Pharmacists: Talk to a Lawyer Before You Talk to an Investigator

By Christopher E. Brown, J.D.

In Florida, You DO NOT Have to Speak to an Investigator!

Despite mailing out hundreds of thousands of postcards and letters to pharmacists, throughout Florida, we continue to receive calls from new clients and from potential clients, after they have already spoken to and made critical harmful admissions against their own interests to investigators. In Florida, you do not have any duty to cooperate with any investigator who is investigating you. This extends to Department of Health (DOH) investigators (who are sometimes titled “Medical Quality Assurance Investigators” or “Medical Malpractice Investigators”), Drug Enforcement Administration (DEA) special agents, police officers, sheriff’s deputies, or criminal investigators of any type.

The Investigator is NOT Your Friend.

Let me state this as succinctly and clearly as possible. If you are being investigated, you will not be better off making a statement. You will not be better off explaining your side of the story. The investigator is not your friend. The investigator is not on your side. All you are doing is falling for a trick and helping the government to make a case against you.

Protect Yourself and Your License.

You have a right under the U.S. Constitution to not make any statement that may be used against you. This is so important that in criminal cases government investigators are required to advise you of this by reciting to you your Miranda rights.

However, in cases where you might have your pharmacy license revoked or have your DEA number revoked, the investigator is not required to advise you of your rights.

In a criminal case, there may be ways to have your statement thrown out. However, in a professional licensing case or other administrative case, it may be too late to avoid the damage. You may be the best witness the government has, and you may be the only witness the government needs to prove this case against you.

In the case where you could receive a $100 criminal fine, the investigators are required to read you your constitutional Miranda rights and to be sure that you understand them before you make a statement. However, in a case where you can lose your professional license, where you could lose your livelihood and ability to make a living, where you could lose everything you have worked so hard to obtain, they are not required to do this. You must protect yourself.

Many pharmacists, when confronted by an investigator, who will usually call at a very inconvenient time (to catch you by surprise) and will usually flash a badge (to intimidate you), will refuse to acknowledge the seriousness of the matter and will fall for the bait to “tell their side of the story.” This can be fatal to your defense and fatal to your license.

Do NOT Help the Investigators; Do NOT Admit to Anything.

In the absence of a statement by the suspect (in this case, let’s assume this is YOU), the government may have a very difficult time of proving that you have committed any offense. It may have other witnesses (who may not be around at the time of any hearing or trial). It may have a lot of physical evidence or documents. But it may be impossible for the government investigators to make any link between you and the evidence, unless you help the investigators do this. You would be surprised at how many pharmacists believe that they can just talk their way out of the situation; in reality, they are just giving evidence that is used to make the case against them.

Any evidence at all, just admitting that you were there, admitting that the documents are yours, admitting that the patient was yours, admitting that you worked at the pharmacy, admitting that filled the prescription, admitting that the property is yours, admitting that you were on duty at the time, admitting that you have taken a drug, admitting that you signed the form, can be a crucial piece of evidence that could not otherwise be proven without your own testimony.

Remember, this is the investigators’ job and profession. This is what they do full time, every day. And they are very good at it. They are 1,000 times better at getting you to admit the crucial elements of a disciplinary infraction than you are in “talking your way out of it.” They will not be convinced by any excuses you make. They do not have to be. They will not be the ones making the final decision against you. Theirs is the job of putting together the case against you. You will help them by talking to them, explaining why your decisions are correct, explaining why what you did is excusable, etc. It will not work. You will merely be giving them enough rope to hang you with.

How to Determine the Purpose of the Investigation.

Hint: If it is a Medicaid Fraud Control Unit (MFCU) special agent (investigator), you are probably under investigation for Medicaid fraud.

Hint: If it is an “auditor,” “surveyor” or “investigator” from an agency or company with “integrity” or “program integrity” in its name, they are probably investigating you for “lack of integrity,” i.e., false claims or fraud.

Hint: If it is a Drug Enforcement Administration (DEA) special agent (investigator) they are probably investigating you to prosecute you or to revoke your DEA registration for drug or prescribing violations.

Hint: If it is an Office of the Inspector General (OIG) special agent (investigator), you are probably under investigation for Medicare fraud or Medicare false claims.

Do Not Try to Talk Your Way Out of the Investigation; Do NOT Lie.

Do not believe for a second that you are smarter than the investigator. Do not believe for a second that you will convince the investigator (or anyone else) that there is a legal or medical justification for what you did or what they allege. If it were as simple as that, then why would there be an investigation and why would you be the one being investigated?

Additionally, do not believe for a second that you can lie your way out of it, either. Remember, if the government cannot prove the basic offense that it is investigating against you, it may be able to prove that you have committed perjury or lied to an investigator. In the case of a federal official or a federal investigation, merely making a false statement (oral or written) to an investigator is a criminal act. This is what Martha Stewart and many others have served time for in federal prisons.

