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Financial Kickbacks for Vaccinations Abusive Illegal and Fraudulent

Published on August 19, 2018
Jeffrey Dach MD

Financial Kickbacks are Illegal in the Medical Field

When I worked in the hospital as a radiologist doing medical imaging, part of my job was to recommend additional imaging studies. For example, if I saw a mass on a chest Xray, I would recommend a chest CAT scan. If I saw blastic lesions in the rib on a chest Xray, I would recommend a radionuclide bone scan, etc. I always thought to myself, what if i owned a radiology imaging center. That would be great because I could really make a lot of money by referring all of these cases to myself. Above image courtesy of Bob the Pharmacist.

Stark Anti-Kickback Laws

However, there is a problem. Referring cases to my own imaging center is illegal, a form of fraud and abuse, a violation of the 1988 Stark Law “Ethics in Patient Referrals Act” (4,5). These laws are summarized by the Office of Inspector General Report Department of Health and Human resources:(4)

“The five most important Federal fraud and abuse laws that apply to physicians are the False Claims Act (FCA), the Anti-Kickback Statute (AKS), the Physician Self-Referral Law (Stark law), the Exclusion Authorities, and the Civil Monetary Penalties Law (CMPL). Government agencies, including the Department of Justice, the Department of Health & Human Services Office of Inspector General (OIG), and the Centers for Medicare & Medicaid Services (CMS), are charged with enforcing these laws. As you begin your career, it is crucial to understand these laws not only because following them is the right thing to do, but also because violating them could result in criminal penalties, civil fines, exclusion from the Federal health care programs, or loss of your medical license from your State medical board.”(4)

Practice of Medicine is Not a Multi-Level Marketing Scheme

In other words, the practice of medicine is not a Multi-Level Marketing Scheme to make money by “gaming the system” by running large numbers of patients through tests or procedures for financial profit. Not only does this waste a huge amount of public money, it may cause considerable harm to the patient population. This is considered unethical behavior by the doctor, who is then subject to various civil and criminal penalties including loss of license.

Pediatricians Allowed to “Game the System”

This brings us to the financial incentives to pediatricians offered by insurance companies for vaccinating our children. The Blue Cross Blue Shield health insurance document explaining these financial incentives can be found here: https://jeffreydachmd.com/wp-content/uploads/2018/08/Pediatricians-Receive-Financial-Incentives-Kickbacks-to-Vaccinate-Children-BCBS-2016-Booklet.pdf  Pediatricians are raking in 40-80 thousand dollars a year from these kickback schemes.

Illegal Kickback Fraud and Abuse

I would argue this type of financial incentive to pediatricians is a form of illegal kickback prohibited by the anti-kickback laws. This type of financial arrangement gives a “green light” to the pediatricians to “game the system” to maximize financial gain by increasing the volume of a procedure. This is fraud and abuse which should be prosecuted by the Office of Inspector General.

Why Does the Health Insurance Company Offer Kickbacks for Vaccinations?

The health insurance company is offering this financial incentive, in reality a cash kickback, because the insurance company thinks vaccination makes a healthier population with fewer insurance claims.(10-11) The insurance company believes they will have fewer insurance claims in heavily vaccinated populations, and will make more money. The insurance company is happy to share their increased profit with the doctors in the form of a “kickback” cash incentive. This is clearly an unethical “kickback” scheme. Pediatricians should be providing health care as part of the routine practice of medicine, not on the basis of a financial kickback. Please contact your congressman and ask them to request the office of inspector general bring a halt this illegal kickback arrangement.

Are Vaccinated Populations Healthier and Utilize Less Health Care Resources?

