Sunday, September 25, 2016

Email sent to Jeff@Amazon.com: You need to address this allegation of fraud

Here.

Friday, September 23, 2016

Name Mispronunciation as a Micro-Aggression and a  Evidence of Bias

I suggest an alternative scheme.

Eventually, this idea will be enforced in judge made law and precedent setting. Schools may face ruinous litigation for the mispronunciation of a name. Today, employers face the same for an off color joke at work. Both employers and school systems are mere pipelines from the tax payer and consumer to the pockets of lawyers, mostly, with some crumbs going to injured plaintiffs.

I propose that the naming of a child with an unusual or difficult to pronounce name be deemed evidence of child neglect. The same should go for misspelled names. Hospitals delivering children should assist parents to spell names correctly. The name is Antoine, not Antwan. The French province is called Brittany, not Britney.  It is established that people with such names are less likely to be hired or to be admitted into schools. They are a signal for bad attitudes, low performance ability, and dangerousness, wrongly or correctly. This problem is a problem of the American South, not of blacks alone. The Spears family is white, but from the South. It says, raised by parents who do not know how to spell.

Based of the great economic performance of African immigrants in the 2010 Census, a really impossible to pronounce name, with tongue clicks and other impossible sounds is associated with a great employment prospect, and a curve busting student. So that is likely to result in a form of reverse bias, and superior performance.

Sunday, September 18, 2016

Reply to Government Propaganda Article.

The_Economic_Burden_of_Prescription_Opioid Overdose, Abuse, and Dependence in the United States, 2013The

You forgot some things to deduct from your cost analysis. 

1) The productivity and tax payments of people able to get to work because of opiate pain relief;

2) The value of the 200 crimes a year not committed by the deceased drug addicts;

3) the value of the deaths of criminals to families that will not be exploited, injured, and abused by the deceased.

Thursday, September 15, 2016

Productive and Non-Infringing Restrictions of Second Amendment Right to Have a Gun

Half the murderers, half the murder victims, half the suicides are legally drunk. The most prevention of gun violence would come from restricting access to guns to people with evidence of alcoholism. Such evidence would include convictions for drunk driving, public intoxication, and alcohol induced liver disease.

Paranoid people kill 10% of murder victims around the world, or around 2000 people a year in the US. That number includes almost all rampage killings. It is in the nature of paranoia to not believe there is anything wrong with oneself. So even people doing well in treatment will try to stop treatment, and will relapse.

In the absence of drug induced paranoia, marijuana is associated with lower rates of violent crime. So, its use should not exclude people from their gun rights.

None of these policies are in place. They have the potential to cut the overall murder and suicide rates by two thirds, without infringing on the Second Amendment. They would withstand the strictest of scrutiny. There are no racial differences in the risks of mental illness.

Tuesday, September 13, 2016

Venezuela, Here We Come

As government grows, so does poverty and shortage.

http://www.zerohedge.com/news/2016-09-12/tent-cities-full-homeless-people-are-booming-cities-all-over-america-poverty-spikes

Past a Low Amount of Money, Increasing Wealth Yields Asymptotic Value, Mostly in Esthetics

The Versailles Palace remains a very beautiful place. At the time of its construction, it would be deemed unfit for human habitation today. Only technology adds the value of utility beyond esthetics. The poorest person in our nation has electricity, and goes to the bathroom indoors in the winter.

As wealthy people, we should therefore invest even more in technological development, to exponentially increase our wealth.

One easy place to get money is from the $trillion wasted on a legal system in failure, in every law subject. The nation should have the research and development budget of a technology company, around 20% of revenues. We have to, or we will be overtaken by Chinese and Indian wealth.

The most opulent hotel in the world, today.

Saturday, September 10, 2016

Obama Succeeds in Denying Access to Care. Doctors Now Spending Twice as Long on the Electronic Record as on Patient Interaction


The Obama Administration achieved what they wanted. To cut clinical care. They imposed electronic record mandates. Now doctors spend twice as long on the record than on patient interaction. Organized medicine is collaborating. The article is in plain English.

This a review of the problems of the electronic record and their one solution. It would save $70 billion a year, and potentially end co-pays. Here.

http://annals.org/article.aspx?articleid=2546704

Thursday, September 1, 2016

Personal Patient Experiences with Alpha Stim

Totals:

Responders:

On Label:

Off Label:
1) An older woman had the compulsion to climb the stairs precisely 60 times a day. She had severe back pain. She had a heart attack, with heart damage. She could potentially suffer heart failure. She got Alpha Stim 20 minutes day, set at 1 for one week, then at 2 for one week. Her compulsion was gone. I stopped the treatment for 2 weeks, and there was no return of her obsessive-compulsive disorder. There was no substitute compulsion, as sometimes occurs. The compulsion has not returned for 4 months. She requested to continue regular treatments for anxiety and for insomnia. I restarted treatment at her request.

2) An adolescent had a form of autism, once called Asperger Syndrome. He had a very high level of rage, despite high doses of a major tranquilizer, with high blood levels. If he did not get what he wanted, he jumped from a high balcony. I asked him what was the date today. He replied, that is a stupid question, and walked out. He had two treatments at a level of 1. He said, he would go to the pool, for the first time of the summer. The bus was 45 minutes late, but he just paced and waited. He went to the pool. He had two more treatments, and a home visit. Instead of being destructive and assaultive, his mother reported he started talking to her about his interests, such as computers and games. After a year, but only a month on Alpha Stim AID, he went home. He was asking for the treatment, and for an extension of the time to 30 minutes. It is unclear if he liked the treatment or access to the internet offered to him while on it.