These investigators are lied to all the time. They are usually better at detecting lies than a polygraph expert is. Furthermore, in most cases, you will be the very last person to be interviewed. Therefore, they will already know just about everything that can be used against you. If your statement contradicts in any way what others have told them, they will know you are the one who is lying. However, knowing something or suspecting something does not mean it will be something that can be proven in court or in an administrative hearing.

Consult a Lawyer Before You Do or Say ANYTHING.

It is much better to make no statement at all. Blame it on your attorney. Tell the investigator that your attorney will kill you if you were to talk to the investigator without your attorney being there ahead of time. “Speak to my attorney.” “My attorney can help you, I can’t.”

All you have to do is state “I must talk to my lawyer before I say anything.” “I will have my lawyer contact you.” “I cannot say anything until I talk to my lawyer.” “I want a lawyer.”

If you are not the one being investigated, then there is no good reason why the investigator would want you to make a statement before you consulted with your attorney. What is the rush?

Then you must also avoid the old trick of the investigator telling you “If you don’t have anything to hide, why would you need a lawyer?” Please don’t fall for this trick, either. This is America. Smart people and rich people spend a lot of money on attorneys and other professionals to represent them and advise them. There is a good reason why they do this.

Far too often the pharmacist only calls us after he has given a statement. This is usually too late to avoid much of the damage that will have been be caused.

Everything above applies to oral statements or written statements. Do not make either. Contact a lawyer as soon as possible, preferably before making any statement, no matter how simple, defensive, self-serving or innocuous you may think it to be.

Think of this as an intelligence test. Are you smart enough to follow this guidance and avoid this type of mistake?

Contact Health Law Attorneys Experienced with Investigations of Pharmacists.

The attorneys of The Health Law Firm provide legal representation to pharmacists in Department of Health (DOH) investigations, Drug Enforcement Administration (DEA) investigations, FBI 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.

About the Author: Christopher E. Brown, J.D. 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 Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

“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 © 1996-2012 The Health Law Firm. All rights reserved.

Healthcare Providers Service Organization (HPSO) Attorneys, Lawyers and Defense Council for Pharmacists

10 Indest-2008-7By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

Often we learn after the fact that a health professional such as a mental health counselor, psychologist, or pharmacist has received Healthcare Providers Service Organization (HPSO) insurance, has had a legal problem, and has not been able to locate an attorney or law firm that accepts this type of insurance. We have offices in Florida and Colorado, but we have attorneys licensed in Florida, Colorado, Louisiana, the District of Columbia, Virginia and other states.

Additionally, we can provide legal advice and representation in license investigations and administrative proceedings in many other states.

If you have HPSO Insurance, do not go without an attorney or with a lawyer that has little or no experience where you need it. Contact us, and we will help you.

We Will Work with Your Insurance Company.

Call us first. We can assist you in determining if your legal problem is covered by your insurance, and we can help you file a claim to have your legal defense expenses and costs covered. In most cases, we will accept the assignment of your insurance so that you do not have to worry about legal bills while your case is going on.

Contact Experienced Health Law Attorneys That Will Work with Insurance Companies.

The Health Law Firm routinely represents pharmacists, pharmacies, physicians, nurses and other health providers in investigations, regulatory matters, licensing issues, litigation, inspections and audits involving the DEA, Department of Health (DOH) and other law enforcement agencies. Its attorneys include those who are board certified by The Florida Bar in Health Law as well as licensed health professionals who are also attorneys.

In cases in which the health care professional has professional liability insurance or general liability insurance which provides coverage for such matters, we will seek to obtain coverage by your insurance company and will attempt to have your legal fees and expenses covered by your insurance company. We will agree to take an assignment of your insurance policy proceeds in order to be able to submit our bills directly to your insurance company, if your insurance company will allow this. Many of these insurers will pay our firm to represent you in the legal defense of an investigation or complaint against your professional (nursing, medical, dental, psychology, mental health counselor) license or for an administrative hearing involving professional discipline.

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., 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.

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 © 1996-2012 The Health Law Firm. All rights reserved.

Selling Tobacco Can Get You Penalized By Insurance Panels

Lance Leider headshotBy Lance O. Leider, J.D., The Health Law Firm

Beware: selling cigarettes could burn a hole in your pocket.

The CVS Health Corporation (CVS), the nation’s second-largest drug store, is currently in the midst of launching a tobacco-free prescription-drug network. The company announced in October 2014, that it will begin offering a tobacco-free pharmacy plan to employers, unions, and insurance companies for which its Caremark arm manages prescription benefits. CVS is slapping patients with an extra co-payment “penalty” if they purchase their medications from pharmacies that sell tobacco products, regardless of whether the patient is a tobacco user.

According to US News, by adding a variable co-payment of up to $15, CVS hopes that this new strategy, comparable to a narrow network insurance design, will perpetuate the company’s health-and-wellness based initiatives.

The new network will start in 2015. Customers will receive a list of participating pharmacies before any network change will take place.

Click here to read more from US News.

The Tobacco-Free Retail Trend.

