Number of Oxycodone-Related Deaths Down in Florida

1 Indest-2008-1By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

It looks like Florida’s prescription drug legislation, the statewide prescription drug monitoring database and the prescription drug crackdowns by law enforcement may be working, according to the Florida Department of Law Enforcement (FDLE). The FDLE states in its semi-annual report, oxycodone-related deaths statewide dropped between January and June of 2012, compared to the same period of time in 2011. A look at the national numbers shows that the number of people abusing prescription drugs is also down.

Florida and National Numbers.

In the first half of 2012, there were 759 oxycodone-related deaths in Florida, according to the Orlando Sentinel. That number is down from 1,058 during the same time period a year before. The Orlando Sentinel states that nationwide 7 million people abused prescription drugs in 2010. By 2011, that number had dropped to 6.1 million. Studies also show prescription drug use among young adults ages 18 to 25 is also on the decline. The Metropolitan Bureau of Investigation Director believes these numbers are down because young people are realizing these drugs are dangerous and can be deadly.

Click here to read the entire article from the Orlando Sentinel.

Florida Cracks Down on Prescription Drug Abuse.

Previously, Florida was known as a state where drug addicts and dealers could easily find a pill mill or go doctor shopping to get prescription drugs. In the past two years, Florida state leaders and law enforcement officials have stepped up regulations and made serious crackdowns on doctors, pharmacists and pharmacies.

In April 2013, a Lake Mary doctor was sentenced to 25 years in prison for trafficking prescription drugs. Click here to read that story. In December 2012, a fake prescription drug ring was busted in Osceola County. To read that story, click here. In June 2012, the Drug Enforcement Administration (DEA) and Florida law enforcement announced operation “Pill Street Blues” targeting doctors and clinic owners across Florida. Click here to read more.

Health Care Professional Must Stay Ahead of Patients with Chronic Pain.

Even though the number of people abusing prescription drugs is down, state regulatory boards, private certification boards and federal agencies are not going to ease up. Many physicians in practice today are eschewing multi-disciplinary approaches to treating chronic pain in favor of monotherapies with narcotic medications.

These physicians do this at their own peril. In our practice we see many physicians in trouble with state medical boards and law enforcement officials because of their prescribing practices. If you treat patients with chronic pain it is imperative that you stay ahead of them. Click here to read a blog on legal tips for health care professionals to manage pain patients.

Contact Health Law Attorneys Experienced with Investigations of Health Professionals and Providers.

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

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

Comments?

Do you think the new legislation, the state prescription drug monitoring database and the crackdowns by law enforcement are making a difference in the war against prescription drugs? Please leave any thoughtful comments below.

Sources:

Pavuk, Amy. “‘We Can Stop This Epidemic,’ CDC Boss Says at Rx-Drug Abuse Summit in Orlando.” Orlando Sentinel. (April 2, 2013). From: http://www.orlandosentinel.com/news/local/breakingnews/os-prescription-drug-abuse-summit-20130402,0,4693169.story

Pavuk, Amy. “Drug-Related Deaths Plunge in First Half of 2012.” Orlando Sentinel. (March 25, 2013). From: http://www.orlandosentinel.com/news/local/breakingnews/os-drug-deaths-down-20130325,0,6750345.story

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 Administration Agents Raid Central Florida Pain Management Clinic

8 Indest-2008-5By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

Drug Enforcement Administration (DEA) agents along with local police and sheriffs’ deputies raided a Longwood, Florida, pain management clinic on June 14, 2013. According to the Orlando Sentinel, agents searched for evidence at the clinic associated with multiple doctors. DEA agents stated the clinic was operating as a “pill mill” and allegedly diverting legal prescriptions for illegal purposes. No one was arrested during the raid. Longwood is a suburb of Orlando.

Investigation Spreads to South Florida.

According to WESH-TV, during the raid agents took everything from the clinic that could help them build a criminal prosecution. This included paper records, computer equipment and prescription drugs. DEA agents would not say how many people they were investigating, but they did say this raid was the result of a two-year long investigation.

In addition to the Longwood pain clinic, DEA agents said they are also searching locations in Brevard County, Florida, where associates of the Longwood clinic allegedly live.

To watch the WESH-TV report, click here.
Two Doctors Associated With the Longwood Clinic Allegedly “Blacklisted” by Pharmacy.

