Pharmacist | The Health Law Firm Blog

Florida Board of Pharmacy Updates Record Retention Rules for Pharmacies

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

At its meeting held on February 12, 2014, the Florida Board of Pharmacy voted to approve language changes to a number of rules. Specifically, those changes were put into effect to establish a uniform four-year retention policy for pharmacy records.

Previously the Board’s rules were not consistent with respect to how long pharmacies were required to retain different types of records.

When approving new rules or changes to existing rules, administrative bodies are required to evaluate the regulatory costs of the changes. In examining these costs the Board found that any financial costs imposed upon small businesses would be balanced by the efficiencies created by a uniform retention period.

Board of Pharmacy Voted to Change the Wording in These Rules.

Below is a list of the administrative rules that were changed:

– Standards for the Approval of Registered Pharmacy Technician Training Programs
Rule 64B16-26.351, Florida Administrative Code

– Standards for Approval of Courses and Providers
Rule 64B16-26.601, Florida Administrative Code

– Continuing Education Records Requirements
Rule 64B16-26.603, Florida Administrative Code

– General Terms and Conditions to be Followed by a Pharmacist When Ordering and Dispensing Approved Medicinal Drug Products
Rule 64B16-27.210, Florida Administrative Code

– Standards of Practice – Continuous Quality Improvement Program
Rule 64B16-27.300, Florida Administrative Code

– Requirement for Patient Records
Rule 64B16-27.800, Florida Administrative Code

– Change of Ownership
Rule 64B16-28.2021, Florida Administrative Code

– Centralized Prescription Filling, Delivering and Returning
Rule 64B16-28.450, Florida Administrative Code

– Transmission of Starter Dose Prescriptions for Patients in Class I Institutional or Modified II B Facilities
Rule 64B16-28.503, Florida Administrative Code

– Class II Institutional Pharmacies
Rule 64B16-28.605, Florida Administrative Code

– Remote Medication Order Processing for Class II Institutional Pharmacies
Rule 64B16-28.606, Florida Administrative Code

– Automated Pharmacy System – Long-Term Care, hospice, and Prison
Rule 64B16-28.607, Florida Administrative Code

– Modified Class II Institutional Pharmacies
Rule 64B16-28.702, Florida Administrative Code

– Record Maintenance for Animal Shelter Permits
Rule 64B16-29.0041, Florida Administrative Code

Make Sure Your Facility is Prepared.

While these rule changes are not final, it is important to recognize if they will be affecting your facility. You should also be making arrangements in your facility to ensure that there is enough computer disk space or physical space to retain these records. Keep in mind that these records retention rules are in addition to any others imposed by other Florida or federal statutes or rules relating to controlled substances or other pharmacy practices.

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?

How do you feel about the requirement of pharmacy records to be retained for four years? Please leave any thoughtful comments below.

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.

Pharmacies May be Liable for Filling Valid Prescriptions

By 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.

Phony Pharmacist Gets Prison Time for Working at Pharmacies in Central Florida

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

On November 2, 2012, a former Altamonte Springs resident was sentenced to three and a half years in federal prison for fraudulently working as a Central Florida pharmacist from 2000 to 2009, according to the Department of Justice (DOJ).

Click here to read the press release from the DOJ.

I previously blogged about this story when the fake pharmacist pleaded guilty. Click here to read that blog.

Man Allegedly Worked at a CVS and Walgreens in Central Florida.

According to an article in the Orlando Sentinel, the man worked at pharmacies throughout Central Florida, including a CVS and a Walgreens. While working at one of the pharmacies, he allegedly gave a customer the incorrect medication, causing that person to suffer a stroke.

Fake Pharmacist Has to Change His Name.

Allegedly, the man fraudulently obtained a pharmacy license in September of 2000
from the Florida Department of Health (DOH) by using the name, date of birth, Social Security number and pharmacy education information of a licensed pharmacist in Arizona. In 2004 the man actually changed his legal name by fraud to the name of the licensed pharmacist.

Along with his prison sentence, the fake pharmacist was ordered to change his name back to his legal name.

Excuse My Alliteration.