Target and CVS have become the poster children for tobacco-free retailers. In 1996, Target spearheaded the fight against tobacco by eliminating all sales of the toxic substance. In September 2014, the CVS Corporation followed suit and completed its tobacco-free overhaul by removing all tobacco products from store shelves across the nation.

The tobacco-free pharmacy networks would include CVS and Target nationally, as well as local or regional pharmacies such as independent pharmacies that abstain from tobacco sales. Walgreens and Walmart pharmacies, two large-scale rival drug chains that sell tobacco, as well as any other grocery or community pharmacy, should expect patient penalties and negative impacts on prescription-drug revenue.

Those Participating in the Tobacco-Free Network.

According to Yahoo! Finance, CVS representatives said the network was created in a response to pharmacy benefit management (PBM) clients that indicated interest in tobacco-free pharmacies. The tobacco-free network will only be used by the PBM customers that voluntarily participate.

The first employer to sign on is the city of Philadelphia, as it promotes a tobacco-free workforce. Philadelphia officials estimate that between 150 and 200 CVS pharmacies will participate in the Philadelphia network.

To read more on this topic from Yahoo! Finance, click here.

Sincere Motives or a Monopoly in the Making?

There are a myriad of arguments regarding CVS’ genuine motive behind the tobacco-free network. Health benefit analysts argue that the network is a disguised anti-competition scheme. With the announcement of the new network plan, CVS opens itself up to criticism for appearing to steer patients to CVS pharmacies, or strong arm the competition into giving up lucrative tobacco revenue. Although the corporation denies these claims of ulterior motives, Dave Balto, a former policy director at the U.S. Federal Trade Commission argued that “…It’s really another effort to limit the ability of their rivals to effectively compete.”

Independent pharmacies are also questioning the industry benefits of such a plan. Small, local pharmacies that have not carried tobacco products for years may be overlooked by the consumers knowingly aware of CVS as a tobacco-free drug store. These mom-and-pop pharmacies will be forced to spend a pretty penny on increased marketing to stand on their own two feet against these mass retail chains.

The Narrow Network Comparison.

Many critics argue that the new CVS plan could be considered a narrow network strategy. A narrow network applies to any health insurance plan that places constraints on doctors and hospitals that are available to their beneficiaries. Typically plans will not cover medical services received out-of-network or they will increase co-payments.

These designs are becoming more common for insurance companies and pharmacy benefit managers. By limiting the choices, insurers say they can better focus on the quality of medical care that is delivered to plan customers.

Comments?

What is your opinion of the new CVS tobacco-free network plan? Do you think it will be beneficial for overall community health or more detrimental to the livelihood of small pharmacies? Please leave any thoughtful comments below.

Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.

The Health Law Firm represents pharmacists and pharmacies in DEA, DOH and FDA investigations, regulatory matters, licensing issues, litigation, administrative hearings, inspections and audits. 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 http://www.TheHealthLawFirm.com.

Sources:

Silverman, Ed and Ziobro, Paul. “CVS Plays Hardball with Rival Drug Chains.” (October 20, 2014). From: http://finance.yahoo.com/news/cvs-plays-hardball-rival-drug-231400764.html

Murphy, Tom. “CVS Health Stretches Anti-tobacco Push to New Prescription Drug Network.” (October 21, 2014). From: http://www.usnews.com/news/business/articles/2014/10/21/cvs-develops-tobacco-free-prescription-network

About the Author: Lance O. Leider 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 Ave., Altamonte Springs, Florida 32714, Phone: (407) 331-6620.

“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 © 1996-2014 The Health Law Firm. All rights reserved.

37 Central Floridians Charged with Illicit Pharmaceutical Drug Trafficking

By Dr. Thu Pham, O.D., Law Clerk, The Health Law Firm

Attorney General Pam Bondi along with special agent Mark R. Trouville of the Drug Enforcement Administration (DEA) and Longwood Police Chief Troy Hickson announced, on June 20, 2012, the execution of 37 arrest warrants stemming from state drug charges.  The defendants all reside in Central Florida.

Click here to read the entire press release from the Florida Attorney General.

The Defendants’ Charged with Felonies.

The charges for the defendants ranged from first degree to third degree felonies.  The defendants have been charged with acts, such as conspiracy to traffic Oxycodone, solicitation to deliver Oxycodone, and possession of Hydromorphone with intent to sell or deliver. 

Law enforcement authorities have been able to apprehend 33 of the 37 charged.

Click here to see our experience representing pharmacists and pharmacies.

Contact Health Law Attorneys Experienced with Representing Pharmacists and Pharmacies.

The attorneys of The Health Law Firm provide legal representation to pharmacists and pharmacies in Department of Health (DOH) investigations, Drug Enforcement Administration (DEA) investigations, FBI 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:

myfloridalegal.com. “DEA: 37 Charged in Longwood Local Impact Drug Trafficking Conspiracy.” AG. (June 20, 2012).  From Press Release: http://www.myfloridalegal.com/newsrel.nsf/newsreleases/9E8D06F29BCB233B85257A230072572A.