According to the Orlando Sentinel, two doctors associated with the Longwood clinic were allegedly “blacklisted” in 2011, by CVS Pharmacy. This means that CVS notified those physicians that the pharmacy chain would no longer fill prescriptions they wrote for certain drugs such as oxycodone, due to suspiciously high prescribing rates. To read a previous blog on the CVS blacklist, click here.

Click here to read the entire Orlando Sentinel article.

The Longwood pain clinic is currently closed. Whether this will be temporary or permanent is unknown at this time.

Different Clinic, Similar Storyline.

This raid on the Longwood clinic is just one of the many we’ve recently seen in Florida. DEA agents and local law enforcement officials are not slowing down in their fight against illegal pill mills, and illegal prescribing and dispensing practices. To read a blog on two Orlando-area pharmacists recently arrested on charges of alleged drug trafficking, click here. Even the biggest pharmacy chains are not immune to investigations. Walgreens just agreed to pay $80 million to settle a DEA investigation into the chain’s dispensing practices of prescription drugs. To read more, click here.

Contact Health Law Attorneys Experienced with DEA Cases and Licensing Actions.

The Health Law Firm represents physicians, 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.
If you are aware of an investigation of you or your practice, or if you have been contacted by the DEA or DOH, contact an experienced health law attorney immediately.

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 about all of these raids on pharmacies and pain clinics? Please leave any thoughtful comments below.

Sources:

McDaniel, Dave. “Agents Raid Longwood Pain Clinic.” WESH-TV. (June 14, 2013). From: http://www.wesh.com/news/central-florida/seminole-county/agents-raid-longwood-pain-clinic/-/17597106/20572512/-/item/0/-/afpnwwz/-/index.html

Pavuk, Amy. “Agents Raid Longwood Pain Clinic.” Orlando Sentinel. (June 14, 2013). From: http://www.orlandosentinel.com/news/local/breakingnews/os-professional-pain-care-raid-20130614,0,3826330.story#tugs_story_display
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 Rules that Government Regulators Can Sue Over Pay-for-Delay Agreements Between Brand and Generic Drug Manufacturers

George F. Indest III, Board Certified by The Florida Bar in Health Law

George F. Indest III, Board Certified by The Florida Bar in Health Law

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

The U.S. Supreme Court ruled on June 17, 2013, that pay-for-delay agreements between brand name and generic drug manufacturers are subject to anti-trust scrutiny. These pay-for-delay agreements, or reverse payments, are usually a form of settlement between the two manufacturers in patent litigation. The Supreme Court decided that each instance must be considered on a case-by-case basis. This verdict rewrites the rules governing the release of generic drugs. It is likely to increase the number of generic drugs in the marketplace and reduce the price of generic drugs.

To read a previous blog on pay-for-delay agreements, click here.

What is a Pay-for-Delay Agreement?

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.

Why the Supreme Court Overruled Court of Appeals Decision.

The 5-3 vote overruled the 11th Circuit Court of Appeals decision that said pharmaceutical companies can’t be sued unless the patent litigation is a sham or a generic drug maker agrees to delay introduction of a generic drug into the market even after the patent has expired.

A Med Page Today article lists the Supreme Court’s five reasons why the appellate court made a mistake in giving blanket immunity to pay-for-delay agreements from the decision written by Justice Stephen Breyer:

–  “A reverse payment, where large and unjustified, can bring with it the risk of significant anticompetitive effects.”

–  “One who makes such a payment may be unable to explain and to justify it.”

–  “Such a firm or individual may well possess market power derived from the patent.”

–  “A court, by examining the size of the payment, may well be able to assess its likely anticompetitive effects along with its potential justifications without litigating the validity of the patent.”

–  “Parties may well find ways to settle patent disputes without the use of reverse payments.”

Click here to read the entire Med Page Today article.

Pay-for-Delay Agreements Allegedly Cost Patients Millions of Dollars a Year.

According to Bloomberg, the high court’s decision may discourage brand name and generic pharmaceutical companies from reaching settlements. 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. The Federal Trade Commission (FTC) claims pay-for-delay agreements cost consumers $3.5 billion a year in the form of higher drug prices.

To read the Bloomberg article, click here.

The Case of the FTC v. Solvay Pharmaceuticals.

