Combating the Opioid Epidemic with the False Claims Act

Posted on March 6, 2020 by Pharmaciststeve

Could this same law be used against docs that are “forcing” pts to have ESI… Since the primary category of meds used in the ESI are Corticosteroids and both the FDA and the primary pharma that makes this category of med DISCOURAGES this category of med being used in ESI.  There are many countries that PROHIBIT the use of this category of meds in ESI’s

Likewise, the FDA discourages the use of pharmacy compounded meds in implanted pain pump, but a large majority of pain clinics used these compounded meds.  There was recently a small study that demonstrated that two commonly used compounded opiates used in implanted pumps are losing 40% -50% of their potency by the time they have been in the pump for 90 days.

Meds pump into pumps are billed under a HCPCS codes, and the pain clinic is reimbursed the same amount regardless of what opiate they put in the pump.  It has be reported that these compounded meds can be obtained for 10% to 25% of the cost of the only commercially available opiate that is approved for use in these implanted pumps (Infumorph/Morphine) and a pump manufacturer (Medtronics) has done studies that Infumorph retains up to 90% of its potency in the pump for SIX MONTHS.

If both of these procedures are being discouraged by the FDA … could/should these services being billed to Medicare/Medicaid/Tricare be considered FALSE CLAIMS and likewise no insurance company will pay for EXPERIMENTAL PROCEDURES… so should both of these procedures be classified as EXPERIMENTAL and thus not a covered service ?

Could this FALSE CLAIMS ACT end up being a TWO-WAY STREET ?

Combating the Opioid Epidemic with the False Claims Act

https://www.americanbar.org/groups/litigation/committees/corporate-counsel/articles/2019/fall2019-combating-the-opioid-epidemic-with-the-false-claims-act/

In an effort to combat the opioid epidemic, the Department of Justice is getting more creative with the tools in its toolbox. Case in point, federal prosecutors nationwide recently started using the False Claims Act, 31 U.S.C. §§ 3729–3733, to investigate health systems’ and prescribers’ opioid-prescribing practices.

This litigation update is the first in a multipart series on the False Claims Act in the health-care context. Part 1 provides a general overview of the False Claims Act. Future updates will explore various aspects of a False Claims Act action, including civil investigative demands, the interplay with the Controlled Substances Act and other federal statutes, special considerations for qui tam actions, cooperation credit, and settlement.

General Overview of the False Claims Act

The False Claims Act is a federal civil fraud statute that dates back to the Civil War. The False Claims Act applies to parties that contract with the U.S. government and imposes liability on parties that defraud government programs. In the health-care context, the False Claims Act applies to health systems and providers that submit false or fraudulent claims for payment under Medicare or Medicaid, as well as other federally funded programs such as Tricare.

The penalties for filing false claims are steep. Violators are currently subject to civil monetary penalties of not less than $11,181 and not more than $22,363 per false claim, plus three times the actual damages incurred by the government due to the fraud. 31 U.S.C. § 3729(a)(1); 28 C.F.R. § 85.5 (2018).

The False Claims Act and the Opioid Epidemic

Government agencies, including the Department of Justice, are under intense pressure to aggressively investigate and prosecute individuals and entities that may have contributed to the opioid epidemic. To that end, the Department of Justice is, with increasing frequency, investigating doctors and health systems with a history of prescribing high quantities of opioids to patients on Medicare or Medicaid. In such cases, the Department of Justice typically alleges that the opioids prescribed were “medically unnecessary,” thereby rendering the claim for reimbursement false.

False Claims Explained

The False Claims Act creates liability for any person who knowingly presents, or causes to be presented, a false or fraudulent claim to the U.S. government for payment or approval. To act knowingly requires a person to have actual knowledge, act in deliberate ignorance, or act in reckless disregard of the truth or falsity of the information. Although acting knowingly does not require proof of specific intent to defraud, innocent mistakes and negligence are not actionable.

Notably, the False Claims Act does not define false or fraudulent. Courts, however, have found liability based on two theories: (1) factually false or fraudulent and (2) legally false or fraudulent. Factually false statements create liability for statements that themselves constitute lies. Legally false statements are those that contain falsity or fraudulence in their certifications. False certification liability arises when a health-care provider fails to comply with ancillary requirements, such as contractual provisions, statutes, and regulations.

Implied Versus Express False Certification Liability

A claim for payment to the government has both express representations outlining services or products provided and implied certifications regarding compliance with all governing rules and regulations. As such, liability may arise under either an implied false certification theory or an express certification theory.

Implied false certification liability is based on the theory that a health-care provider implicitly certifies its compliance every time it submits an invoice to the government—even in the absence of any express certifications of compliance. Liability under the implied false certification theory arises when

  1. the health-care provider submits a claim requesting payment;
  2. the claim makes representations about the goods or services provided;
  3. the provider’s failure to disclose noncompliance with material statutory, regulatory, or contractual requirements makes these representations misleading half-truths; and
  4. the provider had actual knowledge that its noncompliance was material.

The Supreme Court expressly adopted the implied false certification theory in 2016 in the case Universal Health Services v. United States ex rel. Escobar. 136 S.Ct. 1989 (2016) (holding that a mental health-care facility was liable for a patient’s death while the patient was undergoing treatment by doctors who lacked qualifications and licenses).