3) A woman is received Alpha Stim M treatment for neck pain. After several treatments, she reported no improvement in her neck pain. However, her tinnitus (ringing in the ear) of many years was completely gone.


Non-Responders:


Bibliographies:

On label reports here.


Off label reports here

Sunday, August 21, 2016

The Serious and Insurmountable Problems of Evidence Based Medicine

1) Something works in medicine. It spreads around the world in months. When patients are doing well, medicine is a highly paid, piece of cake. It is almost like stealing. When patients are not doing well, it is a living hell of time, effort, and extremely low pay for doctors. So the incentives are in the right direction. Doctors may be trusted to want patients to do great. And the loss of work by patients' cures is not a problem due to the shortage of overly busy doctors.

2) A couple of years later, an academic doctor sees this response, designs a study, writes a research proposal, gets funding, carries out the study, writes up the results, waits for its publication. So, 7 years has passed. A number of studies accumulate. A committee reviews them. They enter a textbook, as accepted practice. It has now been longer than 7 years, by the time a guideline is written based on published studies. Meanwhile, the docs are doing almost nothing the way they were 7 years ago. The standard of care has moved on, except in the minds of guideline writers, government officials using guidelines like laws. These officials only want to slow clinical care to save money by piling bureaucratic procedures, and by denying dark skinned people that white people are getting.

3) On the first day of high school statistics class, coin tossing is discussed. That event is described by the binomial distribution statistic.

4) Studies comparing the fractions of responders to a treatment and to a placebo are supposed to represent the larger population. The parametric statistic is used to compare the fractions. The parametric statistic is the one whose formula describes a bell shaped curve, a common distributions of populations. Before carrying out such a test, one must show that 4 assumptions have been fulfilled. The most important is random selection. So any selection bias, such as an exclusion criterion, makes it so that the test is not even allowed to be done, let alone have any validity. All studies have exclusion criteria and violate the central assumption of parametric statistical testing. The populations in these studies do not represent those in the clinical setting. Doctors do not have exclusion criteria in their practices. Imagine excluding suicidal patients from a depression treatment study. That is routinely done in the FDA approval of new anti-depressants. Worthless.

5) Clinical care differs from the comparisons of the fractions in groups. It is closer to coin tossing. Have or not have a diagnosis. Give or not give a treatment. Have a good result or a bad result. The binomial statistic is more appropriate to clinical care than the parametric. Nevertheless one is not allowed to apply parametric statistics to a population best described by a binomial distribution.

6) Dose response curve is ignored. Low doses of radiation are good for the health, for example, as in radiation hormesis. One must delineate the dose response curve of all remedies. Then one must do so in the individual patient, and this is where experience based medicine beats evidence based medicine in outcomes.

So evidence based medicine has problems, 1) delineation by academic professors with half the clinical experience and therefore half the insider knowledge of clinicians; 2) obsolescence; 3) based on wrong statistical application; 4) violation of the rules of statistical testing by exclusion criteria in all studies; 5) misapplication to individual patients (a treatment killed 99% of patients who had it, this patient has done well on it, follow guidelines and stop this effective treatment?); 6) ignorance of the individualized dose-response curve.

In a legal context of any kind, the suborning of quackery is a violation of the Fifth Amendment procedural due process rights of the defendant to a fair hearing. Evidence based medicine is  itself is a constitutional tort. I would urge all defendants to sue the plaintiff lawyer, the plaintiff, the plaintiff experts, guideline writers, as individuals, their universities, their chairman that failed to supervise them, their association. The association should be charged with civil RICO. That is subject to punitive damages (triple) because it is an intentional act, not just negligence. If it can be shown to have been financially self serving, it can be converted to criminal RICO, and the guideline writers should be arrested, tried, and sentenced to prison. To deter.


Put this forward to the defense lawyer. He will never agree, because it would fully deter the other side, and end his business.

Saturday, August 13, 2016

Nixon to China, or the Immutable Law of Political Opposites

This Nixon to China phrase is a political science term. It means, that you vote for the person opposing your interests to get those interests fulfilled.This effect complicates voting choice.
Only the opponent of your interest has the credibility to get it achieved, if it is advantageous.

Only a rabid anti-Communist could open relationships with China. George Bush II said in a debate, there will be no nation building under my administration. There was an orgy of nation building. Had Gore been elected, he would have been stymied, because he could not be trusted.

If you hate black people, want them impoverished, unemployed and murdered, whom do you vote for, Obama or Romney? If you want massive income inequality, and massive enrichment of billionaires, who will get that done? If you want to kill health insurance so that nothing can be covered nor paid for anymore, and now no one has any real health insurance, whom do you vote for? Obama, of course.

If you want Bin Ladin killed, instead of being allowed to escape from Afghanistan, whom do you vote for?Who can sign a peace treaty between Egypt and Israel? A rabid former Jewish terrorist with open hatred of Arabs, of course.


That brings up this year's election. I supported Sanders to enrich the rich. I may vote for Clinton to do the following opposites of what she advocates, 1)......................; 2) .....................; 3) ................
I am going to let people fill in the blanks with the opposites of what she is advocating.

List of Examples:

Al Gore suggests $4 gasoline to encourage conservation. George Bush is elected, and achieves $4 gasoline. That spurs massive alternative sources, making America the biggest energy producer in the world. Al Gore turns out to have been right, but Only Bush could get it done.

Say, you hate homosexuals. You wish they would suffer unspeakable and unending torment. Do you support or oppose gay marriage?

Welfare reform was achieved by President Bill Clinton in 1996.