The Supreme Court case center around AndroGel, a treatment for low testosterone in men, made by Solvay Pharmaceuticals, Inc. The FTC sued Solvay and three generic drug companies. According to Bloomberg, the FTC said that a payment made by Solvay, the holder of a patent on AndroGel, to the generic drug manufacturers represented an unlawful restraint of trade because it was intended to keep cheaper, generic versions of AndroGel off the market until 2020.

FTC Enthusiastic About the Decision.

In a statement, the FTC Chairwoman said the Supreme Court’s decision is a “significant victory for American consumers, American taxpayers and free market.” She also stated, “The court made it clear that pay-for-delay agreements are subject to antitrust scrutiny.”

Click here to read the full statement from the FTC.

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?

What do you think of the Supreme Court’s ruling? Do you agree or disagree? What effect do you think it will have on the pharmaceutical industry? Please leave any thoughtful comments below.

Sources:

Stohn, Greg. “Drugmakers Opened to ‘Pay for Delay’ Suits by High Court.” Bloomberg. (June 17, 2013). From: http://www.bloomberg.com/news/2013-06-17/drugmakers-opened-to-pay-for-delay-suits-by-high-court.html

Frieden, Joyce. “Supreme Court Split on Pharma ‘Pay for Delay’ Deals.” Med Page Today. (June 17, 2013). From: http://bit.ly/18SfhKb

Kaplan, Peter. “Statement of FTC Chairwoman Edith Ramirez of the U.S. Supreme Court’s Decision in FTC v. Actavis, Inc.” (June 17,2 013). From: http://www.ftc.gov/opa/2013/06/actavis.shtm

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.

More than 30 People Charged with Pharmaceutical Drug Trafficking in Central Florida

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.

Charges are Being Handed Down to the Defendants.

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.

New Details Released on Drug Enforcement Administration’s Investigation of Central Florida Pain Management Clinic

8 Indest-2008-5By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

The Drug Enforcement Administration’s (DEA) investigation into a Longwood, Florida, pain management clinic continues. More details are being revealed about the case. DEA agents along with local police and sheriffs’ deputies raided the pain management clinic on June 14, 2013. Agents believe the evidence they have gathered suggests the clinic was operating as a “pill mill,” according to the Orlando Sentinel. Officials allegedly seized evidence at the clinic associated with at least ten (10) doctors and other clinic employees. No one has been arrested yet, but documents filed in federal court in Orlando suggest charges could be coming.

I previously blogged about this raid. Click here to read that blog.

Details of the Investigation.

According to the Orlando Sentinel, the DEA began surveying the alleged pill mill in January 2011, while investigating a doctor shopper. From July 2011 through May 2013, agents monitored the clinic. During the investigation, agents observed long lines outside the clinic, out-of-state license plates and groups of “patients” arriving at the clinic together. All of this behavior, according to authorities, is associated with pain clinics.

More concrete evidence against the pain management clinic, according to police officials, includes:

–  Patients stating that employees discussed selling pain pills and fake MRIs;

–  DEA agents observing drug deals made by patients coming from the clinic, in the vicinity of the clinic;

–  Used needles were found in nearby parking lots; and

–  Two of the clinic’s patients allegedly died from overdoses during the investigation.

Pain Management Clinic Physicians Made Millions.

It’s reported that the pain management clinic hired ten (10) doctors to write illegal prescriptions and employed others to falsify documents. For their willingness to participate in the illegal activity, the physicians allegedly made millions of dollars.

According to the Orlando Sentinel, the bank accounts of the clinic managers were analyzed as part of the investigation. From 2011 to 2013, more than $5.5 million in cash was deposited into the bank accounts of the clinic managers and physicians.

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

Keep in mind, at this point, these are just allegations made against the clinic and its employees and nothing has been proven by the state or federal government.

Be Mindful of the Prescription Drug Monitoring Database.

DEA agents used Florida’s prescription drug monitoring database to find out what types of pills and how many pills physicians at the Longwood pain clinic were prescribing. The prescription database was not intended to be used for criminal prosecution or law enforcement purposes. Yet it is routinely being used to prosecute physicians, pharmacists and pharmacies among others.

If You are a Health Care Professional Involved with Pain Management, Keep These Tips Handy.

The raid on the Longwood clinic is just one of the many we’ve recently seen in Florida. DEA agents and local law enforcement officials are not slowing down in their fight against illegal pill mills, and illegal prescribing and dispensing practices. I have represented a number of physicians who have been accused of “overprescribing.”  Some of these were criminal investigations by local law enforcement authorities, such as a county sheriff’s office. Some were investigations by the DEA. Some were investigations by the state licensing agency, such as the Florida Department of Health (DOH).