Most cases that allege liability based on medically unnecessary or unreasonable services proceed under an express false certification theory. This is because Medicare and Medicaid reimbursement forms require express certification of adherence to their guidelines. To prove liability under an express false certification theory, the government must show that

  1. the provider submitted a claim;
  2. the claim expressly certified compliance with ancillary legal requirements, such as rules, regulations, standards, or contractual terms;
  3. this claim was false or fraudulent; and
  4. this certification was material to the government’s payment decision.

Medically Unnecessary or Unreasonable Treatment and False Claims

Excluded from Medicare coverage are items and services that are not reasonable and necessary for the diagnosis or treatment of illness or injury. The Medicare Program Integrity Manual defines reasonable and necessary as:

(1)               “Safe and effective”;
(2)               “Not experimental or investigational”;
(3)               “Appropriate, including the duration and frequency that is considered appropriate for the item or service, in terms of whether it is: [(i)] [f]urnished in accordance with accepted standards of medical practice for the diagnosis or treatment of the patient’s condition or to improve the function of a malformed body member; [(ii)] [f]urnished in a setting appropriate to the patient’s medical needs and condition; [(iii)] [o]rdered and furnished by qualified personnel; [(iv)] [o]ne that meets, but does not exceed, the patient’s medical need; and [(v)] [a]t least as beneficial as an existing and available medically appropriate alternative.

Ctrs. for Medicare & Medicaid Servs., U.S. Dep’t of Health & Human Servs. Medicare Program Integrity Manual, at ch. 13, § 5.4 (rev. 863, Feb. 12, 2019).

The Centers for Medicare and Medicaid Services (CMS) may promulgate national coverage decisions (NCDs) that may grant, limit, or exclude Medicare coverage for a specific medical service. NCDs are binding on all Medicare contractors processing Medicare claims. 64 Fed. Reg. 22619. Because coverage decisions are made at the discretion of local contractors, local contractors may also publish local medical review policies (LMRPs) to provide guidance to the public and medical communities regarding when Medicare considers an item or service “reasonable and necessary.” Id. Additionally, Medicare administrative contractors may issue local coverage determinations (LCDs), which are also binding on medical service providers. United States ex rel. Youn v. Sklar, 273 F. Supp. 3d 889 (N.D. Ill. 2017).

Absent any binding guidelines, courts generally require concrete medical, technical, or scientific context in order to allege that a treatment was medically unreasonable or unnecessary. United States ex rel. Presser v. Acacia Mental Health Clinic, LLC, 836 F.3d 770 (7th Cir. 2016).

The Medicare Program Integrity Manual empowers courts to consider accepted standards of medical practice for the diagnosis or treatment of the patient’s condition in determining medical necessity or appropriateness. Claims that are incompatible with standards of accepted medical practice may be medically unnecessary or unreasonable. E.g., United States v. HCA Holdings Inc., No. 12-20638-CIV, 2015 WL 11198933 (S.D. Fla. July 21, 2015).

Courts are split, however, as to whether poor medical judgment, without more, can create liability under the False Claims Act. Some district courts have held that a reasonable difference of opinion between physicians, without more, is not enough to show falsity. United States v. AseraCare Inc., 938 F.3d 1278, 1281 (11th Cir. 2019). The First, Fifth, and Eleventh Circuits have generally adopted the view that False Claims Act liability requires objectivity in falsity. Urquilla–Diaz v. Kaplan Univ., 780 F.3d 1039, 1052 (11th Cir. 2015); United States ex rel. Jones v. Brigham & Women’s Hosp., 678 F.3d 72, 87 (1st Cir. 2012); United States ex rel. Riley v. St. Luke’s Episcopal Hosp., 355 F.3d 370, 376 (5th Cir. 2004). The Third Circuit joins with its view that “expression of opinion, scientific judgments or statements as to conclusions which reasonable minds may differ cannot be false.” United States ex rel. Hill v. Univ. of Med. & Dentistry of N.J., 448 F. App’x 314, 316 (3d Cir. 2011).

Other courts disagree. The Tenth Circuit, for example, has noted that “it is possible for a medical judgment to be ‘false or fraudulent’ as proscribed by the FCA.” United States ex rel. Polukoff v. St. Mark’s Hosp., 895 F.3d 730, 742 (10th Cir. 2018). The Sixth Circuit has similarly noted that “opinions are not, and have never been, completely insulated from scrutiny. At the very least, opinions may trigger liability for fraud when they are not honestly held by their maker, or when the speaker knows of facts that are fundamentally incompatible with his opinion.” United States v. Paulus, 894 F.3d 267, 275 (6th Cir. 2018).

Conclusion

Health systems and prescribers must be cognizant of the fact that the Department of Justice is using the False Claims Act to combat the opioid crisis. To ensure compliance with the False Claims Act, health systems should monitor the prescribing practices of its providers and implement policies and procedures governing the prescribing of opioids.

Sean Bosack is a shareholder and Nina Beck is an associate at Godfrey & Kahn, S.C. in Milwaukee, Wisconsin.

