Responding to a Medicaid Audit: Important Tips You Should Know

6 Indest-2008-3By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

The Agency for Health Care Administration (AHCA), Office of Inspector General (OIG), Bureau of Medicaid Program Integrity, is the Florida agency responsible for routine audits of Medicaid health care providers. Each state has a similar state agency, though it may have a different name.  The agency’s job is to ensure that the Medicaid Program was properly billed for services. Health care professionals receiving large payments from Medicaid or who practice in areas that typically see the most abuse or fraudulent billings, are the ones most likely to be audited.  These include pediatricians, Ob/Gyns, family practice physicians and pediatric dentists.

A different state agency that may also conduct Medicaid audits is the state Medicaid Fraud Control Unit (MFCU).  However, by definition, the MFCU is investigating allegations that there is substantial fraud going on.  You should know that if you are contacted by the MFCU, this is a very serious matter.  This is not a routine audit.
However, on the “routine” audits conducted by the Medica agency, the Medicaid audit usually requests information in a questionnaire that the medical practice is required to complete. Additionally, copies of medical records (including x-rays and other diagnostic studies) on the list of Medicaid patients selected for the audit.

If AHCA (or the state Medicaid agency) determines that Medicaid overpaid for services, it will use a complex mathematical extrapolation formula to determine the repayment amount. The amount of the repayment to the Medicaid Program can be considerably greater than (30 to 100 times as much as) the actual amount of overpayment disclosed by the sample of records audited. Additionally, fines and penalties can be added by the Medicaid Program. However, you can eliminate or reduce the amount of any such repayment by actions taken both before and during the Medicaid audit.

 

General Practice Tips:
There are various ways to manage your practice that will help you in the event that you are selected for a Medicaid Audit.

1. Every patient record entry should be clearly dated and signed or initialed by the provider. Make sure this is always done.

2. When documenting in the patient’s record, make sure that you document exactly what services were needed and completed in order to support what was billed to Medicaid.

3. Communicate with the person responsible for your billing so that the actual services provided are billed for. Do not bill in advance for anticipated services needed as indicated in the appointment calendar or on a treatment plan.

4. Keep the patient records organized and ready for copying if necessary. Use only one sided documents and securely fasten small forms (prescriptions, telephone memos, small sticky notes) onto 8-1/2″ by 11″ paper. Scan all such documents into the patient record if using an electronic health record (EHR).

5. Services provided by a physician who is not enrolled in the Medicaid Program to a Medicaid patient may not be billed to or paid by the Medicaid Program. Therefore, never allow any other physician associated with your practice who is not enrolled as a Medicaid provider to provide services to Medicaid patients. Do not allow a new physician coming into your practice to treat Medicaid patients until he or she actually has received his or her Medicaid provider number. The group may not bill for the services nor may another physician bill for the services.

6. Ensure that all health care professionals’ licenses and permits are kept up to date. Ensure that all x-ray, clinical, lab and diagnostic equipment is permitted and kept up to date. Ensure that any CLIA license or exemption certificate is correct and kept up to date. Services billed by unlicensed personnel or services provided by improperly licensed facilities may not be paid by the Medicaid Program.

7. Use only standard abbreviations in your medical records, documentation, orders, and reports. While an abbreviation may seem common to you or your practice, if it is not a universally accepted abbreviation, the auditors may not recognize it.

8. Make sure all records are timely made, accurate and legible. Safeguard them and never let the original leave your office. Illegible records are treated as a non-record, and payment completely disallowed for an illegible note or order. A missing record, x-ray or chart entry will result in a complete repayment being directed for those services.

The Medicaid Audit:

If you are being audited, AHCA will send you a letter notifying you of the audit. AHCA will also supply you with a list of patients to be sampled a standard sample will include a list of anywhere from 30 to 150 patient names, depending on the size of the practice. Regular audits routinely request 30 to 50 patient records. The audit letter will also include a questionnaire to be completed (Medicaid Provider Questionnaire) and a “Certification of Completeness of Records” form to complete and return with the copies of the patient records. (Please note: this will be used against you in the future if you attempt to add to or supplement the copies of the records you provided).