Excuse my alliteration, but I just love all of those “F” sounds like I used in the title for this blog. For comparison, see my blog on Franck’s Pharmacy fungus case.

More Stories on Phony and Fraudulent Professionals to Come.
In the near future on this blog we will include additional articles on fake doctors and health professionals, some old, some new.

To see a recent blog on a fake dentist in Miami, click here. You can also read the story of a fake plastic surgeon in New York by clicking here.

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.

Comments?

What do you think of all the fake health provider stories? Please leave any thoughtful comments below.

Sources:

FBI.gov. “Pharmacist Impersonator Sentenced to Prison and Ordered to Change His Name.” FBI, Tampa Division. (November 1, 2012). From Press Release: http://www.fbi.gov/tampa/press-releases/2012/pharmacist-impersonator-sentenced-to-prison-and-ordered-to-change-his-name

Pavuk, Amy. “Fake Pharmacist Sentenced to Federal Prison.” Orlando Sentinel. (November 1, 2012). From: http://www.orlandosentinel.com/news/local/breakingnews/os-fake-pharmacist-prison-20121101,0,4565731.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.

By The Health Law Firm|2024-03-14T10:01:08-04:00May 15, 2018|Categories: Department of Health, Florida Board of Pharmacy, Legal Defense for Pharmacists, Pharmacist, Pharmacy, Pharmacy Law|Tags: criminal charges, DEA investigation, DEA number, defense attorney, defense lawyer, Department of Health (DOH), DOH investigation, Drug Enforcement Administration (DEA), identity theft, investigation, legal defense for pharmacists, legal representation for pharmacists, license revoked, pharmacies, pharmacy investigation, quality assurance|Comments Off

Florida Legislature Reforms Pharmacy Benefit Manager Audit Practices

According 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.

By The Health Law Firm|2024-03-14T10:01:17-04:00May 15, 2018|Categories: Florida Board of Pharmacy, Florida Legislature, Pharmacist, Pharmacy, Pharmacy Audit, Pharmacy Law|Tags: defense attorney, defense lawyer, Florida governor, Florida legislature, Florida pharmacy, health law firm, House Bill 745, pharmacist, pharmacist attorney, pharmacist lawyer, pharmacy, pharmacy audit, pharmacy benefit manager, pharmacy evaluation, Rick Scott, Senate Bill 702, the health law firm|Comments Off

Sex, Drugs and Money Lands Avalon Park Pharmacist in Handcuffs

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

Sex, prescription drugs and money – sounds like the next big rock ‘n’ roll song, doesn’t it? According to a number of news sources, the owner of an Avalon Park-area pharmacist was allegedly knowingly filling phony prescriptions for painkillers. The pharmacist is also accused of exchanging sex for drugs with at least one woman, according to the Orlando Sentinel. This investigation was led by the Metropolitan Bureau of Investigation (MBI) and the Drug Enforcement Administration (DEA). Both agencies simultaneously raided the pharmacy on November 29, 2012.

Avalon Park is a community it the greater Orlando area.
Filling Phony Prescriptions.

According to WFTV, the owner of the pharmacy and two employees sat handcuffed outside the pharmacy as federal drug agents reportedly removed boxes of evidence from the pharmacy during the raid. Agents then moved onto the pharmacist’s nearby home.

It’s believed another person was producing fake prescriptions and asking others to get them filled at the Avalon pharmacy and others around town. The people who fill the prescriptions are nicknamed “smurfs.” They are usually hired by a drug ring. They return the pills from the prescriptions they get filled, back to the ring. Click here to read what Papa Smurf has to say about his name being used in such a manner.

According to WFTV, 230 fraudulent prescriptions were produced and 33 were filled at the Avalon-area pharmacy.

Click here to watch WFTV’s report on this raid.
Pharmacist’s Alleged Relationship with Smurf.

A woman, who worked as a smurf, allegedly told federal agents she had sex with the pharmacist. Afterward, the pharmacist gave her cash and oxycodone, according to the Orlando Sentinel. However, we want to make it clear that those who break the law and get caught often point the finger at innocent people, trying to divert blame from themselves.