It is important physicians know how to protect themselves and their licenses from drug-seeking patients.  Click here to read tips I give to physicians I advise on this issue.

Contact Health Law Attorneys Experienced with DEA Cases and Licensing Actions.

The Health Law Firm represents physicians, 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.
If you are aware of an investigation of you or your practice, or if you have been contacted by the DEA or DOH, contact an experienced health law attorney immediately.

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 about all of these raids on pharmacies and pain clinics? Please leave any thoughtful comments below.

Sources:

Pavuk, Amy. “Rx for Danger: Pain Clinic Owners Made Millions, Hired 10 Doctors to Write Illegal Scripts, Feds Say.” Orlando Sentinel. (June 24, 2013). From: http://www.orlandosentinel.com/health/os-professional-pain-care-longwood-20130624,0,1172890.story

Indest, George. “Drug Enforcement Administration Agents Raid Central Florida Pain Management Clinic.” The Health Law Fir. (June 17, 2013). From: http://thehealthlawfirmblog.wordpress.com/2013/06/17/drug-enforcement-administration-agents-raid-central-florida-pain-management-clinic/

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) Blocks Shipping of Controlled Substances at Walgreens Distribution Center in Florida

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 Suspension Order Only Stops the Distribution of Controlled Substances.

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.

Millions of Oxycodone Pills Purchased by Walgreens Stores.

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
.

Continued War on Prescription Drug Abuse.

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.

Oxycodone Numbers Published for Shock Value.

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.

Where Do Legitimate Chronic-Pain Patients Turn?

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.

Top Medicare Prescribers Collect Speaking Fees from Drug Makers-Coincidence?

LOL Blog Label 2By Lance O. Leider, J.D., The Health Law Firm and George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

A recent investigation by ProPublica found that certain doctors who prescribed certain drug brands the most, also have financial ties to the companies that manufacture those prescription drugs. Using Medicare payment data, ProPublica and National Public Radio (NPR) researched physicians who prescribed the most heavily promoted drugs of 2010 and 2011. It was discovered that many of the doctors allegedly had financial relationships with prescription drug manufacturers. ProPublica states that they initiated this investigation out of fear that pharmaceutical payments are influencing doctors to prescribe an expensive, brand name drug over a cheaper, generic version.

To read the ProPublica analysis released June 25, 2013, click here.

According to ProPublica, the company is an independent, nonprofit newsroom that produces investigative journalism in the public interest.

By The Numbers.

The ProPublica analysis looked at a number of drug companies. Until now, doctors’ prescribing practices have not been made public. Disclosure of these records is now mandated in the Affordable Care Act.

According to NPR, at least 17 of the 20 doctors who prescribed the blood pressure medicine Bystolic the most often collected money from the maker, Forest Laboratories. Forest paid those doctors speaking fees for promoting Bystolic at seminars to other doctors. These fees allegedly ranged from $1,250 to $85,750. Additionally, seven of the speakers allegedly received at least $1,000 for meals. Nine of the top 10 prescribers of Exelon, an Alzheimer’s drug, collected speakers’ fees from Novartis. Eight of the top 10 Nucynta prescribers were paid by the painkiller’s manufacturer, Johnson & Johnson, for similar services, according to NPR.

Click here to read the entire NPR article.

Drug Makers Shell Out Millions in Fines for Using Illegal Kickbacks.

Federal whistleblower lawsuits against several pharmaceutical companies have alleged that these speaking payments are little more than “thinly veiled kickbacks,” which are illegal. According to NPR, three years ago Forest paid $313 million to the federal government to settle allegations about its marketing of drugs. The lawsuit alleged the company made cash payments disguised as consulting fees to doctors.

Novartis is currently fielding two different lawsuits filed 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 Novartis 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 Novartis products that were reimbursed by federal health care programs.  Click here to read a previous blog on these lawsuits.

Individual providers are also liable for accepting prohibited remunerations from drug companies. The use of these databases for mining prescribing/promoting practices is likely to lead to increased scrutiny on physicians.

What the Law Says About Using Kickbacks.

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.

Relationship Between Physicians and Pharmaceutical Companies Allegedly Does Not Influence Prescribing Practices.

