Pharmacy | The Health Law Firm Blog

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.

By The Health Law Firm|2012-09-18T14:59:11-04:00May 15, 2018|Categories: Legal Defense for Pharmacists, Pharmacist, Pharmacy, Pharmacy Law|Tags: administrative hearings, controlled substance licenses, DEA raid, defense attorney, Drug Enforcement Administration (DEA) investigation, emergency suspension order, pharmacist, pharmacy, pharmacy investigation, prescription drug trafficking, registration, revoked license|0 Comments

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

By 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.

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.

Recall Alert: FDA Warns Steroid Injections Compounded by Tennessee Pharmacy May Be Contaminated

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

The U.S. Food and Drug Administration (FDA) sent out a warning to health care professionals that steroid injections compounded by Main Street Family Pharmacy, LLC, in Tennessee, may be contaminated. The announcement came on May 24, 2013. So far, seven patients have allegedly suffered adverse reactions from the medications. The FDA says it is working with the Centers for Disease Control and Prevention (CDC) and the Tennessee Board of Pharmacy to investigate. The steroid injections were allegedly sent to 13 states, including Florida.

To read the press release from the FDA, click here.

Steroid Injections Recalled.

According to an article in the Associated Press, officials have not yet confirmed the products are contaminated. The FDA is treating all sterile products from Main Street Family Pharmacy as if they were contaminated as a precaution. The pharmacy has agreed to recall all of its sterile products. Click here to read the Associated Press article.

The injections in question allegedly contain the same drug at the center of the October 2012, deadly fungal meningitis outbreak. More than 55 people, including five in Florida were killed and 740 others were sickened after receiving contaminated injections from a Massachusetts compounding pharmacy. I previously blogged about that outbreak. To read more, click here.

Patients in North Carolina and Illinois Allegedly Reacted to Injections.

Federal authorities have allegedly identified seven cases of patients who have suffered complications after being injected with the potentially contaminated medications. There are five cases in Illinois and two cases in North Carolina. The Illinois patients supposedly have skin infections and one patient in North Carolina allegedly suffered from a fungal infection.

Florida Department of Health Working to Contain Allegedly Tainted Injections Statewide.

According to the Florida Department of Health (DOH), at least three Florida facilities received the drugs under investigation. Two of the facilities are in Melbourne, Florida, and one is in Chipley, Florida. The Florida DOH says it is not aware of any local cases of infections from these drugs.

To read the press release from the Florida DOH, click here.

Previous Florida Case of Contaminated Medication.

We have previously blogged about the problems encountered by Franck’s pharmacy in Ocala, Florida. It has been accused of distributing eye medications that contained a fungal infection. Click here for the first blog and here for the second blog on this.

Congress Debating on Giving Authority Over Compounding Pharmacies to FDA.

Currently, compounding pharmacies are regulated by state pharmacy boards. There is currently legislation moving through Congress that would give the FDA direct authority over the compounding manufacturers. The goal is to prevent any national outbreaks tied to compounded medications.

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.

Sound Off.

Do you think each state should be responsible for regulating compounding pharmacies, or do you think the FDA should be responsible? Please leave any thoughtful comments below.

Sources:

Gentry, Carol. “FL Got Drugs Linked to New Outbreak.” Health News Florida. (May 24, 2013). From: http://health.wusf.usf.edu/post/fl-got-drugs-linked-new-outbreak

Kelly, Christopher. “FDA Alerts Health Care Providers of Adverse Reactions Associated with Steroid Injections from Main Street Family Pharmacy in Tennessee.” Food and Drug Administration (May 24, 2013). From: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm353941.htm

Stobbe, Mike and Loller, Travis. “FDA Warns of Infections Tied to Tennessee Pharmacy.” The Associated Press. (May 24, 2013). From: http://www.npr.org/templates/story/story.php?storyId=186473297

Florida Department of Health. “The Florida Department of Health Partners with Federal and State Health Organizations to Ward of Adverse Reactions Associated with Steroid Injections.” Florida Department of Health. (May 24, 2013). From: http://newsroom.doh.state.fl.us/wp-content/uploads/newsroom/2013/05/052413CDCinfection.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.