To read the article from the Orlando Sentinel, click here.
Pharmacist Facing Charges of Trafficking in Controlled Substance.

The pharmacist faces up to 32 counts of trafficking in controlled substance and one count of conspiracy to traffic. Federal agents believe the pharmacist is part of a larger drug ring.

On the Florida Department of Health (DOH) website his license is still listed as clear/active. To see his license status, click here.

Remember, all who are name or discussed in our blog are innocent until proven guilty in a court of law.
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.
Comments?

Tell us your thoughts on this story. Are federal drug agents fighting a losing battle? Please leave any thoughtful comments below.
Sources:

Barrett, Steve. “Avalon Park Pharmacy Owner Accused of Filling Fake Oxycodone Prescriptions.” WFTV. (November 30, 2012). From: http://www.wftv.com/news/news/local/dea-agents-raid-avalon-park-pharmacy/nTJbw/

Pauk, Amy. “Pharmacist Accused of Over-Dispensing Painkillers, Exchanging Pills for Sex.” Orlando Sentinel. (November 29, 2012). From: http://www.orlandosentinel.com/news/local/breakingnews/os-avalon-park-pharmacy-20121129,0,6040870.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.

By The Health Law Firm|2024-03-14T10:01:08-04:00May 15, 2018|Categories: Pharmacist, Pharmacy, Pharmacy Law, Trafficking Prescription Painkillers|Tags: administrative hearings, criminal charges, DEA investigation, DEA raid, defense attorney, defense lawyer, Drug Enforcement Administration (DEA), drug trafficking, fake prescriptions, Florida Department of Health (DOH), legal defense for pharmacists, legal representation for pharmacists, Metropolitan Bureau of Investigation (MBI), pharmacies, pharmacist, pharmacy investigation, quality assurance, smurfs|Comments Off

OIG Issues Advisory Opinion to Specialty Pharmacy for Support Service Payments

By 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 The Health Law Firm|2024-03-14T10:01:17-04:00May 15, 2018|Categories: Pharmacist, Pharmacy, Pharmacy Law|Tags: advisory opinion, anti-kickback statute, anti-referral statute, Department of Health and Human Services, Office of Inspector General, pharmacist, pharmacy, pharmacy law, specialty pharmacy, stark law|Comments Off

The 25 Biggest Mistakes Pharmacists Make After Being Notified of a Department of Health Complaint

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

The investigation of a complaint which could lead to the revocation of a pharmacist’s license to practice and the assessment of tens of thousands of dollars in fines, usually starts with a simple letter from the Department of Health (DOH). This is a very serious legal matter and it should be treated as such by the pharmacist who receives it. Yet, in many cases, attorneys are consulted by pharmacists after the entire investigation is over, and they have attempted to represent themselves throughout the case. Often, the mistakes that have been made severely compromise an attorney’s ability to achieve a favorable result for the pharmacist.

These are the 25 biggest mistakes we see in the pharmacy cases we are called upon to defend after a DOH investigation has been initiated:

1. Failing to keep a current, valid address on file with the DOH (as required by law), which may seriously delay the receipt of the Uniform Complaint (notice of investigation), letters, and other important correspondence related to the investigation.

2. Contacting the DOH investigator and providing him/her an oral statement or oral interview. (Note: There is no legal requirement to do this.)

3. Making a written statement in response to the “invitation” extended by the DOH investigator to do so. (Note: There is no legal requirement to do this.)

4. Failing to carefully review the complaint to make sure it has been sent to the correct pharmacist. (Note: Check name and license number).

5. Failing to ascertain whether or not the investigation is on the “Fast Track” which may then result in an emergency suspension order (ESO) suspending the pharmacist’s license until all proceedings are concluded. (Note: This will usually be the case if there are allegations regarding drug abuse, alcohol abuse, sexual contact with a patient, mental health issues, or failure to comply with PRN instructions.)

6. Providing a copy of the pharmacist’s curriculum vitae (CV) or resume to the investigator because the investigator requested them to do so. (Note: There is no legal requirement to do this.)

7.Believing that if they “just explain it,” the investigation will be closed and the case dropped.