Saturday, July 9, 2016

Tales of Conduct Disorder

Conduct disorder is childhood antisocial personality disorder. Its features are selfishness, fearlessness, lack of remorse unless the person is suffering personal punishment, impulsivity, lack of empathy, inability to learn from consequences. Other than that, they may be very intelligent. They have social skills in the form of manipulating people to get what they want. They are precocious in their social development. They party like people 10 years older. The crime meter starts to spin fast around age 3. Everyone, including fellow preschoolers knows who they are by then.

You have to wait for or go to the end of the recording to learn of the motivation for the car chase of this 12 year old girl.

http://www.msn.com/en-us/video/downtime/12-year-old-girl-takes-cops-on-100-mph-chase-after-stealing-grandmas-car/vi-AAi8EvM?ocid=spartandhp

Monday, July 4, 2016

The Future of US Health Care as Government Controls More of the Industry

Rio de Janeiro’s hospitals are running out of syringes and basic medications, and their staffs are running on little-to-no pay, with one month to go before the city hosts the 2016 Summer Olympics.

From here:

 http://www.breitbart.com/national-security/2016/07/04/olympics-approach-rio-de-janeiros-hospitals-run-medicine/

Sunday, July 3, 2016

TSA Thugs Beat On a Brain Tumor Teenager


I hope she sues everyone involved, including the Federal government. They negligently hired thugs. They negligently failed to train them. They negligently failed to inform them they work for the public, and not the other way around. Meanwhile, these thugs are failing test contraband by inspectors. Naturally, these thugs are agents of the prosecutor and the lawyer profession.


http://wreg.com/2016/06/30/disabled-st-jude-patient-sues-airport-and-tsa-after-bloody-scuffle-with-airport-police/

Sunday, June 19, 2016

Letters to the Medical Directors of the Medicaid Pharmacy Benefits Insurance Companies About Their Refusing to Pay for Alpha Stim Treatment

I had a trouble finding their mailing addresses, not readily available on any of their websites.

I am therefore listing them here, along with the letter their Medical Directors were sent.

RE: Paying for Alpha Stim without Pre-Authorization

Dear Doctor,
Alpha Stim is an FDA approved Class II medical device, as a condom is classified.  It has FDA approved indications for depression, anxiety, insomnia or pain. It requires a prescription in the United States.

The device is reviewed here:

http://www.alpha-stim.com/

It has the pain management potential to solve the opioid overdose problem. To continue to refuse to pay for it is cruel to extremely distressed patients and unconscionable. It is also stupid. Spend $hundreds on it, save $thousands on medications that can be weaned off and discontinued.

If you pay for other medically indicated FDA approved, medical device of any kind, you must pay for Alpha Stim without a pre-authorization requirement. The Affordable Care Act (ACA) prohibits discrimination against mental health treatment.  I am attaching printed guidance from CMS on the Mental Health Parity provision of the ACA.

If you continue to refuse to fund Alpha Stim treatment, including all necessary accessories, I will be asking the federal prosecutor and the Office of Civil rights to enforce the federal law in federal court. As is my legal duty in Pennsylvania, I will also be initiating regulatory complaints against you personally. Your brazen violation of federal laws is unprofessional conduct.






UPMC Health Plan; U.S. Steel Tower; 600 Grant Street; Pittsburgh, PA 15219

Keystone First; 200 Stevens Dr. ; Philadelphia, PA 19113; Phone:(215) 937-8000

Health Partners; 901 Market St #500; Philadelphia, PA 19107

John B. Bulger, DO, MBA, Medical Director; Geisinger Health Plan Insurance Agency;
108 Woodbine Ln; Danville, PA 17821; Phone:(570) 271-8771

Gateway HealthSM; Four Gateway Center; 444 Liberty Avenue, Suite 2100; Pittsburgh, PA 15222-1222


AmeriHealth Caritas Pennsylvania; 8040 Carlson Drive; Suite 500; Harrisburg, PA 17112


Aetna Better Health Administrative Office; Aetna Better Health; 2000 Market Street, Suite 850
Philadelphia, PA 19103;  1-866-638-1232;  (HealthChoices)

Sunday, April 24, 2016

A Family Theory of History

The Families Theory of History. This is a variation of the Great Man Theory of history. Twenty families put Hitler in power, and did great during the war. They each gave him $5000 (like $500K today) for his campaigns, and made $millions off government contracts. The Allies hanged the Nazis by the hundreds. Those families stayed untouchable, and were actively recruited by our government, despite having been the real cause of WWII.

http://www.amazon.com/Hitler-His-Secret-Partners-Contributions/dp/0671760815/ref=sr_1_sc_7?ie=UTF8&qid=1461534757&sr=8-7-spell&keywords=adolf+hitler+financed



Bush represented West Texas oil families. They did well, when he killed their Takrit competitors and their puppet, Saddam. They did well when gas prices went from 99 cents under Clinton, to $4 a gallon. 


Reagan represented California real estate families. They did well. Inflation made their investments soar in value.


Bill Clinton? Bill is Tyson Chicken. 


Soros and the homosexual billionaires pulling Obama strings have done well under his carpet bombing of the economy, driving all money into the stock marker due to 0% interest rates. Obama also wiped out the small bank competition of his sponsors. They could not survive the regulatory requirements of Dodd-Frank. 


Unless I am missing something, Sanders and Trump are not puppets for any set of families. Both are extreme and frightening. However, they have no nasty "families" behind them.

Friday, April 15, 2016

A Potential Solution to the Problem of the Unemployability of People with a Felony Conviction, or Even Those with a Misdemeanor Conviction

In Pennsylvania, one may deny a job if the felony conviction is relevant to the job. A pedophile may may be denied a job in a daycare center, but may work as a cashier. A thief may be denied a job as a cashier, but may work in a day care.

