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Responding to a Medicare Audit – Practice Tips

Although you may speak of a “routine” Medicare audit, there is really no such creature. This is like saying you have a “routine IRS audit.” The fact is that there is some item you have claimed as a Medicare provider or the amount of claims Medicare has paid in a certain category that has caused you or your practice to be audited.

Having too many claims for level five CPT codes might, for example, cause you to be audited. Having multiple claims submitted for the same date of service, may cause you to be audited. Submitting claims for CPT codes outside of your medical speciality area, might cause you to be audited. Having the dollar amount of claims greater than the average for a similar health practitioner in the same geographical area of the country, may cause you to get audited. Having a greater number of claims submitted than the average for a similar health practitioner in the same geographical area of the country, may cause you to get audited. Filing claims for services that are on the Office of Inspector General’s (OIG) annual work list may cause you to be audited.

“Routine” audits, those that do not involve some suspicion of false billings or fraudulent activities, should, nevertheless, be treated extremely seriously and the physician, group or health provider being audited should give the matter personal attention. Examples of some contractors that may be involved in “routine” audits include DelMarva Foundation, Palmetto GBA, Cigna GBA, or First Coast Service Options, Inc.

However, if the audit letter or audit notice is from a Zone Program Integrity Contractor (ZPIC), such as SafeGuard Services, LLC, or AdvanceMed, the matter is very serious and should not be treated as a routine audit. If the “audit” comes in the form of a subpoena, then it is extremely serious. If any FBI agent or OIG special agent is involved in it, then it is extremely serious. In any of these three cases, an experienced health attorney should be retained immediately.

Even on a “routine” audit, given the possible consequences, we recommend you immediately retain the services of an experienced health attorney to guide you through the audit process, to communicate with the auditors, and to be prepared if it is necessary to challenge the audit findings.

These are some of the items actions we recommend you take and which we take in representing a physician or other health provider in responding to a Medicare audit.

1. All correspondence from Medicare, or the Medicare contractor, should be taken seriously. Avoid the temptation to consider the request from Medicare, or the Medicare contractor, just another medical records request. Avoid the temptation to delegate this as a routine matter to an administrative employee.

2. Read the audit letter carefully and provide all the information requested in the letter. In addition to medical records, auditors often ask for invoices and purchase orders for the drugs and medical supplies dispensed to patients for which Medicare reimbursed you.

3. Include a copy of the complete record and not just those from the dates of service requested in the audit letter. Include any diagnostic tests and other documents from the chart that support the services provided. Many practices document the medications and immunizations given to the patient in a separate part of the chart and not in the progress notes; all documents, the complete record, should be provided to the auditor. Remember that even other physicians records obtained as history, including reports, consultants and records from other physicians or hospitals, should also be included. Consent forms, medical history questionnaires, histories, physicals, other physicians’ orders, all may be a crucial part of the record and should be included. If hospital or nursing home discharge orders or other orders referred the patient to you, obtain these to provide to the auditors.

4. Make sure all the medical records are legible and legibly copied. If the record is not legible, have the illegible record transcribed and include the transcription along with the hand-written or illegible records. Make sure than any such transcriptions are clearly marked as a transcription with the current date it is actually transcribed. Label it accurately. Do not allow any room for there to be any confusion that the newly transcribed part was part of the original record.

5. If your practice involves taking or interpreting x-rays or other diagnostic studies, include these studies. They are part of the patient’s record. If the x-rays are digital, they can be submitted on a compact disc (CD).

6. Never alter the medical records after a notice of an audit. However, if there are consults, orders, test reports, prescriptions, etc., that have not been filed into the chart, yet, have these filed into it, as you normally would, so that the record is complete. Altering a medical record can be the basis for a fraud claim including criminal penalties.

7. Make sure each page of the record is copied correctly and completely. If the copy of the record has missing information because it was cut off, the original needs to be recopied to ensure it includes all the information. Don’t submit copies that have edges cut off, have bottom margins cut off, are copied slanted on the page, or for which the reverse side is not copied. Reduce the copied image to 96% if necessary to prevent edges and margins from being cut off.

8. Make color copies of medical records when the original record includes different colored ink of significance. Colors other than blue and black rarely copy well and may be illegible on standard photocopiers.

9. Include a brief summary of the care provided to the patient with each record. The summary is not a substitute for the medical records, but will assist an auditor that may not be experienced in a particular specialty or practice area. Make sure that any such summaries are clearly marked as summaries with the current date they are actually prepared. Label it accurately. Do not allow any room for there to be any confusion that this new portion was part of the original record.