Justice.gov. “Law Enforcement Dethrones “Queen” of Longwood, Florida.” DEA, Domestic Field Division. (June 20, 2012).  From Press Release: http://www.justice.gov/dea/pubs/states/newsrel/2012/mia062012.html

About the Author: Dr. Thu Pham, O.D., is a law clerk 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 Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

“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 © 1996-2012 The Health Law Firm. All rights reserved.

Feds File Two Lawsuits Against Novartis for Allegedly Giving Kickback to Pharmacists and Physicians

11 Indest-2008-8By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

Novartis Pharmaceuticals Corporation (NPC) is currently fielding two different lawsuits, filed just days apart from each other, by the U.S. Department of Justice (DOJ). The first lawsuit was filed on April 23, 2013, alleging the company gave illegal kickbacks to pharmacists. A second lawsuit was filed on April 26, 2013, alleging illegal kickbacks were paid by NPC to health care providers. According to the DOJ, the government’s complaint seeks damages and civil penalties under the False Claims Act, and under the common law for paying kickbacks to doctors to induce them to prescribe NPC products that were reimbursed by federal health care programs.

Click here to read the entire press release from the DOJ.

Doctors and Pharmacists Allegedly Paid to Prescribe.

Both lawsuits allege NPC violated the Anti-Kickback Statute. In the April 23, 2013, complaint against NPC the lawsuit alleges the company gave kickbacks, in the form of rebates and discounts to pharmacies in exchange for the pharmacies’ cooperation in switching patients from competitors’ drugs to NPC products.

The April 26, 2013, lawsuit accuses NPC of paying doctors to speak about certain drugs at events that were allegedly social occasions. Many of the programs were allegedly held in circumstances in which it would be impossible to have a presentation. According to the DOJ, this included fishing trips off the Florida coast and meetings in Hooters restaurants. NPC is also accused of treating health care professionals to expensive dinners. The payments and dinners were apparently kickbacks to the doctors for writing prescriptions for NPC drugs.

Doctors in the Sunshine State Allegedly Involved.

The lawsuit alleges at least six Florida doctors of participating in the bogus conferences and taking thousands of dollars in kickbacks, according to the Tampa Bay Times. The doctors are not named or charged in the civil lawsuit.

To read the allegations listed in the lawsuit against Florida doctors, click here for the Tampa Bay Times article.

Novartis Claims Discounts and Physician Speaker Programs Were Legitimate.

In a press release, NPC disputes all of the government’s allegations. The pharmaceutical company states that discounts and rebates by pharmaceutical companies are a customary and legal procedure, as recognized by the government. It also addresses the physician speaker programs by saying the programs are also acceptable practices designed to inform physicians about the uses of different types of medicines. Click here to read the entire press release from NPC.

Kickbacks and The Law.

For years drug companies have paid doctors to speak about new drugs at educational conferences with other health care professionals. The practice is legal, but considered questionable.

Under the Anti-Kickback Statute, it’s a felony for health care professionals to accept bribes in exchange for recommending a drug or service covered by Medicare, Medicaid, TRICARE or the Department of Veterans Affairs health care program.

Whistleblower or Qui Tam Lawsuits Can Results in a Big Pay Day.

The original complaint against NPC was allegedly filed under the qui tam, or whistleblower, provisions of the False Claims Act by a former sales representative.

Individuals working in the health care industry, whether for hospitals, pharmacies, nursing homes, medical groups, home health agencies or others, often become aware of questionable activities.  Often they are even asked to participate in it. In many cases the activity may amount to fraud on the government.

In a two-part blog series on whistleblower/qui tam lawsuits I explain types of false claims, the reward programs for coming forward with a false claim, who can file a whistleblower/qui tam lawsuit, and more. Click here to read the first part of this blog, and click here for the second part.

The Health Law Firm Lawyers are Experienced with Qui Tam or Whistleblower Cases.

Attorneys with The Health Law Firm represent plaintiffs, patients, health care professionals and health facilities in qui tam or whistleblower cases. We have developed relationships with recognized experts in health care accounting, health care financing, utilization review, medical review, filling, coding, and other services that assist us in such matters.

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

Sound Off.

Have you head about these two lawsuits? What are your thoughts? Please leave any thoughtful comments below.

Sources:

Masow, Julie. “Novartis Pharmaceuticals Corporation Disputes Allegations in Two US Government Lawsuits and Looks Forward to a Fair Discussion of the Facts.” Novartis Pharmaceuticals. (April 26, 2013). From: http://www.pharma.us.novartis.com/newsroom/pressreleases/137176.shtml

Davis, Brittany Alana. “Lawsuit: Pharmaceutical Company Gave Kickbacks to Florida Doctors.” Tampa Bay Times. (May 3, 2013). From: http://www.tampabay.com/news/courts/lawsuit-pharmaceutical-company-gave-kickbacks-to-florida-doctors/2119133

Department of Justice. “United States Files Complaint Against Novartis Pharmaceuticals Corp. for Allegedly Paying Kickbacks to Doctors in Exchange for Prescribing Its Drugs.” Department of Justice. (April 26, 2013). From: http://www.justice.gov/opa/pr/2013/April/13-civ-481.html

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.