Are vaccinated populations healthier and utilize less health care resources, thereby leading to greater profits for the health insurance industry? The answer is yes, according to this article in 2014 Pediatrics from authors employed by the CDC and the Bill and Melinda Gates Foundation. They concluded the cost savings are enormous. Health insurance company decisions to offer financial incentives to pediatricians for vaccinating children is based on this and similar studies.(11)

Analyses showed that routine childhood immunization among members of the 2009 US birth cohort will prevent 42,000 early deaths and 20 million cases of disease, with net savings of $13.5 billion in direct costs and $68.8 billion in total societal costs, respectively. The direct and societal benefit-cost ratios for routine childhood vaccination with these 9 vaccines were 3.0 and 10.1.(11)

Of course, the article is severely flawed because it is based on historical data and various assumptions and calculations which may turn out to be false. The only way to really know if a highly vaccinated population is healthier than an unvaccinated, and utilizes less health care, is to do a randomized prospective study. Such a study would follow a population of children over 5-10 years with the population randomized to vaccinated or unvaccinated. At the end of the observation period, the numbers can be tabulated for ER visits and hospitalizations, autoimmune disease, and neuro-developmental disorder in the vaccinated vs. unvaccinated groups, and get a real answer to the question. Of course, this study has never been done, and probably never will.

Are Vaccinated Healthier than Unvaccinated?

We have studies which suggest the opposite, that vaccinated populations are not healthier than unvaccinated populations. A study by Neil Z. Miller in the 2016 Journal of Am Phys Surg 2016, reveals the children receiving greater numbers of vaccinations have more ER visits, more hospitalizations and increased mortality reported to the VAERS Database.(7) Mr Miller says that less healthcare is better than more healthcare. He examined the:

“VAERS database from 1990 through 2010. There were more than 325,000 VAERS reports. Our study showed that infants who receive several vaccines concurrently, as recommended by CDC, are significantly more likely to be hospitalized or die when compared with infants who receive fewer vaccines simultaneously”.(7)

CDC Says Receiving Multiple Vaccines Concurrently is Safe ?

The CDC says that receiving multiple vaccines concurrently is safe for children:(8)

“Scientific data show that getting several vaccines at the same time does not cause any chronic health problems. A number of studies have been done to look at the effects of giving various combinations of vaccines, and when every new vaccine is licensed, it has been tested along with the vaccines already recommended for a particular aged child. The recommended vaccines have been shown to be as effective in combination as they are individually. Sometimes, certain combinations of vaccines given together can cause fever, and occasionally febrile seizures; these are temporary and do not cause any lasting damage. Based on this information, both the Advisory Committee on Immunization Practices and the American Academy of Pediatrics recommend getting all routine childhood vaccines on time.”

However, Neil Miller says the CDC is lying to you. He says:”this combination of eight vaccines administered during a single physician visit was never tested for safety in clinical trials.”(7)

“Although CDC recommends polio, hepatitis B, diphtheria, tetanus, pertussis, rotavirus, Haemophilus influenzae type B, and pneumococcal vaccines for two-, four-, and six-month-old infants, this combination of eight vaccines administered during a single physician visit was never tested for safety in clinical trials….CDC urges infants to receive multiple vaccines concurrently without scientific evidence to confirm the safety of this practice. Administering six, seven, or eight vaccine doses to an infant during a single physician visit is certainly more convenient for parents, as opposed to making additional trips to the doctor’s office, and increases the likelihood that the infant will receive all the vaccines, but vaccine safety must remain the highest priority.”(7)

If someone could show me the clinical trials testing eight vaccines in combination at one time, showing them safe, then I would be happy to believe the CDC over Mr. Miller. So far I have been unable to find any of these studies.

Evidence of Harm from Vaccines

Another recent study from Dr. Mawson in Translational Medicine 2017 suggests that vaccinated populations are more prone to neurodevelopmental disorders defined as learning disability, Attention Deficient Hyperactivity Disorder, and Autism Spectrum Disorder. (12-14) The harm was greater if the infant was pre-term.(12-14)

Harming the Pediatric Population for Financial Gain

If these studies are true, this would suggest the Health Insurance program of financial incentives (ie kickbacks) to pediatricians for increasing vaccinations is harming our children. Not only is this unethical and illegal practice based on our existing anti-kickback law, this practice is causing immeasurable harm to the children, the families and our society. Print this article and send a copy to your friends and family. Call, email or write your congressman and ask them to request the Inspector General’s Office to bring a stop to this unethical and illegal kickback scheme.