In a survey, doctors said they are not influenced by relationships with pharmaceutical companies, according to a FiercePharma article. The doctors with a relationship to Forest state a number of reasons for prescribing Bystolic versus other blood pressure dugs. None of the reasons for prescribing Bystolic related to the money they received from Forest.

In the same FiercePharma article, drug makers said they do not choose speakers based on a doctor’s prescribing habits. Click here to read the FiercePharma article.

So is this all a coincidence?

Contact Health Law Attorneys Experienced with Investigations of Health Professionals and Providers.

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

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

Comments?

Is it a coincidence that top prescribers also collect from drug makers? As a health care professional, would you be influenced to prescribe one drug if you were getting paid by the drug maker? Please leave any thoughtful comments below.

Sources:

Staton, Tracy. “Top-Prescribing Docs Collect Cash From Drugmakers.” FiercePharma. (June 25, 2013). From: http://www.fiercepharma.com/story/top-prescribing-docs-collect-cash-drugmakers/2013-06-25

Ornstein, Charles, Weber, Tracy and Lafleur, Jennifer. “Top Medicare Prescibers Rake In Speaking Fees From Drugmakers.” National Public Rado. (June 25, 2013). From: http://www.npr.org/blogs/health/2013/06/25/195232541/top-medicare-prescribers-rake-in-speaking-fees-from-drugmakers

Ornstein, Charles, Weber, Tracy and Lafleur, Jennifer. “Top Medicare Prescibers Rake In Speaking Fees From Drugmakers.” ProPublica. (June 25, 2013). From: http://www.propublica.org/article/top-medicare-prescribers-rake-in-speaking-fees-from-drugmakers

About the Authors: 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 Avenue, Altamonte Springs, Florida 32714, Phone:  (407) 331-6620.

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.

More Than 20 Arrest Warrants Issued by Polk County Sheriff’s Office in Connection to Pill Mill Investigation

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

The Polk County Sheriff’s Office issued 25 arrest warrants in connection to an ongoing pill mill investigation involving a medical clinic in Winter Haven, Florida. On September 19, 2012, the sheriff’s office announced that ten suspects in the case have been arrested, and 15 suspects with arrest warrants remain at large.

Click here to see the press release from the Polk County Sheriff’s Office.
Authorities Used the Prescription Drug Monitoring Program to find Suspects.

Last year the state launched the Prescription Drug Monitoring Program, which requires doctors and pharmacists who dispense controlled substances to report the information to a statewide database.

According to the Polk County Sheriff’s Office, the database was used to round up those associated with the Winter Haven medical clinic.

In an article in the News Chief, deputies said 13 of the suspects were allegedly acting as “smurfs” (people hired by a drug ring to take fake prescriptions to be filled, then turning the pills over to the ring). Another 12 people were accused of “doctor shopping,” which is the practice of going to multiple doctors to get many prescriptions for narcotics.

To read the entire article from the News Chief, click here.

This case was investigated by the Polk County Sheriff’s Office, the Florida Department of Law Enforcement (FDLF), the Florida Department of Health (DOH) and the Attorney General’s (AG) Office.

“These people are giving the smurfs a bad name,” Papa Smurf stated. “We should be happy that law enforcement is doing a good job rounding up the read ‘bad guys,’”added Brainy Smurf.
Legal Tips for Physicians to Manage Pain Patients.

Doctors, pharmacists and all healthcare professionals who are involved in schemes relating to overprescribing or trafficking in narcotics may be targeted by many different agencies.

We have represented physicians who have been the subjects of Drug Enforcement Administration (DEA) investigations. The DEA will often use undercover agents and informants to pose as patients, wired for audio recording. The DEA will often work with local law enforcement authorities and the Department of Health (DOH).

Other investigations and arrests may be initiated by a statewide prosecutor’s office, which is under the Attorney General (AG). Still others have been initiated by the Medicaid Fraud Control Unit (MFCU) where Medicaid funds are used.

Click here to see an article on our website with tips for to help manage pain patients.

Give us your thoughts on this story below.

Contact Health Law Attorneys Experienced in Representing Health Care Providers in DOH Cases.

The Health Law Firm represents pharmacists, pharmacies, physicians, nurses, and other health care providers in investigations, regulatory matters, licensing issues, litigation, inspections and audits involving the DEA, Department of Health (DOH), and other law enforcement agencies.

If you are aware of an investigation of you or your practice, or if you have been contacted by the DEA or DOH, contact an experienced health law attorney immediately.