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 © 1996-2012 The Health Law Firm. All rights reserved.

South Florida Man Pleads Guilty to Fraudulently Working as a Pharmacist

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

On July 24, 2012, a 49-year-old man from Ruskin in South Fla., pleaded guilty in federal court to fraudulently working as a Central Florida pharmacist from 2000 to 2009, according to the Department of Justice (DOJ) in a press release.

Fake Pharmacist was Working at Central Florida Pharmacies.

Prosecutors said this man worked at pharmacies throughout Central Florida, including CVS pharmacy and Walgreens. According to the Orlando Sentinel, while working at one of the pharmacies, he gave a customer the incorrect medication, causing that person to suffer a severe reaction and stroke.

Alleged Identity Theft to Obtain Pharmacist License.

Allegedly, the man fraudulently obtained a pharmacist license in September of 2000 from the State Department of Health (DOH) by using the name, date of birth, Social Security number and pharmacy education information of a licensed pharmacist.

The fake pharmacist was able to renew the license and was allegedly receiving paychecks from pharmacies through the mail.

Will The Real Pharmacist Please Stand Up?

Local authorities began investigating the South Florida man after a legitimate pharmacist in Arizona reported that his identity had been stolen.

The legitimate pharmacist first learned in 2007 that someone was using his identity in Florida when the Internal Revenue Service (IRS) contacted him about undeclared earnings. He had never worked in Florida and learned someone was posing as him and working as a pharmacist under his name, according to the court records.

To see the full press release on this case, click here.

A Long List of Charges Could Mean Prison Time.

The fraudulent pharmacist pled guilty to mail fraud, aggravated identity theft, and money laundering in Orlando. He faces up to 20 years in federal prison for the mail fraud charge, 10 years for the money laundering charge, and a minimum of two years for any other sentence for the aggravated identity theft charge, the Justice release said.

The Federal Bureau of Investigation (FBI) and the Drug Enforcement Administration (DEA) investigated the case with assistance from the Florida Department of Health’s Division of Medical Quality Assurance.

Click here to see our experience representing pharmacists and pharmacies.

Contact Health Law Attorneys Experienced with Representing Pharmacists and Pharmacies.

The attorneys of The Health Law Firm provide legal representation to pharmacists and pharmacies in Department of Health (DOH) investigations, Drug Enforcement Administration (DEA) investigations, FBI 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:

FBI.gov. “Pharmacist Impersonator Charged with Mail Fraud, Identity Theft, and Money Laundering.” FBI, Tampa Division. (July 24, 2012). From Press Release: http://www.fbi.gov/tampa/press-releases/2012/pharmacist-impersonator-pleads-guilty-to-mail-fraud-identity-theft-and-money-laundering

TBO.com. “Ruskin Man Admits Identity Theft in Fake Pharmacist Case.” Tampa Bay Online. (July, 24, 2012). From: http://www2.tbo.com/news/health-4-you/2012/jul/24/ruskin-man-admits-identity-theft-in-fake-pharmacis-ar-440248/

Pavuk, Amy. “Feds: Man Stole Pharmacist’s Identity, Worked at Pharmacies Across Metro Orlando.” Orlando Sentinel. (July 24, 2012). From: http://articles.orlandosentinel.com/2012-07-24/news/os-pharmacist-stolen-identity-20120724_1_pharmacies-illinois-court-federal-court

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.

“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 © 1996-2012 The Health Law Firm. All rights reserved.

 

Two Central Florida CVS Pharmacies Get Controlled Substance Licenses Pulled by Drug Enforcement Administration (DEA)

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

The U.S. Drug Enforcement Administration (DEA) revoked the registrations (controlled substance licenses) from two CVS pharmacies in Sanford, Florida, on September 12, 2012, according to a number of sources. The two pharmacies will no longer be able to fill prescriptions for drugs such as oxycodone, Dilaudid, Vicodin, Ritalin and Xanax. This decision is in response to a government crackdown on the distribution of painkillers. Sanford is in Seminole County, a suburb of the greater Orlando area.

To see the court records from this case, click here.

We’ve been following this story and previously blogged on this topic in our blogs on February 10, 2012, February 29, 2012, and March 7, 2012.

DEA Believed the Two Pharmacies Filled an Inappropriate Number of Prescriptions for Oxycodone.

According to an article from Reuters, the DEA believed the stores, located on Orlando Drive and West First Street, in Sanford, were allegedly filling an inappropriate number of prescriptions for oxycodone and had a suspicious number of sales of other controlled substances.

In the same article, CVS argued that the large number of oxycodone and other prescription painkillers from the two stores is due to that fact that the two locations are busy stores, with one store open 24 hours a day. The DEA apparently did not accept this justification.

Click here to read the entire article from Reuters.

Same Two CVS Pharmacies were Raided in February 2012.

