Nation Rx Drug Abuse Summit Held in Central Florida-Leaders Share Struggles and Triumphs in “War Against Prescription Drugs”

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

From April 2 through April 4, 2013, the country’s leading experts on the prescription drug epidemic met in Central Florida for the National Rx Drug Abuse Summit, according to the Orlando Sentinel. National leaders including the White House drug czar, the director of the Centers for Disease Control and Prevention (CDC), U.S. Food and Drug Administration (FDA) commissioner and Florida’s Attorney General (AG) shared ongoing challenges and strides each department has made in its fight against prescription drugs.

Good News in the War Against Prescription Drugs.

The Florida Department of Law Enforcement (FDLE) stated in its semi-annual report that oxycodone-related deaths statewide dropped between January and June of 2012, compared to the same period of time in 2011. In the first half of 2012, there were 759 oxycodone-related deaths in Florida. That number is down from 1,058 during the same time period a year before.

A look at the national numbers shows that the number of people abusing prescription drugs is down. According to the White House drug czar, seven 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. To read the article from the Orlando Sentinel, click here.

Summit Focused on Need for More State Prescriptions Drug Monitoring Programs.

During the summit leaders spoke of the need to help state prescription drug monitoring programs succeed.

Just in March 2013, three states made moves to tighten monitoring and prescribing of controlled substances. Legislators in California, Pennsylvania and Kentucky are contemplating new regulations regarding the use of prescription drug monitoring programs. What this means is that whatever state you may be in, you should be aware that lawmakers are implementing similar programs and laws in their governments. To learn more, click here.

Drug Monitoring Programs Can Be Used as a Prosecution Tool.

Health professionals should take note, these prescription drug monitoring programs can, and will be, used as a prosecution tool. Enforcement of drug laws and prescribing regulations has been ever increasing in recent years. The implementation of these databases and corresponding regulations are going to provide more tools for law enforcement and state medical boards to crack down on physicians. In order to avoid trouble it is crucial that you take time to review your state’s prescribing and record keeping laws with an experienced health care attorney.

From experience, we have seen the database in Florida used mostly as a tool for prosecution of pain management physicians and pharmacists. Even in cases where the pharmacist has been the one to notify the authorities of suspected forged prescriptions and where the pharmacist has cooperated in prosecuting the criminals, I have seen this database cited as evidence against him or her. I do not believe this is what the legislation intended. Physicians and pharmacists should consider using whatever database is implemented in their respective states, or otherwise remaining vigilant to avoid being labeled an overprescriber.

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?

Does the state where you are located have a prescription drug monitoring program? What do you think of these programs? Are they necessary? 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

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.

United Parcel Service (UPS) Agrees to Pay Settlement for Online Pharmacy Shipping

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

United Parcel Service, Inc. (UPS) will pay $40 million to the Department of Justice (DOJ) to settle a probe related to its shipments on behalf of illicit online pharmacies. This announcement came on March 29, 2013.

Click here to read the press release from the DOJ.

UPS and FedEx Corp., have been the targets of a federal investigation to crackdown on illegal sales of prescription drugs.

UPS Had Previous Warning of Investigation.

From 2003 to 2010, the government warned UPS that internet pharmacies were using its services to distribute controlled substances and prescription drugs, according to the Orlando Sentinel. Federal law prohibits the purchase of controlled substances without a valid prescription from a physician. Even after being made aware, the government alleges UPS did not implement procedures to close these pharmacies’ accounts.

According to the Orlando Sentinel, because of the settlement agreement, the government agreed not to prosecute UPS. The company has also agreed to enhance its compliance policies with respect to shipments made from internet pharmacies. The company could have faced charges ranging from money laundering to distribution of controlled substances. Click here to read the entire article from the Orlando Sentinel.

FedEx Calls the Investigation a Threat to Privacy.