8. Failing to submit a timely objection to a DOH subpoena when there are valid grounds to do so.

9. Failing to forward a complete copy of the patient medical record when subpoenaed by the DOH investigator as part of the investigation, when no objection is going to be filed.

10. Delegating the task of providing a complete copy of the patient medical record to office staff, resulting in an incomplete or partial copy being provided.

11. Failing to keep an exact copy of any medical records, documents, letters or statements provided to the investigator.

12. Believing that the investigator has knowledge or experience in medical procedures or health care matters or procedures being investigated.

13. Believing that the investigator is merely attempting to ascertain the truth of the matter and this will result in the matter being dismissed.

14. Failing to check to see if their medical malpractice insurance carrier will pay the legal fees to defend them in this investigation.

15. Talking to DOH investigators, staff or attorneys, in the mistaken belief that they are capable of doing so without providing information that can and will be used against them.

16. Believing that because they haven’t heard anything for six months or more the matter has “gone away.” The matter does not ever just go away.

17. Failing to submit a written request to the investigator at the beginning of the investigation for a copy of the complete investigation report and file and then following up with additional requests until it is received.

18. Failing to wisely use the time while the investigation is proceeding to interview witnesses, obtain witness statements, conduct research, obtain experts, and perform other tasks that may assist defending the case.

19. Failing to exercise the right of submitting documents, statements, and expert opinions to rebut the findings made in the investigation report before the case is submitted to the Probable Cause Panel of your licensing board for a decision.

20. Taking legal advice from their colleagues regarding what they should do (or not do) in defending themselves in the investigation.

21. Retaining “consultants” or other non-lawyer personnel to represent them.

22. Believing that the case is indefensible so there is no reason to even try to have it dismissed by the Probable Cause Panel.

23. Attempting to defend themselves.

24. Believing that because they know someone with the Department of Health or a state legislator, that influence can be exerted to have the case dismissed.

25. Failing to immediately retain the services of a health care attorney who is experienced in such matters to represent them, to communicate with the DOH investigator for them, and to prepare and submit materials to the Probable Cause Panel.

Bonus Point: 26. Communicating with the Department of Health about the pending case.

Not every case will require submission of materials to the Probable Cause Panel after the investigation is received and reviewed. There will be a few where the allegations made are not “legally sufficient” and do not constitute an offense for which the pharmacist may be disciplined.

In other cases, an experienced health care attorney may be successful in obtaining a commitment from the DOH attorney to recommend a dismissal to the Probable Cause Panel. In other cases (usually the most serious ones), for tactical reasons, the experienced health care attorney may recommend that you waive your right to have the case submitted to the Probable Cause Panel and that you proceed directly to an administrative hearing. The key to a successful outcome in all of these cases is to obtain the assistance of a health care lawyer who is experienced in appearing before the Board of Pharmacy in such cases and does so on a regular basis.

Contact Health Law Attorneys Experienced with Department of Health Investigations of Pharmacists.

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.

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.

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

By The Health Law Firm|2024-03-14T10:01:09-04:00May 15, 2018|Categories: Florida Board of Pharmacy, Legal Defense for Pharmacists, Pharmacist, Pharmacy Law|Tags: criminal charges, dea, DEA investigation, department of health, doh, FBI, I’ve been notified of a DOH complaint Department of Health, investigation, legal defense for pharmacists, legal representation for pharmacists, license revoked, pharmacies DEA number, pharmacy investigation, quality assurance, What to do if you’re being investigated|Comments Off

Selling Tobacco Can Get You Penalized By Insurance Panels

By 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.

By The Health Law Firm|2024-03-14T10:01:18-04:00May 15, 2018|Categories: Florida Board of Pharmacy, Insurance, Insurance Network Plan, Pharmacist, Pharmacy, Pharmacy Benefit Manager, Prescription-Drug Network|Tags: CVS pharmacy, drug store, health insurance, health insurance plans, narrow network plan, pharmacist attorney, pharmacist lawyer, pharmacists, pharmacy, pharmacy attorney, pharmacy lawyer, prescription benefit manager (PBM), prescription drug network, prescription drug plan, prescription network, tobacco-free, tobacco-free network|Comments Off

Specialty Pharmacy Settles Lawsuit Over Illegal Kickbacks

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

The Department of Justice (DOJ) announced on December 27, 2012, that a specialty pharmacy, based in San Diego, California, has agreed to pay a $11.4 million settlement. That payment is to resolve allegations that the company used kickbacks to persuade doctors to write prescription for its products. The allegations came from a whistleblower lawsuit filed by a former employee.

