Pharmacy

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

5 Indest-2008-2By 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 Legislature Reforms Pharmacy Benefit Manager Audit Practices

1 Indest-2008-1According to the Florida Legislature, it’s time for pharmacists to focus on their patients instead of paperwork. On June 13, 2014, Florida Governor Rick Scott signed Florida Senate Bill 702 into law. This law introduces clear guidelines of acceptable audit practices of pharmacies in the Sunshine State.

There are more than 2,700 pharmacies across Florida that are routinely evaluated by Pharmacy Benefit Managers (PBMs). The purpose of these audits is to verify that certain claims are submitted and handled properly. If a PBM audit uncovers fraud or abuse, the pharmacy will be subject to penalties, including reimbursement of amounts paid. With the increase of rules regulating pharmacies, these audits have progressively become more time consuming for pharmacists.

Florida SB 702 becomes effective on October 1, 2014. To read a summary of the law, click here.

What’s the Need of the New Law?

In the United States, a PBM is most often a third party administrator of prescription drug programs. The PBM is primarily responsible for processing and paying prescription drug claims.
Currently, PBMs have broad discretion to penalize pharmacies. This means that pharmacies can be forced to pay thousands of dollars as the result of basic clerical or typographical mistakes, many of which are not the fault of the pharmacist or pharmacy staff. This law was enacted to provide reasonable standards for pharmacy audits while allowing PBMs to continue penalizing for true fraud and abuse.

Pharmacy Rights Included in New Law.

SB 702 makes common-sense auditing standards that include:

–    At least seven days advance notice before an on-site audit is conducted;
–    On-site audits scheduled after the first three days of the month;
–    A limit on the audit period of 24 months after the date claim is submitted;
–    Audits requiring clinical judgment must be conducted by or with a pharmacist;
–    Use of written practitioner records to validate pharmacy records in accordance with state and federal law;
–    Reimbursement of claims retroactively denied for clerical, typographical or computer errors unless pharmacy has a pattern of fraudulent billing;
–    Delivery of initial audit reports to pharmacists within 120 days after an audit is completed;
–    Receipt of final audit report within six months of the preliminary report;
–    Allowing 10 days for pharmacists to provide documentation to address any discrepancies found during an audit;
–    Prohibiting the use of extrapolations in auditing claims; and
–    The Office of Insurance Regulation will study pharmacy complaints of willful violations of audit provisions by PBMs.

Stipulation of Rights.

The rights listed above do not apply to audits that are based on suspicions of fraud or willful misrepresentation; audits of claims paid for by federally funded programs; or concurrent reviews or desk audits that occur within three business days after transmission where no chargeback or recoupment is demanded.

An entity that audits a pharmacy located within a Health Care Fraud Prevention and Enforcement Action Team Task Force area designated by the U.S. Department of Health and Human Services (HHS) and the U.S. Department of Justice (DOJ) is not required to provide seven days prior notice of an audit if the pharmacy has been a member of a credentialed provider network for less than 12 months.

What This Means for You.

For once there is a new law that does not make a pharmacist’s job more complicated. This law may actually alleviate some of the stress that comes with dealing with an audit. We’re hoping with the implementation of this law pharmacists will be able to spend more time focusing on patient care.

Comments?

What do you think of this new law? Will it affect your pharmacy? Please leave any thoughtful comments below.

Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.

The Health Law Firm represents pharmacists and pharmacies in DEA, DOH and FDA investigations, regulatory matters, licensing issues, litigation, administrative hearings, inspections and audits. The firm’s attorneys include those who are board certified by The Florida Bar in Health Law as well as licensed health professionals who are also attorneys.

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

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

 

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

Pharmacies May be Liable for Filling Valid Prescriptions

Lance Leider headshotBy Lance O. Leider, J.D.

Florida pharmacies have had their potential liability significantly expanded by the Fifth District Court of Appeal. In its recent decision, Oleckna v. Daytona Discount Pharmacy, the appellate court held that a pharmacy owes a duty to its patients that go beyond following the prescribing physician’s directions and properly dispensing the medication.

The court defined the pharmacy’s duty to use due care in filling a prescription to mean more than what it called “robotic compliance” with the instructions of the prescribing physician.

From the court’s decision and some others from around the state it would seem that Florida pharmacists are now under an obligation to question the quantity, frequency, dosage, combination, and possibly even the purpose of a valid prescription. Florida pharmacies are no longer simply a conduit for validly prescribed prescription medications. They are now an integral part of the health care system where trained professionals are expected to act as a check and balance on physicians and other prescribers.