By The Health Law Firm|2013-06-18T18:59:56-04:00May 15, 2018|Categories: Compounding pharmacy, Department of Health, Legal Defense for Pharmacists, Pharmacist, Pharmacy, Pharmacy Law|Tags: administrative complaints, administrative law, attorney administrative law, Board of Pharmacy, Centers for Disease Control and Prevention (CDC), compounding pharmacy, defense attorney, defense lawyer, Department of Health (DOH), DOH attorney, DOH investigation, DOH lawyer, drug recall, legal defense for administrative complaints, licensing issues, Main Street Family Pharmacy, meningitis, meningitis outbreak, pharmacist, pharmacist attorney, pharmacist lawyer, pharmacy, pharmacy attorney, pharmacy deficiencies, pharmacy inspections, pharmacy investigation, pharmacy lawyer, product recall, speciality pharmacy, sterile drugs, steroid injection, the health law firm, U.S. Food and Drug Administration (FDA)|0 Comments

Pharmacists: Beware of Scammers that Call and Claim to be DEA Agents

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

The Drug Enforcement Administration (DEA) is warning pharmacists to be aware of a prescription drug scam. This telephone scheme is extorting money from people all over the country. On November 28, 2012, the DEA released a press release explaining the details of the scam.

Con Artists Claim to Be DEA Agents and Request Money Over the Phone.

The scam starts with criminals posing as DEA agents calling victims by telephone. Frequently the victims will have recently purchased prescription drugs over the internet or by phone. The imposters tell the victims that purchasing the drugs in that manner is illegal, and that they must pay a fine. If the victims refuse to send money, the phony DEA agents threaten to arrest the victims or search their property. Some of the victims have also reported unauthorized use of their credit cards after purchasing the prescription drugs.

Click here to read more on this scam from a DEA press release.

The DEA wants to remind pharmacists that no DEA agent will ever contact you by telephone. They might show up at your house early in the morning or while you are eating dinner, however. Also, agents never request money or any other form of payment.

Isn’t it Illegal to Buy Prescription Drugs Over the Internet or By Phone?

Many times it may be illegal to purchase controlled drugs by phone or over the internet. That’s why you should go to Canada to do it. There are direct flights from Orlando. However, some pharmacies that meet stringent requirements and are registered by the DEA are allowed to sell drugs over the internet or by phone. So don’t be fooled by this telephone scam.

How Does Your Information Get Into the Hands of Criminals?

The scammers are counting on the fact that if you have done this, you, as a pharmacist, will get scared and believe their accusations. Many people have no idea whether such conduct is legal or illegal. These imposters are banking on your ignorance and fear of losing your license to practice. They are also banking on the fact you won’t report this to the real police.

Where do they get this information? Chances are, they are just “cold-calling” people. There are bound to be a certain number of people they reach who have done this. However, if they seem to have your personal information (or credit card number) report this to the police right away. Be sure to obtain a written police report. Also, you should file a HIPAA Privacy Complaint with the Office of Civil Rights (OCR) to begin an investigation if you believe your personal information has been stolen by or given to someone else to use.

Pain Patients Turn to Alternative Means to Get the Drugs They Need.

It is no surprise that the DEA, along with other law enforcement agencies, has stepped up its efforts to cut down on overprescribing. To see examples of what I am talking about read my past blogs: Walgreens fights the Drug Enforcement Administration’s (DEA) immediate suspension order and Drug Enforcement Administration (DEA) pulls controlled substance licenses from two Sanford, Florida, CVS pharmacies.

If the largest, legitimate pharmacy chains in the state and nation are not allowed to fill these prescriptions, where will chronic-pain patients turn? Are these actions driving our citizens into the hands of shady pharmacies that have fewer safeguards and less accountability, such as online pharmacies? Are these actions driving our citizens to seek out illegal drug dealers and turn to illegal drugs to cope with their legitimate medical problems? That is just one opinion. Tell us yours below.