Click here to read the press release from the DOJ.

Expensive Kickbacks Used on Doctors.

An article in Modern Healthcare states that the specialty pharmacy allegedly used tickets to sporting events, concerts, plays, spa outings, golf games and ski trips to bribe doctors to write prescriptions for its products. The company also had representatives schedule paid “preceptorships,” where the reps would follow doctors in their offices in an attempt to increase prescriptions written for their products.

To read the Modern Healthcare article, click here.

Settlement Details.

The specialty pharmacy company agreed to a forfeiture of $1.4 million to resolve the anti-kickback statue allegations. It will also pay $9.9 million to resolve false claims allegations, according to the DOJ. Representatives with the DOJ said that by entering the deferred prosecution agreement the company was able to avoid criminal and civil liability for the kickback and false claims violations.

Whistleblower Gets Reward.

According to the DOJ, the settlement resolves a False Claims Act lawsuit that was filed by a former sales representative for the specialty pharmacy. As part of the resolution, that whistleblower will receive $1.7 million.

Whistleblowers stand to gain substantial amounts, sometimes as much as thirty percent (30%), of the amount the government recovers under the False Claims Act (31 U.S.C. Sect. 3730). Such awards encourage employees and contractors to come forward and report fraud. You can learn more on the False Claims Act on the DOJ website.

Contact Health Law Attorneys Experienced with Qui Tam or Whistleblower Cases.

Attorneys with The Health Law Firm also represent 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.

What Do You Think?

What do you think of the settlement agreement? As a health professional are you tempted with kickbacks? Please leave any thoughtful comments below.

Sources:

Department of Justice. “Victory Pharma Inc. of San Diego Pays $11.4 Million to Resolve Kickback Allegations in Connection with Promotion of Its Drugs.” Department of Justice. (December 27, 2012). From: http://www.justice.gov/opa/pr/2012/December/12-civ-1547.html

Kutscher, Beth. “$11.4 Million Settlement in Pharma Kickback Case.” Modern Healthcare. (December 27, 2012). From: ttp://www.modernhealthcare.com/article/20121227/NEWS/312279957/

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

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

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

By The Health Law Firm|2024-03-14T10:01:09-04:00May 15, 2018|Categories: Legal Defense for Pharmacists, Pharmacist, Pharmacy, Pharmacy Law, Whistleblower|Tags: Anti-kickback statue, Department of Justice (DOJ), false claims act, health care fraud, health care scheme, kickback scheme, legal representation, pharmaceutical company, qui tam suits, specialty pharmaceutical company, whistleblower, whistleblower attorney, whistleblower lawyers, whistleblower protection|Comments Off

South Florida Man Pleads Guilty to Fraudulently Working as a Pharmacist

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

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

Fake Pharmacist was Working at Central Florida Pharmacies.

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

Alleged Identity Theft to Obtain Pharmacist License.

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

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

Will The Real Pharmacist Please Stand Up?

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

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

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

A Long List of Charges Could Mean Prison Time.

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

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

Click here to see our experience representing pharmacists and pharmacies.

Contact Health Law Attorneys Experienced with Representing Pharmacists and Pharmacies.

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

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

Sources:

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

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

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

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

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

By The Health Law Firm|2024-03-14T10:01:38-04:00May 15, 2018|Categories: Legal Defense for Pharmacists, Pharmacist, Pharmacy, Pharmacy Law|Tags: criminal charges, dea, DEA investigation, DEA number, department of health, Department of Justice, doh, DOJ, FBI, identity theft, investigation, legal defense for pharmacists, legal representation for pharmacists, license revoked, pharmacies, pharmacy investigation, quality assurance|Comments Off