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Losing Faith in My Profession

Posted on March 6, 2020 by Pharmaciststeve

I can so relate to the situation that a daughter/son/husband/wife can encounter with a loved one in a healthcare facility (hospital, physical rehab, nursing home, etc, etc).  More times that I wish  when Barb has been in a facility and I have had to bring into the conversation that ” I’m am a Pharmacist” to get the attention of the staff that are suppose to be attending to her health needs and they are NOT DOING THEIR JOB !  Unfortunately, not every first contact with the facility’s staff gets results, but those staffers tend to under estimated my tenacity. I really don’t care how many times I have to take my concerns to someone above the person I am talking to.    Generally, at sometime going up the corporate ladder someone is going to get pissed that my concerns have gotten to their level and the person under them did not take care of my concerns about inadequate care being provided my wife.

To get proper care for my mother, did I really have to tell everyone I’m a doctor?

https://www.medpagetoday.com/blogs/kevinmd/85249

I believe in the practice of medicine and enjoy teaching others this amazing art. However, after experiencing nine months of interactions through medicine as the daughter of a sick patient, I struggle with my pride in the profession and fear of the healthcare system.

My mother would proudly tell all her physicians that her daughter was a doctor. I knew she was proud, but I didn’t believe in using my title to change the care she received. That belief changed when she became sick.

The first time I exploited my title, senior specialists at another hospital tried to perform a procedure and weren’t successful. Upon arrival at the new hospital, my mother politely asked the ICU residents not to attempt the procedure without the attending in the room. The residents glibly responded, “we are the A team – and he’ll be out there.” When they didn’t listen, she looked at me with fear. I walked out and spoke with the attending. I said, “I am a doctor, and I train residents. Your residents aren’t listening to their patients.” After my explanation, he stopped what he was doing, unsuccessfully attempted the procedure, and came up with a different plan that prevented my mother from having additional pain.

When discharged from the hospital, the physician team did not know how to help us obtain sufficient home healthcare. I called a friend, a physician leader in the organization, and found she could help us. She knew the keywords to say and who to ask for. This personal, professional connection allowed my mother to immediately have home health.

I took my mother to the emergency room after I showed up to her house and found blood clots in the place of what she thought was diarrhea. I cleaned it up before we got in the car. I saw how much blood she lost. I personally provided the admitting resident her history. I knew her new medications and potential side effects. I knew her lab results from the previous week. I could do the math. Based on her new results, she lost the equivalent of 4 pints of blood in the past 4 hours, and she was still bleeding. The resident told me she didn’t need a transfusion. When the resident was not open to the idea of a blood transfusion, I used my title. I called her cardiologist on his cell phone and told him the situation. He logged into the medical system, and the next thing I knew, the transfusion had been started.

On my birthday, my mother rapidly decompensated. I was renewing my CPR license as a cardiac resuscitation was called. I arrived at the hospital, and the resident gave me basic information. My mother’s cardiologist used my title. He said, “No, she is a doctor. She deserves a more thorough update. You will keep her fully updated.” This resident tried, but I also received personal updates from the cardiologist.

So it continued. During every hospital visit, I mentioned my title to someone to ensure proper care or communication. My title was required to ensure the care my mother deserved as a patient.

In her final week, my mother suffered a massive stroke. I was coming to terms with the biggest decisions I made for my mother. It was time for her to officially change her status to DNR. I even had medical power of attorney forms in hand. I asked to sign papers to this effect and was told that wouldn’t be necessary. Knowing this wasn’t accurate, I used my title with the nurse to ensure I would receive an immediate call if anyone tried resuscitation. I signed paperwork to withdraw all care the next morning. The dialysis technician wheeled in the dialysis machine. I said, “No, she doesn’t need that. I have withdrawn care.” After several minutes of arguments, I finally said, “I am a physician, I know that I have the right to refuse.” Similar conversations occurred with the neurosurgeon, who was recommending aggressive medical management, the nurse who wanted to check her blood sugar, and the resident who tried to talk me out of the decision to transfer to hospice.

The final time I used my title, was when I asked the team to complete FMLA paperwork. I watched the resident quickly flip through the paperwork and called his attending, upset by the amount of work involved. He came back out and said, “Well, the family member has to complete this.” I responded, “Did you read this? The family section is complete. All you have to do is write her diagnosis here and that she was here in the ICU. You indicate unknown time.” He responded that he didn’t have the time to complete this form today. I asked him if he knew I was a physician, and he looked up startled. I said, “As an attending who teaches residents, I hope my residents never treat families how you just treated me. You just told me that you don’t have time to ensure that I can be by my mother’s side during her final days.” Trembling in anger, I walked away to the hospice unit. Although that resident did not help me, after sharing my story in the hospice unit, they ensured my paperwork was done within two hours of our arrival.

My mother had many healthcare interactions in her final nine months. I have no regrets for using my title to ensure the best care. I regret the necessity. I regret that a patient’s wishes weren’t respected and that she needed a physician daughter advocate. I fear for patients without physician daughters who understand the system or have colleagues who know code words. I regret that I carried my title of physician, and was not just a daughter, holding her mother’s hand in the final months of her life.

Santina Wheat, MD, is a family physician.

