older, sicker individuals, some with uninsurable conditions. With a new administration that’s making bold steps against the ACA way of doing health care, there are many reasons not to enroll in a flawed government system that compromises care, ties doctors’ hands and shares our private medical information.”

CCHF’s “10 Reasons Not to Enroll in Obamacare” include the following:

  1. Obamacarecoverage is a government program; not private insurance.
  2. It’s “a second Medicaid-style program,” said former CBO director Douglas Holtz-Eakin.
  3. The Affordable Care Act (ACA) exchanges facilitate redistribution of American’s wages, reported Fox News in 2010, just days after the law was signed.
  4. User fees added to premiums fund operations of these ‘command and control’ exchanges, according to an “Overview of Health Insurance Exchanges” from the Congressional Research Service.
  5. ACA exchanges may automatically enroll you in Medicaid, such as this story in Minnesota.
  6. If you underestimate your income, the IRS can ‘claw back’ premium subsidies you received.
  7. Your choices are limited, as a result of “narrow networks” of doctors and hospitals.
  8. Federal law and most states no longer penalize you for refusing to buy insurance.
  9. Health care sharing is a more affordable, cash-based option for coverage.
  10. The federal exchange database (“Health Insurance Exchange Program” System of Records) collects, stores and shares private information from all enrollees.

For many years, CCHF has also shared a list of wise—and legal—alternatives to signing up for costly government coverage:

  1. Buy private insurance outside the government exchanges, such as a private policy, employer-sponsored coverage or a private insurance exchange.
  2. Claim one of several general exemptions to the mandate or one of its many hardship exemptions. The Trump administration added several hardship exemptions in April, including one related to abortion, and also announced earlier this month that documentation is not required for those who take these exemptions.
  3. Become a member of a health care sharing ministry, a viable, affordable option for some families that is skyrocketing in enrollment—and the second of the nine general exemptions.

“Americans also need to understand that although the mandate and penalty are gone in a practical sense, they are technically still in place,” said Brase. “While Congress zeroed out the penalty tax starting in 2019, Congress did not repeal the ACA mandate to be insured or the penalty itself. It only zeroed out the penalty for going uninsured. The language for the mandate and the penalty are still in law, but the cost of the penalty is now zero dollars. While this provides welcome relief to many, a future Congress could turn around and easily reinstate the penalty for being uninsured because the penalty language is still in law. They could simply go from zero to whatever penalty they wish to impose for going uninsured.”

Americans should also know that the individual penalty was zeroed out beginning in 2019, so those who went without coverage in 2018 may be still on the hook for penalties—and may still be able to claim exemptions to avoid those penalties.

For more information about CCHF, visit www.cchfreedom.org, its Facebook page or its Twitter feed @CCHFreedom. Also view the media page for CCHF here. For more about CCHF’s initiative The Wedge of Health Freedom, visitwww.JointheWedge.comThe Wedge Facebook page or follow The Wedge on Twitter @wedgeoffreedom.

Medicare for All Will Sabotage Your Healthcare and Your Freedom

Politicians promise to lower costs and assure quality medical care, but voters need to beware.

Here are some common misconceptions about Medicare for All:

Myth: Medicare for All would get rid of profiteering insurance companies and thereby save billions.

FACT: The “insurance” monoliths would still be there to manage the system. Look at the profits of Medicare Advantage plans and Medicaid managed-care contractors. Their business plan is to deny care.

Myth: Quality would be assured by government.

FACT: “Quality” would be defined by government, based on compliance with population-based guidelines, not what is best for individual patients.

Myth: Government would “negotiate” lower prices.

FACT: Government would impose price controls. Cuts of 40 percent to providers have been proposed. Overhead is at least 50 percent of a physician’s revenue, and if a practice can’t cover its costs, it closes.

Myth: The system would be like in Western Europe: free, but with great care available when you need it.

FACT: Private insurance is available and widely used in Europe. It would be outlawed in Medicare for All. Cost-saving methods in Europe include Britain’s Liverpool Care Pathway—dehydrating troublesome patients to death, and expanding euthanasia in Belgium, the Netherlands, and Switzerland.

Myth: Corporations and the “rich” would pay for it with “modest” tax hikes.

FACT: Costs of greater than $40 trillion cannot be paid by any available or proposed source of revenue. And of course business costs are paid by the consumer, or the business disappears.

Myth: Care would be “equal” and “fair.

FACT: It is obviously not possible to reduce spending and give more care to the disadvantaged without cutting off care to some who now receive it (such as the elderly).           “

Obama promised—falsely—that if you liked your health plan or your doctor you could keep your doctor or your health plan. With Medicare for All, your insurance plan would be outlawed, and ‘your doctor’ would be the assigned plan ‘provider,’ who may have minimal training or experience. The candidates supporting Medicare for All are preparing to sabotage the voluntary American system of medical care and replace it with a system that will resemble Venezuela, not Denmark.

Looking for more information?

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.