FedEx, has acknowledged it is under investigation, but called the probe a threat to customers’ privacy, and “absurd and deeply disturbing,” according to an article in the Wall Street Journal. FedEx has allegedly asked the Drug Enforcement Administration (DEA) to give the company a list of pharmacies it believes to be illegally operating so FedEx can shut down shipping services to those pharmacies. So far, FedEx is not facing any charges. To read the article from the Wall Street Journal, click here.

DEA Went After Doctors, Pharmacists and Pharmacies First.

Law enforcement including the DEA, the Federal Bureau of Investigation (FBI), and the Department of Health (DOH) all seem to be having a hard time keeping up with prescription drug abuse, especially in Florida. These agencies have increased their efforts on doctors, pharmacies and pharmacists to crackdown on violators.

Click here to read a blog on an Orlando physician accused of prescribing painkillers to undercover agents. Click here to read a blog DEA’s investigation of six Walgreens pharmacies in Florida. Click here to read a blog on a Florida pharmacy owner who allegedly committed a $23 million health care fraud scheme. Check our website for similar blogs.

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, 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?

What do you think of the government’s investigation into UPS and FedEx? Do you think it could possibly be an invasion of privacy? Please leave any thoughtful comments below.

Sources:

Barrett, Devlin. “UPS to Settle Web Pharmacy Case.” Wall Street Journal. (March 29, 2013). From: http://online.wsj.com/article/SB10001424127887323501004578390623687298836.html

Pavuk, Amy. “UPS Agrees to $40M Settlement in Online Pharmacy Shipping Probe.” Orlando Sentinel. (March 29, 2013). From: http://articles.orlandosentinel.com/2013-03-29/news/os-ups-dea-prescription-drugs-20130329_1_online-pharmacies-prescription-drugs-ups

Department of Justice. “UPS Agrees to Forfeit $40 Million in Payments from Illicit Online Pharmacies for Shipping Services.” Department of Justice. (March 29, 2013). From: http://www.justice.gov/usao/can/news/2013/2013_03_29_UPS.forfeit.press.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.

Food and Drug Administration (FDA) Recalls Products from Two Different Compounding Pharmacies

By Carole C. Schriefer, R.N., 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

Two different compounding pharmacies have recently recalled products due to concerns from the Food and Drug Administration (FDA). The New Jersey compounding pharmacy, Med Prep Consulting, and Clinical Specialties Compounding in Georgia, both recalled products between March 17, 2013 and March 20, 2013.

The recalls were issued as the FDA and state agencies step up regulation on compounding pharmacies across the country. These agencies are trying to prevent another widespread outbreak, like the fungal meningitis outbreak in the fall of 2012, which is responsible for 50 deaths.

All Products from Med Prep Consulting Recalled.

Med Prep Consulting first issued a recall on March 17, 2013, for all lots of magnesium sulfate for injections after a hospital reported seeing visible particles in the containers. Three days later, the compounding pharmacy recalled all of its compounded products. Med Prep Consulting has halted production, processing and shipping. The FDA reported products distributed through March 15, 2013, in New Jersey, Pennsylvania, Delaware and Connecticut need to be returned to the company. Click here to see all the recalled products from Med Prep Consulting.

Products from Georgia Compounding Pharmacy Allegedly Causing Eye Infections.

According to Modern Healthcare, at least five people have acquired serious eye infections associated with the use of the cancer drug Avastin packaged in syringes from Clinical Specialties Compounding. At the company’s facility in Georgia the FDA raised concerns about the lack of sterility assurance. Products covered under the recall were distributed nationwide, between October 19, 2012 and March 19, 2013. Until further notice, healthcare providers are asked to stop using all of these sterile products and return them to the company. Click here to read the press release on the recall from the FDA.

Franck’s Compounding Pharmacy in Florida  Caused Fungal Growth.

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.

Compounding Pharmacies Under the Microscope.