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Dr. Thomas Kline, MD, PhD: Medical Myths Revealed –Pharmacies: It’s Not Their Fault

Posted on March 5, 2020 by Pharmaciststeve

Pharmacies have started turning away people with opioid prescriptions, or giving them half-doses because the pharmacies are being shorted by distributors . But the Pharmacies are trying but you don’t receive your shipment of automobiles you’re not gonna sell any cars. If distributors decide without your permission or standardization with the help of analytic hired guns invent percentage of narcotics vs store sales this is terrorism. When did distributors get this much power to ration pain medicine your business fails. State pharmacy boards are the real ones you should be contacting about opioid pain prescriptions, or lack there of. The more people who do, the stronger the message will be painful disease pain patients should not have their lives ruined because of the belief if you reduce substance your reduce addiction which we all know is not true

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CVS Places Consumers at Risk of Harm, And is Destroying the Profession of Pharmacy! – PART 2

Posted on March 5, 2020 by Pharmaciststeve

CVS Places Consumers at Risk of Harm, And is Destroying the Profession of Pharmacy! – PART 2

https://pharmacistactivist.com/2020/March_2020.shtml

Most of the responses I received to Part 1 of the series of editorials (February issue of The Pharmacist Activist) on this topic are from two groups of individuals. Current and former CVS pharmacists and technicians voice appreciation for the extended awareness and concern about the working conditions imposed by their management that increase the risk of errors. They also express their gratitude to Ellen Gabler, the New York Times (NYT) investigative reporter, for recognizing and exposing the stressful work environment they experience and the resultant risks for consumers. I also hear from many pharmacists at Rite Aid, Walgreens, and Walmart with the request, “Don’t forget us – our working conditions are as bad as those at CVS.” I recognize that and many of the comments that I make about CVS in these editorials apply equally to those chain stores. However, CVS, with its huge network of stores combined with its Caremark and Aetna components, is responsible for the greatest risk for harm for consumers and is the most potent destructive force in pharmacy.

Updates

Much has happened in the short period of time since I published Part 1 of this series. Ellen Gabler has published a follow-up report, “Walgreens Had Consultants Cut Staff Complaints About Errors,” in a page 1 (A1) story in the February 22, 2020 print edition of the NYT. This story also addresses additional concerns involving CVS stores, as well as responses from CVS to the first story in the NYT. Hundreds, if not thousands, of comments have been posted on certain social media sites. And then, there is the editorial commentary in Chain Drug Review, “Retail pharmacies will overcome biased story.” Although this latter commentary is supportive of the role of and trust in pharmacists, it includes the following comments that must be challenged:

Chain Drug Review (CDR): “As The New York Times has been doing of late with astonishing regularity and surprising frequency, the newspaper of record has at last gotten round to demolishing the retail pharmacy business.”

The Pharmacist Activist (TPA): The NYT article pertains to concerns and errors in chain pharmacies, and does not focus on the entire “retail pharmacy business.” The NYT article addresses errors in the context of “chaos” and working conditions in chain pharmacies. It provides readers with information that is important for them to know for their own protection. It is not an attempt to “demolish” chain pharmacies. To the contrary, any “demolishing” is self-inflicted by the chains. If they did that just to themselves, it would be for the betterment and safety of the public. However, unfortunately, the policies and actions of the chains are destructive for the entire profession of pharmacy, as well as for consumers.

CDR: “They (pharmacists) are, at times, overworked and overlooked, unreasonably and unfairly called upon to multitask.”

TPA: “At times?” “Frequently” would be more accurate and some chain pharmacists would respond “all of the time.” CDR: “When they (pharmacists) complain, as they frequently did in this article (NYT), it is often anonymously, at a time when using their name and identifying the retailer for whom they work might have helped curtail or control the mistakes that do occur.”

TPA: Chain pharmacists who use their names and identify their employers will be terminated, but for an alleged violation of some company policy in an attempt to prevent the termination from appearing retaliatory. Even pharmacists who are no longer employed in a chain pharmacy are fearful of criticizing their former employers because of concerns they will find some way to retaliate.

CDR: “Typical of the Times, as it is much of print journalism, this article is long on criticism but woefully short on suggestions for appropriate action. The story leaves the cures for this unacceptable malady to the retailers…”

TPA: I fully agree that the current situation is “unacceptable.” However, it is not the responsibility of the Times to provide suggestions for appropriate action. Chain pharmacies have created the terrible working conditions that increase the risk of errors and harm, and it is chain pharmacies that should take the appropriate actions. However, it is clear that they don’t and won’t, and they have no basis for the complaint that the Times is exposing the errors and other problems the chains want to cover up. It is also noteworthy that the CDR does the same thing for which it is criticizing the Times by not providing suggestions for appropriate action. However, The Pharmacist Activist does have recommendations for appropriate action which are provided later in this editorial.

CDR: “And if one patient passes on by swallowing a drug not prescribed or dispensed to treat the malady the proper drug is generally used to treat, that’s reprehensible.”

TPA: I fully agree, and “passes on” sounds so much better than “died” or “killed.” The terminology is also a factor in identifying the frequency with which errors occur in CVS and other chain pharmacies. CVS contends that errors are “rare.” The CDR commentary initially notes that errors occur “occasionally,” and then “not often.” There is a trend here and many CVS pharmacists would say that the most accurate designation is “frequently.”