This decision is in keeping with recent Florida Board of Pharmacy cases dealing with narcotic pain medications. The Board has interpreted Section 465.003(6), Florida Statutes, and Rule 64B16-27.820, Florida Administrative Code, to place a duty on a pharmacist to use his or her skill and experience to evaluate the propriety of every prescription presented on a global level.

While courts and the Board are more than willing to expand the scope of a pharmacist’s duty to his or her patients, unfortunately, neither have provided any prospective guidance on how to fulfill the duty.

Suggestions for Compliance.

Below are some suggestions for ensuring your pharmacy is fulfilling its obligation to its patients. This list is by no means exhaustive and is only intended to offer some basic guidance.

1. Know the physician and verify the credentials of an unfamiliar one;
2. Check the Prescription Drug Monitoring Program (PDMP);
3. Do not fill prescriptions that are more than 30 days old without verifying them with the prescribing physician;
4. Question higher than normal dosages and more frequent administration instructions;
5. Do not provide early refills without verifiable documentation and contact the physician when the patient is seeking an early refill on a medication with a high potential for abuse (the physician is usually in the best position to recognize drug seeking behaviors);
6. Flag concerning prescriptions for mandatory counseling prior to dispensing to give you an opportunity to discuss the risks with the patient;
7. Check the patient’s profile for interactions and discuss them with the patient and, if necessary, the prescribing physician;
8. Periodically check with the prescribing physician on long term medications;
9. Document everything done to verify the propriety of a prescription in the patient’s record; and
10. Most importantly, don’t be afraid to refuse a fill.

In addition to these steps, you should also be conducting regular staff meetings and routine reviews of your processes to ensure that they remain functional and able to be followed.

Comments?

Do you think a pharmacy or pharmacist should be held liable for filling valid prescriptions? How do you verify you or your employees are in compliance? Please leave any thoughtful comments below.

Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.

The Health Law Firm represents pharmacists and pharmacies in DEA, DOH and FDA investigations, regulatory matters, licensing issues, litigation, administrative hearings, inspections and audits. The firm’s attorneys include those who are board certified by The Florida Bar in Health Law as well as licensed health professionals who are also attorneys.

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

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

“The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.
Copyright © 1996-2015 The Health Law Firm. All rights reserved.

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

CCS Blog LabelBy 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.

OIG Issues Advisory Opinion to Specialty Pharmacy for Support Service Payments

LLA Headshot smBy Lenis L. Archer, J.D., M.P.H., The Health Law Firm

There is an inherent risk in entering into financial arrangements where payments to a service provider are only made when a referral is generated. On August 15, 2014, the Office of Inspector General (OIG) made this perfectly clear in an unfavorable advisory opinion issued to a specialty pharmacy that wanted to pay local retail pharmacies for providing support services to it.

Background of Request for OIG Advisory Opinion.

According to the OIG, the requestor, a specialty pharmacy, dispenses specialty pharmaceuticals used to treat a variety of chronic and life-threatening illnesses. The specialty pharmacy stated that the drugs offered at its establishment are frequently unavailable to retail pharmacies. In light of this, the specialty pharmacy asked whether it would be permissible to enter into agreements with various local pharmacies in which the specialty pharmacy would provide its specialty drug prescriptions to local pharmacies’ patients. Under the proposed contractual arrangement, the local pharmacies would be required to provide various support services, including:

1. Accepting the prescription from the patient or prescriber;
2. Gathering patient and prescriber demographic information;
3. Recording patient-specific history and use, including drug names, strength and directions;
4. Patient counseling;
5. Informing the patients about access to specialty drugs, including the availability from pharmacies other than the specialty pharmacy;
6. Obtaining patient consent to forward the prescription to the specialty pharmacy;
7. Transferring prescription information to the specialty pharmacy; and
8. Providing ongoing patient assessments for subsequent refills.

The retail pharmacies would be paid a “per-fill fee” by the specialty pharmacy at the time that the initial prescription was transmitted and upon each subsequent refill.

OIG Issued Negative Opinion Due to Anti-Kickback Statute.

The OIG issued an unfavorable opinion for this proposed agreement, concluding that the federal Anti-Kickback Statute was implicated because the specialty pharmacy would pay a per-fill fee for support services each time a local pharmacy referred a specialty drug prescription. After evaluating the arrangement, the OIG concluded that the per-fill fees were inherently subject to abuse because they were paid only when the support services provided by the retail pharmacy resulted in a referral to the specialty pharmacy. Thus, the OIG found that such a per-fill fee is directly linked to business generated by the local pharmacy for the specialty pharmacy, and could influence the local pharmacy’s referral decisions. OIG noted that the Anti-Kickback Statute is implicated if one purpose of the remuneration is to generate referrals.

