Showing posts with label Regulations. Show all posts
Showing posts with label Regulations. Show all posts

Tuesday, February 21, 2017

From The Volokh Conspiracy





There should be presumption of organ donation. Instead of checking off that one wants to be a donor, one should check off that one refuses to be a donor. Presumption of donation increases donations ten fold in comparable jurisdictions around the world.

The Kelo mentions only property, not real property. It therefore applies to chattel and corpses are chattel. The government should take corpses, and crush families that refuse to cooperate.  The idea of donating organs to feeding the worms or burning them in cremation is idiocy.

Because of their self dealt immunities, violence against legislators, regulatory officials,  and appellate judges has full justification in formal logic. These are not even human beings. They should be attacked but not killed. If they are killed they will be replaced by grateful competitors.  Included on the hit list should be religious leaders or ethicists, including doctors, opposing a market place for organ donations. They believe they know the interests of the donors better than they do. They are mostly elitist and stupid.

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.

Friday, March 12, 2010

Rare Good News for the Victims of Government Bullying, $6.5 Million Verdict Against Government Inspectors

A rare instance of accountability.


Philly.com
Business
Verdict against DEP employees' actions stirs fears
Posted: 03/11/2010 5:38 PM

By Chris Mondics
Inquirer Staff Writer

A federal jury's verdict that four Pennsylvania Department of Environmental Protection employees are liable for $6.5 million in damages stemming from a series of disputed enforcement actions has triggered shock waves in Harrisburg, where officials are voicing concern that they will be held personally liable for efforts to uphold environmental laws.

The verdict, by a jury in U.S. District Court in Philadelphia, found that the four DEP employees had launched an intensive crackdown on MFS Inc., of Bethlehem, a now-defunct manufacturer of industrial insulation and ceiling tiles, as retaliation after the company complained to state lawmakers about unfair treatment.

"We are really concerned by the verdict, and we have a motion pending before [U.S. District Judge Joel Slomsky] to have the verdict thrown out," said DEP Secretary John Hanger. "I believe it is a miscarriage of justice."

Hanger added that the state would also, if necessary, pay the costs of the jury award - a clear signal of concern in Harrisburg, observers said, that the verdict could cause individual DEP officials to pull back and overall undermine enforcement actions in a department that has suffered through a series of budget cuts and downsizing.

Wayne C. Stansfield of Reed Smith L.L.P. in Philadelphia, who is representing MFS, declined to comment yesterday on the verdict.

The case has drawn attention from a wide variety of environmental lawyers and officials, who described it as highly unusual. Typically, state government workers are protected by the doctrine of sovereign immunity, which bars lawsuits against government agencies exercising normal duties.

In this instance, MFS overcame the sovereign-immunity barrier by alleging that the DEP officials individually violated its constitutional right of due process and free speech by improperly enforcing environmental laws and acting outside the scope of their employment.

"I see this as a problem on the enforcement side," said Joel Bolstein, deputy secretary of the DEP from 1995 to 1998 and an environmental lawyer with the Philadelphia firm Fox Rothschild L.L.P. "Up until now, state workers in this agency never imagined that they could be subject to a discrimination claim and personal liability for making a decision on a permit."

The employees, who were sued as individuals, are Michael Bedrin, director of the DEP's northeast regional office; Thomas DiLazaro, former air-quality program manager, who retired; Mark Wejksner, the current air-quality program manager; and Sean Robbins, a lawyer with the agency.

According to papers filed in the case, the dispute dates to late 2001, when the DEP issued a violation notice to MFS for odors allegedly coming from its plant.

Little more than a year later, the DEP issued another citation, a field-enforcement order, late on a Friday afternoon that required the company to respond by the following Monday.

MFS responded by complaining to lawmakers in Harrisburg, who were not identified in the complaint. At least one wrote the DEP expressing concern about the enforcement action.

Shortly thereafter, DEP officials lodged 13 citations against MFS in a two-week period, the documents say. One of the defendants in the case allegedly told an MFS official that he had been irked that the company sought a political solution by reaching out to elected lawmakers.

In an opinion issued last year denying a request that the case be thrown out, Slomsky, quoting press coverage of the case, said one of the defendants, DiLazaro, had declared that "MFS is definitely a nuisance."

The company alleged that DEP officials knew there was another potential source of odor, a nearby sewage-treatment plant. MFS denied that it was the source of the odors and alleged that the DEP never proved otherwise.

...

Contact staff writer Chris Mondics at 215-854-5957 or cmondics@phillynews.com.