Back in February of 2012, the DEA raided the same two Sanford CVS pharmacies. The DEA called the pharmacies an “imminent danger” to the public and filed immediate suspension orders against both stores. I previously wrote a blog about the emergency suspension order and the subsequent request from CVS for a restraining order against the DEA. Click here to read the blog.

DEA Fights Prescription Drug Epidemic.

In a press release, a special agent in charge of the DEA’s Miami Division said the final order reflects “the continued commitment of the DEA to identify and bring to light the diversion of controlled substance pharmaceutical drugs.”

To see the entire press release from the DEA, click here.

According to the Orlando Sentinel, the major newspaper in Orange County and Seminole County, this measure is thought to be the first of its kind against a national retail pharmacy chain.

In my personal opinion, if the large retail giants can’t survive such an attack, the small independent pharmacies stand little chance.

Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.

The Health Law Firm represents pharmacists and pharmacies in DEA investigations, regulatory matters, licensing issues, litigation, administrative hearings, inspections and audits. 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:

Reuters. “U.S. Revoking 2 CVS Stores’ Controlled Substance Licenses” Thomson Reuter. (September 12, 2012). From: http://www.reuters.com/article/2012/09/12/us-usa-drugstores-cvs-idUSBRE88B0KN20120912

Pavuk, Amy. “Two Sanford CVS Pharmacies Banned from Selling Oxycodone, Other Controlled Substances.” Orlando Sentinel. (September 12, 2012). From: http://articles.orlandosentinel.com/2012-09-12/news/os-sanford-cvs-caremark-revoke-drugs-20120912_1_revokes-prescription-drug-abuse-oxycodone-and-other-prescription

Holiday CVS, L.L.C., v. Eric H. Holder, JR., et al., No. 12-5072 United States Court of Appeals for the District of Columbia Circuit. (September 11, 2012), available at http://www.thehealthlawfirm.com/uploads/CVS%20License%20Revoked.pdf.

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.

“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 © 1996-2012 The Health Law Firm. All rights reserved.

Supreme Court to Determine if Pay-for-Delay Agreements Between Brand and Generic Drug Manufacturers are Legal

7 Indest-2008-4By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

The Supreme Court is currently looking into whether brand name drug manufacturers may pay generic drug manufacturers to keep the generic drugs off the market. These payments, often called pay-for-delay, are usually a form of settlement between the two manufacturers in patent litigation. The Supreme Court’s decision may be worth billions to pharmaceutical companies and consumers.

In January 2013, the American Medical Association (AMA) teamed up with the American Association of Retired Persons (AARP) and other organizations seeking to eliminate pay-for-delay agreements. The groups filed a friend-of-the-court brief in the Supreme Court case.

Click here to read the friend-of-the-court brief.

History of Pay-For-Delay Agreements.

Pay-for-delay agreements came as the result of the Drug Price Competition and Patent Term Restoration Act of 1984, also known as the Hatch-Waxman Act. The Hatch-Waxman Act gives generic drug manufacturers an incentive to challenge brand name drug patents because the first generic drug manufacturer to received U.S. Food and Drug Administration (FDA) approval to launch a generic copy of a brand name drug can receive a 180-day marketing exclusivity period for the product. The FDA cannot approve any other generic applications for the same drug until the first-to-file generic manufacturer has sold its product for 180 days or has given up its exclusivity period. Click here to read the Hatch-Waxman Act.

Brand name manufacturers often challenge generic drug manufacturers who try to sell their product prior to patent expiration. This results in litigation to determine whether the generic manufacturer is violating the brand name manufacturer’s patents.

Instead of going to court over this, brand name manufacturers often choose to pay a settlement to the generic drug manufacturers for agreeing to delay the launch of its competing product.

The Impact of Pay-For-Delay Agreements.

It’s been found that pay-for-delay agreements can delay a generic drug almost 17 months before it can be put on the market. In the meantime, patients must pay higher prices for the brand name version. This also impacts Medicare and Medicaid programs.

According to an article on National Public Radio (NPR), the number of pay-for-delay agreements is increasing. Click here to read the entire NPR article.

Legalized Extortion Causes Patients to Pay High Drug Prices.

This type of legalized extortion does nothing more than drive up drug prices for all patients by keeping generic drugs off the market. On the other hand, it vastly increases the profits made by big name pharmacy companies who are able to derive even more money from expired patents.

AMA Fights to Get Rid of Pay-for-Delay Agreements.

According to a press release, AMA, AARP, the National Legislative Association for Prescription Drug Prices and the U.S. Public Interest Research Groups all signed onto the friend-of-the-court brief filed in the Supreme Court.

The AMA is concerned that pay-for-delay agreements extend patent monopolies, increase health care costs and restrict doctors’ ability to treat patients. To read the entire press release from the AMA, click here.

Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.

The Health Law Firm represents pharmacists and pharmacies in investigations, regulatory matters, licensing issues, litigation, inspections and audits. 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.

Comments?

As a health care professional, how do you feel about pay-for-delay agreements? Please leave any thoughtful comments below.