It is crucial that you retain the services of an expert consultant or experienced health care attorney in correctly and accurately completing the questionnaire. The letter will also request that you provide copies of the patient records for the list of patients included with the letter. You will only be given a short time to provide these documents.

1. When receiving a notice of a Medicaid audit, time is of the essence. Be sure to calendar the date that the records need to be in the AHCA office and have the records there by that date. Note: the due date is not the last date on which you can mail the records but rather is the date that the records must be received at AHCA.

2. Obtain and review a copy of the claims you submitted and what Medicaid has paid on each of the patients being audited. This information can be found in the Medicaid portal, in your billing system, or in the Explanation of Benefits. Compare this information to the medical records to see if any issues may arise when AHCA reviews the records. (Keep this for your use, do not provide it as part of the audit records).

3. Provide a complete copy of the entire record, not just the parts from the period of time covered by the audit. Remember that other physician records obtained as history, including reports and consultations should be included. Consent forms, medical history questionnaires, histories, physicals, and other physicians’ orders, may be a crucial part of the record.

4. If you suspect that an issue may arise with a particular patient, prepare a separate explanation to submit with the patient’s file. AHCA will have an expert review the records, so an explanation in advance will help the expert to assess if there is in fact an issue. Any explanatory notes or other explanations should be clearly labeled as such and dated as of the date actually prepared, so there is no confusion as to whether or not it was part of the original record.

5. If your practice involves taking x-rays or using other diagnostic studies, these procedures are part of the patient’s record. If the x-rays are digital, they can be submitted on a compact disc. Be sure to include the number of x-rays on the compact discs in the Certification of Completeness of Records.
6. Complete the Medicaid Provider Questionnaire in its entirety to send with the patient records. Do not leave any section blank. Use “not applicable” or “none” if necessary. Attach all required documents. Consult with an experienced health law attorney to assist in completing the form.

To learn more about the Medicaid audit process and how The Health Law Firm can assist you, click here to watch our short video blog.

Don’t Wait Until It’s Too Late, Contact Health Law Attorneys Experienced in Handling Medicaid and Medicare Audits.

The Health Law Firm’s attorneys routinely represent physicians, medical groups, clinics, pharmacies, durable medical equipment (DME) suppliers, home health agencies, nursing homes and other healthcare providers in Medicaid and Medicare investigations, audits and recovery actions.
If you or your practice has been sent notice of a Medicaid or Medicare audit, please contact us at (407) 331-6620 or (850) 439-1001 or visit our website at www.TheHealthLawFirm.com for more information.

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.

KeyWords: Legal representation for Medicaid audits, Medicaid audit defense attorney, health care fraud defense attorney, health care fraud investigation defense attorney, legal representation for health care fraud investigation, legal representation for health care fraud, Medicaid fraud defense attorney, legal representation for Medicaid fraud, legal representation for fraudulent billing, legal representation for submitting false claims to the government, legal representation for overbilling, health care fraud attorney, The Health Law Firm, reviews of The Health Law Firm attorneys, reviews of The Health Law Firm
“The Health Law Firm” is a registered fictitious business name of and a registered service mark of The Health Law Firm, P.A., a Florida professional service corporation, since 1999.Copyright © 2017 The Health Law Firm. All rights reserved.

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U.S. Court in Florida Dismisses Whistleblower’s Complaint Against Nuclear Pharmacy

PS 4 Indest-2009-3By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

On September 28, 2017, the U.S. District Court for the Middle District of Florida dismissed a relator’s (whistle blower’s) False Claims Act (FCA) complaint against a nuclear pharmacy in Tampa. The court found that the relator failed to plead fraud with the required amount of specificity that the law requires.  The case awas filed against GE Healthcare, Inc.’s nuclear pharmacy.

The Allegations.

GE Healthcare operates 31 nuclear pharmacies in the United States, where it produces radiopharmaceuticals through a process of compounding drugs.  The relator was a board-certified nuclear pharmacist who formerly worked at GE Healthcare, Inc.’s nuclear pharmacy in Tampa, Florida. The relator’s allegations included the manner in which GE compounded and labeled radiopharmaceuticals. More specifically, the whistle blower claimed that GE sold diluted and expired drugs. Additionally, the whistle blower alleged that GE falsely inflated the reimbursement rate for certain drugs by providing false sales data to Medicare.

