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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.

Doctor Sentenced to 40 Years For Alleged Interstate Pill Mill

By Carole C. Schriefer, R.N., J.D.

On October 2, 2019, a physician in Virginia 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 reportedly 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 (DOJ). Click here to view the court’s sentencing document in full.

The Alleged Interstate Pill Mill Operation.

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 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, 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 in This Case.

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: Carole C. Schriefer is an attorney and registered nurse. She practices with The Health Law Firm, which has a national practice. Its regional office is in the Northern Colorado, area. www.TheHealthLawFirm.com The Health Law Firm, 155 East Boardwalk Drive, Fort Collins, Colorado 80525. Phone: (970) 416-7456. Its main office is in the Orlando, Florida area.

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 |2019-11-06T20:48:18+00:00November 6th, 2019|Categories: Colorado Health Law Blog|Tags: , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |0 Comments

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 |2019-11-06T20:33:34+00:00November 6th, 2019|Categories: Pharmacy Law Blog|Tags: , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |0 Comments

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.

So, the ZPIC Medicare Auditor Wants to Talk to You? What You Should Expect

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

You are a physician, nurse or other health care provider who bills Medicare. You have received that dreaded letter from the Zone Program Integrity Contractor (ZPIC) for Medicare advising you that it is auditing you for the Centers for Medicare and Medicaid Services (CMS). You know that the words “Program Integrity” by themselves mean that possible fraud is being investigated, at least that is the suspicion giving rise to this particular audit.

To read an earlier blog which I wrote on tips for responding to ZPIC audits, click here.

You have dutifully contacted an experienced health law attorney to aid you in responding to the ZPIC’ s request for records and information. You have obtained all of the requested medical records documentation, authoritative medical journal articles and other information that may be useful in supporting the care you delivered and for which you billed, added explanatory notes (clearly and contemporaneously dated, of course) where necessary or where records were missing, and done all you can to fully and completely respond to the audit.

After the Initial Audit Response and Site Visit.

Now, several weeks later, the ZPIC auditor/investigator contacts you and advises you that he would like you to come to his office to answer a few questions. The ZPIC auditor/investigator states that this is “just routine” and should only take approximately 20 minutes.

After discussing this with your attorney, knowing that you have committed no fraud and that your medical records are in pretty good shape to support your billing, you decide to go to the ZPIC office for the interview. (Note: I know that many attorneys would recommend against this action, but often we advise a client, with the right set of facts, of course, to do this.) What should you expect?

What to Expect When You Show up to Be Interviewed by the ZPIC Auditor.

Although we cannot guarantee you that you will experience the same as we have in the past, this is what happened often enough with us where it seems to be somewhat common practice in such audits.

1. Expect the ZPIC office to be in a building with good security, including magnetic/electronic scanning for guns and weapons, like at the airport or court house. Do not attempt to take any type of weapon inside the building, including pen knives on key chains and tear gas or pepper spray canisters.

2. Bring a valid government identification card with your photograph. If you are with an attorney or a consultant, that person will also need one. One of the first things that will happen is that you will be asked to show your identification cards to prove you are who you say you are.

3. Be sure you have your correct office address on file with Medicare. If the auditors show up at an address you have listed and your practice is not there, you will either get a letter automatically terminating your Medicare billing privileges or you will be called down for this interrogation by the ZPIC. This is a primary reason for such ZPIC interrogations. Be sure your physical office address, including suite number, apartment number, office number, etc., are correctly reflected in the Provider Enrollment and Chain/Ownership System (PECOS), the electronic portal through which Medicare providers enroll in Medicare.

4. You aren’t going to be interviewed by just one person and it isn’t going to be just “20 minutes.”

5. In most cases, there will be three or more auditors/investigators involved in the interview with you. This is why it is a good idea to bring your attorney and her paralegal so that you also have some support, as well. The least number of auditor/investigators that we have ever seen involved in such interviews is two. Don’t be surprised if there are three or four.

6. The questioning and interviewing will take much longer than you expected. Plan on taking the rest of the day off so that you are not rushed and do not feel pressured to get it over with fast. It is not going to be over with fast.

