Physician Gets 40 Years For Illegally Prescribing More Than Half a Million Opioid Doses

George Indest HeadshotBy George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law
On October 2, 2019, a Virginia doctor received a 40-year prison sentence for illegally prescribing more than half a million opioid pills over 19 months. The U.S. District Court for the Western District of Virginia handed down the sentence to Joel Smithers, who was reported to have operated a “pill mill” out of Virginia, according to authorities. In addition to prison time, he was given an $86,000 fine and will serve three years of supervised release upon the completion of his prison time, according to court documents.

The sentence is lighter than it could have been. He was facing up to life in prison and a fine of more than $200 million, according to officials at the U.S. Justice Department. Click here to view the court’s sentencing document in full.

Alleged Pill Mill.

In May 2019, Smithers was convicted by a jury on more than 859 federal drug charges, including one count of possessing with the intent to distribute controlled substances and one count of maintaining a place for the purpose of unlawfully distributing controlled substances. Additionally, he was also convicted on hundreds of counts of unlawfully distributing a controlled substance without a legitimate medical purpose or beyond the bounds of medical practice.

When he opened his Virginia practice in 2015, Justice Department officials said he prescribed controlled substances to “every patient in his practice, resulting in over 500,000 Schedule II controlled substances being distributed.” Authorities say that he allegedly ran an operation that was less a medical practice and more an interstate drug distribution network.

Smithers was able to rake in over $700,000 in cash and credit card payments before the search warrant was executed at his office on March 7, 2017. Click here to read the press release issued by the U.S. Attorney’s Office in the Western District of Virginia.

To learn about a similar case involving two Florida doctors, click here.

The Problems I See.

I tell you that I take issue with many of the cases of this sort. I do not know enough about the actual facts of this physician’s case, but I can comment generally based on other similar cases I have had in the past. The government, both state and federal, has come down like a hammer on individual physicians and pharmacists in its over-zealous campaign to crack down on opioids. Many physicians and pharmacists, just trying to do a good job and legitimately treat their patients, are being caught up and persecuted. Chronic pain patients, many of whom are disabled veterans or people injured on the job, are unable to find physicians to treat them anymore or, if they can, any pharmacists willing to fill their prescriptions.

All sorts of under-handed techniques are used to try to make a case against conscientious health professionals who are merely trying to do their jobs. These do include the tactic seen in the case we are reporting on, which I call “bean counting.” The government comes in and, instead of proving how many allegedly illegal prescriptions were written or how many patients the physician gave the prescriptions to, breaks these out into the number of pills. This greatly exaggerates the case and these large numbers alone make it look like the doctor (or pharmacist) is doing something wrong or extremely way out of the norm.

For example, if a patient was receiving a low dose of a pain killer, say 10 mg Oxycodone every 4 to 6 hours, prescribed for four times a day, the ordinary monthly prescription for this medication alone (and such patients rarely receive one type of medication alone) this equates to 120 pills per month. If 10 mg pills are not available and/or the prescription is filled with 5 mg pills, instead, this is 240 pills a month. A years’ worth is 1,440 pills or 2,880 pills for just one patient. If the physician has 50 similar patients, this is 72,000 pills or 144,000 pills a year that the physician is writing and a pharmacy or pharmacies are filling.

This does not seem extreme or unusual to me, at all, and these amounts are on the low side. Yet just as government agencies love to inflate the “street value” or contraband drugs they seize, they love to break down the number of opioids a physician writes so it seems to a layperson to be extraordinarily large. Furthermore, a pain management physician or any other kind of physician cannot survive with just 50 patients a month. It is far more likely for a physician to have a thousand (1,000) or more patients a month. I call this type of numerical exaggeration “bean counting.” But it has put a number of physicians and pharmacists in jail.

Judges should not allow such exaggerated numbers to be introduced into evidence in the absence of further information that places them in context. It is unfairly prejudicial to the defendant to do so.

Contact Health Law Attorneys Experienced with DEA Cases.

The attorneys of The Health Law Firm are experienced in handling Drug Enforcement Administration (DEA) cases, board of medicine cases and board of pharmacy cases regarding allegations of over-prescribing and illegal prescribing. If you are currently being investigated or facing other adverse actions by the DEA contact one of our attorneys by calling (407) 331-6620 or (850) 439-1001. You can also visit our website for more information at www.TheHealthLawFirm.com.

Sources:

Booker, Brakkton. “Doctor Gets 40 Years For Illegally Prescribing More Than Half A Million Opioid Doses.” NPR. (October 2, 2019). Web.

“Virginia doctor could get life in prison today for prescribing 500,000 opioid pills.” RTV6. (October 2, 2019). Web.

Almasy, Steve. “Virginia doctor who illegally prescribed 500,000 opioid pills sentenced to 40 years in prison.” CNN. (October 2, 2019). Web.