Sources:

Mills, Robert. “AMA Joins Other Groups Seeking to Overturn Pay-for-Delay Drug Agreement.” American Medical Association. (January 30, 2013). From: http://www.ama-assn.org/ama/pub/news/news/2013-01-30-amicus-brief-ftc-vs-watson-pharmaceuticals.page

Federal Trade Commission v. Watson Pharmaceuticals, Inc. Case Number 12-416. Brief for AARP, American Medical Association, National Legislative Association for Prescription Drug Prices and U.S. Public Interest Research Groups as Amici Curiae in Support of Petitioner. January 29, 2013. From: http://www.thehealthlawfirm.com/uploads/2013-01-29-amicus-brief-ftc-vs-watson-pharmaceuticals.pdf

Purvis, Leigh. “Pay-for-Delay Agreements and Prescription Drug Costs.” AARP. (May 13, 2013.) From: http://blog.aarp.org/2013/05/13/pay-for-delay-agreements-and-prescription-drug-costs/

Totenberg, Nina. “Supreme Court Hears ‘Pay to Delay’ Pharmaceutical Case.” National Public Radio. (March 25, 2013). From: http://www.npr.org/2013/03/25/175043758/supreme-court-hears-pay-to-delay-pharmaceutical-case

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.

“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 © 1996-2012 The Health Law Firm. All rights reserved.

Drug Enforcement Agency (DEA) Serves Up Immediate Suspension Order for Walgreens Distribution Center

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

On September 14, 2012, the Drug Enforcement Agency (DEA) blocked the Walgreens distribution center in Jupiter, Florida, from shipping oxycodone and other controlled drugs to its pharmacies in Florida and the East Coast with an immediate suspension order, according to the DEA. In the press release, the DEA called the Walgreens distribution facility an “imminent danger” to the public.

To see the entire press release from the DEA, click here.

Back in April 2012, the DEA served an administrative inspection warrant at the same facility, as well as its six top retail Walgreens pharmacies in Florida. To see my blog post on that story, click here.

DEA Named the Distribution Center “Largest Distributor of Oxycodone Products in Florida.”

The DEA said the Jupiter distribution center has been “the single largest distributor of oxycodone products in Florida” since 2009. The DEA issued the suspension order because it believes Walgreens failed to maintain proper controls to ensure its retailers didn’t dispense drugs to addicts and drug dealers.

The order only applies to the Jupiter distribution center and only suspends the distribution of controlled substances.

Whether or not bath salts fall into this category is unclear. The Florida Legislature recently banned the sale of bath salts and 90 other substances to help stop the big face-eating zombie outbreak in Florida. See my blog on bath salts and the zombie outbreak in Florida.

Recently, the DEA revoked the controlled substance licenses from two CVS pharmacies in Sanford, Florida. The two stores are accused of dispensing an inappropriate number of prescriptions for oxycodone and had a suspicious number of sales of other controlled substances. There is a blog on this story on our website, click here to read it.

Six Walgreens Pharmacies Allegedly Purchased Millions of Oxycodone Pills.

According to a USA Today article, six of Walgreens’ Florida pharmacies allegedly ordered more than a million oxycodone pills a year. One pharmacy in Oviedo, Florida, went from ordering more than 80,000 oxycodone pills in 2009, to nearly 1.7 million in 2011.

Click here to read the USA Today article.

DEA Continues to Fight Prescription Drug Abuse in Florida.

According to the DEA, this is an effort to curb Florida’s prescription drug epidemic. Special Agent Mark Trouville, with the DEA’s Miami Division, said all DEA licensees “have an obligation to ensure that medications are getting into the hands of legitimate patients. When they choose to look the other way, patients suffer and drug dealers prosper.”

Neither Agent Trouville nor the DEA was, apparently, requested to comment on the bath salts ban and its effect on the zombie outbreak, however.

 Meaningless Numbers Used for Shock and Awe.

I really do not see why the public or our elected representatives are shocked and awed by the meaningless numbers and statistics used in connection with these matters. The fact that Walgreens, the biggest pharmacy retailer in Florida, might distribute over a million oxycodone pills in a year, is a meaningless statistic by itself. If a doctor prescribes a pain management patient a prescription for three (3) pills a day, that is approximately 90 pills per month or 1,080 pills per year. If Walgreens has only 1,000 patients with such a prescription in a year throughout the entire state of Florida, that is in excess of one million (1,000,000) pills per year. I would venture to guess that many single Walgreens retail stores have more than 1,000 customers per day, much less all Walgreens stores throughout Florida.

My point is that any such statistics are meaningless out of context and are only meant to sound huge of one doesn’t stop and think about it.

Another concern is that many, if not the vast majority of the Walgreens customers who now will not be able to get their prescriptions filled, are legitimate pain management patients with legitimate prescriptions written by legitimate physicians.

Crackdowns Leave Pain Patients to Suffer.

I am constantly being contacted by patients who are in dire straits, suffering because they cannot locate a pharmacy to fill their legitimate pain medicine prescriptions. These include injured military veterans, patients who are 100% disabled and on disability or social security, patients injured in automobile accidents and job-related accidents (whose medications are paid for by insurance, if they can find a pharmacy to fill it) and others with real chronic pain issues.