Contact Health Law Attorneys Experienced with Investigations of Pharmacists.
The attorneys of The Health Law Firm provide legal representation to pharmacists and other health providers in Department of Health (DOH) investigations, Drug Enforcement Administration (DEA) investigations, FBI investigations, Medicare investigations, Medicaid investigations and other types of investigations of health professionals and providers.

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

Comments?

As a pharmacist, have you been contacted by these phony DEA agents? Please leave any thoughtful comments below.

Sources:

Pavuk, Amy. “DEA Warns of Prescription-Drug Scam.” Orlando Sentinel. (November 29,2012). From: http://www.orlandosentinel.com/news/local/breakingnews/os-dea-warns-scam-internet-20121128,0,5800536.story

Drug Enforcement Administration. “DEA Scam Alert – Extortion Scheme.” DEA. (November 28, 2012). From: http://www.justice.gov/dea/divisions/mia/2012/mia112812a.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.

“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.

Key West Pharmacy Blows Whistle on Medicaid Fraud and Comes Out on Top

By Danielle M. Murray, J.D.

On September 27, 2012, Public Citizen, a watchdog group, reported whistleblowers have initiated $6.6 billion in penalties against drug manufacturers in 2012. Most of these penalties are for fraudulently overcharging government programs. The report names a small Key West, Florida, pharmacy as one of the top whistleblowers in the country. The pharmacy noticed and reported that drug manufacturers were charging highly inflated prices to Medicaid.

To read the entire report on from Public Citizen, click here.

Whistleblowing Can Pay Off Big.

The study shows that the government collected billions of dollars, just in 2012, as a result of whistleblower efforts.

For whistleblowers such as the Key West pharmacy, helping the government fight fraud has its rewards. According to the Miami Herald, the government collected an estimated $1.3 to $2.5 billion dollars thanks to the pharmacy. As a reward for its whistleblowing, the government gave the pharmacy an estimated $340 million dollars.

Click here to read the Miami Herald article.

One major victory was in 2012, the pharmacy won a settlement with Boehringer Ingelheim, a large pharmaceutical company, for $289 million for overcharging government health programs for various drugs.

To read the entire whistleblower complaint file, click here.

States Low on Funds Take Closer Look at Medicaid Fraud.

It’s no surprise that states are short of funds to pay for Medicaid. As a result, fraud enforcement is increasing, in hopes that the recoveries will make up that deficit. According to studies, states that have elected to enforce whistleblower claims against the pharmaceutical industries have found that the outcome pays for the cost of enforcement.

How This Affects Providers.

If states find that fraud recovery produces large results, they will increase their efforts in other areas besides the pharmaceutical industry. This could result in additional audits against individual providers, with states hopeful that they will uncover overpayments and other problems that would allow recoupment of funds. In fact, this is already happening in some areas, and the auditors are actually incentivized to find mistakes that providers make.

Faced with an Medicaid Audit? Contact Health Law Attorneys Experienced in Handling Medicaid Audits.

Medicaid fraud is a serious crime and is vigorously investigated by the state MFCU, the Agency for Healthcare Administration (AHCA), the Zone Program Integrity Contractors (ZPICs), the FBI, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (DHHS). Often other state and federal agencies, including the U.S. Postal Service (USPS), and other law enforcement agencies participate. Don’t wait until it’s too late. If you are concerned of any possible violations and would like a confidential consultation, contact a qualified health attorney familiar with medical billing and audits today. Often Medicaid fraud criminal charges arise out of routine Medicaid audits, probe audits, or patient complaints.

The Health Law Firm’s attorneys routinely represent physicians, medical groups, clinics, pharmacies, assisted living facilities (AFLs), home health care agencies, nursing homes, group homes and other healthcare providers in Medicaid and Medicare investigations, audits and recovery actions.

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

Comments?

Like this story? Don’t like it? Any Comments? Please submit any thoughtful comments below.