References:

1) Blue Cross Blue Shield 2016 Booklet Financial Incentives to Pediatricians to Vaccinate Children. Pediatricians Receive Financial Incentives Kickbacks to Vaccinate Children BCBS 2016 Booklet

2) Blue Cross Blue Shield Pays Your Doctor A $40,000 Bonus For Fully Vaccinating 100 Patients Under The Age of 2 By Paul Meizner

3) Are Physicians Given Financial Incentives to Vaccinate Our Children?

1 By Jonathan Wright on September 8, 2017

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4) A Roadmap for New Physicians Fraud & Abuse Laws Office of Inspector General

The five most important Federal fraud and abuse laws that apply to physicians are the False Claims Act (FCA), the Anti-Kickback Statute (AKS), the Physician Self-Referral Law (Stark law), the Exclusion Authorities, and the Civil Monetary Penalties Law (CMPL). As you begin your career, it is crucial to understand these laws not only because following them is the right thing to do, but also because violating them could result in criminal penalties, civil fines, exclusion from the Federal health care programs, or loss of your medical license from your State medical board.

Taking money or gifts from a drug or device company or a durable medical equipment (DME) supplier is not justified by the argument that you would have prescribed that drug or ordered that wheelchair even without a kickback.

The Physician Self-Referral Law, commonly referred to as the Stark law, prohibits physicians from referring patients to receive “designated health services” payable by Medicare or Medicaid from entities with which the physician or an immediate family member has a financial relationship, unless an exception applies

5) Anti-kickback & Stark Compliance Information AAFP

What is the anti-kickback rule? The anti-kickback statute makes it illegal for providers (including physicians) to knowingly and willfully accept bribes or other forms of remuneration in return for generating Medicare, Medicaid or other federal health care program business.

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document: General Accountability Office Report: MEDICARE Implementation of Financial Incentive Programs under Federal Fraud and Abuse Laws

However, there are no exceptions or safe harbors specifically for financial incentive programs intended to improve quality and efficiency, and legal experts reported that the constraints of existing exceptions and safe harbors make it difficult to design and implement a comprehensive program for all participating physicians and patient populations.

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6) Cornell Law Review

h) Preventive screening tests, immunizations, and vaccines. Preventive screening tests, immunizations, and vaccines that meet the following conditions:

(1) The preventive screening tests, immunizations, and vaccines are subject to CMS-mandated frequency limits.

(2) The arrangement for the provision of the preventive screening tests, immunizations, and vaccines does not violate the anti-kickback statute (section 1128B(b) of the Act).

Does not violate the anti-kickback statute

Does not violate the anti-kickback statute, as used in this subpart only, means that the particular arrangement –

(1)

(i) Meets a safe harbor under the anti-kickback statute, as set forth at § 1001.952 of this title, “Exceptions”;

(ii) Has been specifically approved by the OIG in a favorable advisory opinion issued to a party to the particular arrangement (for example, the entity furnishing DHS) with respect to the particular arrangement (and not a similar arrangement), provided that the arrangement is conducted in accordance with the facts certified by the requesting party and the opinion is otherwise issued in accordance with part 1008 of this title, “Advisory Opinions by the OIG”; or

(iii) Does not violate the anti-kickback provisions in section 1128B(b) of the Act.

(2) For purposes of this definition, a favorable advisory opinion means an opinion in which the OIG opines that –

(i) The party’s specific arrangement does not implicate the anti-kickback statute, does not constitute prohibited remuneration, or fits in a safe harbor under § 1001.952 of this title; or

(ii) The party will not be subject to any OIG sanctions arising under the anti-kickback statute (for example, under sections 1128A(a)(7) and 1128(b)(7) of the Act) in connection with the party’s specific arrangement.