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

Parody, Clifford. “25 Warrants Issued in Ongoing Pill Mill Case.” News Chief. (September 20, 2012). From: http://www.newschief.com/article/20120920/NEWS/209205012

Pavuk, Amy. “25 Arrest Warrants Issued in Pill-Mill Probe.” Orlando Sentinel. (September 19, 2012). From: http://articles.orlandosentinel.com/2012-09-19/news/os-polk-pill-mill-arrests-20120919_1_pill-mill-probe-arrest-warrants-fraudulent-prescriptions

Eleazer, Carrie. “25 Arrest Warrants Issued in Connection to On-Going Pill Mill Investigation.” Polk County Sheriff’s Office. (September 19, 2012). From: http://www.polksheriff.org/NewsRoom/News%20Releases/Pages/09-19-2012.aspx
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.

Central Florida Pain Management Clinic Falls Victim to Civil Forfeiture

DPP_12By Christopher E. Brown, J.D., The Health Law Firm

On June 14, 2013, Drug Enforcement Administration (DEA) agents, along with local police and sheriffs’ deputies raided a Longwood, Florida, pain management clinic. In addition to criminal charges, the physicians and employees associated with this clinic face another lesser known threat,  the civil forfeiture of their money and property. During the raid agents took everything from the clinic that could help them build a criminal prosecution. This included paper records, computer equipment and prescription drugs. In addition to the Longwood pain management clinic, DEA agents also searched homes in Brevard County, Florida, where associates of the Longwood clinic allegedly live. To read more on the raid, click here.

This is just one example. Recently we’ve noticed that it is becoming more common for government prosecutors and agencies, including the Medicaid Fraud Control Unit (MFCU), the U.S. Attorney’s Office, and local sheriff and police departments to use the Florida Contraband Forfeiture Act against health professionals and health facilities in health-related cases.

The Difference Between Criminal and Civil Forfeiture Laws.

There are two types of forfeiture laws, criminal and civil.  Criminal forfeiture laws allow the seizure of property only after a conviction beyond a reasonable doubt. On the other hand, civil forfeiture laws allow the government to gain possession of a person’s property immediately and without any determination of guilt.

Property is Subject to Forfeiture if Criminally Derived.

Under the idea that the property is itself guilty by association, federal and local law enforcement authorities may take your property without convicting or arresting you, putting the burden on you to prove that property was not associated with a criminal enterprise.  The property seized does not have to belong to the alleged bad actor or criminal.  This can occur because civil forfeiture is a civil lawsuit against property. The legal action has less to do with a person’s guilt and more to do with the property’s use as an instrumentality in a crime.  If the property has been used in association with or to aid criminal acts, the property is subject to civil forfeiture proceedings.

This is what the physicians and employees of the Longwood clinic are now facing.  While these individuals’ homes and property may not be directly associated with criminal activity, the government is still arguing that the property is subject to forfeiture because the money used to buy it was “criminally derived.”

Fighting Civil Forfeiture.

We believe the main purpose in the government’s use of civil forfeitures is to shut down the alleged criminal and make it so he or she cannot hire an attorney to defend the person(s) accused. This does, unfortunately, often work. However, a prompt, aggressive defense to these actions may recover the property or funds seized and, more importantly, a good defense can be used to help resolve any pending criminal charges.

The key to success in civil forfeiture actions is to immediately consult with an experienced attorney after the property has been seized.  Your best defense is to act as quickly as possible. To read more what defenses can be used to fight civil forfeiture, click here for a previous blog.

Contact Health Law Attorneys Experienced in Civil Forfeiture Cases.

The Health Law Firm routinely represents physicians, nurses, pharmacists, dentists, mental health counselors and other health providers in investigations, regulatory matters, licensing issues, litigation, civil forfeitures, inspections and audits involving the Drug Enforcement Administration (DEA), Federal Bureau of Investigation (FBI), 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.

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 the Civil Forfeiture Act being used against health care professionals and health facilities? Please leave any thoughtful comments below.

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.

Orlando Pharmacist in Hot Water After Filling Fraudulent Prescriptions

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.

 Ongoing Investigation Led to Pharmacy Raid.

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.

Pharmacists Beware of Phony Prescription Rings Around the State.

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.

How to Handle Legal Issues.

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.

Spike in Pharmacy Raids and Shutdowns in the Sunshine State.

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: ttp://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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