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

KeyWords: legal representation for pain management physicians and pharmacists, legal representation for pharmacies, pharmacy defense attorney, pain management physician defense attorney, pharmacist defense lawyer, pain management physician defense lawyer, representation for False Claims Act (FCA) investigation, False Claims Act representation, FCA defense lawyer, board representation for pharmacists, board representation for pharmacies, board representation for physicians, Board of Pharmacy investigation representation, legal representation for board investigations, Drug Enforcement Administration (DEA) defense attorney, board of medicine attorney, board of pharmacy attorney, Department of Health investigations, pain clinics, over prescribing painkillers, Drug Enforcement Administration (DEA) investigation attorney, The Health Law Firm, administrative hearing defense attorney, DEA order to show cause (OSC) defense lawyer, legal representation for administrative hearings, administrative complaint representation, Board of Medicine representation, Board of Medicine attorney, Board of Medicine defense attorney, representation for Board of Medicine investigations, representation for Board of Medicine complaints, DEA hearing defense attorney, DEA investigation attorney, DEA hearing representation, DEA investigation representation, representation for DEA investigations against physicians, representation for pill mill allegations, representation for allegations of overprescribing, representation for overbilling, DOJ defense lawyer, representation for DOJ investigations, representation for health care professionals, reviews of The Health Law Firm, The Health Law Firm attorney reviews, DEA order to show cause (OSC) defense attorney

“The Health Law Firm” is a registered fictitious business name of and a registered service mark of The Health Law Firm, P.A., a Florida professional service corporation, since 1999.
Copyright © 2019 The Health Law Firm. All rights reserved.

By |2024-03-14T10:00:06-04:00December 26, 2019|Categories: Health Facilities Law Blog|Tags: , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |Comments Off on Physician Gets 40 Years For Illegally Prescribing More Than Half a Million Opioid Doses

Florida’s New E-Prescribing Law: How It May Affect You and Your Career

George Indest HeadshotBy George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law
In 2019, Florida’s Governor Ron DeSantis signed House Bill 831 (2019), Electronic Prescribing, into law. The new bill provides important requirements for prescribers to generate and transmit all prescriptions electronically upon their license renewal or by July 1, 2021, whichever is earlier. The bill will go into effect on January 1, 2020.

Summary of New Law, HB 831.

The new law applies to any health care practitioner who is licensed by law to prescribe a medicinal drug. The law, HB 831 sets forth the following general rule for prescribing:

If you are licensed to prescribe a medicinal drug, and you:

(1) Maintain a system of electronic health records; or

(2) Are an owner, employee or contractor of a licensed healthcare facility or practice that maintains a system of electronic health records and are prescribing in your capacity as an owner, employee or contractor of the licensed healthcare facility;
then you must electronically transmit your prescriptions unless an exception applies.

 

How the New Law May Affect You, a Licensed Health Professional.

The law requires prescribers to generate and transmit all prescription electronically, unless:

• The practitioner and the dispenser are the same entity;

• The prescription cannot be transmitted electronically under the most recently implemented version of the National Council for Prescription Drug Programs SCRIPT Standard;

• The practitioner has been issued a waiver by the Department of Health, not to exceed one year, due to demonstrated economic hardship, technology limitations that are not reasonably within the control of the practitioner, or another exceptional circumstance demonstrated by the practitioners;

• The practitioner reasonably determines that it would be impractical for the patient in question to obtain a medicinal drug prescribed by electronic prescription promptly and such delay would adversely impact the patient’s medical condition;

• The practitioner is prescribing a drug under a research protocol;

• The prescription is for a drug for which the U.S. Food and Drug Administration (FDA) requires the prescription to contain elements that may not be included in electronic prescribing;

• The prescription is issued to an individual receiving hospice care or who is a resident of a nursing home facility; or

• The practitioner determines that it is in the best interest of the patient, or the patient determines that it is in his or her own best interest to compare prescription drug prices among area pharmacies. The practitioner must document such determination in the patient’s medical record.

About half of Florida’s medical doctors must renew their licenses by January 31, 2020. Medical doctors that renew their licenses between January 1, 2020, and January 31, 2020, must comply with the new law by the date they renew their licenses.

View the full text of HB 831 – Electronic Prescribing here.

For more information, including a list of frequently asked questions, visit the Florida Board of Medicine’s website.

Contact Health Law Attorneys Experienced in the Representation of Health Professionals and Providers.

The attorneys of The Health Law Firm provide legal representation to physicians, nurses, nurse practitioners, CRNAs, pain management doctors, dentists, pharmacists, psychologists and other health providers in Department of Health (DOH) investigations, Drug Enforcement Administration (DEA) investigations, FBI investigations, Medicare investigations, Medicaid investigations and other types of investigations of health professionals and providers.

To contact The Health Law Firm, please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.

Sources:

“ALERT: Electronic Prescribing Requirements.” Florida Board of Medicine. (October 21, 2019). Web.

Scott, Jeff. “What Florida’s new e-prescribing law means for you.” Florida Medical Association (FMA). (June 18, 2019). Web.

About the Authors: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm.
Michael L. Smith, R.R.T., J.D., is Board Certified by The Florida Bar in Health Law
Its main office is in the Orlando, Florida area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620

KeyWords: Board of Medicine representation, Board of Medicine attorney, Board of Medicine defense attorney, representation for Board of Medicine investigations, representation for Board of Medicine complaints, DEA hearing defense attorney, DEA investigation attorney, DEA hearing representation, DEA investigation representation, Board of Pharmacy representation, Board of Pharmacy investigation representation, Board of Pharmacy attorney, Board of Nursing representation, Board of Nursing attorney, Board of Nursing investigation representation, nurse attorney, representation for nurses, nurse defense attorney, Board of Dentistry representation, Board of Dentistry attorney, representation for dentists, dentist defense lawyer, representation for e-prescribing, physician attorney, health care professional defense attorney, representation for health care professionals, professional licensure defense attorney, professional licensure representation, licensure defense attorney, representation for licensure issues, license renewal representation, license renewal defense lawyer, pharmacy defense lawyer, representation for pharmacists, representation for pharmacies, review of The Health Law Firm, The Health Law Firm attorney reviews

“The Health Law Firm” is a registered fictitious business name of and a registered service mark of The Health Law Firm, P.A., a Florida professional service corporation, since 1999.
Copyright © 2019 The Health Law Firm. All rights reserved.