It never works out that way. And no felon has challenged the denial of a job not related to the conviction. Thank the lawyer profession for the unemployability of former felons. Employers are not willing to risk litigation for negligent hiring, should the worker commit a tort. The lawyer profession must be crushed if this problem is to be solved. Naturally, this burden falls heaviest on black people.

Here is a list of the collateral civil consequences of a criminal conviction. There are 50,000 of them. Thank the lawyer profession.

http://www.abacollateralconsequences.org/

I have several patients with some petty infraction, committed years ago, who cannot find a job, and are living in poverty despite skills, and even licensed craft skills, such as electrician.

I have advised them to read this article, and to consider going into this business on their own. Guy made $250,000 a year. And, this activity is a win-win-win-win for everyone.

http://www.wired.com/2015/02/high-end-dumpster-diving-matt-malone/

Wednesday, April 13, 2016

The Solution to the Problems of the Electronic Medical Record is Simple, Saves $Billions, and Helps Patients, not Insurance Companies: Video Recording, Period, and Nothing Else



Authors: David Behar, MD, is an adult and child psychiatrist in the Philadelphia area. Brian P. Moquin, Esq., is the president of Digital Abacus Corporation in Silicon Valley and has a law practice, doing civil litigation.


The electronic medical record (EMR) has been touted as a panacea for health care, by reducing costs and errors, increasing efficiency, improving access to care, leading to better diagnoses through data mining. EMR has been a dismal failure, difficult to use, with no interoperability, and focusing practitioner attention away from the patient.

Consider the EMR in psychiatry. An EMR template must be filled out for each patient visit. Patient sobs that her boyfriend was killed in a motorcycle accident. Facing a screen, I reply, “How is your appetite?” the next item on the template. Our relationship has become that with the staff at the Department of Motor Vehicles. Because of the data-gathering demands imposed by EMR, ordinary human sympathy has been replaced by impersonal form filling. These demands also turn a ten-minute medication visit into a fifteen-minute visit: in contrast to its promise, the adoption of EMR has added millions of hours in waiting room delays. While this is a nuisance in psychiatry, increased waiting times for the emergency room is unforgivable.

The problem is that EMR is not an innovation: EMR has replaced the piece of paper with a screen that shows a picture of that piece of paper. The input is still by the keyboard of a 1945 Underwood typewriter. The major difference is that the EMR forces the doctor to do his own transcribing, and doctors have poor transcription skills. Burnout, delays in access to care, frustration result.

One of the stated goals of EMR is to be the “single source of truth” regarding a patient. The set of fixed, predetermined fields (including check boxes) miss most information from each encounter. Problems in mapping a patient’s statements onto the predefined fields of an EMR, as well as the lack of free-form text areas in many EMR templates, virtually guarantee that an EMR will be incomplete, inaccurate, sometimes dangerously misleading. The EMR paradigm forces the health care practitioner to conform the information provided by the patient to a structured data format that offers little or no ability to capture subtleties, ambiguities, and qualities that are not easily quantified. To wit: I had to stare at a beautiful teenage girl because her pediatric record, three times, indicated her penis was anatomically correct, and her testicles had both descended. I just accepted her “No” when I asked if there was something really unusual about her. In short, the EMR paradigm ignores the realities of the practice of medicine as not an exact science.

We can do better.

A Solution: The Real Electronic Record (RER)

We propose a simple fix: the video recording of each medical encounter is stored, with no typing or dictation. We call this a “Real Electronic Record,” since it is an actual recording of the medical encounter. At the end of each patient encounter, the doctor also records a one-minute summary of “What We Found Today” and “The Current Plan of Action,” providing a brief recap of the visit for quick review.

There are currently 1.2 billion outpatient medical encounters per year with an annual cost of more than $700 billion. The estimated cost of storing HD video recordings of all of these encounters is approximately $400 million per year. If records must be preserved for seven years, the total cost would come to $2.8 billion per year. That seems like a lot until one realizes that the HITECH Act of 2009 included $20 billion in incentives for hospitals, physicians, and for infrastructure.

We do not advocate video recording against the will of the patient. Those refusing might have to pay a higher fee for record keeping.

Using Real Electronic Records, the doctor would spend no time transcribing data into an electronic format, instead devoting that time to patient treatment. We estimate a savings of 10%— $70 billion per year—which could be used to lower health care costs or to increase doctor productivity, allowing doctors to see more patients. The arrival of the uninsured could lead to a collapse of the system; consequently, freeing up doctor time is crucial.

With a RER, the patient could review her encounter on demand through a secure Internet portal, and videos will soon become searchable, allowing for direct data mining.

The RER will reduce malpractice claims and defensive medicine, saving another 5-10% spent on worthless care.

The $70 billion in savings should be returned directly to patients in the form of no co-pay. That offer is wildly popular with every patient whom I have ever asked.

Most importantly, when a patient sobs that her boyfriend has just been killed, the doctor will be able to hold her hand, look her in the eye, and express ordinary human sympathy, rather than having to transcribe information into an EMR. That means both patient and doctor can stay human.
References:
Kennebeck, SS, Timm, N, Farrell, MK, Spooner, SA. Impact of electronic health record implementation on patient flow metrics in a pediatric emergency department. J Am Med Inform Assoc 2012 19:443-447. (Longer ER waiting times due to EMR.)