GE argued that the realtor’s claims should be dismissed pursuant to the FCA’s public disclosure bar because the allegations overlapped with an action filed by a different relator, James Wagel, in 2006. To read about this FCA case, click here.

The Court’s Decision. 

The court found that Sunil Patel’s allegations were not “based on” or “substantially the same as” the allegations in the prior public disclosures. However, the court dismissed the realtor’s claims on another ground:  failing to plead the allegedly fraudulent claims with sufficient particularity. According to the court, the allegations that defendant “presented or caused to be presented” a false claim fell “well short of alleging ‘exact billing data.'”  In other words, the relator failed to plead one or more false claims by giving the specifics, such as date, amount, patient, billing code, amount paid by the government, etc.  The court found that the relator identified no “particular facts about the ‘who,’ ‘what,’ ‘where,’ ‘when,’ and ‘how’ of fraudulent submissions to the government.”

The case is United States ex rel. Patel v. GE Healthcare Inc., No. 8:14-cv-120-T-33TGW (M.D. Fla. Sept. 28, 2017).

Click here to read one of my prior blogs on a similar FCA case involving a pharmaceutical company.

Specifics of the False Claims Are Required for Any Qui Tam Whistle Blower’s Case.

This is one of the biggest short comings we see in potential clients who contact us with information about false claims being submitted by their employers or other healthcare providers.  They do not have the specifics of any single false claim.  Yet the law requires this or a whistle blower’s case can get dismissed by the court outright.  You can do an awful lot of work investigating, pleading and litigating a whistle blower’s case only to have the court dismiss it without its ever getting anywhere near a trial.  Even if a scheme or system is inherently fraudulent, you must be able to show one or more claims that were submitted were actually false claims.

We advise health care professionals who consult us with possible False Claims Act/whistle blowers cases, be sure you have the details, and preferably copies of the documents, that show a false bill was submitted to the government.  This can be a CMS Form 1500 or an explanation of benefits that the patient and the insurer or facility receives back.  Sometimes you can get these form the patient if you do not have access to these from the employer.  But without a false claim and, preferably, a number of false claims, you don’t really have a False Claims Act suit.

Contact Health Law Attorneys Experienced with Qui Tam or Whistle Blower Cases.

Attorneys with The Health Law Firm also represent health care professionals and health facilities in qui tam or whistleblower cases both in defending such claims and in bringing such claims. 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. We have represented doctors, nurses and others as relators in bringing qui tam or whistleblower cases, as well.

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:

Fraud and Compliance. “U.S. Court in Florida Dismisses Whistleblower Action Against Nuclear Pharmacy.” AHLA Weekly. (October 6, 2017). Web.

Mayo, Rebecca. “Evidence of likely submission not enough to prove FCA violation.” Wolters Kluwer Health Law Daily. (October 2, 2017). Web.

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.

KeyWords: Health care fraud defense attorney, legal representation for allegations of health care fraud, False Claims Act (FCA) attorney, FCA defense attorney, False Claims attorney, legal representation for FCA investigations, legal representation for FCA complaints, Whistleblower attorney, Whistleblower defense attorney, legal representation for Whistleblower investigations, legal representation for Whistleblower complaints, qui tam attorney, qui tam defense attorney, legal representation for qui tam cases, legal representation for qui tam investigations, FCA legal representation, relator attorney, relator defense attorney, health law defense attorney, The Health Law Firm, reviews of The Health Law Firm, The Health Law Firm attorney reviews

“The Health Law Firm” is a registered fictitious business name of and a registered service mark of The Health Law Firm, P.A., a Florida professional service corporation, since 1999.Copyright © 2017 The Health Law Firm. All rights reserved.

Florida-Based Compounding Pharmacy Violated False Claims Act by Overcharging Tricare, Feds Claim

9 Indest-2008-6By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

On July 3, 2017, a compounding pharmacy based in Tampa, Florida, charged Tricare at least 2,000 percent more for drugs than it charged cash payers, according to the government. Teh government claimed that the Florida pharmacy acted in violation of the False Claims Act (FCA), as it intervened in a whistleblower’s suit.