Florida Compounding Pharmacy Reaches $21 Million Settlement to End FCA Kickback Suit

George IndestBy George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law
On September 19, 2019, a Florida compounding pharmacy reached a $21.4 million settlement with the U.S. Department of Justice (DOJ) in the Southern District of Florida to resolve claims they orchestrated a $70 million kickback scheme. Diabetic Care Rx LLC, which does business as Patient Care America, and private equity firm Riordan Lewis & Haden Inc. agreed to pay to bring the False Claims Act (FCA) lawsuit to a close.

According to the DOJ, the Florida pharmacy, two executives and the private equity firm schemed to recruit beneficiaries of Tricare for medically unnecessary prescriptions such as expensive pain creams.

Details of the Case.

The DOJ claimed PCA used marketers to help recruit beneficiaries of Tricare. They allegedly paid kickbacks to solicit medically unnecessary prescriptions for expensive compounded drugs that were filled by the pharmacy and then charged to Tricare.

As a result, the pharmacy allegedly billed Tricare about $68 million for compounded drugs over eight months in 2014 and 2015.
For more information, click here to read the press release issued by the DOJ.

The lawsuit resolved by the settlement was originally filed under the whistleblower (or “qui tam”) provisions of the False Claims Act by two former employees of PCA. To learn more about whistleblower or qui tam cases, click here to read one of my prior blogs.

Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.

The Health Law Firm represents pharmacists and pharmacies in DEA, DOH and FDA investigations, qui tam and whistleblower cases, regulatory matters, licensing issues, litigation, administrative hearings, inspections, and audits. The Firm also represents both plaintiffs (whistle blowers or relators) and defendants in False Claims Act (whistleblower or qui tam) cases. The firm’s attorneys include those who are board certified by The Florida Bar in Health Law as well as licensed health professionals who are also attorneys.

To contact The Health Law Firm please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.

Sources:

Stawiki, Steve. “Pharmacy, PE Fund Ink $21M Deal To End FCA Kickback Suit.” Law360. (September 20, 2019). Web.

Bolado, Carolina. “Pharmacy, PE Fund Near Deal To End Feds’ FCA Kickback Suit.” Law360. (July 1, 2019). Web.

“Compounding Pharmacy, Two of Its Executives, and Private Equity Firm Agree to Pay $21.36 Million to Resolve False Claims Act Allegations.” Florida Record. (September 24, 2019). Web.

About the Author: George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law is an attorney with The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Avenue, Altamonte Springs, Florida 32714, Phone: (407) 331-6620.

KeyWords: legal representation for pharmacists, legal representation for pharmacies, pharmacy defense attorney, pharmacist defense lawyer, representation for False Claims Act investigation, False Claims Act representation, FCA defense lawyer, board representation for pharmacists, board representation for pharmacies, board representation for physicians, Board of Pharmacy investigation representation, legal representation for board investigations, administrative hearing defense attorney, representation for administrative hearings, administrative complaint representation, Board of Medicine representation, Board of Medicine attorney, Board of Medicine defense attorney, representation for Board of Medicine investigations, representation for Board of Medicine complaints, DEA hearing defense attorney, DEA investigation attorney, DEA hearing representation, DEA investigation representation, representation for DEA investigations against physicians, representation for pill mill allegations, representation for allegations of overprescribing, representation for overbilling, DOJ defense lawyer, representation for DOJ investigations, representation for health care professionals, reviews of The Health Law Firm, The Health Law Firm attorney reviews

“The Health Law Firm” is a registered fictitious business name of and a registered service mark of The Health Law Firm, P.A., a Florida professional service corporation, since 1999.
Copyright © 2019 The Health Law Firm. All rights reserved.

Physician Sentenced to 40 Years in Prison For Illegally Prescribing Opioid Pills

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

On October 2, 2019, a Virginia doctor received a 40-year prison sentence for illegally prescribing more than half a million opioid pills over 19 months. The U.S. District Court for the Western District of Virginia handed down the sentence to Joel Smithers, who was reported to have operated a “pill mill” out of Virginia, according to authorities. In addition to prison time, he was given an $86,000 fine and will serve three years of supervised release upon the completion of his prison time, according to court documents.

The sentence is lighter than it could have been. He was facing up to life in prison and a fine of more than $200 million, according to officials at the U.S. Justice Department. Click here to view the court’s sentencing document in full.

Alleged Interstate Pill Mill.

In May 2019, Smithers was convicted by a jury on more than 859 federal drug charges, including one count of possessing with the intent to distribute controlled substances and one count of maintaining a place for the purpose of unlawfully distributing controlled substances. Additionally, he was also convicted on hundreds of counts of unlawfully distributing a controlled substance without a legitimate medical purpose or beyond the bounds of medical practice.

When he opened his Virginia practice in 2015, Justice Department officials said he prescribed controlled substances to “every patient in his practice, resulting in over 500,000 Schedule II controlled substances being distributed.” Authorities say that he allegedly ran an operation that was less a medical practice and more an interstate drug distribution network.

Smithers was able to rake in over $700,000 in cash and credit card payments before the search warrant was executed at his office on March 7, 2017. Click here to read the press release issued by the U.S. Attorney’s Office in the Western District of Virginia.

To learn about a similar case involving two Florida doctors, click here.

The Problems I See.