Consumers at risk

CVS places millions of consumers at risk of harm from inappropriate or less-than-optimal drug therapy by failing to provide them with the counseling and services its pharmacists are in a position to provide. CVS management denies this assertion or blames its pharmacists, but their denial is contradicted by the inadequate staffing of pharmacists and technicians, the stressful workplace environment, and the lack of adequate time for pharmacists to speak with patients. In the most serious situations, consumers experience adverse events, some of which are fatal, as a consequence of preventable errors and other drug-related problems.

Many errors are not even known or recognized, either because there are not consequences, or consequences occur but an error is not suspected and the resultant problem is attributed to another explanation. When errors are discovered but harm has not occurred or the consequences are considered “minor,” consumers are placated with sufficient coupons for store merchandise or other incentives to “resolve” the experience.

Some errors that result in harm are so clear and indisputable that CVS will compensate the victims in an amount sufficient to avoid lawsuits. Errors that do result in lawsuits rarely become known to the media, the public, or even state Boards of Pharmacy, because they are settled out of court with the settlements being sealed with confidentiality restrictions. In some settlements the terms even permit the defendant chain pharmacy to “acknowledge no wrongdoing,” the accurate translation of which would be “there was wrongdoing.” While claiming that errors are “rare,” CVS stonewalls requests to provide information/data regarding errors, as it did in responding to the reporter for the NYT. However, the outrage is increasing and the stone wall is starting to crumble. A rhyme comes to mind that is ripe for paraphrasing:

CVS sat on a crumbling wall;
CVS had a great fall;
All the CEO’s millions,
And all the CEO’s men and women
Couldn’t put CVS together again!

Can a rhyme become reality?

Recommendations

Much more must be done to expose preventable medication errors and other drug-related problems, as well as irresponsible decisions of the executives of chain pharmacies. Ellen Gabler and the NYT have pulled open the veil of secrecy that has hidden these problems, but the momentum of increasing disclosure must not diminish. There are steps that can be taken now and the following recommendations are provided:

  1. Pharmacies must report to the state Board of Pharmacy medication errors that cause harm and/or require increased patient monitoring. The definition of medication errors and risk assessment index established by the National Coordinating Council on Medical Error Reporting and Prevention (NCC MERP) should be used for the reporting of errors in the following categories to the Board:
    Category D: Errors that result in the need for increased patient monitoring but no patient harm;

    Category E: Errors that result in the need for treatment or intervention and caused temporary patient harm;

    Category F: Errors that result in initial or prolonged hospitalization and caused temporary patient harm;

    Category G: Errors that result in permanent patient harm;

    Category H: Errors that result in a near-death event (e.g., anaphylaxis);

    Category I: Errors that result in patient death.

    Boards of Pharmacy must be accountable in enforcing the reporting of errors, assessing the risk factors, and taking appropriate action.

  2. Standards/guidelines must be established to assure the level of staffing of pharmacists and pharmacy students and technicians that is appropriate for the number of patients served and/or prescriptions dispensed during a specified period of time. There are too many variables to establish specific quantitative requirements of this type, but the appropriateness of the level of staffing must be assessed as a potential contributing factor when errors occur. The number of patients served during a particular period of time, whether or not a prescription is dispensed for every patient, would be the best parameter to assess whether a pharmacist has sufficient time to fulfill her/his responsibilities to patients. However, this parameter is not used in current pharmacy practice, and the number of prescriptions dispensed during a particular period of time should be used initially as a less satisfactory but adequate measure. I propose the following guidelines:
    An average of 15 prescriptions per hour per pharmacist (i.e., one every 4 minutes, 120 in 8 hours, 150 in10 hours, 180 in12 hours) should be identified as the number of prescriptions that can be dispensed by a pharmacist that is consistent with obtaining and reviewing pertinent patient information, accurate preparation and dispensing of the prescription, patient counseling, phone calls, supervision of pharmacy students and technicians, and other responsibilities.

    Some will respond that this number is too high and some will respond that is too low. The number should be applicable whether the pharmacist is working alone, or with any number of pharmacy students and technicians whom the pharmacist must supervise.

    The proposed average of 15 prescriptions per hour per pharmacist can be, but would not be required to be a criterion for an employer to determine the number of hours of staffing of pharmacists and pharmacy students and technicians. However, when a medication error in one of the above categories occurs and is reported to the Board of Pharmacy, the description of the error must be accompanied by documentation regarding the number of prescriptions dispensed on the date the error occurred and the number of hours of staffing of pharmacists. In addition to any disciplinary actions taken by the Board with respect to the nature and severity of the error, additional penalties/actions should be imposed if the average of 15 prescriptions per hour per pharmacist is exceeded by more than 20%

  3. Pharmacists who are employed by for-profit corporations that are not owned by pharmacists should not be eligible to serve on a state Board of Pharmacy. The responsibilities of members of a Board of Pharmacy are to protect the interests and safety of the citizens of the state with respect to the licensure and practices of pharmacists and pharmacies, and conflicts of interest can occur when the priorities of a corporation are not consistent with those responsibilities.
  4. A communications network should be established in which chain pharmacists can participate anonymously (i.e., Chain Pharmacists Anonymous Network [CPAN]), because of their fear of retaliation if they voice concerns. This initiative should start with CVS pharmacists and subsequently be expanded to include pharmacists employed at other chains.
  5. The profession of pharmacy should appeal to the Federal Trade Commission and Department of Justice to require divestment of Aetna and Caremark from CVS, as well as similar actions for other corporations that have acquired anticompetitive and excessively dominant positions in pharmacy and health care.