Sources:

Dorschner, John. “Key West Pharmacy Top Whistle-Blower.” Miami Herald.(September 27, 2012). From: http://www.miamiherald.com/2012/09/27/3023894/key-west-pharmacy-top-whistleblower.html

About the Author: Danielle M. Murray 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.

By The Health Law Firm|2012-10-09T20:41:48-04:00May 15, 2018|Categories: Legal Defense for Pharmacists, Pharmacist, Pharmacy, Pharmacy Law, Whistleblower|Tags: audit, defense attorney, false claims act, FCA, Florida defense attorney, government health programs, legal defense, legal representation, medicaid, medicaid audit, Medicaid defense attorney, Medicaid fraud, Medicaid fraud defense attorney, Medicaid overbilling, Medicaid scheme, qui tam suits, whistleblower, whistleblower protection|0 Comments

Two Orlando-Area Pharmacists Arrested on Charges of Allegedly Trafficking Drugs

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

Two Orlando-area pharmacists were arrested on June 4, 2013, allegedly in connection to trafficking oxycodone, according to a number of local media sources. An Orlando Sentinel article states that the pharmacists are also co-owners of an Orlando pharmacy that was raided by the Metropolitan Bureau of Investigation (MBI).

This is the fourth pharmacy in the Orlando area in which a pharmacist has been arrested as a result of an MBI investigation into alleged forgery and drug trafficking operations, according to the Orlando Sentinel.

I want to point out that these are just allegations made against the pharmacists at this point in time and nothing has been proven by the state.

Pharmacists Allegedly Filling Fake Prescriptions for Drug Traffickers.

According to the Orlando Sentinel, MBI agents said the pharmacists had been under investigation since 2011. They are accused of accepting fraudulent forged prescriptions from drug-trafficking ringleaders. The drug traffickers would allegedly print off hundreds of fake prescriptions for pain medications, which were then taken to be filled at pharmacies around Central Florida.

To read the entire Orlando Sentinel article, click here.

Prescriptions Allegedly Full of Red Flags.

According to a WESH-TV report, the arrests were based on evidence of illegally selling pain medications to a local drug trafficking organization under circumstances in which there could be no reasonable good faith belief of a medical necessity. After reviewing the case, a Florida Department of Health (DOH) expert pharmacist said there were nine red flags that should have indicated that the prescriptions filled by the two arrested pharmacists were forged.

Click here to watch a report on the arrests from WESH-TV.

The Result of Crackdowns on Florida Pill Mills.

According to the director of Orange County’s Office for a Drug Free Community, the number of pill mills in Orange County, Florida, has dropped from 60 in 2010, to 23 clinics in June 2013. The number of oxycodone-related deaths are down in Florida as well. Click here to read a blog on that. However, with prescription pills harder to come by and more expensive, addicts are finding their replacement fix in heroin. To read a blog on the fight against heroin in Florida, click here.

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.

Comments?

What do you think of these pharmacy raids around Central Florida? As a pharmacist, what safeguards do you have in place so you do not fall under investigation? Please leave any thoughtful comments below.

Sources:

Pavuk, Amy. “Agents Raid South Orange Pharmacy, Arrest Pair.” Orlando Sentinel. (June 4, 2013). From: http://www.orlandosentinel.com/news/local/breakingnews/os-jr-pharmacy-raid-arrests-20130604,0,2706542.story

McDaniel, Dave. “Pharmacists Arrested on Trafficking Charges.” WESH TV. (June 4, 2013). From: http://www.wesh.com/news/central-florida/orange-county/pharmacists-arrested-on-trafficking-charges/-/12978032/20414548/-/13bxurx/-/index.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.

Finding a Healthcare Providers Service Organization (HPSO) Insurance Defense Lawyer

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

We are sometimes told by the health professionals we represent especially pharmacists, licensed mental health counselors (LMHCs), advanced registered nurse practitioners (ARNPs), massage therapists and physical therapists that after they received a complaint regarding their license from the Florida Department of Health (DOH) they had difficulty finding an experienced attorney in Florida who would accept their professional liability insurance. In this case, I am speaking specifically about Healthcare Providers Service Organization (HPSO) Insurance.