I tell you that I take issue with many of the cases of this sort. I do not know enough about the actual facts of this physician’s case, but I can comment generally based on other similar cases I have had in the past. The government, both state and federal, has come down like a hammer on individual physicians and pharmacists in its over-zealous campaign to crack down on opioids. Many physicians and pharmacists, just trying to do a good job and legitimately treat their patients, are being caught up and persecuted. Chronic pain patients, many of whom are disabled veterans or people injured on the job, are unable to find physicians to treat them anymore or, if they can, any pharmacists willing to fill their prescriptions.

All sorts of under-handed techniques are used to try to make a case against conscientious health professionals who are merely trying to do their jobs. These do include the tactic seen in the case we are reporting on, which I call “bean counting.” The government comes in and, instead of proving how many allegedly illegal prescriptions were written or how many patients the physician gave the prescriptions to, breaks these out into the number of pills. This greatly exaggerates the case and these large numbers alone make it look like the doctor (or pharmacist) is doing something wrong or extremely way out of the norm.

For example, if a patient was receiving a low dose of a pain killer, say 10 mg Oxycodone every 4 to 6 hours, prescribed for four times a day, the ordinary monthly prescription for this medication alone (and such patients rarely receive one type of medication alone) this equates to 120 pills per month. If 10 mg pills are not available and/or the prescription is filled with 5 mg pills, instead, this is 240 pills a month. A years’ worth is 1,440 pills or 2,880 pills for just one patient. If the physician has 50 similar patients, this is 72,000 pills or 144,000 pills a year that the physician is writing and a pharmacy or pharmacies are filling.

This does not seem extreme or unusual to me, at all, and these amounts are on the low side. Yet just as government agencies love to inflate the “street value” or contraband drugs they seize, they love to break down the number of opioids a physician writes so it seems to a layperson to be extraordinarily large. Furthermore, a pain management physician or any other kind of physician cannot survive with just 50 patients a month. It is far more likely for a physician to have a thousand (1,000) or more patients a month. I call this type of numerical exaggeration “bean counting.” But it has put a number of physicians and pharmacists in jail.

Judges should not allow such exaggerated numbers to be introduced into evidence in the absence of further information that places them in context. It is unfairly prejudicial to the defendant to do so.

Contact Health Law Attorneys Experienced with DEA Cases.

The attorneys of The Health Law Firm are experienced in handling Drug Enforcement Administration (DEA) cases, board of medicine cases and board of pharmacy cases regarding allegations of over-prescribing and illegal prescribing. If you are currently being investigated or facing other adverse actions by the DEA contact one of our attorneys by calling (407) 331-6620 or (850) 439-1001. You can also visit our website for more information at www.TheHealthLawFirm.com.

Sources:

Booker, Brakkton. “Doctor Gets 40 Years For Illegally Prescribing More Than Half A Million Opioid Doses.” NPR. (October 2, 2019). Web.

“Virginia doctor could get life in prison today for prescribing 500,000 opioid pills.” RTV6. (October 2, 2019). Web.

Almasy, Steve. “Virginia doctor who illegally prescribed 500,000 opioid pills sentenced to 40 years in prison.” CNN. (October 2, 2019). Web.

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

KeyWords: legal representation for pain management physicians and pharmacists, legal representation for pharmacies, pharmacy defense attorney, pain management physician defense attorney, pharmacist defense lawyer, pain management physician defense lawyer, representation for False Claims Act (FCA) investigation, False Claims Act representation, FCA defense lawyer, board representation for pharmacists, board representation for pharmacies, board representation for physicians, Board of Pharmacy investigation representation, legal representation for board investigations, Drug Enforcement Administration (DEA) defense attorney, board of medicine attorney, board of pharmacy attorney, Department of Health investigations, pain clinics, over prescribing painkillers, Drug Enforcement Administration (DEA) investigation attorney, The Health Law Firm, administrative hearing defense attorney, DEA order to show cause (OSC) defense lawyer, legal representation for administrative hearings, administrative complaint representation, Board of Medicine representation, Board of Medicine attorney, Board of Medicine defense attorney, representation for Board of Medicine investigations, representation for Board of Medicine complaints, DEA hearing defense attorney, DEA investigation attorney, DEA hearing representation, DEA investigation representation, representation for DEA investigations against physicians, representation for pill mill allegations, representation for allegations of overprescribing, representation for overbilling, DOJ defense lawyer, representation for DOJ investigations, representation for health care professionals, reviews of The Health Law Firm, The Health Law Firm attorney reviews, DEA order to show cause (OSC) defense attorney

“The Health Law Firm” is a registered fictitious business name of and a registered service mark of The Health Law Firm, P.A., a Florida professional service corporation, since 1999.
Copyright © 2019 The Health Law Firm. All rights reserved.

By |2024-03-14T10:00:09-04:00November 6, 2019|Categories: Pharmacy Law Blog|Tags: , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |1 Comment

Compounding Pharmacy Agrees to Pay $21 Million to End FCA Kickback Suit

Headshot of attorney George IndestBy George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

On September 19, 2019, a Florida compounding pharmacy reached a $21.4 million settlement with the U.S. Department of Justice (DOJ) in the Southern District of Florida to resolve claims they orchestrated a $70 million kickback scheme. Diabetic Care Rx LLC, which does business as Patient Care America, and private equity firm Riordan Lewis & Haden Inc. agreed to pay to bring the False Claims Act (FCA) lawsuit to a close.

According to the DOJ, the Florida pharmacy, two executives and the private equity firm schemed to recruit beneficiaries of Tricare for medically unnecessary prescriptions such as expensive pain creams.

Details of the Case.

The DOJ claimed PCA used marketers to help recruit beneficiaries of Tricare. They allegedly paid kickbacks to solicit medically unnecessary prescriptions for expensive compounded drugs that were filled by the pharmacy and then charged to Tricare.