Part 3 of this series will focus on the experiences of CVS pharmacists and technicians, and the destructive effects that CVS has had on the profession of pharmacy.”

Daniel A. Hussar
danandsue3@verizon.net

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PBM: why your prescription COSTS TOO DAMN MUCH !

Posted on March 3, 2020 by Pharmaciststeve

PBM Express Scripts: PROFITS TRIPLED TO $4.5 BILLION in just 4 years, while REVENUES DECLINED AND PRESCRIPTIONS PLUMMETED? How Possible?

https://drugpricetruth.org/pbm-express-scripts-profits-tripled-to-4-5-billion-in-just-4-years-while-revenues-declined-and-prescriptions-plummeted-how-possible/

There is only one explanation – A massive increase in secret “fees” from their drug company collusion “partners”, directly tied to skyrocketing U.S. brand drug prices/price increases, FOR DOING FAR LESS WORK.

Below are the shocking financial numbers for the top pharmacy benefit manager (PBM), Express Scripts, from their own financial statements on file with the Securities and Exchange Commission (SEC).

Express Scripts is now part of Cigna, after more mergers (including CVS/Aetna)  that only worsen the public harm, while serving to increase the secrecy of the ongoing simple pharma/health insurer/PBM “fee” price collusion scheme.

Remember, pharmacy benefit manager (PBM) is just a long-winded term for the insurance company that is supposed to manage the drug part of our health plans. Their main purpose is supposed to be getting us all lower drug prices (i.e., rebates, another name for discounts) from pharmaceutical companies. Unfortunately, rather than doing their job, they have been secretly colluding with drug companies to massively raise U.S. brand drug prices and profits for themselves, while passing the costs on to us. The simple scheme began long ago with Medicare Part D. Very sad and very harmful, but true.

After recent mergers, all the dominant PBMs are now part of the four dominant broader health insurers (United Health/Optum, Cigna/Express Scripts, CVS/Aetna and Humana) that control 80-90% of  private US drug plans and Medicare Part D. You can now mostly just use the term dominant health insurer and ignore PBM.

And even if these big four health insurers are not listed by name on your health/drug plan, one of them is likely involved as a partner behind the scenes with your prescriptions. Lots of side partnerships as well. Check your insurance card or other fine print.

Express Scripts’ Financial Information
                                            Revenues       Prescriptions           Profits              Employees
2013                                   $104 billion          1.2 billion                 $1.8 billion              29,975
2014                                   $101 billion          1.06 billion                $2.0 billion             29,500
2015                                   $102 billion          1.04 billion                $2.5 billion             25,900
2016                                   $100 billion          1.0 billion                   $3.4 billion             25,600
2017                                   $100 billion          0.99 billion                 $4.5 billion             26,600
Change 2013-17                     -4%                     -18%                               +150%                  -11%

The obvious question:

How could Express Scripts have nearly TRIPLE ITS PROFITS TO $4.5 BILLION in just four years from 2013 to 2017.…

– While its number of prescriptions for patients dropped -18%?

– While its number of employees dropped -11%?

– While its total revenues dropped -4%?

By the way, Express Scripts revenues and prescriptions were falling because it was losing market share to the other dominant health insurer/PBMs, especially CVS and UnitedHealth.

So Express Scripts was losing clients and business in a big way, but still had no problem massively increasing profits? Really?

Common sense would tell you that this would not be possible in a legitimate market.

And you would  be dead right.

So how could this have happened?  – Again, nothing complicated.

All due to the simple, but secretive, pharma/health insurer/PBM “fee” scheme at the center of my false claim (qui tam) whistleblower cases – the two largest healthcare whistleblower cases in history.

Express Scripts is getting paid a lot more money from drug companies, for doing a lot less work – all driven by massive price increases on U.S. brand drugs, which account for 85% of Express Scripts’ sales

By the way, no surprise or mere coincidence that this bizarre surge in Express Scripts’ profits began in 2013, just following its merger with Medco (the prior largest PBM) in 2012. That is when the PBM industry became super-concentrated and the price collusion “fee” scheme with pharma accelerated across the nation.

How does the “fee” scheme work? I already sound like a broke record on this website, even though it is less than two months old.

Pharma “fees” paid as a “percent” of uniformly and massively increasing “sticker” or “list” U.S. brand drug prices, especially for top-selling multiple sclerosis, diabetes, cancer, rheumatoid arthritis drugs.

By law, these pharma “fees” are supposed to be for helping patients. More patients, more support and more “fees”. Right? A very basic concept. Makes sense.

Instead pharma and Express Scripts shockingly decided to structure these secret national “fee” contracts as a “percentage” of massive brand “sticker” prices and price increases.  All began a long time ago with Medicare Part D.

How am I sure? Because I heard it directly from the industry insider’s doing it! A long time ago now and it has gotten a lot worse. Now a national crisis.