10. Include an explanatory note and any supporting medical literature, clinical practice guidelines, local coverage determinations (LCDs), medical/dental journal articles, or other documents to support any unusual procedures or billings, or to explain missing record entries. See item 9 immediately above.

11. When receiving a notice of a Medicare audit, time is of the essence. Be sure to calendar the date that the records need to be in to the auditor 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 at the auditor’s office.

12. Any telephone communication with the auditor should be followed up with a letter confirming the telephone conference.

13. Send all communications to the auditor by certified mail (or express mail), return receipt requested so you have proof of delivery.

14. Properly each copy of each medical record you provide and page number everything you provide the auditors, by hand, if necessary. Medical record copies often get shuffled or portions lost or damaged during copying, storage, scanning or transmission.

15. Keep complete, legible copies of all correspondence and every document you provide. When we provide records to a Medicare auditor, we make a complete copy for the auditor, for the client, for us (legal counsel) and two for your future expert witnesses (to challenge any audit results) to use.

16. Consult an experienced health law attorney early in the audit process to assist in preparing the response.

The above check list is by no means comprehensive. Nor do we mean to suggest that you should respond on your own. The above is illustrative of the many actions that should be taken to help protect your interests when you are subjected to a Medicare audit.

Visit our website at www.TheHealthLawFirm.com for more information on Medicare audits, ZPIC audits, health care subpoenas, Medicare and Medicaid search warrants and Medicare and other federal administrative hearings.

By The Health Law Firm|2024-03-14T10:00:25-04:00June 1, 2018|Categories: Health Care Industry, In the Know, Medicare, The Health Law Firm Blog|Tags: attorney, florida, health law, medical, medicare, medicare audit|Comments Off

Guilty Plea to Research Misconduct Results in 4 1/2 Year Prison Sentence

By Michael L. Smith, R.R.T., J.D., Board Certified by The Florida Bar in Health Law and George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

Dong-Pyou Han, a former Iowa State University scientist was sentenced to four-and-a-half (4 ½) years in prison on Wednesday July 1, 2015, for falsifying his research results concerning the effectiveness of an experimental HIV vaccine. A plea agreement also required Han to pay $7.2 million in restitution to the National Institutes of Health (NIH), which funded the research. Han was testing the experimental HIV vaccine on rabbits. He spiked the rabbit blood with human antibodies to make it falsely appear the experimental vaccine caused the rabbits to develop antibodies to HIV.
Click here to the entire AP article.

What is Research Misconduct?

“Research misconduct” is intentional fabrication, falsification, or plagiarism during the course of clinical research. It is not honest differences of opinion or differences in the interpretation of data. In Han’s case, the test results were fabricated in order to fraudulently secure millions of dollars in grants from the NIH.

Click here to read one of our blogs on the ABCs of IRBs. For more resources, visit the Research Misconduct Website at National Institutes of Health.

Han’s Attorney Requests Probation, Not Prison.

According to an AP article, Han was represented by a federal public defender who asked the court to sentence Han to probation rather than prison. The public defender argued that Han already lost his ability to work as a scientist and would most likely be deported to his native South Korea. Instead, the judge in this case sentenced Han to four-and-a-half years (4 ½) in prison.

Prison Sentences Unusual for Research Misconduct Cases.

Research misconduct investigations do not often result in prison sentences. Most often, the sanction imposed on a scientist found to have committed research misconduct is a requirement to retract published articles, research or reports, and the loss of their research positions. When NIH funding is involved, a prohibition on conducting any future NIH-funded research for a period of time is also often imposed. A finding of research misconduct usually ends the research career of a scientist or physician. However, when the fraud is blatant or when it involves a large amount of grant money, criminal prosecution may follow.

Contact Health Law Attorneys Experienced with Research Misconduct.

The attorneys of The Health Law Firm provide legal representation to doctors and other scientists involved in research in addition to representing healthcare providers in numerous other matters.

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

Comments?

Have you ever heard of research misconduct? Do you think the scientist received a fair punishment for his research misconduct? Please leave any thoughtful comments below.