As a result, the pharmacy allegedly billed Tricare about $68 million for compounded drugs over eight months in 2014 and 2015.
For more information, click here to read the press release issued by the DOJ.

The lawsuit resolved by the settlement was originally filed under the whistleblower (or “qui tam”) provisions of the False Claims Act by two former employees of PCA. To learn more about whistleblower or qui tam cases, click here to read one of my prior blogs.

Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.

The Health Law Firm represents pharmacists and pharmacies in DEA, DOH and FDA investigations, qui tam and whistleblower cases, regulatory matters, licensing issues, litigation, administrative hearings, inspections, and audits. The Firm also represents both plaintiffs (whistle blowers or relators) and defendants in False Claims Act (whistleblower or qui tam) cases. The firm’s attorneys include those who are board certified by The Florida Bar in Health Law as well as licensed health professionals who are also attorneys.

To contact The Health Law Firm please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.

Sources:

Stawiki, Steve. “Pharmacy, PE Fund Ink $21M Deal To End FCA Kickback Suit.” Law360. (September 20, 2019). Web.

Bolado, Carolina. “Pharmacy, PE Fund Near Deal To End Feds’ FCA Kickback Suit.” Law360. (July 1, 2019). Web.

“Compounding Pharmacy, Two of Its Executives, and Private Equity Firm Agree to Pay $21.36 Million to Resolve False Claims Act Allegations.” Florida Record. (September 24, 2019). Web.

About the Author: George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law is an attorney with The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Avenue, Altamonte Springs, Florida 32714, Phone: (407) 331-6620.

KeyWords: legal representation for pharmacists, legal representation for pharmacies, pharmacy defense attorney, pharmacist defense lawyer, representation for False Claims Act investigation, False Claims Act representation, FCA defense lawyer, board representation for pharmacists, board representation for pharmacies, board representation for physicians, Board of Pharmacy investigation representation, legal representation for board investigations, administrative hearing defense attorney, representation for administrative hearings, administrative complaint representation, Board of Medicine representation, Board of Medicine attorney, Board of Medicine defense attorney, representation for Board of Medicine investigations, representation for Board of Medicine complaints, DEA hearing defense attorney, DEA investigation attorney, DEA hearing representation, DEA investigation representation, representation for DEA investigations against physicians, representation for pill mill allegations, representation for allegations of overprescribing, representation for overbilling, DOJ defense lawyer, representation for DOJ investigations, representation for health care professionals, reviews of The Health Law Firm, The Health Law Firm attorney reviews

“The Health Law Firm” is a registered fictitious business name of and a registered service mark of The Health Law Firm, P.A., a Florida professional service corporation, since 1999.
Copyright © 2019 The Health Law Firm. All rights reserved.

Alaska Board Sends Contradictory Letter to Pharmacists Over Filling Opioid Prescriptions (Part 1)

Headshot of attorney George IndestBy George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

The “Opioid Crisis” in the U.S.

We all know that there is an “opioid crisis” in the U.S. It is probably prevalent in every state. In Florida we have been suffering under it for the past ten to fifteen years. So it is nothing new to Florida. Government regulators including, but not limited to the Florida Department of Health (DOH), Florida Attorney General (AG), different State’s Attorneys’ (prosecutors) offices, multi-jurisdictional task forces, local law enforcement agencies, the U.S. Drug Enforcement Administration (DEA) and the Department of Justice (DOJ), along with federal prosecutors, have been involved in ongoing efforts in Florida for the past fifteen years or so, to shut down “pill mills” and attempt to eliminate the “opioid crisis.” Florida was, unfortunately, leading this trend.

The “Opioid Crisis;” Nothing New in Florida.

During this same period of time, my firm and I have been involved in defending physicians and pharmacists in criminal, civil, and administrative actions seeking to prosecute them, revoke their licenses, revoke their DEA registrations, terminate them from Medicaid participation, levy fines on them and other punitive actions. Florida was also, unfortunately, leading this trend.

So our opinions and comments in this blog, Part 1, and its Part 2, Part 3, Part 4 and Part 5 are informed by long years of experience with something that is old news in Florida, but may be new news in other states.

Alaska Sends out its Warning to Pharmacists to Keep Filling Prescriptions for Opioids.

On January 23, 2019, the Chairman of the Alaska Board of Pharmacy sent out an open letter to Alaska pharmacists, discussing the negative effect on patient health that has arisen in response to the fact that many pharmacists have stopped filling prescriptions for opioids. From its tone, it warns pharmacists to keep filling such prescriptions under threat of possible disciplinary action against their licenses, at least that is my interpretation of it. Here is a copy you can read for yourself, click here.

The two-page letter begins by stating:
The [Alaska] Board of Pharmacy has had an influx of communication concerning patients not able to get controlled substance prescriptions filled for various reasons, even when signs of forgery or fraudulence were not presented.

The letter continues stating:
As a professional reminder, failing to practice pharmacy using reasonable knowledge, skill, competence, and safety for the public may result in disciplinary actions under Alaska statute and regulation. These laws are: AS [Alaska Statutes] 08.80.261 DISCIPLINARY ACTIONS.

It then continues, quoting and citing other statutes and administrative codes under which a pharmacist could be charged for refusing to fill an opioid prescription for a patient.

Chilling? Mixed Signals? You be the Judge!

The problem I have is where is the state board of pharmacy (in any state, not just Alaska), when the DEA comes in to the pharmacy with its search warrants and arrest warrants? Where is the state board of pharmacy when the raid by local police/sheriff/multi-jurisdictional task force comes into the pharmacy? Where is the state board of pharmacy when the U.S. Attorney’s Office indicts and prosecutes the pharmacist? Where is the state board of pharmacy when the DEA issues its Order to Show Cause (OTSC) why the pharmacy’s or pharmacist’s DEA registration should not be revoked.