U.S. Census Bureau, Statistical Abstract of the United States: 2012. Table 168: Ambulatory Care Visits to Physicians’ Offices and Hospital Outpatient and Emergency Departments: 2008. Available at
http://www.census.gov/compendia/statab/2012/tables/12s0169.pdf. (1.2 billion visits per year.)

Health Care Cost and Utilization Report: 2011. Health Care Cost Institute, Inc., Sept. 2012, p. 3. Available at
http://www.healthcostinstitute.org/files/HCCI_HCCUR2011.pdf. ($709.2 billion in 2011.)

This assumes that the average medical encounter is 15 minutes in length, yielding 300 million hours of video per year. The estimated cost was calculated based upon current storage, equipment, connectivity, electricity, and data center facility costs. (Storage cost estimate.)

Tuesday, April 12, 2016

Letter Submitted to the Federal Trade Commission on the Inexplicably  High Price of Generic Modafinil Produced by Four Companies

        RE: Anomalous Higher Price of Generic Modafinil than Patented Metabolite, Nuvigil (Armodafinil)

Dear Madam or Sir:
Modafinil is a medication that effectively promotes wakefulness. It has found many uses on and off label. Its patent expired. Regulatory action took place after generic companies were paid to delay producing it, in the FTC’s Pay to Delay matter.  (https://www.ftc.gov/news-events/press-releases/2015/05/ftc-settlement-cephalon-pay-delay-case-ensures-12-billion-ill)

A metabolite (break down product), armodafinil, was patented, as Nuvigil. Its maker priced modafinil higher to promote the sales of Nuvigil. I understand the logic and their right to do so. Modafinil has longer action, and less of a crashing sleepiness effect than armodafinil. Thus, the longer half life of the original molecule, modafinil, may be more desirable to doctors and patients.

What I do not understand is why other companies making generic modafinil would also price it higher than Nuvigil, a product they do not make. Nuvigil (armodafinil) 150 mg has the same strength as Provigil (modafinil) 200 mg.

Prices for 30 pills (according to Giant Pharmacy, 9/21/15).

Modafinil 200 mg, by Par, Teva, Watson (Actavis), and Qualitest: all $1000.

Nuvigil 150 mg, (armodafinil): $670.

There appears to be a concerted effort to control the pricing of modafinil that violates the anti-trust laws.  Why would a competitor not price the perfectly equivalent, or even superior, modafinil a $1 less than Nuvigil and capture the large market for this medication?

Generic modafinil is also made in India. Its retail cost in a pharmacy in India  is 80 cents a pill. People who have taken it report it to be as good as the US medication. No doubt, maker and pharmacist are making a profit at that price.

I request an investigation into this anomalous pricing situation. The argument that these are different medications is specious. Modafinil is converted into armodafinil by the liver. 

I have standing to take the place of my patients in legal disputes (granted by the Third Circuit, in Behar v DOT)

Sincerely Yours,

David Behar, MD

Maker of Provigil and Nuvigil

Teva Pharmaceuticals
41 Moores Road
Frazer, PA 19355

Makers of Modafinil (generic Provigil)

Par

http://parpharm.com/

300 Tice Boulevard
Woodcliff Lake, NJ 07677
 (201) 802 4000

Teva

Teva North America
1090 Horsham Road
North Wales, PA 19454 USA
888-TEVA-USA (888-838-2872)

Watson (now Actavis)

 Morris Corporate Center III
 400 Interpace Parkway
 Parsippany, NJ 07054 USA

 862-261-7000
 Fax: +1-862-261-7914

Qualitest

3241 Woodpark Blvd
Charlotte, NC 28206
704-598-5011

Monday, April 11, 2016

Request for Waiver from Pennsylvania Regulation Mandating a Minimum of 15 minutes for a Medication Visit in an Outpatient Mental Health Clinic

I sent copies of these arguments to the Inspectors General of the US and of Pennsylvania, and to the local US Attorney, requesting investigation into and potential prosecution of  Pennsylvania for Medicaid abuse.

RE: Waiver of Standards Request under your § 5200.48 from Your Regulation § 1153.52 (c) (1). Payment conditions for various services. “Psychiatric clinic medication visits shall be a minimum duration of 15 minutes.”

Dear Madam:
I am a Board certified adult and child psychiatrist in practice in several counties of Pennsylvania. I request to be exempted from your regulation referenced above in all my practice locations in Pennsylvania. I request to be completely exempted from the above regulation because 1) it violates the laws of Pennsylvania and of the United States, including several Supreme Court decisions; 2) it is Medicaid abuse; 3) it is unethical and represents a misunderstanding of the nature of a medication visit; 4) it hurts the interest of my patients, their families, and of the public; 5) it is pretextual (a phony and lying use of the law), and damaging policy.

Background:
Pennsylvania Medicaid now requires that all outpatient mental health clinic visits last 15 minutes. If one lasts 14.999 minutes, payment must be denied. This is an across the board, non-individualized requirement that has had adverse effect on clinical care. The real intent is to limit access to care by reducing the number of scheduled appointments in the time of the provider.

Violations of Law:
1) Affordable Care Act (ACA). Unless you are requiring that all specialties have 15 minute visits, your rule violates the spirit and the letter of the Mental Health Parity Provision of the ACA. (Section 1312,  (j) APPLICABILITY  OF MENTAL HEALTH PARITY .—Section 2726 of the Public Health Service Act shall apply to qualified health plans in the same manner and to the same extent as such section applies to health insurance issuers and group health plans.)  Here is the guidance from the CMS website, “... the law requires a general equivalence in the way MH/SUD and medical/surgical benefits are treated with respect to annual and lifetime dollar limits, financial requirements and treatment limitations, ...” and, “ the financial requirements (e.g., deductibles and co-payments) and treatment limitations (e.g., number of visits or days of coverage) that apply to MH/SUD benefits must be no more restrictive than the predominant financial requirements or treatment limitations that apply to substantially all medical/surgical benefits (this is referred to as the “substantially all/predominant test”). This test is discussed in greater detail in the MHPAEA regulation (linked below) and the summary of the MHPAEA regulation found below.”  (At https://www.gpo.gov/fdsys/pkg/FR-2013-11-13/pdf/2013-27086.pdf  ). Time limitations decrease the number of visits that can be scheduled, in violation of parity.