The government claimed that RS Compounding LLC and its owner, Renier Gobea, knew it was illegal to provide discounts to cash payers but not the government. However, the company still went through with a scheme to do it, the partial-intervention complaint says. Prosecutors are seeking triple damages and civil penalties.

The False Claims Act provisions in Tricare cases are a little different from those in Medicare cases. In Tricare cases, recovery can be had for any “fraud, waste or abuse.” It is not limited to just fraud or false claims. Abusive claims can lead to recoveries by the government and by whistle blowers.

The Whistleblower Suit.

The suit was brought forward by former sales representative McKenzie Stepe. She filed her whistleblower suit in December 2013. Stepe’s suit alleges that RS Compounding used the average wholesale price in place of the lower acquisition cost when reporting what it paid for drugs. Additionally, the company then reported the usual and customary cost of the compounded drug to be equal to the average wholesale price, and as a result the government paid more for the drug that it needed to when reimbursing RS Compounding, the complaint says.

Between January 1, 2012, and January 31, 2014, the company was charging cash customers less without telling the government, according to the complaint.

Click here to read the complaint in full.

Unfortunately, this is not the first time a Florida pharmacy has allegedly defrauded government programs such as Tricare through compounding activities. The Tricare program is a health care program that provides benefits for U.S. military personnel, their defendants and retired military personnel.

Click here to read one of my prior blogs on a similar case against Tricare.

Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.

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

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

Kass, Dani. “Fla. Compounding Pharmacy Ripped Off Tricare, Feds Claim.” Law360. (July 3, 2017). Web.

“Florida Compounding Pharmacy Ripped Off Tricare.” Law of Compounding Medication. (July 4, 2017). Web.

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.

KeyWords: False Claims Act defense attorney, FCA legal counsel, Anti-Kickback Statute (AKS) defense attorney, legal representation for allegations of violating Anti-Kickback Statute, TRICARE false claims legal defense attorney, TRICARE physician representation, legal representation violating False Claims Act, pharmaceutical fraud lawyer, compounding pharmacy attorney, fraudulent practices of pharmaceutical companies, whistle blower lawyer, FCA violations, fraud detection, financial interest in physician referrals, TRICARE fraud attorney, health attorney, defense attorney, The Health Law Firm, health law firm, fraud investigations, consumer reports of health care fraud, conflict of interest in physician referrals, compound medication prescriptions, compounding pharmacy lawyer, prescription reimbursement, legal defense of military physicians, legal defense of TRICARE providers, attorney reviews of The Health Law Firm, Veterans Administration (VA) physician defense attorney, The Health Law Firm attorney reviews

“The Health Law Firm” is a registered fictitious business name of and a registered service mark of The Health Law Firm, P.A., a Florida professional service corporation, since 1999.
Copyright © 2017 The Health Law Firm. All rights reserved.

 

Florida Gov. Rick Scott Makes Changes to Florida Impaired Practitioners Program

indest1By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

On May 31, 2017, Florida Governor, Rick Scott, signed into law House Bill 229 (Ch. 2017-41, Laws of Florida), which made changes to the statutory basis for Florida’s impaired practitioner programs. The impaired practitioner program for nurses in Florida is the Intervention Project for Nurses (IPN), which is a for-profit corporation, The impaired practitioner program for doctors, dentists, pharmacists, optometrists, and all other licensed health professionals is the Professionals Resource Network (PRN), a non-profit corporation.

The program, as envisioned in the statute, is designed to assist health care practitioners who are impaired as a result of the misuse or abuse of alcohol or drugs, or of a mental or physical condition, which could affect the ability to practice with skill and safety.

Revisions to the Program.

The new law requires DOH to establish terms and conditions of the program by contract, provides contract terms, requires DOH to refer practitioners to consultants and revises grounds for refusing to issue or renew license, certificate, or registration in health care professions.

