California Doctor Arrested For Writing Prescriptions Without A Medical Purpose - Charges Filed in Ventura County

On July 8, 2013, after a two month undercover investigation, a physician Kiansi Boni in Camarillo, California was charged with two felony counts of violating Health and Safety Code Section 11152(a) and 11153(a) of issuing prescriptions for controlled substances (Vicodin, Suboxone, methadone, Xanax and codeine) without a legitimate medical purpose.

Section 11153(a) provides in relevant part that "A prescription for a controlled substances shall only be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his or her professional practice."  Dr. Boni is alleged to have had cash patients in the practice where the patients paid for a physical exam that did not meet the standard of care before being issued prescriptions.

An additional felony count of violating Business and Profession Code Section 2052 was charged because the physician's license had been suspended during a period of time due to failure to pay child support.
Bail was set at $50,000.

This investigation began after a number of the patients were arrested for selling the opiate medications prescribed by the doctor. A coordinated investigation by Ventura County's Pharmaceutical Crimes Unit, the Medical Board and other agencies began. According to the discovery provided by the government, the doctor did not physically examine the patients to determine whether there was a legitimate medical necessity for the prescriptions.

The physician is lucky that this is a state case and that the federal drug laws are not being used to charge him with distributing controlled substances which carry much higher penalties and potential sentences. Nevertheless, these are serious charges which the Medical Board is taking very seriously and is demanding revocation of licenses where these allegations are made even where there are not criminal cases.

Posted by Tracy Green, Esq.
Email: tgreen@greenassoc.com
Green and Associates - Los Angeles, California
Office: 213-233-2260

Pharmacist Sentenced To 120 Months For Dispensing Oxycodone Outside Legtimate Medical Purpose And Not In Usual Course of Professional Practice

In March 2013, U.S. District Judge James D. Whittemore sentenced pharmacist Emmanuel Mekowulu to 10 years (120 months) in federal prison for conspiring with other persons to knowingly and intentionally distribute and dispense and cause the distribution and dispensing of oxycodone outside of a legitimate medical purpose and not in the usual course of professional practice. 

The pharmacist had dispensed over 340 prescriptions from Neurology and Pain Center clinics. The physician presigned prescriptions for people that were not patients and 60 of the prescriptions were issued in the names of employees of the medical clinic. The court also ordered the pharmacist to forfeit his professional license and the pharmacy license he held for the Felky Pharmacy.

How can pharmacists be charged with distributing oxycodone or other Schedule II drugs?  The Controlled Substances Act, Title 21, United States Code, Sections 841(a)(1) and 846 make it unlawful for any person knowingly or intentionally to distribute or dispense a controlled substance or to conspire to do so. Medical professionals, such as physicians and pharmacists, are excepted from this general prohibition as long as they comply with the legal requirements of their licenses and DEA registration.

In the cases we have seen, the issues against pharmacists are based primarily on their “corresponding responsibility” to determine that a Schedule II prescription is based on a legitimate medical need and is not outside the usual scope of practice. In the past, pharmacists were not vigilant about confirming medical need and asking for medical records to satisfy themselves once the determined the physician wrote the prescription. Now that the pharmacy world knows that some physicians will write prescriptions to patients or fake patients, it is dangerous for pharmacists to trust physicians or the patients.

Where the pharmacist did not have actual knowledge that the physician wrote the prescription for cash payment without medical necessity, the government uses the theory of “willful blindness” or “deliberate ignorance” to show that the pharmacist dispensed the prescriptions without verifying the question or validity of the prescriptions where there were obvious red flags.

The juries in these pharmacy cases are allowed to consider model guidelines, federal DEA laws and regulations, state pharmacy laws and regulations, along with all other evidence, when determining whether or not the pharmacists dispensed controlled substances other than for a legitimate medical purpose and not in the usual course of professional practice. Evidence is then presented by experts about the red flags that appeared in these prescriptions and the fact that no one followed up on these issues.  Deliberate ignorance is used to show intent to join the conspiracy to distribute oxycodone. 

There is a war on prescription drugs and pharmacists must look at each prescription and create their own protocols and procedures in order to protect themselves from civil and criminal liability in these cases. Pharmacists who dispense Schedule II narcotics should have their practices reviewed by outside counsel or compliance experts and make sure that they comply with their own policies and procedures. 

Posted by Tracy Green, Esq.

Green and Associates

213-233-2260

tgreen@greenassoc.com 

California Pharmacists: Pharmacists' Corresponding Responsibility And CURES Program

One of the biggest changes in DEA enforcement and Pharmacy Board enforcement these past couple of years is holding pharmacists responsible for "corresponding responsibility."  Certainly, pharmacists for years have known the term but now the government is beginning to charge pharmacists for knowing and intentionally distributing controlled substances as if they are drug dealers. 

We are currently handling one such federal criminal case for a pharmacist and it is something our client never thought he would ever face in his career. Cases like this are being charged across the country. The theory being used in this case and other cases is that the pharmacist deliberately ignored red flags on questionable prescriptions -- not that they "knew" is was not legitimate. 