Sources:

Pitt, David. “Ex-Iowa State Scientist Gets Prison for Faking HIV Research” Associated Press. (July 1, 2015). From:

http://abcnews.go.com/Technology/wireStory/iowa-state-scientist-prison-faking-aids-research-32161935

About the Authors: Michael L. Smith, R.R.T., J.D., is Board Certified by The Florida Bar in Health Law. He is an attorney with The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

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: research misconduct, attorney, research fraud defense, misconduct in science, clinical investigation fraud defense attorney, National Institutes for Health, NIH, fraud defense lawyer, medical investigation, clinical research fraud, clinical trials, grant fraud, institutional review board investigation, IRB, misconduct in science committee, MISC, defense counsel, data falsification, researcher’s attorney

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.

By The Health Law Firm|2024-03-14T10:01:00-04:00June 1, 2018|Categories: In the News, The Health Law Firm Blog|Tags: attorney, clinical investigation fraud defense attorney, clinical research fraud, clinical trials, data falsification, defense counsel, fraud defense lawyer, grant fraud, institutional review board investigation, IRB, medical investigation, MISC, misconduct in science, misconduct in science committee, National Institutes for Health, NIH, research fraud defense, research misconduct, researcher’s attorney|Comments Off

Nurses: Insuring Your Legal Protection

Though many nurses pursue a career in nursing hoping that they will never face disciplinary charges, any number of events not in a nurse’s control can lead to an investigation or administrative action. Nurses need to make sure they are covered if this ever occurs, with appropriate insurance.

The primary reason that a nurse should purchase a professional liability insurance policy is that this type of insurance usually includes coverage for legal defense of licensing and disciplinary action commenced against a nurse.

License defense coverage pays the legal fees and costs associated with defending a nurse when an investigation is initiated that may result in action against her nursing license or disciplinary action against the nurse. Coverage is usually available from the time the nurse receives written notice that an investigation by a state agency has been initiated. It will also cover formal complaints made against the nurse, informal hearings before the Board of Nursing, and formal administrative hearings before an administrative law judge.

Such investigations, complaints, and administrative action may be opened based on events including patient complaints, hotline calls, Code 15 reports, nursing home and home health agency surveys, abuse investigations by the Department of Children and Families (DCF), newspaper articles, copies of lawsuits, and many other sources. It is far more likely that a nurse will be involved in one of these types of actions than being sued for nursing negligence.

Professional liability policies, which provide coverage for licensure defense, will usually provide compensation to the nurse for her out-of-pocket expenses (travel, postage, etc.) that she herself incurs, as well as lost wages because of working time missed for hearings, depositions, etc. However, the maximum coverage available under such policies for licensure defense is usually limited. to between $10,000 and $15,000. This amount will usually be sufficient to provide for most of the legal fees and costs involved in defense of such a case.

Does Vicarious Liability Actually Absolve the Nurse From Liability?

The assumption that vicarious liability or the legal doctrine of respondeat superior protects a nurse against a medical negligence claim is a mistaken one. If the employer provides legal representation, the attorney representing the nurse will almost always be the same attorney representing and being paid by the hospital or employer.

In many circumstances, the nurse may conclude that her interests are contrary to those of the hospital or employer, which could result in the attorney hired by the hospital withdrawing from further representation of the nurse. Additionally, it may be necessary for the nurse to raise evidence showing that the injury was caused by another nurse or hospital employee, in order to defend herself. It is doubtful that an attorney representing the employer or hospital would raise this defense since it would prove liability against the employer hospital.

Many employers will not provide legal representation if the matter involves licensing or disciplinary action against the nurse. This could force the nurse to fund all the fees and costs associated with her defense. However, some larger corporations with good risk management programs will provide the nurse with legal representation for such matters.

If you are an agency nurse, a home health agency nurse, a nursing home nurse, an independent duty nurse, or you are not employed by a large hospital chain, then you should consider nursing liability insurance mandatory. It appears that complaints of negligence against nurses working in these positions are far more likely. This may be because of the high turnover of nurses in some types of healthcare facilities (such as nursing homes), or because the nurse is no longer employed at the facility when the investigation begins (for example, in the case of an agency nurse). Additionally, agency nurses may only work in facility for a short period of time making them less familiar with the facility’s policies and procedures, and not a part of the permanent team of nurses who may have established relationships with each other and are more likely to cover for each other.

As previously mentioned, a number of different proceedings may be covered by the licensure defense coverage provided in professional liability insurance. These proceedings may include an investigation by the Department of Health based on a patient complaint or Code 15 report; an abuse investigation (abuse of a child, abuse of a developmentally disabled or vulnerable person, or abuse of an elderly person) by the Department of Children and Families (DCF); allegations of nursing negligence or abuse being investigated by a state “surveyor” by the Agency for Health Care Administration (AHCA); an investigation into allegations of Medicaid over-billing or fraud; an investigation by the Agency for Health Care Administration or on the Attorney General’s State-wide Medicaid Task Force; and allegations of improper Medicare billing or fraud.