A significant change in the program involved a licensee’s duty to report colleagues that have or are suspected of having an impairment. The new law creates an exception to the mandatory reporting of an impairment to the DOH. The new revision will allow a licensee who knows that a person is unable to practice with reasonable skill and safety due to an impairment, to report such information to the consultant, rather than DOH. Both the core licensure statute and individual practice acts are amended to include this language.

Be sure to check Florida’s DOH website regularly for news and updates, here.

To learn more about how The Health Law Firm can help you with matters involving the DOH, click here.

If You Are Instructed to Contact IPN or PRN, Call an Attorney First.

If you are ever instructed by your employer or anyone else to report yourself to the Intervention Project for Nurses (IPN) or to the Professionals Resource Network (PRN), consult with an experienced health law attorney first. There are many problems that you can avoid by having good legal advice before you make a stupid mistake. We are often consulted and retained by clients when after they have made mistakes in talking to the wrong people about the wrong things and are in a situation they could have avoided.

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

The attorneys of The Health Law Firm provide legal representation to physicians, nurses, nurse practitioners, CRNAs, dentists, pharmacists, psychologists and other health providers in Department of Health (DOH) investigations, Drug Enforcement Administration (DEA) investigations, FBI investigations, Medicare investigations, Medicaid investigations and other types of investigations of health professionals and providers. We represent impaired physicians and other health professionals in Professional Resource Network (PRN) and disruptive physician matters.

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

“Changes to Florida Reporting for Impaired Practitioners.” Holland & Knight LLP. (June 7, 2017). Web.

Mckown, Mia. “Changes to Florida Reporting for Impaired Practitioners.” Lexology. (June 7, 2017). Web.

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.

KeyWords: Legal representation for impaired physicians, Legal representation for Department of Health (DOH) investigations, Intervention Project for Nurses (IPN) attorney, Professionals Resource Network (PRN) defense legal counsel, DOH investigation defense attorney, legal representation for investigations against health care professionals, legal representation for Florida DOH investigations, Florida DOH representation, DOH complaint defense, legal representation for DOH complaint, Florida impaired practitioners program, legal representation for PRN matters, legal representation for IPN matters, legal representation for disruptive physician issues, health law defense attorney, legal representation for health care professionals, changes to Florida impaired practitioners program, legal representation for health care investigations, The Health Law Firm reviews, reviews of The Health Law Firm attorneys, The Health Law Firm

“The Health Law Firm” is a registered fictitious business name of and a registered service mark of The Health Law Firm, P.A., a Florida professional service corporation, since 1999.
Copyright © 2017 The Health Law Firm. All rights reserved.

 

Florida Doctors and Pharmacists Beware: Gov. Scott Declares State of Emergency for Opioid Abuse Crisis

6 Indest-2008-3By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

On May 3, 2017, Florida Gov. Rick Scott declared a state of emergency to combat Florida’s opioid-addiction epidemic. According to the governor, the number of overdose deaths has reached epidemic proportions. This declaration will allow nearly $30 million in federal funding to be spent for treatment and prevention services.

Given past state actions taken to attempt to eliminate prescription pain medication abuse, physicians writing such prescriptions and pharmacies filling such prescriptions should beware. Get prepared, not only through having a good compliance program, but by contacting and having a good attorney on retainer in the event of a subpoena, raid, search warrant or arrest warrant. Additionally, always talk to your lawyer before speaking with any investigator or special agent about anything.

The Emergency Declaration.

An emergency declaration gives Governor Scott the power to spend immediately without the Legislature’s approval. Therefore, public health officials can move quickly to respond to a crisis. Additionally, the emergency declaration will free up nearly $30 million in federal funds for prevention, treatment and recovery services. These services include workshops focused on addressing the major opioid abuse problem in Florida’s areas hit hardest with this crisis.

The Opioid Epidemic.

According to the Center for Disease Control and Prevention (CDC), in 2015 nearly 3,900 people died across the state of Florida as a direct result of opioid abuse. Governor Scott’s emergency declaration has strengthened the Florida Legislature’s effort this year to address the opioid abuse crisis in several additional proposals.

Among the additional measures state legislators are considering one that rewrites Florida’s drug trafficking statute. The new measure would create tougher penalties for dealers and users, specifically those caught with fentanyl. Fentanyl is a synthetic drug that can be 100 times more potent than morphine.