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7) Combining Childhood Vaccines at One Visit Is Not Safe by Neil Z. Miller Journal of American Physicians and Surgeons, Volume 21, Number 2, Summer 2016

Combining Childhood Vaccines at One Visit Is Not Safe Neil Z Miller J Am Phys Surg 2016

Although CDC recommends polio, hepatitis B, diphtheria, tetanus, pertussis, rotavirus, Haemophilus influenzae type B, and pneumococcal vaccines for two-, four-, and six-month-old infants, this combination of eight vaccines administered during a single physician visit was never tested for safety in clinical trials.

CDC urges infants to receive multiple vaccines concurrently without scientific evidence to confirm the safety of this practice. Administering six, seven, or eight vaccine doses to an infant during a single physician visit is certainly more convenient for parents, as opposed to making additional trips to the doctor’s office, and increases the likelihood that the infant will receive all the vaccines, but vaccine safety must remain the highest priority.

Vaccine Adverse Event Reporting System (VAERS)

VAERS database from 1990 through 2010. There were more than 325,000 VAERS reports.

Our study showed that infants who receive several vaccines concurrently, as recommended by CDC, are significantly more likely to be hospitalized or die when compared with infants who receive fewer vaccines simultaneously.

8) Getting multiple vaccines at the same time has been shown to be safe. Centers for Disease Control and Prevention. CDC twenty four seven. Saving Lives, Protecting People

Scientific data show that getting several vaccines at the same time does not cause any chronic health problems. A number of studies have been done to look at the effects of giving various combinations of vaccines, and when every new vaccine is licensed, it has been tested along with the vaccines already recommended for a particular aged child. The recommended vaccines have been shown to be as effective in combination as they are individually. Sometimes, certain combinations of vaccines given together can cause fever, and occasionally febrile seizures; these are temporary and do not cause any lasting damage. Based on this information, both the Advisory Committee on Immunization Practices and the American Academy of Pediatrics recommend getting all routine childhood vaccines on time.

9) How Much Money Do Pediatricians Really Make From Vaccines?

10) Zhou, Fangjun, et al. “Economic evaluation of the 7-vaccine routine childhood immunization schedule in the United States, 2001.” Archives of pediatrics & adolescent medicine 159.12 (2005): 1136-1144.

Participants A hypothetical 2001 US birth cohort of 3 803 295 infants was followed up from birth through death.

Main Outcome Measures Net present value (net savings) and benefit-cost ratios of routine immunization.

Results Routine childhood immunization with the 7 vaccines was cost saving from the direct cost and societal perspectives, with net savings of $9.9 billion and $43.3 billion, respectively. Without routine vaccination, direct and societal costs of diphtheria, tetanus, pertussis, H influenzae type b, poliomyelitis, measles, mumps, rubella, congenital rubella syndrome, hepatitis B, and varicella would be $12.3 billion and $46.6 billion, respectively. Direct and societal costs for the vaccination program were an estimated $2.3 billion and $2.8 billion, respectively. Direct and societal benefit-cost ratios for routine childhood vaccination were 5.3 and 16.5, respectively.

Conclusion Regardless of the perspective, the current routine childhood immunization schedule results in substantial cost savings.

11) Zhou, Fangjun, et al. “Economic evaluation of the routine childhood immunization program in the United States, 2009.” Pediatrics (2014): peds-2013. Economic evaluation routine childhood immunization program United States 2009 Zhou Fangjun Pediatrics 2014

Analyses showed that routine childhood immunization among members of the 2009 US birth cohort will prevent 42 000 early deaths and 20 million cases of disease, with net savings of $13.5 billion in direct costs and $68.8 billion in total societal costs, respectively. The direct and societal benefit-cost ratios for routine childhood vaccination with these 9 vaccines were 3.0 and 10.1.