The state board of pharmacy is usually the one providing the expert witnesses to testify against the pharmacist or pharmacy, that’s where. The state board of pharmacy is standing by ready to take disciplinary action against the pharmacist or pharmacy, after the other government agencies get finished.

If pharmacists and pharmacies are refusing to fill prescriptions for opioids, which is something that I advise my clients to do, if they can afford to do so, then that is a smart move, until state agencies, including the state boards of pharmacy, take action to help them out of this predicament. The pharmacists are caught on the horns of a dilemma: face federal and state criminal prosecutions and actions by the DEA for filling opioid prescriptions; or face possible administrative actions by the state board of pharmacy for not filling opioid prescriptions. My advice is to choose the latter as it is much easier to defend a state administrative action, especially if you are not trying to do so from a federal prison somewhere.

The cost of defending a DEA action to revoke a DEA registration is prohibitive if done correctly, even if the pharmacist is completely innocent of any wrongdoing. The goal of these proceedings, despite the innocence of the pharmacist or pharmacy, is to put them out of business, and it almost always succeeds! Click here to read one of my prior blogs about DEA investigations of health care professionals.

To read my additional opinions on the types of actions that can be taken by states and state agencies to address the issues which the Alaska Board letter attempts to address, please see Part 2 of this blog. Click here to read Part 3 of this blog series and stay tuned for Parts 4 and 5!

To learn more on administrative and informal hearings before the Florida Board of Pharmacy, click here to read one of my prior blogs.

Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.

The Health Law Firm represents pharmacists and pharmacies in DEA, DOH and FDA investigations, qui tam and whistleblower cases, regulatory matters, licensing issues, litigation, administrative hearings, inspections and audits. The Firm also represents both plaintiffs (whistle blowers or relators) and defendants in False Claims Act (whistle blower or qui tam) cases. The firm’s attorneys include those who are board certified by The Florida Bar in Health Law as well as licensed health professionals who are also attorneys.

To contact The Health Law Firm please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.

About the Author: George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law is an attorney with The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Avenue, Altamonte Springs, Florida 32714, Phone: (407) 331-6620.

KeyWords: legal representation for pharmacists, legal representation for pharmacies, pharmacy defense attorney, pharmacist defense lawyer, board representation for pharmacists, board representation for pharmacies, board representation for physicians, Board of Pharmacy investigation representation, legal representation for board investigations, administrative hearing defense attorney, representation for administrative hearings, administrative complaint representation, Board of Medicine representation, Board of Medicine attorney, Board of Medicine defense attorney, representation for Board of Medicine investigations, representation for Board of Medicine complaints, DEA hearing defense attorney, DEA investigation attorney, DEA hearing representation, DEA investigation representation, representation for DEA investigations against physicians, representation for pill mill allegations, representation for allegations of over prescribing, representation for health care professionals, reviews of The Health Law Firm, The Health Law Firm attorney reviews

“The Health Law Firm” is a registered fictitious business name of and a registered service mark of The Health Law Firm, P.A., a Florida professional service corporation, since 1999.
Copyright © 2019 The Health Law Firm. All rights reserved.

Alaska Board of Pharmacy Sends Letter to its Pharmacists Sending Mixed Signals Over Filling Opioid Prescriptions (Part 1 of a 2 part series)

George IndestBy George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

The “Opioid Crisis” in the U.S.

We all know that there is an “opioid crisis” in the U.S. It is probably prevalent in every state. In Florida we have been suffering under it for the past ten to fifteen years. So it is nothing new to Florida. Government regulators including, but not limited to the Florida Department of Health (DOH), Florida Attorney General (AG), different State’s Attorneys’ (prosecutors) offices, multi-jurisdictional task forces, local law enforcement agencies, the U.S. Drug Enforcement Administration (DEA) and the Department of Justice (DOJ), along with federal prosecutors, have been involved in ongoing efforts in Florida for the past fifteen years or so, to shut down “pill mills” and attempt to eliminate the “opioid crisis.” Florida was, unfortunately, leading this trend.

The “Opioid Crisis;” Nothing New in Florida.

During this same period of time, my firm and I have been involved in defending physicians and pharmacists in criminal, civil, and administrative actions seeking to prosecute them, revoke their licenses, revoke their DEA registrations, terminate them from Medicaid participation, levy fines on them and other punitive actions. Florida was also, unfortunately, leading this trend.

So our opinions and comments in this blog, Part 1, and its Part 2, are informed by long years of experience with something that is old news in Florida, but may be new news in other states.

Alaska Sends out its Warning to Pharmacists to Keep Filling Prescriptions for Opioids.

On January 23, 2019, the Chairman of the Alaska Board of Pharmacy sent out an open letter to Alaska pharmacists, discussing the negative effect on patient health that has arisen in response to the fact that many pharmacists have stopped filling prescriptions for opioids. From its tone, it warns pharmacists to keep filling such prescriptions under threat of possible disciplinary action against their licenses, at least that is my interpretation of it. Here is a copy you can read for yourself, click here.

The two-page letter begins by stating:

The [Alaska] Board of Pharmacy has had an influx of communication concerning patients not able to get controlled substance prescriptions filled for various reasons, even when signs of forgery or fraudulence were not presented.

The letter continues stating:

As a professional reminder, failing to practice pharmacy using reasonable knowledge, skill, competence, and safety for the public may result in disciplinary actions under Alaska statute and regulation. These laws are: AS [Alaska Statutes] 08.80.261 DISCIPLINARY ACTIONS.