Click here to read OIG Advisory Opinion No. 14-06.

Exceptions to Anti-Kickback Laws.

Like many other regulatory frameworks, the Anti-Kickback Statute has exceptions. The law provides a number of safe harbors to the rule which allow otherwise impermissible referral arrangements to pass muster.

Because the exceptions are numerous and often subject to change, it is highly recommended that any new business arrangement, or substantial change to an existing one, is reviewed by a health law attorney experienced in the area of Anti-Referral and Anti-Kickback Laws.

Consult With A Health Law Attorney Experienced in the Representation of Pharmacists and Pharmacies.

We routinely provide deposition coverage to pharmacists, pharmacies and other health professionals being deposed in criminal cases, negligence cases, civil cases or disciplinary cases involving other health professionals.

We can review business referral arrangements and provide legal counsel on whether they are not in violation of federal and state anti-referral laws.

The lawyers of The Health Law Firm are experienced in both formal and informal administrative hearings and in representing physicians, physician assistants and other health professionals in investigations and at Board of Pharmacy hearings. Call now or visit our website www.TheHealthLawFirm.com.

Sources:

Department of Health and Human Services Office of Inspector General. “OIG Advisory Opinion No. 14-06” (August 15, 2014). From: https://oig.hhs.gov/fraud/docs/advisoryopinions/2014/AdvOpn14-06.pdf

Ciesla, Frank, Christian, Beth, and Burd, Ari. “Office of Inspector General (OIG) Issues Unfavorable Advisory Opinion to Specialty Pharmacy for Support Service Payments.” The National Law Review. (August 18, 2014). From: http://www.natlawreview.com/article/office-inspector-general-oig-issues-unfavorable-advisory-opinion-to-specialty-pharma

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

“The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.
Copyright © 1996-2014 The Health Law Firm. All rights reserved.

By |2014-08-28T09:00:40+00:00May 15th, 2018|Pharmacist, Pharmacy, Pharmacy Law|0 Comments

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

By Christopher E. Brown, J.D.

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

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

The Investigator is NOT Your Friend.

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

Protect Yourself and Your License.

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

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

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

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

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

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

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

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

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

How to Determine the Purpose of the Investigation.

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

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

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

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

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

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

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

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

Consult a Lawyer Before You Do or Say ANYTHING.

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

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

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

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

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

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

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

Contact Health Law Attorneys Experienced with Investigations of Pharmacists.

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

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

About the Author: Christopher E. Brown, J.D. is an attorney with The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

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

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

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

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

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

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

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

We Will Work with Your Insurance Company.

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

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

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

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

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

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

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

Selling Tobacco Can Get You Penalized By Insurance Panels

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

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

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

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

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

Click here to read more from US News.

The Tobacco-Free Retail Trend.

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

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

Those Participating in the Tobacco-Free Network.

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

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

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

Sincere Motives or a Monopoly in the Making?

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

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

The Narrow Network Comparison.

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

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

Comments?

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

Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.

The Health Law Firm represents pharmacists and pharmacies in DEA, DOH and FDA investigations, regulatory matters, licensing issues, litigation, administrative hearings, inspections and audits. The firm’s attorneys include those who are board certified by The Florida Bar in Health Law as well as licensed health professionals who are also attorneys.

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

Sources:

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

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

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

“The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.
Copyright © 1996-2014 The Health Law Firm. All rights reserved.

37 Central Floridians Charged with Illicit Pharmaceutical Drug Trafficking

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

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

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

The Defendants’ Charged with Felonies.

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

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

Click here to see our experience representing pharmacists and pharmacies.

Contact Health Law Attorneys Experienced with Representing Pharmacists and Pharmacies.

The attorneys of The Health Law Firm provide legal representation to pharmacists and pharmacies in Department of Health (DOH) investigations, Drug Enforcement Administration (DEA) investigations, FBI investigations and other types of investigations of health professionals and providers.

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

Sources:

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

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

About the Author: Dr. Thu Pham, O.D., is a law clerk with The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area.  www.TheHealthLawFirm.com  The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

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

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

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

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

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

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

Doctors and Pharmacists Allegedly Paid to Prescribe.

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

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

Doctors in the Sunshine State Allegedly Involved.

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

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

Novartis Claims Discounts and Physician Speaker Programs Were Legitimate.

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

Kickbacks and The Law.

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

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

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

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

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

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

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

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

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

Sound Off.

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

Sources:

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

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

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

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law.  He is the President and Managing Partner of The Health Law Firm, which has a national practice.  Its main office is in the Orlando, Florida, area.  www.TheHealthLawFirm.com  The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

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