2) Medicaid Abuse. The Medicaid program considers it fraud to pay for procedures that are not medically necessary. A fifteen minute duration is unnecessary in patients with no complaint, and no change in status or in prescription. Imagine a mass, non-individualized procedure. For example, a chest surgeon stents everyone with chest pain. Some have reflux, some rib arthritis. That surgeon is going to jail for Medicaid fraud. Some people need acid medication, others need anti-inflammatory for a rib muscle strain. It is required that the doctor act like a doctor and individualize care, and not carry out the same procedure on everyone coming to him. The fifteen minute requirement is a massive prescription, and represents Medicaid abuse as defined in the regulation. ( 42 CFR 455.2: Abuse means provider practices that are inconsistent with sound fiscal, business, or medical practices, and result in an unnecessary cost to the Medicaid program, or in reimbursement for services that are not medically necessary or that fail to meet professionally recognized standards for health care.)

3) Civil Rights Act of 1964. The rolls of Medicaid have more members of racial and ethnic minorities than the general population. That over-representation  is sufficient to demonstrate  racial discrimination according to the Supreme Court (Texas Dep't of Hous, & Cmity Affairs v. Inclusive Communities Project, Inc. 576 U.S. ___ (2015). It is self evident that minority members are being denied access to care, and that whites would never be restricted in their access that way.



4) American with Disabilities Act Amendment Act of 2008 (ADAAA). The ADA requires that all government services be made available and accessible to people with disabilities. The ADAAA expanded the covered disabilities to mental health conditions (but not to substance abuse disorders). Obstruction of access to medication management violates this law. This regulation is an obstruction to seeing more patients for shorter periods.

5) The Undue Burden  doctrine of Carey v. Population Services International, 431 U.S. 678 (1977). The Court held that a state may not place an undue burden on people seeking contraception so they may have fun having worry free sex. These Pennsylvania requirements place an undue and unconstitutional burden on people seeking to treat serious mental problems. I may stand in for my patients in future litigation.

6) Pennsylvania Administrative Law Act. No psychiatrist I know received notice of the new requirements. I cannot find a comment listing, nor a transcript of hearings held prior to adoption of this regulation.

7) Violation of the Medical Practice Act of Pennsylvania. (§ 16.61 (a) (6). Unprofessional and immoral conduct.  Practicing the healing arts fraudulently, or with reckless indifference to the interests of a patient on a particular occasion, or with negligence on repeated occasions. ) The practice of mass applied care, of non-individualized care violates the fraud and negligence provisions of that section.

8) The lengthened visit time requirement did not come with any increase in fees. It therefore represents a regulatory taking in violation of Fifth Amendment Procedural Process rights.

Unethical and a Misunderstanding

1) Philosophically, a medication visit should address one complaint and should result in one change. If more than one change is made, and a benefit or damage results, it is hard to know which change caused either.

2) The idea of a mass prescription of a procedure to all patients is unethical, not individualized. Unethical care violates professional standards of due care.

Adverse to Interests of Patients, Families, and the Public:
1) Interference with the doctor patient relationship. One result has been that patients discharged from inpatient care have had to wait several months for their first outpatient visit instead of several weeks. During that time, either they run out of medication, or must have their medications renewed without first being seen and individually evaluated. Almost by definition, inpatients have engaged in dangerous acts against themselves or against others. It is a matter of time before these delays in follow up care will result in serious injury or death to patient, family or the police. At best, the prolonged time to follow up will result in greater expense and impairment from high rates of re-hospitalizations

2) Attack on the black and Hispanic family. If these children are dangerous to the rest of the family, they will require out of home placement. In a training on child abuse, your department has admitted to a disparate impact on out of home placement of race.  This regulation will worsen the disparity.

3) Inpatients and patients in partial hospitalization programs (attending from 9 AM to 3 PM, daily) have more treatment resistant problems, are more impaired, dangerous, distressed, difficult to manage, subject to far greater social stresses. Their symptoms are multi-factorial, including trauma, substance abuse, deprived upbringing, and reluctance to accept treatment. Despite neediness that may be 10 times greater than that of working outpatients, there is no minimum time for a brief medication visit for them. This proves the pretextual, phony, unnecessary nature of the 15 minute minimum visit rule.

Damaging and Dangerous Policy:
1) As a result of this policy, the number of people scheduled to be seen during any period of time, such as a day, has marked dropped. As a direct result of this irresponsible regulation, the time between discharge from a mental hospital and first follow up visit has gone from 4 weeks to 4 months. Inpatient and partial hospitalization doctors refuse to write prescriptions for more than a month’s supply. During this 4 months’ time the clinician has the choice of allowing the patient to run out of medication and to fully relapse, or to renew the medications for someone he not examined, yet. This is untenable. It is a matter of time before a serious injury or death results from these long waits.

2) Pennsylvania is suborning garbage science and quackery. There is no evidence that following the 15 minutes requirements improves care. It is in the interest of doctor and of patient to provide information on the treatment. Doctors who fail to do so get many phone calls about side effects. Patients forgetting the discussion have access to the internet. It provides specialist level information for anyone interested.