Benefits of HPSO Insurance.

The professionals who are covered by HPSO Insurance have excellent insurance coverage. HPSO Insurance provides professional liability coverage that protects in the event of a lawsuit or negligence claim. But much more often the professional receives a notice of an investigation, a subpoena for a deposition in someone else’s case, a demand because of an allegation of sexual harassment or sexual impropriety, a complaint because of a breach of medical records confidentiality or Health Insurance Portability and Accountability Act (HIPAA) Privacy complaint, or some other administrative type of action.

HPSO provides great coverage for these. For example, HPSO currently reimburses up to $10,000 in legal fees and expenses just for representation of you at depositions. HPSO currently reimburses up to $25,000 in legal fees and expenses for your defense in a DOH or Agency for Health Care Administration (AHCA) notice of investigation or complaint. HPSO currently reimburses up to $25,000 in legal fees and expenses for your legal representation in defense of a complaint or investigation regarding breach of medical confidentiality.

If you are a pharmacist, own a pharmacy, are a massage therapist, own an assisted living facility (ALF), are a mental health counselor or a social worker, or you are one of the many other types of health care professionals who HPSO insures, it should be fairly easy to find experienced health lawyers to represent you, especially in Florida.

Our firm and our attorneys, including George F. Indest III, Michael L. Smith, Joanne Kenna, Carole C. Schriefer, Lance O. Leider, Christopher E. Brown and Danielle M. Murray, routinely represent licensed health care professionals, interns and students in all types of administrative investigations and hearings and in defending lawsuits and other actions that have been filed. We also represent health facilities in license defense, survey complaints and administrative hearings. We represent them throughout Florida, from Pensacola, to Jacksonville, to Key West. We also occasionally represent them in other states, as well. We accept HPSO Insurance assignments.

Free Legal Advice: Get Insurance Immediately.

It is very important for every health professional to carry insurance that covers any investigation, complaint or administrative hearing that might be filed or opened against your license. You may think that you are covered for this by your employer, but you are not. If your employer contradicts this, ask for a statement in writing that your employer will pay for your legal defense for any such matter arising during your employment.

What typically happens, especially in the case of a hospital employee, nursing home employee, pharmacy employee or corporate employee, is that the employer is the one who terminates the employee and then files a complaint with the DOH. The DOH then opens an investigation against the health professional. The employer is not going to pay your legal defense costs if the employer has reported you.

You may very well be out of work, out of money and face an investigation and complaint that could terminate your professional license and career. You should not take this chance. Insurance such as HPSO Insurance is inexpensive and reliable. Buy it while you can afford it. After the actions have occurred, it is too late.

Find an Experience Health Law Attorney in the Event of an Investigation.

Also, you should immediately contact an experienced health law attorney if you are telephoned or visited by any investigator, or if you receive a letter advising you that an investigation has been opened regarding your care. Call immediately for advice before you speak with an investigator or provide any documents or statements of any kind.

You cannot and should not seek “legal advice” on what to do from the investigator, from a DOH employee, from your professional board or from any attorney representing any of them. They are not your friends. They are on the side against you. You should definitely not take any advice from them.

Do Not Skimp on Insurance Coverage.

If you have good insurance, it will pay for your legal expenses from the very beginning, so use it. However, beware of cheap insurance policies from professional associations that do not provide any coverage for disciplinary complaints and licensure investigations. Always check to be sure this is covered. Get it in writing. With some companies you have to pay an extra premium to obtain this coverage. With some insurers, they do not offer it, and you have to purchase a completely separate policy covering just this. It is worth it! Do it!

Contact Health Law Attorneys Experienced in Representing Health Care Professionals and Providers.

Our firm regularly represents pharmacists, massage therapists, mental health counselors, registered nurses, assisted living facilities, home health agencies, nurse practitioners, lab technicians, occupational therapists, physical therapists, social workers, physician assistants, psychologists and other health professionals in many different legal matters.

