Federal and State Prescription Fraud

Some of my blogs are extremely dense.  This and the next several blogs focus on the intersection of  federal and state criminal statutes and regulations concerning illegally written prescriptions and the potential criminal consequences.

Federal criminal statutes are intentionally written extremely broad.  Title 21, United States Code, Section 841(a)(1) is the Federal Drug Act.  Typically used for drug dealers, this provision is the tool federal prosecutors use to criminally charge physicians who improperly write prescriptions for controlled substances that are not medically necessary.  The language of the federal criminal statute is quite simple.

Title 21, United States Code, Section 841(a)(1), provides that “[e]xcept as authorized by this subchapter, it shall be unlawful for any person to knowingly or intentionally manufacture, distribute, or dispense, or possess with intent to manufacture, distribute or dispense, a controlled substance.”  Title 21, United States Code, Section 802(10), provides that the term “dispense” means to deliver a controlled substance to an ultimate user or research subject by, or pursuant to the lawful order of, a practitioner, including the prescribing and administering of a controlled substance and the packaging, labeling or compounding necessary to prepare the substance for delivery.

Section 821, provides that “[t]he Attorney General [of the United States] is authorized to promulgate rules and regulations …relating to the registration and control of the manufacture, distribution, and dispensing of controlled substances.”   21 Code of Federal Regulations § 1306.04, governing the issuance of prescriptions, which provides, among other things, that a prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice. Moreover, an order purporting to be a prescription issued not in the usual course of professional treatment is not a prescription within the meaning and intent of section 309 of the Act [21 U.S.C. § 829] and the person knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to the penalties provided for violations of the law relating to controlled substances.

The Pennsylvania Code of Professional and Vocational Standards, Title 49, Chapter 16.92, defines the authority of physicians licensed by the Commonwealth of Pennsylvania to prescribe or dispense controlled substances. Chapter 16.92 provides in pertinent part:

(a) A person licensed to practice medicine and surgery in this Commonwealth or otherwise licensed or regulated by the Board, when prescribing, administering or dispensing controlled substances, shall carry out, or cause to be carried out, the following minimum standards:

  • Initial medical history and physical examination….. [B]efore commencing treatment that involves prescribing, administering or dispensing a controlled substance, an initial medical history shall be taken and an initial examination shall be conducted unless emergency circumstances justify otherwise. Alternatively, medical history and physical examination information recorded by another health care provider may be considered if the medical history was taken and the physical examination was conducted within the immediately preceding thirty days. The physical examination shall include an evaluation of the heart, lungs, blood pressure and body functions that relate to the patient’s specific complaint.
  • Among the factors to be considered in determining the number and the frequency of follow-up evaluations that should be recommended to the patient are the condition diagnosed, the controlled substance involved, expected results and possible side effects. For chronic conditions, periodic follow-up evaluations shall be recommended to monitor the effectiveness of the controlled substance in achieving the intended results.

 

  • Patient counseling. Appropriate counseling shall be given to the patient regarding the condition diagnosed and the controlled substance prescribed, administered or dispensed. Unless the patient is in an inpatient care setting, the patient shall be specifically counseled about dosage levels, instructions for use, frequency and duration of use and possible side effects.

 

  • Medical Records. [C]ertain information shall be recorded in the patient’s medical record on each occasion when a controlled substance is prescribed, administered or dispensed. This information shall include the name of the controlled substance, its strength, the quantity and the date it was prescribed, administered or dispensed to a patient. The medical record shall also include a specification of the symptoms observed and reported, the diagnosis of the condition for which the controlled substance is being given and the directions given to the patient for the use of the controlled substance. If the same controlled substance continues to be prescribed, administered or dispensed, the medical record shall reflect changes in the symptoms observed and reported, in the diagnosis of the condition for which the controlled substance is being given and in the directions given to the patient.

When the federal law is read in conjunction with Pennsylvania’s Code governing appropriate medical practices, prescriptions written without a medical basis or therapeutic need but for which the physician bills federal, state, or private insurance companies for both visits and reimbursement, the physician is exposed criminal liability. The criminal liability is both for insurance fraud and violation of the federal drug act.

As a doctor of medicine, physicians are authorized to dispense to patients Schedules II, III, IV and V controlled substances and to prescribe medicine to patients, including controlled substances, for legitimate medical purposes and in the usual course of professional practice.

Call to discuss any federal criminal target letter or indictment.