Since the widespread fungal meningitis outbreak, compounding pharmacies have fallen under heightened scrutiny. The FDA is beefing up their oversight of compounding pharmacies, and, according to Modern Healthcare, the FDA and state Department of Health (DOH) agencies have been paying surprise visits to compounding pharmacies. Click here to read more from Modern Healthcare.

Deficiencies That are Common in Pharmacy Inspections.

Pharmacies and pharmacists are subject to many types of inspections. These inspections are necessary to determine whether the business and its employees are complying with state and federal laws and regulations. Administrative agencies, such as the Drug Enforcement Administration (DEA), FDA and DOH, have the authority to inspect pharmacies.

With our experience working with pharmacists and pharmacies we’ve seen a number of different inspection deficiencies. These errors may result in a complaint being filed and the beginning of the administrative law process regarding investigations and hearings.

Here are some common deficiencies often found during pharmacy inspections:

1. Pharmacy technicians not properly identified with name tags and identified as
pharmacy technicians (as opposed to pharmacists);

2. Pharmacy technicians not supervised by pharmacist;

3. Medication on shelves not properly labeled (including exact number of pills remaining in bottle);

4. Controlled substances not accurately recorded on appropriate forms; and

5. Not keeping schedule II inventory and dispensing records separate from schedule III-V records.

Click here to read a recent blog listing more deficiencies and your best defense to protect your pharmacy license and pharmacist license.

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 harsher regulations compound pharmacies are now facing? Please leave any thoughtful comments below.

Sources:

Meinhardt, Jane. “Compounding Pharmacies Set to Navigate Potential Regulations.” Tampa Bay Business Journal. (January 25, 2013). From: http://www.bizjournals.com/tampabay/print-edition/2013/01/25/compounding-pharmacies-set-to-navigate.html?s=print

Blesch, Gregg. “Georgia Compounding Pharmacy Widens Recall.” Modern Healthcare. (March 22, 2013). From: http://www.modernhealthcare.com/article/20130322/NEWS/303229959/#

Clinical Specialties. “Clinical Specialties Compounding Pharmacy Announces Voluntary Nationwide Recall of All lots of Sterile Products Repackaged and Distributed by Clinical Specialties Compounding Due to Lack of Sterility Assurance.” Food and Drug Administration. (March 20, 2013). From: http://www.fda.gov/Safety/Recalls/ucm344786.htm

About the Authors: Carole C. Schriefer 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.

California, Pennsylvania and Kentucky Move to Tighten Laws Related to Controlled Substance

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

In reports from both coasts, three states have recently made moves to tighten monitoring and prescribing of controlled substances. Legislators in California, Pennsylvania and Kentucky are contemplating new actions. Health professionals should take note, these prescription drug monitoring programs can, and will be, used as a prosecution tool.

Details of the Prescription Drug Monitoring Program Possibly Coming to Your State.

According to the Los Angeles Times, California is looking to utilize its prescription drug monitoring program CURES to find physicians who are a little too loose with the prescription pad. Lawmakers are contemplating mining the data compiled by CURES to find physicians who are overprescribing and take action against them. Click here to read the entire Los Angeles Times article.

The Pennsylvania house recently forwarded a bill from committee to the floor for a final vote. The bill would establish a monitoring program like those in California, Florida and Kentucky. This monitoring program would be used to combat abuse and doctor shopping by identifying patients that have already received an adequate supply of medications.

Kentucky, already the home of some tough prescription drug laws, is looking to fine tune its regulatory scheme. According to The Courier-Journal, the new bill would clarify existing regulations by providing medical exemptions for patients that would otherwise be wrapped up in the enforcement provisions. To learn more on the proposed changes to Kentucky’s prescription drug laws, click here.

Most States Looking into Prescription Drug Monitoring Programs.

Lawmakers in all three states cited laws and regulations from other states as inspiration for the moves to consider new laws to monitor prescriptions of controlled substances. What this means is that whatever state you may be in, you should be aware that lawmakers are looking around the country at what works and are implementing similar programs and laws in their governments.