3) Doctors have a right to dignity. These denials and the frustrating obstacles placed by the state of Pennsylvania are humiliating to physicians. Uneducated clerks are cancelling their orders as if they were a joke.

4) There will be fewer visits per hour under this regulation. There has been no raise in fees. That implies the favored and privileged insurance companies will profit from the obstruction of clinical care.

5) These delays, obstructions, extended visits,  and deterrence of physicians from prescribing these medications to their mental patients, result in increased profits of the people doing the denials of payment. They represent a serious conflict of interest and unjust enrichment of politically connected insurance companies. In future litigation, discovery will seek to reveal collusions, and will result in referrals for criminal prosecution.

Request for Waiver from Regulation of Pennsylvania Requiring Laboratory Testing, AIMS Scale Completion, Failure of Psychological Treatment Before Authorizing Major Tranquilizer Use in Those Under 18 Years of Age

I sent copies of these arguments to the Inspectors General of the US and of Pennsylvania, and to the local US Attorney, requesting investigation into and potential prosecution of  Pennsylvania for Medicaid abuse.


March 6, 2016

Marcy Rachko
Human Services Program Rep II
OMHSAS, Scranton Field Office
100 Lackawanna Avenue, Room 321
Scranton, PA 18503
(570) 963-4942


RE: Waiver of Standards Request under your § 5200.48 from Your Regulation 55 Pa. Code §1101.67 (a), Medical Assistance Bulletin 01-16-08; Prior Authorization of Anti-psychotics - Pharmacy Service.

Dear Madam:
I am a Board certified adult and child psychiatrist in practice in several counties of Pennsylvania. I request to be exempted from your regulation referenced above in all my practice locations in Pennsylvania. I request to be completely exempted from the above regulation because 1) it violates the laws of Pennsylvania and of the United States, including several Supreme Court decisions; 2) it mislabels a class of medications; 3) it hurts the interest of my patients, their families and of the public; 4) it is damaging policy.

Background:

Pennsylvania Medicaid now requires that all children under 18 provide the results of blood testing, weights, heights, completion of AIMS Tardive Dyskinesia Scale, and blood levels of lipids and fasting glucose, before they can get major tranquilizers paid for by medicaid pharmacy benefits insurance companies. They must also have failed to respond to behavior, cognitive and family therapy. The latter can take months to complete.

Close to a million children have been prescribed major tranquilizers across the nation. These are by doctors who have not colluded, but instead independently found them to be effective. These tranquilizers have then  been dispensed day by day by the people who take the consequences of not prescribing them, parents and school personnel. When they have forgotten to do so, and the symptoms recur, they are reminded and motivated to adhere to treatment. Children experiencing their benefits will often remind parents they have forgotten to give them.

Roughly 1 in 1500 children and adolescents will have abnormal glucose metabolism. That rate triples to 1 in 500 in children taking second generation neuroleptic tranquilizers. Most of them have gained much weight by artificial stimulation of the hunger center. One still has to test 500 children to find a single case. That is a poor screening procedure. One should allow doctors to act like doctors, and to test only those mostly likely to have the abnormality, children who have gained weight and those with a family history of diabetes. The guidelines do not take into account the worldwide obesity epidemic, and the high rates of diabetes in psychiatric patients in reports of the 1920's. 

If the state were sincerely interested in reducing the risk of lipidemia and of diabetes in children, it would promote the use of modern brand name medications that are not associated with changes in glucose and lipid levels. The state Medicaid program strongly opposes and blocks the prescription of these newer medications, and allows the use of older medications that cause obesity, such as risperidone, olanzepine, and quetiapine. They are cheaper in the short run. Mandatory testing is therefore pretextual, an obstruction to care to reduce expenditures. And the testing is phony,  to obstruct care and not to prevent the development of diabetes.

Violations of Law:

1) Affordable Care Act (ACA). Dozens of medications used in children require lab monitoring, those for epilepsy, arthritis, non-steroidal anti-inflammatories, etc. Pennsylvania does not require lab work to grant pre-authorization for those categories. It therefore violates the spirit and the letter of the Mental Health Parity Provision of the ACA. (Section 1312,  (j) APPLICABILITY  OF MENTAL HEALTH PARITY .—Section 2726 of the Public Health Service Act shall apply to qualified health plans in the same manner and to the same extent as such section applies to health insurance issuers and group health plans.)

2) Medicaid Fraud. The Medicaid program considers it fraud to pay for procedures that are not medically necessary. The mass testing of patients to be started these medications is not medically necessary, and only 2% of physicians comply in practice. It will cost 500 times the cost of lab testing to find one case, enriching laboratories, with no benefit to patient, and no medical necessity.

3) Civil Rights Act of 1964. The rolls of Medicaid have more members of racial and ethnic minorities than the general population. That over-representation  is sufficient to demonstrate  racial discrimination according to the Supreme Court (Texas Dep't of Hous, & Cmity Affairs v. Inclusive Communities Project, Inc. 576 U.S. ___ (2015)

4) American with Disabilities Act Amendment Act of 2008 (ADAAA). The ADA requires that all government services be made available and accessible to people with disabilities. The ADAAA expanded the covered disabilities to mental health conditions (but not to substance abuse disorders). Obstruction of access to medication violates this law.

5) Supremacy Clause and FDA Regulation Allowing Off Label Prescribing. Physicians may prescribe off label, for off label indications, to off label ages, and at off label dosages
( http://www.fda.gov/RegulatoryInformation/Guidances/ucm125126.htm ). The restrictive requirements interfere with that federal right in violation of the Supremacy Clause.

