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.