Alcohol on the Job as a Medical Professional

Many nursing board prosecutions start from on-the-job claims of co-workers  smelling alcohol on a licensee’s breath while working or a nursing administrator thinking a licensee has slurred speech and seemed “scattered”.   Lets go get a drug and alcohol test.

Pennsylvania’s medical related licensing board investigates this type of allegation under 63 P.S. §§63 P.S. §§2205(b)(4) and (b)(5) for being unable to practice professional nursing with reasonable skill and safety by reason of mental or physical illness or condition or dependence upon alcohol, hallucinogenic or narcotic drugs or other drugs which tend to impair judgment or coordination.  In western Pennsylvania the Board sends individuals for the mental and physical examination to Robert Wettstein, M.D.  The purpose of Dr. Wettstein’s evaluation is conduct a psychiatric examination of the licensee to determine, if under the the DSM-V the licensee meets any one of, or a multiple of the eleven (11) criteria relevant to the diagnosis of an Alcohol or Drug Use Disorder.

Importantly the PHP, SARPH, and the PHP sucker, trap, scare medical professional licensees into the PHMP/PHP/PNAP programs after they are subjected to, and reveal, a positive Urine Ethyl Glucuronide test (“EtG”) which is not one of the eleven (11) criteria relevant to a diagnosis of an Alcohol Use Disorder set forth within the DSM-V.

In a recent case, the following facts were present: a negative drug screen on the day of the instance, not being terminated and no other work place discipline or termination from nursing employment, and a prior DUI ARD following a DUI arrest.  The licensee stated to Dr. Wettstein that she typically drank one or two bottles of draft beer or a mixed drink once or twice a week at a club, usually with her boyfriend.  The good doctor determined she was an alcoholic and concluded she could not practice safely with out going into the PHMP.

Wettstein diagnosed the licensee with an Alcohol Use Disorder based upon her EtG test results with the following Alcohol Use Disorder symptoms: 1) Respondent consumes more alcohol than intended as demonstrated through her purported ” blackout”/”brownout”; 2) Respondent has lost control of her alcohol use over time; 3) Respondent likely self-medicated with alcohol to address the emotional distress she experienced from the death of her brother; 4) Respondent is not attentive to her alcohol use or her alcohol experience as demonstrated by her 2010 DUI arrest and statement to him that she was not intoxicated at the time of her arrest; and 5) Respondent denied having an Alcohol Use Disorder or needing treatment for such a Disorder.

This licensee fought the case and won. Importantly, the licensee’s EtG test was positive and at 40-times the normal limit, but her Carbohydrate Deficient Transferrin (“CDT”) test was negative for heavy alcohol use.  The CDT test is a valid diagnostic test which tests for biomarkers indicative of heavy alcohol use.   This is a huge inconsistency in objective test results.

Importantly, the hearing officer thoroughly reviewed the factual record and concluded: “the record shows as a threshold matter that Dr. Wettstein failed to identify the diagnostic criteria for an Alcohol Use Disorder under the DSM-V in either his written report or through his hearing testimony. Nor did Dr. Wettstein identify the specific DSM-V criteria Respondent purportedly satisfies. In the absence of such critical information , any finding that Respondent has an Alcohol Use Disorder would necessarily be predicated exclusively upon Dr. Wettstein’ s opinion alone that Respondent has an Alcohol Use Disorder based upon the undisclosed DSM-V diagnostic criteria.”

An easy simple interpretation of this legal/medical conclusion is Dr. Wettstein made up his conclusion and did not rely upon any proper medical evidence to determine the licensee was impaired and unable to safely practice her profession.

The hearing officer relied upon an appellate case I handled and won.  In that case, Dr. Voskanian did the same thing — made up his opinion.  There, the court stated: Absent expert testimony establishing the diagnostic criteria for an Alcohol Use Disorder, the particular criteria a licensee purportedly satisfies, and how the licensee satisfies those criteria, the record fails to contain substantial evidence to support Dr. Voskanian’s diagnosis of an Alcohol Use Disorder but, instead, requires  the Board to merely accept his diagnosis at face value. See, e.g., Thim v. Bureau of Professional and Occupational Affairs, 1019 WL 3315143 at *8-9 (Pa. Cmwlth. July 24, 2019).  This, the court would not allow the Board to do.

The appellate court and the hearing examiners are starting to push back on Board experts’ baseless, made up, medical legal conclusions.  Call me to discuss your case.

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