In October 2013, I attended an industry “fee” conference (the only one I am aware of) for two days at which 50-60 pharmaceutical/PBM executives, and their close legal and consultant advisers, admitted the whole thing in colorful detail.

I sat in the front row with another colleague and took 80 pages of notes while aghast. I had already been following these drug and health insurer/PBM companies closely for 20 years as a professional analyst at that point and never heard of these secret “fee” payments before. And these company are still hiding it to this day, with a lot of help unfortunately.

Read about this shocking insider conference  in the whistleblower documents at this link: /wp-content/uploads/2020/03/SDNYComplaintFeeConference.pdf

Here are a couple of the definitive firsthand insider comments I heard at the conference which verified the simple scheme:

Secret “pharma fees” (as a percent of brand drug “sticker” prices) were the PBM’s “main source of income”
“When would the government be ‘dangerous enough to understand how industry works”
“I hope the conference was not being recorded”

Just these three firsthand insider quotes sum it up, but there are lots more.

To my shock and dismay, the Justice Department admitted repeatedly to me and my attorney that it never interviewed under oath any insiders from the conference in its 4-year investigation of my whistleblower cases.

As a non-insider at these companies, these firsthand witnesses from the definitive insider conference were the reason I filed the whistleblower cases promptly in the public interest starting in January 2014, with the Justice Department’s support.

Making the simple scheme even more ridiculous and abusive, for many of the old top-selling U.S blockbuster brands, Express Scripts and the others have gotten massive increases in “fees” routinely for drugs that are plummeting in use by physicians and patients.

Biogen’s Avonex (multiple sclerosis): 10-fold “sticker” price increase (to $100,000/patient now) with “fees” to health insurer/PBMs attached, while Rxs are down -60-70% over the past decade. Really?

Hard to imagine Biogen’s and numerous other pharmaceutical companies’ executives doing this with any kind of conscience?

Even harder to imagine these executives deceiving all intentionally for a decade-plus while accelerating the scheme amid wide-ranging patient/public harm and outcry?

And getting away with such a preposterously simple scheme causing massive patient and public harm for 15 years? Perhaps the most shocking of all.

Same ridiculous dynamics for many other old blockbuster U.S. brands, including Amgen’s Enbrel (rheumatoid arthritis), Teva’s Copaxone (MS), Novartis’ Gleevec, Eli Lilly’s Humulin (insulin), Pfizer’s Viagra (impotence) and Premarin (hormone), etc.

So, Biogen and many others paying the PBM/health insurers 5-10 times as much in “fees” for “supporting” half or less as many patients and prescriptions over more than a decade now? Really?

And what other magic did Express Scripts’ management perform to generate massive profits and pump its stock price, while its business was in free fall between 2013 and 2017?

Again, simple. Massively cut spending for “supporting” patients and get rid of employees.

Easy to do when your surging profits are just for passing through pharma’s price increases to your own trusting clients, patients and taxpayers whom you have pledged to protect, while doing far less work.

Express Scripts cut its “support” costs (called S,G&A in the financial world) by 30%, from $4.6 billion to in 2013 to $3.3  billion in 2017.

As Dire Strait famously said: Money for Nothing.

Less than nothing in this case! More Money for far less work!

And to further help its earnings per share (EPS) and the stock price central to massive Express Scripts’ executive compensation packages?

Use a lot of the free money from the pharma “fees” to buyback massive amounts of stock.

Express Scripts’ shares outstanding decreased 30% from 2013 to 2017.

While its corporate profits surged 150% in just four years as its legitimate business was plummeting, Express Scripts’ EPS went up even more!

Express Scripts EPS went up 230% between 2013 and 2017 –  for a business in sharp decline! Really?

In the end, I return to the remarkably simple nature of this secretive financial scheme and national crisis orchestrated by just a handful of misguided executives.

It really is just printing illicit money, profits and huge stock compensation packages for a very few executives, while they guard the secret like King Tut’s tomb.

I remind people that 99% of the hardworking people in the pharmaceutical and health insurance industries know nothing about this highly centralized secretive scheme harming all Americans across the nation.

And based on their own feedback,  very few health insurer/PBM employees are benefiting from the massive profits or like what is going on at these companies.

In July 2015, Express Scripts was ranked as “the worst company to work for in the United States”, according the reviews of its own employees on the Glassdoor career website. CVS was ranked the 12th worst company to work for in the country. See link: https://www.pharmacytimes.com/news/express-scripts-cvs-rank-in-worst-companies-for-workers

Quite an accomplishment for both Express Scripts and CVS, since Glassdoor includes the self-reported employee reviews for 400,000 companies around the world.

The prices of these old MS, cancer, rheumatoid arthritis and insulin drugs are now 5-10-fold or more higher in the U.S. compared to major European and other countries.

There are no PBMs outside the United States.

These brand drugs were the same price in the U.S. and Europe when this simple “fee” scheme began when these dominant PBMs were entrusted by Congress and the American people to manage the vital Medicare Part D program.

Instead, the PBMs chose to secretly partner with pharma to massively raise U.S. brand drug prices for profit rather than protect American citizens.

That about says it all regarding the real “value” that PBMs are providing to U.S. patients and taxpayers, despite their endless self-promotional public rhetoric to the contrary.