It then continues, quoting and citing other statutes and administrative codes under which a pharmacist could be charged for refusing to fill an opioid prescription for a patient.

Chilling? Mixed Signals? You be the Judge!

The problem I have is where is the state board of pharmacy (in any state, not just Alaska), when the DEA comes in to the pharmacy with its search warrants and arrest warrants? Where is the state board of pharmacy when the raid by local police/sheriff/multi-jurisdictional task force comes into the pharmacy? Where is the state board of pharmacy when the U.S. Attorney’s Office indicts and prosecutes the pharmacist? Where is the state board of pharmacy when the DEA issues its Order to Show Cause (OTSC) why the pharmacy’s or pharmacist’s DEA registration should not be revoked.

The state board of pharmacy is usually the one providing the expert witnesses to testify against the pharmacist or pharmacy, that’s where. The state board of pharmacy is standing by ready to take disciplinary action against the pharmacist or pharmacy, after the other government agencies get finished.

If pharmacists and pharmacies are refusing to fill prescriptions for opioids, which is something that I advise my clients to do, if they can afford to do so, then that is a smart move, until state agencies, including the state boards of pharmacy, take action to help them out of this predicament. The pharmacists are caught on the horns of a dilemma: face federal and state criminal prosecutions and actions by the DEA for filling opioid prescriptions; or face possible administrative actions by the state board of pharmacy for not filling opioid prescriptions. My advice is to choose the latter as it is much easier to defend a state administrative action, especially if you are not trying to do so from a federal prison somewhere.

The cost of defending a DEA action to revoke a DEA registration is prohibitive if done correctly, even if the pharmacist is completely innocent of any wrongdoing. The goal of these proceedings, despite the innocence of the pharmacist or pharmacy, is to put them out of business, and it almost always succeeds! Click here to read one of my prior blogs about DEA investigations of health care professionals.

To read my additional opinions on the types of actions that can be taken by states and state agencies to address the issues which the Alaska Board letter attempts to address, please see Part 2 of this blog. To read more on pill mill cases in the state of Florida, click here.

To learn more on administrative and informal hearings before the Florida Board of Pharmacy, click here to read one of my prior blogs.

Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.

The Health Law Firm represents pharmacists and pharmacies in DEA, DOH and FDA investigations, qui tam and whistleblower cases, regulatory matters, licensing issues, litigation, administrative hearings, inspections and audits. The Firm also represents both plaintiffs (whistle blowers or relators) and defendants in False Claims Act (whistle blower or qui tam) cases. The firm’s attorneys include those who are board certified by The Florida Bar in Health Law as well as licensed health professionals who are also attorneys.

To contact The Health Law Firm please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.

About the Author: George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law is an attorney with The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Avenue, Altamonte Springs, Florida 32714, Phone: (407) 331-6620.

KeyWords: legal representation for pharmacists, legal representation for pharmacies, pharmacy defense attorney, pharmacist defense lawyer, board representation for pharmacists, board representation for pharmacies, board representation for physicians, Board of Pharmacy investigation representation, legal representation for board investigations, administrative hearing defense attorney, representation for administrative hearings, administrative complaint representation, Board of Medicine representation, Board of Medicine attorney, Board of Medicine defense attorney, representation for Board of Medicine investigations, representation for Board of Medicine complaints, Drug Enforcement Administration (DEA) hearing defense attorney, DEA investigation attorney, Drug Enforcement Administration (DEA) hearing legal representation, Drug Enforcement Administration (DEA) investigation legal defense attorney representation, representation for DEA investigations against pharmacists and physicians, legal representation for pill mill allegations, legal representation for allegations of over prescribing, lawyer providing representation for health care professionals, reviews of The Health Law Firm, The Health Law Firm attorney reviews, defense for Drug Enforcement Administration (DEA) Order to Show Cause (OTSC), responding to Drug Enforcement Administration (DEA) Order to Show Cause (OTSC), Drug Enforcement Administration (DEA) Order to Show Cause (OTSC) attorney and legal defense

“The Health Law Firm” is a registered fictitious business name of and a registered service mark of The Health Law Firm, P.A., a Florida professional service corporation, since 1999.
Copyright © 2019 The Health Law Firm. All rights reserved.

By |2024-03-14T10:00:17-04:00February 6, 2019|Categories: Uncategorized|Tags: , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |Comments Off on Alaska Board of Pharmacy Sends Letter to its Pharmacists Sending Mixed Signals Over Filling Opioid Prescriptions (Part 1 of a 2 part series)

Virginia Doc Lands 40 Years in Prison For Running Multi-state Pill Mill

George Indest HeadshotBy George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law
On October 2, 2019, a Virginia doctor received a 40-year prison sentence for illegally prescribing more than half a million opioid pills over 19 months. The U.S. District Court for the Western District of Virginia handed down the sentence to Joel Smithers, who was reported to have operated a “pill mill” out of Virginia, according to authorities. In addition to prison time, he was given an $86,000 fine and will serve three years of supervised release upon the completion of his prison time, according to court documents.

The sentence is lighter than it could have been. He was facing up to life in prison and a fine of more than $200 million, according to officials at the U.S. Justice Department. Click here to view the court’s sentencing document in full.

Alleged Interstate Drug Distribution Network.

In May 2019, Smithers was convicted by a jury on more than 859 federal drug charges, including one count of possessing with the intent to distribute controlled substances and one count of maintaining a place for the purpose of unlawfully distributing controlled substances. Additionally, he was also convicted on hundreds of counts of unlawfully distributing a controlled substance without a legitimate medical purpose or beyond the bounds of medical practice.