6) The Undue Burden  doctrine of Carey v. Population Services International, 431 U.S. 678 (1977). The Court held that a state may not place an undue burden on people seeking contraception so they may have fun having worry free sex. These Pennsylvania requirements place an undue and unconstitutional burden on people seeking to slow down their children trying to kill themselves, attacking themselves, their families, their classmates, destroying the ability of others to learn, generating massive health costs for mental hospitals and injury care, generating dangerous and costly police and legal remedies. Hundreds actually kill themselves on purpose. Dozens murder other children. When their conditions go untreated a type of brain damage takes place that is prevented by this class of medication (the neuroprotective effect). Untreated, the progress of this brain damage makes treatment require higher doses, for longer periods, with a lower chance of success. Think of treating a breast cancer early, the size of a pinhead, versus delay of care and treating a breast cancer the size of an orange. The effect of delay on the chances of success is the same.

7) Pennsylvania Administrative Law Act. No psychiatrist I know received notice of the new requirements. I cannot find a comment listing, nor a transcript of hearing held prior to adoption of these new regulations.

Mislabeling: These medications are not anti-psychotics. They are major tranquilizers. They quiet the brain in a completely non-specific manner. The brain is supposed to be quiet until external world stimuli arrive, and it has to react. All psychiatric disorders come from a weakened inhibition of the brain, and emerging reactions of the brain not warranted by environmental events. So, it is normal to have  no eye blinking without irritation of the cornea (tics), no tearfulness without loss (depression), no anger without an external attack (irritability), no hearing of voices when no sound has entered the ears (psychosis and hallucination), no nausea and vomiting without a poisoning, no cleaning without dirtiness (obsessive-compulsive disorder), no hiccups without irritation of the diaphragm (going on for 3 weeks), no uncontrollable laughter without anything funny (for hours), no self injury, no attempt to kill oneself, no racing thoughts making sleep impossible, no rapid, pressured speech, no fear when there is no danger (anxiety), no retaliation when there is no threat (paranoia). This class of medication addresses these disinhibited states.

These non-specific medications are not for psychosis (voices paranoia, and a formal thought disorder). They are for the disinhibited states that cause injury and incapacitation in abnormal children. Blanket obstruction to the use of these medications injure children suffering from all the above conditions, and not just behavioral dyscontrol.

Adverse to Interests of Patients, Families, and the Public:

1) Interference with the doctor patient relationship. Children are more sensitive to pain they will remember the doctor ordered these painful blood tests. They will have to be held down much of the time., needlessly traumatizing them.

2) Attack on the black and Hispanic family. If these children are dangerous to the rest of the family, they will require out of home placement. In a training on child abuse, your department has admitted to a disparate impact on out of home placement of race.  This regulation will worsen the disparity.

3) Foster parents will not do better than families of origin. Without adequate treatment, they will have to placed in institution over several years.  This violates their right to the least restrictive care, as determined by their doctors and families.

4) Police and court resources will be diverted to these dangerous children, and away from real criminals. Encounters with these disturbed children will be more likely to result in shootings and injury to both patients and police.

5) These children commit violent crimes at a rapid rate, and injuries are taking place at a rapid pace, directly as a result of the denial of these medications by insurance companies hiding behind these state regulations.

Damaging and Dangerous Policy:

1) Before insulin, diabetes was treated by the “behavioral” approach of starvation. Would it be appropriate to demand that diabetics first fail to respond to starvation before Pennsylvania Medicaid rules allow payment for insulin? Why is it appropriate to demand that children fail to respond to cognitive, behavioral and family based treatment. These can take months to determine their success. Medication management enhances their likelihood of success.

Most of the children referred for major tranquilizers have failed to respond to parental discipline, all the way to the extreme of physical abuse. So requiring evidence of failure to respond to behavioral approaches is pretextual and inappropriate.


2) Pennsylvania is suborning garbage science and quackery. There is no evidence that following these requirements reduces the incidence or prevalence of diabetes or of hyperlipedimia in users of these medications. There is evidence of lower rates of disease in new brand names. But the state resists their use to the utmost, and allows the use of strongly diabetogenic drugs. The required completion of the AIMS scale for tardive dyskinesia was validated on 60 year old state hospital patients who took thousands of milligrams of first generation tranquilizers over decades. It is completely invalid and irrelevant to young people who will be taking second generation tranquilizers. These were developed because they had one tenth the likelihood of causing dyskinesia as the first generation. “Tardive” dyskinesia is defined as a “late” dyskinesia. It requires that the patient be off tranquilizers for a year, to avoid counting dyskinesia from drug side effect or from acute withdrawal from these drugs. You have a total misconception of what tardive dyskinesia is.

3) Doctors have right to dignity. These denials and the frustrating obstacles placed by the state of Pennsylvania are humiliating to physicians. Uneducated clerks are cancelling their orders as if they were a joke.

4) Second generation major tranquilizers have a neuroprotective effect against the progressive brain damage caused by the disorders, as they go untreated. This brain damage will result in long term disability and a lower chance of recovery.

5) The fact that close to a million children have been placed on these medications indicates the widely accepted standard of professional due care. The denials and the obstructions placed by the state are forcing care that is below the standard of care.

6) These delays, obstructions, promotion of cheap generics, and deterrence of physicians from prescribing these medications result in increased profits of the people doing the denials. They represent a serious conflict of interest and unjust enrichment of politically connected insurance companies. In future litigation, discovery will seek to reveal collusions, and will result in referrals for criminal prosecution.