For more information and statistics on the opioid epidemic in Florida, click here.

To read one of my prior blogs for physicians prescribing pain medication, click here.

Contact Experienced Health Law Attorneys for Opioid Abuse Concerns.

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

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

Sources:

Auslen, Michael. “Gov. Scott declares public health emergency over opioid crisis.” Miami Herald. (May 4, 2017).

Ceballos, Ana. “Florida Bolsters Response to Opioid-Addiction Crisis.” Associated Press. (May 4, 2017). Web.

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.

KeyWords: Florida’s opioid abuse crisis, legal representation for opioid prescribing, legal representation for physicians prescribing opioids, Drug Enforcement Administration (DEA) defense lawyer, legal representation for over-prescribing pain medication, Board of Medicine hearing attorney, Board of Pharmacy hearing attorney, Florida prescription drug crackdown, health care defense attorney, legal representation for drug diversion, drug diversion defense attorney, legal representation for health care professionals, health care professional defense attorney, Board of Medicine defense counsel, Board of Pharmacy defense lawyer, Florida health care defense attorney, reviews of The Health Law Firm, The Health Law Firm attorney reviews, The Health Law Firm, attorneys for physicians, pharmacist legal defense attorney, Board of Medicine defense lawyer, Department of Health defense counsel, Drug Enforcement Administration (DEA) Order to Show Cause (OTSC) attorney, Drug Enforcement Administration (DEA) hearing lawyer

“The Health Law Firm” is a registered fictitious business name of and a registered service mark of The Health Law Firm, P.A., a Florida professional service corporation, since 1999.
Copyright © 2017 The Health Law Firm. All rights reserved.

Purpose of Florida E-FORCSE Prescription Database Not for Disciplinary or Criminal Prosecution Purposes Against Physicians, Pharmacists or Other Health Professionals

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

8 Indest-2008-5As you are no doubt aware now, Florida has an active prescription drug monitoring program (PDMP). It is called the “Electronic-Florida Online Reporting of Controlled Substances Evaluation” or “E-FORCSE.” More often it is referred to simply as the “prescription drug database” by Florida physicians.

The Florida Legislature adopted the E-FORCSE system in Florida by Section 893.055, Florida Statutes.

Section 893.055(7)(b), Florida Statutes, States Access to Program’s Database is Limited to Program Manager.

A pharmacy, prescriber, or dispenser shall have access to information in the prescription drug monitoring program’s database which relates to a patient of that pharmacy, prescriber, or dispenser in a manner established by the department as needed for the purpose of reviewing the patient’s controlled substance prescription history. Other access to the program’s database shall be limited to the program’s manager and to the designated program and support staff, who may act only at the direction of the program manager or, in the absence of the program manager, as authorized. Access by the program manager or such designated staff is for prescription drug program management only or for management of the program’s database and its system in support of the requirements of this section and in furtherance of the prescription drug monitoring program. Confidential and exempt information in the database shall be released only as provided in paragraph (c) and s. 893.0551. . . .

Data from E-FORCSE Not Intended to be Used to Bring Disciplinary Action Against Health Care Practitioners.

Most notably, it was not the intent of the Legislature for any state or federal agency to use the data from the E-FORCSE system primarily as evidence for the purpose of taking licensure or disciplinary action against physicians, dentists, pharmacists or other licensed health professionals.

Unfortunately, we have seen cases where, contrary to the Legislature’s intent, data from E-FORCSE has been recited in a case against a licensed health professional as an example of “substandard performance,” “falling below the standard of care,” or professional “negligence.” Additionally, we have been informed of the alleged use of the E-FORCSE system by state and federal law enforcement authorities in criminal investigations and prosecutions of licensed health professionals. However, the exact wording of Sections 893.055 and 893.0551, Florida Statutes, should be carefully analyzed in determining under what conditions access and use of the information are authorized.

Defending Against E-FORCSE Data’s Being Used Against a Health Care Practitioner.