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12) Mawson, Anthony R., et al. “Preterm birth, vaccination and neurodevelopmental disorders: a cross-sectional study of 6-to 12-year-old vaccinated and unvaccinated children.” J Transl Sci 3 (2017). Preterm birth vaccination and neurodevelopmental disorders vaccinated and unvaccinated children Mawson Anthony R J Transl Sci 2017

From about 8% to 27% of extremely preterm infants develop symptoms of autism spectrum disorder, but the causes are not well understood. Preterm infants receive the same doses of the recommended vaccines and on the same schedule as term infants. The possible role of vaccination in neurodevelopmental disorders (NDD) among premature infants is unknown, in part because pre-licensure clinical trials of pediatric vaccines have excluded ex-preterm infants. This paper explores the association between preterm birth, vaccination and NDD, based on a secondary analysis of data from an anonymous survey of mothers, comparing the birth history and health outcomes of vaccinated and unvaccinated homeschool children 6 to 12 years of age. A convenience sample of 666 children was obtained, of which 261 (39%) were unvaccinated, 7.5% had an NDD (defined as a learning disability, Attention Deficit Hyperactivity Disorder and/or Autism Spectrum Disorder), and 7.7% were born preterm. No association was found between preterm birth and NDD in the absence of vaccination, but vaccination was significantly associated with NDD in children born at term (OR 2.7, 95% CI: 1.2, 6.0). However, vaccination coupled with preterm birth was associated with increasing odds of NDD, ranging from 5.4 (95% CI: 2.5, 11.9) compared to vaccinated but non-preterm children, to 14.5 (95% CI: 5.4, 38.7) compared to children who were neither preterm nor vaccinated. The results of this pilot study suggest clues to the epidemiology and causation of NDD but question the safety of current vaccination practices for preterm infants. Further research is needed to validate and investigate these associations in order to optimize the impact of vaccines on children’s health.

13) Mawson, Anthony R., et al. “Pilot comparative study on the health of vaccinated and unvaccinated 6-to 12-year-old US children.” J. Transl. Sci 3.3 (2017): 1-12. Pilot comparative study on the health of vaccinated and unvaccinated 6-to 12-year-old US children Mawson Anthony Transl. Sci 2017

Vaccinations have prevented millions of infectious illnesses, hospitalizations and deaths among U.S. children, yet the long-term health outcomes of the vaccination schedule remain uncertain. Studies have been recommended by the U.S. Institute of Medicine to address this question. This study aimed

1) to compare vaccinated and unvaccinated children on a broad range of health outcomes, and

2) to determine whether an association found between vaccination and neurodevelopmental disorders (NDD), if any, remained significant after adjustment for other measured factors. A cross-sectional study of mothers of children educated at home was carried out in collaboration with homeschool organizations in four U.S. states: Florida, Louisiana, Mississippi and Oregon. Mothers were asked to complete an anonymous online questionnaire on their 6- to 12-year-old biological children with respect to pregnancy-related factors, birth history, vaccinations, physician-diagnosed illnesses, medications used, and health services. NDD, a derived diagnostic measure, was defined as having one or more of the following three closely-related diagnoses: a learning disability, Attention Deficient Hyperactivity Disorder, and Autism Spectrum Disorder. A convenience sample of 666 children was obtained, of which 261 (39%) were unvaccinated. The vaccinated were less likely than the unvaccinated to have been diagnosed with chickenpox and pertussis, but more likely to have been diagnosed with pneumonia, otitis media, allergies and NDD. After adjustment, vaccination, male gender, and preterm birth remained significantly associated with NDD. However, in a final adjusted model with interaction, vaccination but not preterm birth remained associated with NDD, while the interaction of preterm birth and vaccination was associated with a 6.6-fold increased odds of NDD (95% CI: 2.8, 15.5). In conclusion, vaccinated homeschool children were found to have a higher rate of allergies and NDD than unvaccinated homeschool children. While vaccination remained significantly associated with NDD after controlling for other factors, preterm birth coupled with vaccination was associated with an apparent synergistic increase in the odds of NDD. Further research involving larger, independent samples and stronger research designs is needed to verify and understand these unexpected findings in order to optimize the impact of vaccines on children’s health.

14) New Studies Reveal Vaccine Harm June 06, 2017 By Dr. Mercola