7. Don’t joke around with the ZPIC auditors. This is a very serious matter. Many talented government investigators will attempt to joke and make light of things in order to get you to let your guard down. Do not play into this. Be serious and act seriously at all times.

8. You are not in an endurance contest. Ask for bathroom breaks, water breaks or just a break to talk with your attorney, as many times as you desire. Do this at least once each hour. This will help to keep your blood circulating and keep you alert.

9. You will be confronted with what the ZPIC auditors believe they have found that violates Medicare regulations. This may include, for example, billing services for patients who were dead at the time, billing for services on dates after the patient was no longer qualified to receive them, billing for services that were billed by another provider, etc. Do not guess at why this happened if you did not know for a fact. You can advise the investigator that you will take down the investigation, look into it and provide the information to him or her at a later date.

10. Don’t be surprised if the ZPIC auditor has incorrect information. Often the ZPIC will have confused information on two different Medicare beneficiaries with the same names or whose Medicare numbers were incorrectly recorded. For example, in one recent ZPIC investigator interview with my client, the investigator accused the physician of billing for services provided to a patient who had been deceased for two years. The physician had just seen the patient on a follow-up visit a month prior to the interview. The ZPIC had confused a dead patient who had the same name with the live patient. This is not uncommon.

11. Don’t be surprised if the ZPIC auditor asks you about other Medicare provider’s billings for the same patient. This also happened to a client of mine in a recent case. The ZPIC investigator questioned why the XYZ company would have billed for the same services as those provided by my client, a solo practitioner. My client did not know. He correctly told the auditor that he did not know why the other party had billed Medicare for the same services, but he had provided the services to his patient and he had billed for the services. He could not know whey someone else did something.

12. If there have been intervening factors affecting your billing practices, disclose these to the investigator. In one case, my client had changed software for her electronic health records and billing. One of the reasons this was necessary was because of bugs that made the billings sometimes unreliable. Records more than four (4) years old were no longer available. The client disclosed this.

13. Be sure you are able to reconcile the number of patients seen per day, the number of hours the CPT codes billed to Medicare are supposed to reflect, and that these seem reasonable. If you are billing time-based CPT codes for patients that it would take you 27 hours to see in a day, you are in trouble. You must know this ahead of time and either have a reasonable answer to address the problem (e.g., an incorrect date entry in the billing software caused two days worth of services to accidentally be billed for the same date of service) or correct the over-billing error.

14. Know what rules, regulations and guidelines apply to the billings for the CPT codes you are billing. Check to see if there are local coverage decisions (LCDs) from your area Medicare Administrative Carrier (MAC) or National Coverage Decisions (NCDs) from CMS and know them. Be sure you have followed them and are following them.

15. Know the licensure rules and regulations for your profession, as well as the Medicare guidelines for billing for your profession. Sometimes billing for what an assistant, trainee, or ancillary provider does is allowed, and sometimes it isn’t. If you bill for what an assistant does, be sure you know the rules and are properly billing. The ZPIC investigator certainly will ask questions about this.

16. Your health record entries, assessments, evaluations, progress notes, etc., are required to be made contemporaneously with your delivery of the services. This generally means within 24 hours, as a rule of thumb. Records made a week or a month later are not considered to be reliable or accurate. So be sure you have made and are making your records contemporaneously with seeing the patient or providing the services.

17. Check the location code for the claims you have submitted. Make sure they reflect the correct site that the services were delivered. There could be differences in payments based on the site/location code. You will be asked about this if there are discrepancies.

18. If you identify problems and issues when preparing for your ZPIC interview, go ahead and correct them. This way you will be able to show you have made an honest mistake, have changed your procedures and the mistake(s) will not happen again in the future. Sometimes this may require terminating your billing company, purchasing new software, retaining a professional consultant, asking for an educational site visit from the MAC, and obtaining additional continuing education on billing practices and procedures for you and your staff (some of which CMS offers online).

We have many helpful resources on our webpage and YouTube page. Click here to view our video Q&A on ZPIC audits for more information.

To read an additional blog I wrote on preparing for an audit, click here.

Don’t Wait Until It’s Too Late; Consult with a Health Law Attorney Experienced in Medicare and Medicaid Issues Now.