When he opened his Virginia practice in 2015, Justice Department officials said he prescribed controlled substances to “every patient in his practice, resulting in over 500,000 Schedule II controlled substances being distributed.” Authorities say that he allegedly ran an operation that was less a medical practice and more an interstate drug distribution network.

Smithers was able to rake in over $700,000 in cash and credit card payments before the search warrant was executed at his office on March 7, 2017. Click here to read the press release issued by the U.S. Attorney’s Office in the Western District of Virginia.

To learn about a similar case involving two Florida doctors, click here.

The Problems I See.

I tell you that I take issue with many of the cases of this sort. I do not know enough about the actual facts of this physician’s case, but I can comment generally based on other similar cases I have had in the past. The government, both state and federal, has come down like a hammer on individual physicians and pharmacists in its over-zealous campaign to crack down on opioids. Many physicians and pharmacists, just trying to do a good job and legitimately treat their patients, are being caught up and persecuted. Chronic pain patients, many of whom are disabled veterans or people injured on the job, are unable to find physicians to treat them anymore or, if they can, any pharmacists willing to fill their prescriptions.

All sorts of under-handed techniques are used to try to make a case against conscientious health professionals who are merely trying to do their jobs. These do include the tactic seen in the case we are reporting on, which I call “bean counting.” The government comes in and, instead of proving how many allegedly illegal prescriptions were written or how many patients the physician gave the prescriptions to, breaks these out into the number of pills. This greatly exaggerates the case and these large numbers alone make it look like the doctor (or pharmacist) is doing something wrong or extremely way out of the norm.

For example, if a patient was receiving a low dose of a pain killer, say 10 mg Oxycodone every 4 to 6 hours, prescribed for four times a day, the ordinary monthly prescription for this medication alone (and such patients rarely receive one type of medication alone) this equates to 120 pills per month. If 10 mg pills are not available and/or the prescription is filled with 5 mg pills, instead, this is 240 pills a month. A years’ worth is 1,440 pills or 2,880 pills for just one patient. If the physician has 50 similar patients, this is 72,000 pills or 144,000 pills a year that the physician is writing and a pharmacy or pharmacies are filling.

This does not seem extreme or unusual to me, at all, and these amounts are on the low side. Yet just as government agencies love to inflate the “street value” or contraband drugs they seize, they love to break down the number of opioids a physician writes so it seems to a layperson to be extraordinarily large. Furthermore, a pain management physician or any other kind of physician cannot survive with just 50 patients a month. It is far more likely for a physician to have a thousand (1,000) or more patients a month. I call this type of numerical exaggeration “bean counting.” But it has put a number of physicians and pharmacists in jail.

Judges should not allow such exaggerated numbers to be introduced into evidence in the absence of further information that places them in context. It is unfairly prejudicial to the defendant to do so.

Contact Health Law Attorneys Experienced with DEA Cases.

The attorneys of The Health Law Firm are experienced in handling Drug Enforcement Administration (DEA) cases, board of medicine cases and board of pharmacy cases regarding allegations of over-prescribing and illegal prescribing. If you are currently being investigated or facing other adverse actions by the DEA contact one of our attorneys by calling (407) 331-6620 or (850) 439-1001. You can also visit our website for more information at www.TheHealthLawFirm.com.

Sources:

Booker, Brakkton. “Doctor Gets 40 Years For Illegally Prescribing More Than Half A Million Opioid Doses.” NPR. (October 2, 2019). Web.

“Virginia doctor could get life in prison today for prescribing 500,000 opioid pills.” RTV6. (October 2, 2019). Web.

Almasy, Steve. “Virginia doctor who illegally prescribed 500,000 opioid pills sentenced to 40 years in prison.” CNN. (October 2, 2019). Web.

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

KeyWords: legal representation for pain management physicians and pharmacists, legal representation for pharmacies, pharmacy defense attorney, pain management physician defense attorney, pharmacist defense lawyer, pain management physician defense lawyer, representation for False Claims Act (FCA) investigation, False Claims Act representation, FCA defense lawyer, board representation for pharmacists, board representation for pharmacies, board representation for physicians, Board of Pharmacy investigation representation, legal representation for board investigations, Drug Enforcement Administration (DEA) defense attorney, board of medicine attorney, board of pharmacy attorney, Department of Health investigations, pain clinics, over prescribing painkillers, Drug Enforcement Administration (DEA) investigation attorney, The Health Law Firm, administrative hearing defense attorney, DEA order to show cause (OSC) defense lawyer, legal representation for administrative hearings, administrative complaint representation, Board of Medicine representation, Board of Medicine attorney, Board of Medicine defense attorney, representation for Board of Medicine investigations, representation for Board of Medicine complaints, DEA hearing defense attorney, DEA investigation attorney, DEA hearing representation, DEA investigation representation, representation for DEA investigations against physicians, representation for pill mill allegations, representation for allegations of overprescribing, representation for overbilling, DOJ defense lawyer, representation for DOJ investigations, representation for health care professionals, reviews of The Health Law Firm, The Health Law Firm attorney reviews, DEA order to show cause (OSC) defense attorney

“The Health Law Firm” is a registered fictitious business name of and a registered service mark of The Health Law Firm, P.A., a Florida professional service corporation, since 1999.
Copyright © 2019 The Health Law Firm. All rights reserved.

By |2024-03-14T10:00:19-04:00January 16, 2019|Categories: Mental Health Law Blog|Tags: , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |2 Comments
Go to Top