If you are a physician, dentist or pharmacist, and data from E-FORCSE is used in or discussed in any complaint investigation, license investigation, Drug Enforcement Administration (DEA) investigation, criminal investigation, administrative complaint, charge sheet or indictment, you should ask your attorney to research the advisability of filing a motion to strike it. In addition, your attorney should also consider filing a motion in limine, before any major hearing or trial, to exclude all use or mention of the data and E-FORCSE system.

In addition, the attorney for the licensed health professional may explore the possibility of moving to exclude any and all information and evidence derived from the unauthorized use of the E-FORCSE databank under the “fruit of the poisonous tree” doctrine. To date, we have not seen any cases where this has been done.

Again the exact language of Sections 893.055 and 893.0551, Florida Statutes, should be consulted to determine whether access and use have been properly authorized.

Information on Florida’s Prescription Drug Monitoring Program from the Florida Department of Health.

The information below is taken from an informational pamphlet distributed by the Florida Department of Health (DOH) called “E-FORCSE; Florida’s Prescription Drug Monitoring Program.” It is available online, at http://www.e-forcse.com.

Florida’s Prescription Drug Monitoring Program Facts.

E-FORCSE will take in controlled substance dispensing data from pharmacies and health care practitioners, and will make the information available to all health care practitioners who can then use the database to guide their decisions when prescribing and dispensing certain highly-abused prescription drugs. With this information, health care practitioners may be able to identify patients who are “doctor shopping”—obtaining multiple prescriptions for the same controlled substance from multiple health care practitioners. Doctor shopping is a felony in Florida.

Who is Required to Report Controlled Substance Dispensing Information to E-FORCSE?

Any health care practitioner who has dispensed a controlled substance in schedule II, III and IV, as defined in section 893.03, Florida Statutes-like OxyContin, Percocet, Vicodine, etc., will be required to report to the database. This includes pharmacies licensed under chapter 465, Florida Statutes, (including mail order and Internet pharmacies that dispense controlled substances into Florida) and health care practitioners licensed under chapters 458, 459, 461, 462, 465, or 466, Florida Statutes.

Who is Not Required to Report Controlled Substance Dispensing Information to E-FORCSE?

A health care practitioner who:

– Administers a controlled substance directly to a patient if the amount is adequate to treat the patient during that particular treatment session;
– Administers a controlled substance to a patient or resident receiving care as a patient, at a hospital, nursing home, ambulatory surgical center, hospice or intermediate care facility for the developmentally disabled;
– Administers or dispenses a controlled substance in the health care system of the Florida Department of Corrections;
– Administers a controlled substance in the emergency room of a licensed hospital;
– Administers or dispenses a controlled substance to a patient under the age of 16; and
– Dispenses a one-time, 72-hour re-supply of a controlled substance.

How Can E-FORCSE Help Improve a Patient’s Standard of Care?

– It allows the health care practitioners to choose and prescribe controlled substances that will not negatively interact with medicines prescribed by other health care practitioners.
– Pharmacists can determine for their patients if their health care practitioners have prescribed controlled substances that might negatively interact when used together.
– Health care practitioners can determine if their patient has had multiple prescriptions for the same drugs from multiple health care practitioners. This identifies those patients potentially engaged in the crime of doctor shopping. When health care practitioners intervene, they can help their patients find treatment.

How Can E-FORCSE Help Improve the Public Health of Florida?

Health care practitioners can identify a potentially illegal diversion pattern for drugs when they request and receive a Patient Activity Report (PAR). A PAR can alert health care practitioners to doctor shopping. In addition, this information can assist law enforcement, medical regulatory boards and the Attorney General’s Medicaid Fraud Control Unit (MFCU) with active investigations into criminal activity regarding controlled prescription drugs.

Who Has Access to the Information Stored in E-FORCSE?

A health care practitioner who is subject to licensure or regulation by the DOH under chapter 458, chapter 459, chapter 461, chapter 462, chapter 464, chapter 465, or chapter 466, Florida Statutes, will have direct access to their specific patient’s information. Other direct access to information will be limited to the E-FORCSE program manager and designated staff for the purpose of program management.

Indirect access may be requested by the following organizations upon being verified and authenticated by E-FORCSE staff.