Databases Can Be Used as a Prosecution Tool.

Enforcement of drug laws and prescribing regulations has been ever increasing in recent years. The implementation of these databases and corresponding regulations are going to provide more tools for law enforcement and state medical boards to crack down on physicians. In order to avoid trouble it is crucial that you take time to review your state’s prescribing and record keeping laws with an experienced health care attorney.

From experience, we have seen the database in Florida used mostly as a tool for prosecution of pain management physicians and pharmacists. Even in cases where the pharmacist has been the one to notify the authorities of suspected forged prescriptions and where the pharmacist has cooperated in prosecuting the criminals, I have seen this database cited as evidence against him or her. I do not believe this is what the legislation intended. Physicians and pharmacists should consider using whatever database is implemented in their respective states, or otherwise remaining vigilant to avoid being labeled an overprescriber.

To read legal tips to manage pain patients, click here.

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.

Opinions?

Does the state where you are located have a prescription drug monitoring program? Is it similar to any of programs we mentioned in this blog? What do you think of these programs? Are they necessary? Please leave any thoughtful comments below.

Sources:

Girion, Lisa and Glover, Scott. “Atty. Gen. Kamala Harris Urges Funding for Prescription Tracking.” Los Angeles Times. (March 3, 2013). From: http://latimesblogs.latimes.com/lanow/2013/03/attorney-general-kamala-harris-funding-prescription-database-.html

Wynn, Mike. “Kentucky Legislature Overhauls Prescription Drug Law.” The Courier-Journal. (March 4, 2013). From: http://www.courier-journal.com/apps/pbcs.dll/article?AID=2013303040093&nclick_check=1

Associated Press. “Lawmakers Mull Prescription Drug Monitoring.” Associated Press. (March 4, 2013). From: http://meadvilletribune.com/local/x986702017/Lawmakers-mull-prescription-drug-monitoring

About the Author: Lance O. Leider is an attorney with The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Avenue, Altamonte Springs, Florida 32714, Phone: (407) 331-6620.

The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.
Copyright © 1996-2012 The Health Law Firm. All rights reserved.

Drug Enforcement Administration (DEA) Investigates Six Walgreens Pharmacies in Florida

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) served an Order to Show Cause (OSC) on a Fort Myers Walgreens pharmacy on February 21, 2013. According to the DEA, the OSC was served as a notice to provide Walgreens with an opportunity to show cause as to why their DEA registration should not be revoked. The Fort Myers pharmacy is one of six Walgreens pharmacies to be targeted for prescribing practices by the DEA.

Click here to read the press release from the DEA.

According to the DEA, these investigations are part of an effort to curb Florida’s prescription drug epidemic.

Six Walgreens Pharmacies and One Distribution Center Targeted by DEA.

In April 2012, the DEA served and Administrative Inspection Warrant (AIW) on the Fort Myers Walgreens pharmacy, as well as five other Walgreens pharmacies in Florida and its distribution center in Jupiter. According to the DEA, the AIWs were served to determine if the pharmacies were dispensing prescriptions for legitimate medical purposes.

Based on the DEA’s findings, the Walgreens distribution center was served with an immediate suspension order (ISO). Click here to read our previous blog on the ISO served on the distribution center.

Between November 2012 and February 2013, the DEA has served OSCs on six Florida Walgreens pharmacies.

According to an article in Naples News, no action has been taken against the stores’ licenses, so they are still able to fill prescriptions pain medications and controlled substances. An administrative hearing will be held in April 2013. The hearing is an opportunity for Walgreens to present their cases. To read the entire Naples News article, click here.

Two CVS Stores in Sanford, Florida Lost Controlled Substance Licenses.

In September 2012, 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.

The Ultimate Results of Such Crackdowns.
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.

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 investigations on big pharmacies? Please leave any thoughtful comments below.