The federal regulation for "corresponding responsibility" means that the pharmacist who fills the prescription has the same duty as the physician to determine legitimate medical need for a Schedule II prescription. Thus, pharmacists in today's world need to go far beyond determining that the prescription is valid, that a physician issued it and that the prescription has not been tampered with at all, or that the patient is obtaining prescriptions from multiple physicians. Pharmacists need to look at any red flags and document follow up on anything suspicious as well as confirm diagnoses that support the medication being dispensed and show that he or she exercised sound professional judgment.

The California Board of Pharmacy is holding a joint training with the DEA on Pharmacist's Corresponding Responsibility and California's CURES program. It will be held on July 25, 2013 in Downey, California and pharmacists and pharmacy technicians can register online. If you cannot attend that seminar, I recommend watching some of the other Pharmacy Board online seminars that have been posted.  

Physicians and the California Medical Association are concerned about the aggressiveness of the DEA and Pharmacy Board in having pharmacists challenge medical necessity for pain medications that are controlled substances. They are asking physicians to contact them if and when they cannot fill medically necessary prescriptions. 

Pharmacies such as Walgreens (who just paid the U.S. a $80 million fine for not having its pharmacists meet their corresponding responsibilities) are asking for information on diagnosis, ICD-9 codes, expected length of therapy and medications previously tried and failed. However, what does the pharmacist do if the information provided is not accurate? How far does the pharmacist need to go? 

Posted by Tracy Green, an experienced health care and pharmacist attorney. 

Email: tgreen@greenassoc.com     Office: 213-233-2260

How Do I Get Reinstated To OIG For Medicare After My Exclusion Period Has Ended?

One of the frequent issues we handle is OIG exclusion following a conviction for health care related offense.  An OIG exclusion bars a health care provider from working with any provider that received any federally funded program funds. For example, if an individual received a 5 year OIG exclusion, he or she cannot work as an employee, independent contractor or volunteer for any Medicare provider with some very limited exceptions for that time period. However, after the 5 year period it is important to know that reinstatement is NOT automatic.

We have assisted clients over the years with their OIG reinstatement. Here are a couple of facts to know. First, there is no way to obtain early termination of the exclusion time period once it has been effective. If you received an OIG exclusion notice, it is important to submit information at that time to help make sure that the period will not be longer than the minimum 5 years. If you fail to submit information at that time, you will not be able to do it later. The only exception is for emergency services. There is an appeal process.

For example, OIG sent a notice to one of our clients that because a former owner was excluded by OIG, that entity was going to be excluded. We submitted proof that the entity had been sold, that the former owner was no longer involved and that the entity should not have been excluded. If that information had not been provided within the first 30 days, then the entity would have been excluded and lost its right to appeal. Thus, if there is an exclusion letter received, act on it right away.

Second, if you have been excluded, you can begin the reinstatement process 90 days before your exclusion period is to end. If we send the reinstatement package before that date, it will not be considered.

Third, there are a number of factors that OIG considers in determining reinstatement. One of them is whether you have been providing services to Medicare providers during your exclusion period. This also includes management and administrative services. There will be a request for information as to all places you have worked and or provided services. OIG also conducts a background check. 

Fourth, remember that in California even if you are reinstated by OIG, you also have to seek reinstatement from the Medi-Cal program. When Medi-Cal issues a suspension following a conviction, it is lifetime and you must seek to be reinstated. It is best to start this process after you have been reinstated by OIG as that is an additional ground for lifting the suspension.

This is only a starting point but it is important to remember the rules regarding OIG exclusion. If an OIG excluded provider works with any Medicare or Medi-Cal provider, that provider will be strictly liable for having to repay those funds. It can also subject the excluded provider to civil penalties.

Posted by Tracy Green, Esq.
Green and Associates, Attorneys at Law
Email: tgreen@greenassoc.com
Office: 213-233-2260

Respiratory Therapist Arrested For Practicing Medicine Without A License For Botox Injections And Representing Himself As Naturopathic Doctor

On June 20, 2013, a licensed respiratory therapist, Santiago Alvarez was arrested as part of an undercover investigation by the Medical Board of California’s Operation Safe Medicine Task Force. The case has been filed in the Riverside County Superior Court by the District Attorney’s Office. Mr. Alvarez has been charged with practicing medicine without a license, along with grand theft by false pretenses. Mr. Alvarez is presumed to be innocent.

It is alleged that Mr. Alvarez owned and operated LogiHealth and Rejuvenix Medical, LLC, both located in Moreno Valley, California. A licensed Respiratory Care Practitioner, he allegedly represented himself as a Naturopathic doctor “Board Certified in Anti-Aging Medicine.” As part of the undercover operation, he allegedly provided Botox injections at both locations, which by law are required to be administered by a licensed physician, or a physician’s assistant, advanced nurse practitioner or registered nurse under direct supervision of a licensed physician. It was further alleged that Mr. Alvarez used the DEA number and forged the signature of another licensed physician to obtain prescriptions.

This case shows that complaints are increasingly being referred for undercover operations. We have seen an increase in undercover agents being sent into clinics being investigated to see if the rules against the unlicensed practice of medicine are being violated.

Posted by Tracy Green, Esq.
Contact: tgreen@greenassoc.com
Green and Associates, Attorneys at Law