– DOH or appropriate health care regulatory boards who are involved in a specific investigation involving a designated individual for one or more prescribed controlled substances;
– The Attorney General (AG) for Medicaid fraud cases involving prescribed controlled substances; and
– A law enforcement agency during active investigations regarding potential criminal activity, fraud or theft of prescribed controlled substances.

Are Health Care Practitioners Required to Access E-FORCSE Before Prescribing a Controlled Substance?

Health care practitioners will not be required to access E-FORCSE before prescribing a controlled substance. It will be voluntary; however, physicians are encouraged to use it as a tool to improve patient care.

Is E-FORCSE Compliant with the Federal Health Insurance Portability and Accountability Act (HIPAA)?

Yes, in addition to meeting the federal HIPAA requirements, E-FORCSE will meet all required DOH security requirements.

What is the Penalty for Disclosure of Confidential Information in the E-FORCSE Database?

A health care practitioner or other individual who has access to the information in the E-FORCSE database who discloses confidential information will be committing a third-degree felony.

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

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

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

Comments?

As a health care practitioner, do you use E-FORCSE? Why or why not? Please leave any thoughtful comments below.

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

KeyWords: prescription drug monitoring program, PDMP, Florida prescription drug monitoring program, Electronic-Florida Online Reporting Controlled Substance Evaluation, E-FORCSE, E-FORCSE data, prescription database, physician, doctor, pharmacist, dentist, health care professional, health care provider, health care practitioner, Florida Legislature, prescriber, cases against licensed health care professionals, substandard performance, falling below the standard of care, professional negligence, criminal investigation, criminal investigation of a physician, prosecution of health care professional, prosecution of physician, compliant investigation, license investigation, Drug Enforcement Administration, DEA, DEA investigation, administrative complain, charge sheet or indictment, defense attorney, defense lawyer, Florida defense attorney, Florida defense lawyer, Florida Department of Health, DOH, doctor shopping, controlled substance, Attorney General, AG, Medicaid Fraud Control Unit (MFCU), dispensing controlled substances, reporting to E-FORCSE, who can access E-FORCSE, Health Insurance Portability and Accountability Act, HIPAA, E-FORCSE HIPAA compliant, health law firm, The Health Law Firm

“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.

FDA Issues New Warning for Popular Type 2 Diabetes Drug

2 Indest-2009-1By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law
The Food and Drug Administration (FDA) recently warned that a new class of type 2 diabetes drugs may cause a serious condition and can lead to hospitalization. Included in that warning is Invokana, the first in a new class of frontline treatment for type 2 diabetes. It was approved in 2013 and quickly gained popularity among health care providers and patients. Other drugs in the class include Invokament, Jardiance, Xigduo XR, Farxinga and Glyxambi. These drugs, known as SGLT2 inhibitors, are intended to improve glycemic control in patients with type 2 diabetes by blocking the absorption of glucose in the kidneys.

The Problem.

According to the FDA’s warning, SGLT2 inhibitors can lead to the development of diabetic ketoacidosis, a serious condition that can result in cerebral edema, pulmonary edema, heart attacks, strokes, cardiac dysrhythmia, nonspecific myocardial injury, diabetic retinopathy, severe dehydration, coma and death. The FDA recently took notice of these significant health risks and issued a safety announcement that warned of the serious side effects potentially resulting from treatment with SGLT2 inhibitors. To read the FDA’s warning, click here. To read one of our blogs on a similar case, click here. Click here to find out how The Health Law Firm can help you with a situation such as this.

Comments?

Did you develop ketoacidosis after taking a SGLT2 drug such as Inkovana? If you or a loved one took Invokana or another type 2 diabetes drug that resulted in ketoacidosis, you may have legal options. Please leave any thoughtful comments below.

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

KeyWords: Food and Drug Administration, FDA, defense attoryney, defense lawyer, defense counsil, Inkovana, Type 2 Diabetes Drug, SGLT2 inhibitors, products liability attorney, products liability lawyer, ketoacidosis, safety announcement, recall, safety warning, drug side effects, plaintiff products liability attorney, health care attorney, health care lawyer, health law, The Health Law Firm

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.