Sources:

Drug Enforcement Administration. “DEA Serves an Order to Show Cause on Walgreen’s Pharmacy in Fort Myers.” Drug Enforcement Administration. (February 22, 2013). From: http://www.justice.gov/dea/divisions/mia/2013/mia022213a.shtml

Freeman, Liz. “DEA Targets Fort Myers Walgreens, 5 Other State Stores.” Naples News. (March 7, 2013). From: http://www.naplesnews.com/news/2013/mar/07/dea-targets-fort-myers-walgreens-5-other-state/?print=1

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.

Florida’s Medicaid Program Receives Settlement Payment from Pharmaceutical Company

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

The Florida Attorney General’s (AG) Medicaid Fraud Control Unit (MFCU), 46 other states and the federal government reached a $48 million agreement with pharmaceutical company Healthpoint Ltd., on February 25, 2013. According to the Florida AG, the settlement is in response to allegations of misrepresenting the regulatory status of an ointment used to treat skin conditions and submitting false Medicaid claims. Florida’s Medicaid program will receive almost $900,000 of the settlement.

Click here to see the press release from the AG’s office.

Pharmaceutical Company Allegedly Submitted False Claims to Medicaid.

According to the Department of Justice (DOJ), Healthpoint launched the ointment for the treatment of nursing home patients with bed sores. The settlement resolves allegations that Healthpoint marketed the ointment, Xenaderm, without the approval of the Food and Drug Administration (FDA) by modeling it on a pre-1962 drug that the FDA never reviewed. The DOJ states that the main ingredient in Xenaderm was determined by the FDA to be less-than-effective for its intended use. The government contends those determinations render the ointment ineligible for Medicaid reimbursements. Healthpoint is accused of knowingly submitting false claims to Medicaid programs.

To read the press release on the settlement from the DOJ, click here.

The settlement is th result of litigation by the United States Attorney’s Office for the District of Massachusetts, the DOJ and fifteen (15) states, including Florida.

Responding to a Medicaid Audit.

Should you find yourself, your facility or your health practice the subject of a Medicaid audit by your state Medicaid agency or audit contractor, there are a few things you should know.

The most important thing is that just because you are being audited, it does not mean that you or your business has done anything wrong. State and federal governments conduct audits for many different reasons. Typical ones include: special audits of high-fraud geographic areas, auditing of particular billing codes, randomly selected provider auditing, and complaints of possible fraud.

Click here to see a complete list of steps you should take in order to compile and provide a set of records that will best serve to help you avoid any liability at the conclusion of the audit process.

Contact Health Law Attorneys Experienced in Handling Medicaid Audits, Investigations and other Legal Proceedings.

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, dentists, orthodontists, 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. We also represent health professionals and others who know of Medicare and Medicaid fraud to file whistleblower and qui tam cases.

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 settlement agreement? Please leave any thoughtful comments below.

Sources:

Meale, Jenn. “Attorney General Bondi’s Office Reaches Settlement with Pharmaceutical Company.” Florida Office of the Attorney General. (February 25, 2013). From: http://www.myfloridalegal.com/newsrel.nsf/newsreleases/D69C285712F6FF9185257B1D004D275D

Department of Justice. “Healthpoint Ltd. to Pay up to $48 Million for False Medicaid and Medicare Claims for Unapproved Prescription Drug.” Department of Justice. (December 6, 2013). From: http://www.justice.gov/opa/pr/2012/December/12-civ-1459.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.

Negligence Will Determine the Success or Failure of the Meningitis Lawsuits Against Doctors and Clinics

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

The victims and survivors of the meningitis outbreak are now filing lawsuits against the physicians and clinics that administered the tainted steroids. According to an article in The Tennessean, on January 29, 2013, a husband who lost his wife to fungal meningitis filed the first lawsuit against a Nashville outpatient clinic. It’s believed hundreds of people were injected at the same clinic with the tainted steroids. The man is now seeking $12.5 million in damages.