Money for Nothing.

No – Money for Far Less than Nothing.

Money for Severe Harm.

I would greatly appreciate your sharing this blog post and the website. Thanks for your interest.  

I remain hopeful that other experienced healthcare professionals will eventually help end this abuse. Unfortunately, that has not happened yet despite my repeatedly contacting many of them.

Regardless, the main goal of my efforts and this website is to inform and engage the broader American public.

Please share this with any and all. We are all being harmed and are in this together.

“PEOPLE OVER PROFITS”

I would be glad to speak with any interested party. I can be easily reached by email at info@drugpricetruth.org.

John R. Borzilleri, M.D.

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Dr. Thomas Kline, MD, PhD: Medical Myths Revealed : IT IS TIME TO ACT 02-29-20

Posted on March 2, 2020 by Pharmaciststeve

Yes there are problems, but far far less than reported. Just like wearing masks to prevent coronovirus has been shown to be waste of time (hand washing is key) people do it .FEAR. We will do anything to keep dope fiends out of our neighborhoods so we have a medical police state with interrogations,(i was just interrogated by a pharmacist today), denials of medications, raided doctors and druggists. Addicts do not go to pharmacies but drug hustlers do, but only 1%. Do we use a cannon or a nightstick. We need to stop check point charlie mentality. It did not work. People always figure a way over the wall. How much do we expend? How many do we harm. THIS NEEDS TO STOP WERE ARE CLOSE TO THE PROP/CDC GOAL OF NO PAIN MEDICINES FOR AMERICANS – EVER

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Dr. Thomas Kline, MD, PhD: Medical Myths Revealed ENOUGH IS ENOUGH TIME TO ACT 02/28/20

Posted on February 29, 2020 by Pharmaciststeve

Terrorism is fear engendered without clear reason. Medical terrorism started in 2016 with the unauthorized “voluntary” CDC guidelines now reviewed in detail by JATH, LLC and the results are startling.

Filed under: General Problems | 4 Comments »

Dr. Thomas Kline, MD, PhD: Medical Myths Revealed: War on Doctors Day 8… 2nd Part 1

Posted on February 27, 2020 by Pharmaciststeve

https://youtu.be/BdyV7ANw9vE

I want crooks caught too. They steal prescriptions and dont pay taxes.
But what are the real tip offs. Only 1.5 % divert. How does one catch the 1.5% without harming the 98.5% who are not diverting and need opiate pain medicine which is the only stuff that works.

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What a Narxcare score means to chronic pain/subjective disease pts

Posted on February 27, 2020 by Pharmaciststeve

 

 

This is the latest and greatest thing that Appriss Health has brought to the market place that is designed to created a “FICO ” type score as to the pt’s risk of OVERDOSING.

Notice that a pt who is taking  50 + MME their “risk score” jumps dramatically and the pt gets to 90 MME/day and jumps even more.. actually in the UPPER 1/3 of the highest score on the chart.

https://apprisshealth.com/solutions/narxcare/

According to Appriss’ own comments the reference range was developed in 2014 from a Ohio study on just 1687 “unintentional OD deaths”..

Just how did they determine the at the OD was UNINTENTIONAL – and there is nothing to suggest from this reference that the OD’s were from prescription meds only !

There was a report from Ohio in 2017 that 99% of OD’s contained ILLEGAL FENTANYL  Dayton Ohio area: 99% of opiate OD’s tested positive for ILLEGAL FENTANYL ANALOG

First of all no one in these studies COMMITTED SUICIDE ?  We have about 50,000 suicides every  year and one million attempts and who believes that people ODing jumped from ZERO PER-CENT in 2014 in Ohio to 99% in 2017 ?

Apparently some state’s PMP programs have interfaced Narxcare within their reports on pts.  It has been reported that Walmart was one of the first pharmacies to implement this database program.

Apparently this program use the defective MME conversion programs to come to some of their conclusions — YES all MME conversion programs are inaccurate and defective !

Is this just another example of convoluting the truth so that it helps perpetuate the fabricated opiate crisis ? 

It would not surprise me that some chain pharmacies will interface this report into their pharmacy software programs and allow it to create HARD STOPS that a pharmacist cannot over-ride and will be given no choice but to turn the pt away without their necessary medication.

 

 

 

 

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NBC: TV Show New Amsterdam (02/25/2020) – promoting ZERO OPIATES for pain pts ?

Posted on February 26, 2020 by Pharmaciststeve

The NBC network has seemingly waded “hip-deep” in fighting the war on drugs and our fabricated opiate crisis… this clip is from the show 02/26/2020 and I am currently watching Chicago  Med  (NBC) and there is a doctor on the show who is opiate abuser.

There was a trailer on Law & Order Special Victims Unit for tomorrow night on NBC where the story line is about a doc that trades opiate Rxs for sex.

The number of shows – on all the networks – that seem to have taken on the task of helping to address/solve the fabricated opiate crisis

They just announced that there is a CROSS-OVER event from Chicago Fire and Chicago P.D. dealing with the national epidemic has reach Chicago.

Has the fabricated opiate crisis … reached a fabricated HYSTERIA ?

Filed under: General Problems | 9 Comments »

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