The attorneys of The Health Law Firm represent healthcare providers in Medicare audits, ZPIC audits and RAC audits throughout Florida and across the U.S. They also represent physicians, medical groups, nursing homes, home health agencies, pharmacies, hospitals and other healthcare providers and institutions in Medicare and Medicaid investigations, audits, recovery actions and termination from the Medicare or Medicaid Program.

For more information please visit our website at www.TheHealthLawFirm.com or call (407) 331-6620 or (850) 439-1001.

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.

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Copyright © 2019 The Health Law Firm. All rights reserved.

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.

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NYC Doctor Gets Prison Term for Posing as Clinic Owner in $30 Million Fraud Scheme

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

On August 22, 2018, a doctor received a sentence of one year and a day in prison from a New York federal court for his part in a $30 million scheme to defraud Medicare and the state Medicaid program. The doctor admitted to posing as the owner of a medical clinic and falsely claiming to have seen hundreds of patients. He pled guilty on January 11, 2018, to health care fraud and conspiracy to commit health care fraud, mail fraud and wire fraud, the U.S. Attorney’s Office said.

Lies and Cover-ups.

The New York City doctor accepted responsibility for falsely posing as the owner of two medical clinics that were actually owned by a corrupt businessman, according to the U.S. Attorney’s Office for the Southern District of New York. Under New York state law, medical clinics must be owned and operated by a medical professional. The businessman was able to evade the requirements of the law by hiring doctors to pose as the owners of each clinic.

The corrupt businessman owned and operated six medical clinics in Brooklyn between 2007 and 2013 that fraudulently billed Medicare and Medicaid. Approximately $30 million was billed for services and supplies that were not provided, according to the indictment and other documents filed in federal court, as well as statements made during the doctor’s plea proceeding and sentencing.

Additionally, the doctor fabricated false medical records to support the fraudulent reimbursement claims and wrote prescriptions and referrals for medically unnecessary tests and supplies, the U.S. attorney’s office said.

The Punishment.

U.S. District Judge Lorna G. Schofield sentenced the doctor to three years of supervised release in addition to the prison term for his role in the scheme. He was also ordered to pay restitution of approximately $1.83 million and to forfeit $269,412 in unlawful gains. The three other defendants involved in this case, a doctor, a physical therapist and an occupational therapist, are scheduled to go to trial at a later date. Click here to learn more.

“The Medicare and Medicaid programs are intended to provide essential medical services to the elderly and the needy, not to enrich corrupt doctors and other fraudsters,” U.S. Attorney Geoffrey S. Berman said in a statement. “Today’s sentence sends a strong message that those who cheat Medicare and Medicaid, including physicians who abuse their licenses and professional oaths, will be held accountable.” You can view the U.S. Attorney’s press release here.

To read about a similar case of fraud, click here to read one of my prior blogs.

This is a Dangerous Pitfall of Which all Doctors and Dentists Must Be Aware.

This is the type of situation we often see in which a doctor or dentist is victimized by dishonest and corrupt scofflaws, especially here in Florida. Most often an older physician who is retired or semi-retired is asked to become the “medical director” or “dental director” of a clinic that is owned in whole or in part by someone else. The physician may not even know who its true owners are. Later the physician or dentist is asked to serve as the “president” or as a “director” of the company and his/her name is placed on all the corporate papers. The trouble really begins, however, when the true owner(s) places the physician’s or dentist’s name on corporate papers and licensing papers as an “owner,” “shareholder” or “member” of the business, when the physician has paid nothing for the business and is not truly the owner.

If a physician or dentist becomes aware of such a scheme and gets out of it as soon as she or her finds out, the physician or dentist may be able to avoid prosecution or liability. However, if the physician or dentist continues to do business with the true owners as an “owner on paper,” “shell owner,” or “sham owner,” (they all mean the same thing, “fraudulent owner”) then he or she can be in for some serious civil and criminal liability.