Click here to read the entire article from The Tennessean.

This lawsuit is just one in what is expected to be a series of lawsuits, in not just Tennessee, but across the country.

Compounding Pharmacy Allegedly Behind the Meningitis Outbreak is Out of Business.

The meningitis outbreak was at a peak in the fall of 2012. Contaminated steroid injections were allegedly made at the New England Compounding Center (NECC) in Framingham, Massachusetts. NECC is accused of shipping thousands of vials of tainted drugs across the country. There are allegedly 45 deaths nationwide from the steroids. The company shut down in October 2012, and filed for bankruptcy in December, according to an article in American Medical News.

Tennessee Complaint Alleges Outpatient Clinic Put Money Before Patients.

The man suing the Nashville outpatient clinic believes, among other things, that officials at the clinic put the company’s bottom line before patient care. The lawsuit specifically alleges:

1. The outpatient clinic ignored important information when it chose NECC to purchase thousands of vials of steroids,
2. That clinic officials failed to properly notify the victim that she had been injected with a potentially contaminated steroid,
3. That clinic officials failed to recommend the victim should receive treatment,
4. The clinic chose to purchase drugs from NECC because it was a cheaper than the safer alternatives.

Click here to read the entire complaint.

The Responsibility of Doctors and Clinics.

Negligence is the most common claim used against doctors in cases of defective medication. The assumption is that the physician breached the standard of care because he or she knew or should have known that NECC was not meeting applicable standards in compounding the medications. Another legal theory is that the physician should have known that certain medications should not have been compounded, but rather obtained directly from a manufacturer. I believe the liability of physicians and clinics might be established to the extent that the physicians were aware that the steroids distributed by NECC violated regulations on compounding prescription medications.

It’s imperative physicians and clinics are sure of the credentials of all vendors and suppliers.

I was recently quoted in an American Medical News article about physicians and clinics that are entangled in tainted drugs lawsuits. To read the entire article, click here.

Florida Compounding Pharmacy No Stranger to Fungal Outbreaks.

Florida has seen its share of fungal outbreaks. I previously blogged about the problems encountered by Franck’s pharmacy in Ocala, Florida. It was accused of distributing eye medications that contained a fungal infection. Click here for the first blog and here for the second blog.

Pharmacists Need to Obtain Good Professional Liability Insurance.

Many pharmacists, especially those who work for state agencies, large hospitals, pharmacy chains or other large institutions, scrimp on their purchase of professional liability insurance. Many mistakenly believe their employer will cover any legal defense expenses. This is not true and is often found out too late.

A pharmacist should always carry his/her own professional negligence insurance. It is inexpensive and can cover many types of legal actions other than just civil negligence cases. Always, always, always be sure your insurance includes at least $25,000 in professional license defense coverage. Get this in writing!

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 about the lawsuits against these doctors and clinics? Who do you think should be help responsible: the compounding pharmacy that shipped the contaminated steroids, or the doctors and clinics that administered the steroid shots? Please leave any thoughtful comments below.

Sources:

Roche Jr., Walter. “Meningitis Outbreak: Victim’s Husband Sues Saint Thomas Clinic.” The Tennessean. (January 31, 2013). From: http://www.tennessean.com/apps/pbcs.dll/article?AID=2013301300211&nclick_check=1

Wayne A. Reed v. Saint Thomas Outpatient Neurosurgical Center. Case Number 13C-417. Complaint. (January 29, 2013). From: http://www.thehealthlawfirm.com/uploads/Reed%20v.%20St.%20Thomas%20Outpatient.pdf

Gallegos, Alicia. “Physicians Entangled in Tainted Drugs Lawsuits.” American Medical News. (February 11, 2013). From: http://www.thehealthlawfirm.com/uploads/AMN_PhysicianLawsuits.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. http://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.

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