If the largest legitimate chains of pharmacies in the state and nation are not allowed to fill these prescriptions, where will these suffering patients turn? Are these actions driving our citizens into the hands of shady independent pharmacies that have fewer safeguards and less accountability? Are these actions driving our citizens to seek out illegal drug dealers and turn to illegal drugs to cope with their legitimate medical problems? I hope not.

Thank you. I will get off my soapbox now.

Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.

The Health Law Firm represents pharmacists and pharmacies in DEA investigations, regulatory matters, licensing issues, litigation, administrative hearings, inspections and audits. 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:

Leinwand, Donna. “DEA Inspects Walgreens for Oxycodone Probe.” USA Today. (September 15, 2012). From: http://www.usatoday.com/news/nation/story/2012/09/14/walgreens-and-oxycodone/57782912/1

Pavuk, Amy. “DEA Blocks Controlled-Substance Distribution at Florida Walgreens Facility.” Orlando Sentinel. (September 14, 2012). From: http://articles.orlandosentinel.com/2012-09-14/news/os-walgreens-dea-suspension-20120914_1_distribution-center-dea-miami-field-division

DEA. “DEA Serves a Suspension Order on Walgreens Distribution Center in Jupiter, Florida.” DEA.gov. (September 14, 2012). From: http://www.justice.gov/dea/divisions/mia/2012/mia091412.shtml

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. He does not own stock in Walgreens or any other pharmacy.

“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 © 1996-2012 The Health Law Firm. All rights reserved.

Filling Phony Prescriptions for Pain Killers Lands Orlando Pharmacist Behind Bars

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

Another pharmacist was led away in handcuffs during a September 25, 2012, raid on an Orlando-area pharmacy, according to a number of sources. The pharmacist is accused of filling prescriptions for oxycodone, even though he allegedly knew the prescriptions were not legitimate.

Click here to see video of the arrest from WFTV in Orlando.

Investigation by Narcotics Agents Led to Arrest.

In December 2011, narcotics agents searched the same pharmacy and found 22 prescriptions that were suspected to be fraudulent, according to the Orlando Sentinel.

Agents believed the prescriptions were fakes because they apparently matched phony prescriptions found at other local pharmacies. The prescriptions had the same patient names, and the telephone number listed on the prescription belonged to a suspected drug abuser, not a physician.

One customer who received pills from the pharmacist told the Orlando Sentinel that because she was using fake prescriptions, the pharmacist would mark up the price of the pills.

Legal Advice for Those Involved in Phony Prescription Rings.

We have previously published several blogs about groups of criminals who have operated phony prescription rings in Central Florida. In a number of cases they have obtained professional counterfeit-proof paper and had prescription forms printed that are indistinguishable from the real thing.

Click here to see blog one. Click here to see smurf blog.

Given that there are mandatory minimum prison sentences for such activities, young people (those who are usually involved) should avoid these people like the plague. It is just not worth the risk for a few hundred dollars or a few pills. You screw up your life forever, and you spend years in prison.

Pharmacist’s Charges.

The pharmacist in this casewas arrested on 22 counts of trafficking in oxycodone, 22 counts of conspiracy to traffic in oxycodone, and one count of trafficking in hydrocodone. On top of those charges, the Department of Health (DOH) ordered an emergency suspension order on the pharmacist’s license.

To read the article from the Orlando Sentinel, click here.

To see our blog on possible remedies for an emergency suspension order, click here.

Florida is Seeing a Surge in Pharmacy Raids and Shutdowns.

If you’ve been watching the news at all lately, you can tell there have been an increased number of raids on pharmacies, arrests of pharmacists and emergency suspension orders issued from the Department of Health (DOH).

Just in the past month the Drug Enforcement Agency (DEA) served a Walgreens distribution center in Florida with an immediate suspension order (click here to read more on this story), and pulled the controlled substance licenses from two Central Florida CVS Pharmacies (to learn more, click here).

In my personal opinion, if the large retail giants can’t survive, the small independent pharmacies stand little chance.

Do you agree? What do you think of the war on prescription drugs in Florida? Leave your comments on this story below.

Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.

The Health Law Firm represents pharmacists and pharmacies in DEA investigations, regulatory matters, licensing issues, litigation, administrative hearings, inspections and audits. 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:

Pavuk, Amy. “Agents Raid Orlando-Area Pharmacy, Arrest Pharmacist.” Orlando Sentinel. (September 25, 2012). From: http://www.orlandosentinel.com/news/local/breakingnews/os-pharmacist-arrested-orlando-20120925,0,6879000.story

WFTV. “Pharmacist Arrested on Charges of Trafficking Oxycodone.” WFTV.com. (September 25, 2012). From: http://www.wftv.com/news/news/local/pharmacist-arrested-charges-trafficking-oxycodone/nSLgg/

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.

 

“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 © 1996-2012 The Health Law Firm. All rights reserved.

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