Services we provide include representation before your professional board, in DOH investigations, in administrative hearings, in civil litigation, in defense of malpractice claims, in professional licensing matters, in defense of allegations concerning HIPAA privacy violations and medical record breaches, in Drug Enforcement Administration (DEA) actions, and in many other matters.

We routinely represent physicians, dentists, nurse practitioners, and others in defending against malpractice claims, civil lawsuits, administrative complaints, peer review actions, DOH investigations, Medicare audits, Medicaid audits, and other matters. 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. If allowed, 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.

We also defend health professionals and health facilities in general litigation matters and business litigation matters.

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

Comments?

Do you have professional liability insurance? Why or why not. Please leave any thoughtful comments below.

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.

CVS Has Allegedly Been Refilling Prescriptions and Submitting Insurance Claims Without Patients’ Permission

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

The Office of Inspector General (OIG) for the U.S. Department of Health and Human Services (HHS) has reportedly launched an investigation into CVS’ practice for refilling prescriptions. According to an article in the Los Angeles Times, authorities are looking into reports that CVS has been refilling prescriptions and submitting insurance claims without patients’ permission. The Los Angeles Times article, released October 12, 2012, names an official with knowledge of this matter as the source.

We want to emphasize that this is from an unconfirmed news story. The government rarely announces investigations of specific subjects ahead of time.

Click here to read the entire article from the Los Angeles Times.

CVS Has Not Been Notified of Prescription Refill Investigation.

A related article in Reuters states that CVS said it has not been contacted by the government about the investigation. The pharmacy also said, as a policy, the company does not condone unauthorized refills. Officials said to allow unauthorized prescription refills could be considered insurance fraud, especially if insurers weren’t refunded for any drugs rejected by patients.

The probe might be, in part, related to the programs offered by many drugstores that allows a pharmacy to refill prescriptions even before a refill request has been made by the patient.

Click here to read the entire article from Reuters.

So far there is no news from the OIG for the HHS officially confirming this investigation.

Tempest in a Teapot?

It is unclear to me why there would be any cause to investigate CVS, if Medicare was not being billed until the customer actually picked up the prescription. If the customer fails to pickup the prescription, every drug store I know of restocks the medication after a short period and no one is ever billed for it. It seems that it would be a quick and simple matter for the OIG to check this.

Furthermore, it could also be argued that CVS actually is promoting good health by this practice. Patients may forget to renew or refill their prescriptions or may fail to notice they are running low.

Two Central Florida CVS Stores Get Controlled Substance Licenses Revoked by DEA.

On September 12, 2012, the U.S. Drug Enforcement Administration (DEA) revoked the registrations (controlled substance licenses) from two CVS pharmacies in Sanford, Florida. The two pharmacies are no longer able to fill prescriptions for drugs such as oxycodone, Dilaudid, Vicodin, Ritalin and Xanax. This decision was in response to a government crackdown on the distribution of painkillers. Click here to read a blog on this story.

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.

Comments?

What do you think of this story? Do you think CVS is doing anything wrong? How is this any different from the practice of many managed care plans mailing out 90 days of medications to its patients at a time? Please leave any thoughtful comments below.

Sources:

Lazarus, David. “CVS Caremark Prescription Refills Under Scrutiny, Source Says.” Los Angeles Times. (October 12, 2012). From: http://www.latimes.com/business/la-fi-lazarus-20121012,0,1032269.column

Alawadhi, Neha, Wohl, Jessica, and Morgan, David. “CVS Unaware of Any Government Prescription Refill Probe.” Reuters. (October 12, 2012). From: http://www.reuters.com/assets/print?aid=USBRE89B19520121012

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.

By The Health Law Firm|2012-10-22T20:23:17-04:00May 15, 2018|Categories: Legal Defense for Pharmacists, Pharmacist, Pharmacy, Pharmacy Law|Tags: administrative hearings, administrative law attorney, CVS pharmacy, defense attorney, defense lawyer, Florida defense attorney, Florida defense lawyer, investigation, medicare, Medicare fraud, Medicare investigation, Office of Inspector General (OIG), pharmacist, pharmacy, pharmacy investigation, prescription refills|0 Comments