There can be serious criminal penalties, such as the one reported on in this blog. For example, in Florida, it is a felony for a non-dentist (meaning a dentist not licensed in Florida) to own or control a dental clinic in Florida. It is also a criminal offense for a layperson (or a business entity owned by lay persons), to own or control a medical clinic, unless it goes through the strict health care clinic license requirements that Florida law requires. If the clinic is owned or operated illegally (even if it’s “just on paper”), then all of the bills it issue are also illegal.

Contact Health Law Attorneys Experienced in Handling Medicare and Medicaid Fraud Cases.

The Health Law Firm’s attorneys routinely represent physicians, medical groups, clinics, pharmacies, durable medical equipment (DME) suppliers, home health agencies, nursing homes and other healthcare providers in Medicare and Medicaid investigations, audits and recovery actions. They also represent them in preparing and submitting corrective action plans (CAPs), requests for reconsideration, and appeal hearings, including Medicare administrative hearings before an administrative law judge.

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

Sources:

Hanson, Joyce. “Doc Gets Year In Prison For Role In $30M Medicare Fraud.” Law360. (August 22, 2018). Web.

“NYC Doctor Gets Prison Term for Role in $30M Fraud Scam.” Bloomberg Law. (August 22, 2018). 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: Medicare and Medicaid fraud representation, false claims attorney, false claims representation, representation for overbilling, representation for DOJ investigations, fraud defense attorney, representation for medicare issues, representation for Medicaid issues, Medicare lawyer, Medicaid lawyer, health care fraud investigation representation, health care fraud defense representation, Medicare fraud representation, health care professional representation, representation for physicians, representation for physician reimbursement, licensure defense attorney, professional license representation, licensure defense representation, representation for health care professionals, The Health Law Firm reviews, reviews of The Health Law Firm attorneys, Florida health law defense lawyer, owner on paper, shell owner, or sham owner, paper owner, Florida dental clinic ownership, health care clinic license

“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 © 2018 The Health Law Firm. All rights reserved.

 

Two Nursing Home Co-Conspirators Sentenced in $19 Million Fraud Kickback Scheme

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

On July 9, 2018, two co-conspirators in a $19.4 million healthcare fraud scheme involving a nursing home chain, American Senior Communities, were sentenced in Indiana federal court. Both pled guilty to various conspiracy and money laundering charges.

The Multi-Million Dollar Scheme.

Prosecutors allege that the men reached side deals with vendors who handled things like nurse call systems, food and medical supplies for the nursing home chain. According to the U.S. Department of Justice (DOJ), the kickback scheme generated nearly $19.4 million that the men spent on vacation homes, private planes, golf trips, Rolex watches, gold bullion and casino chips. Both were charged in 2016, along with two others for their roles in the same scheme. Read more about their involvement here.

The Sentencing.

The DOJ said Steven Ganote received a five-year sentence with two years of supervised release and was ordered to pay $7 million in restitution. Additionally, Joshua Burkhart was handed a four-month sentence with two years of supervised release and ordered to pay $420,000 in restitution. Each of the men is charged with one count of conspiracy to commit mail, wire and health care fraud, money laundering and conspiracy to violate the Anti-Kickback Statute (AKS).

To learn more about these types of illegal kickback schemes, click here to read one of my prior blogs on health care fraud.

Don’t Wait Until It’s Too Late; Consult with a Health Law Attorney Experienced in Medicare and Medicaid Issues, Fraudulent Billing and Overbilling Now.

The attorneys of The Health Law Firm represent healthcare providers in cases of medical billing fraud, overbilling, Medicare audits, ZPIC audits and RAC audits throughout Florida and across the U.S. They also represent physicians, medical groups, nursing homes, home health agencies, pharmacies, hospitals and other healthcare providers and institutions in Medicare and Medicaid investigations, audits, recovery actions and termination from the Medicare or Medicaid Program.

For more information please visit our website at www.TheHealthLawFirm.com or call (407) 331-6620 or (850) 439-1001.

 

Sources:

Fowler, Haylay. “Nursing Home Schemer Sentenced In $19M Kickback Scheme.” Law360. (July 9, 2018). Web.

Kass, Dani. “Ex-Nursing Home Execs Indicted In $16M Kickback Scheme.” Law360. (October 12, 2016). 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.

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“The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.
Copyright © 2018 The Health Law Firm. All rights reserved.