A nurse might be involved in a Medicaid fraud investigation, for example, in the case of an Advance Registered Nurse Practitioner (ARNP), Certified Registered Nurse Anesthetist (CRNA) or Certified Nurse Midwife (CNM) who has her own provider identification number and is allowed to bill as part of a group practice or independently. This might also occur, for example, in the case of a nurse working for a home health agency which receives its reimbursement for the nurse’s services from Medicare or Medicaid.

Cost of Professional Liability Coverage is Minimal

Nurses can purchase liability coverage rather inexpensively. For example, an excellent insurance policy providing coverage for nurses is available through the Nurses Service Organization (N.S.O.) for less than $100 per year. Professional liability coverage provided by this type of insurance represents a bargain at these rates.

Focusing on Protecting the Nurse’s Individual Interests

Perhaps most importantly, the nurse should have an attorney focusing on her interests only in defending her against any type of negligence or licensing complaint. A nurse with her own professional liability insurance coverage will be able to hire a separate, independent attorney, and often the insurer will allow her to pick her own attorney.

Important Considerations When Purchasing Liability Protection

When deciding on which professional liability insurance to purchase, the nurse should inquire as to the extent of coverage for licensing in disciplinary defense coverage. Some professional liability insurers have a “broad form” of coverage which may provide legal defense for the nurse in almost any type of administrative action. This might include, for example, defense of a discrimination complaint filed against the nurse with the Florida Commission on Human Relations (FCHR) or the U.S. Equal Employment Opportunity Commission and for Medicare and Medicaid complaints. Other companies limit coverage to only actions that may result in disciplinary action against the nurse’s license. The nurse should always attempt to get the broadest coverage available for disciplinary defense and licensure defense coverage.

Additionally, the nurse should inquire as to whether or not she will be allowed to select her own attorney. Many insurance companies have contracts with certain law firms to provide legal services on their cases for a reduced fee. The insurance company may require you to use one of its own contracted attorneys, or even one of its in-house attorneys which it employs directly. Given the limited number of attorneys with experience at handling nursing law issues and trying malpractice cases, the nurse should attempt to obtain coverage through a company which allows her to choose her own attorney.

The most important reason to purchase professional liability insurance is for the licensure defense coverage. A nurse does not want to risk losing her nursing license because she was unsuccessful at defending an investigation against her license or did not have the resources to do so. Since there are far more complaints filed each year against nurses’ licenses than here are nursing malpractice lawsuits, it is far more likely that a working nurse will need legal defense of a licensure complaint investigation.

For more information about the legal needs of nurses visit www.TheHealthLawFirm.com.

By The Health Law Firm|2024-03-14T10:00:26-04:00June 1, 2018|Categories: Health Care Industry, Insurance, Nurses, The Health Law Firm Blog|Tags: attorney, crna, florida, insurance, lawyer, nurses, professional liability insurance|1 Comment

Benchmark: DEA Conduct Resulted in Dismissed Charges

In light of the DEA‘s recent focus on Florida’s prescription drug trafficking problem, we wanted to discuss a former case in which the DEA‘s actions resulted in a favorable outcome for alleged drug dealers.

According to the Daily Journal, in 2004, U.S. District Judge Florence-Marie Cooper dismissed charges against three alleged methamphetamine dealers after an attorney to one of the defendants argued that the informant improperly relied on a “subinformant” to set up drug transactions in order for DEA agents to bust suspected dealers. According to the attorney, the informant used the intermediary to protect himself and the DEA from entrapment claims. Because of this, defense attorneys could not derive from the primary witness how the drug sale was arranged.

The attorney claimed that the subinformant contacted old friends and acquaintances in low-income areas and informed them of money to be made if they could find a large amount of methamphetamine for a prospective buyer. The informant posed as the buyer. By repeatedly calling these individuals to find a source for the methamphetamine transactions, the subinformant would turn the case over to the informant right before the transaction took place.

In this case, the DEA provided evidence only of the final interactions between the informant and the defendants. The attorney wanted to show that the entrapment actually occurred earlier, when the subinformant allegedly pressured the defendants to complete the methamphetamine deal.

In laying out the subinformant scheme in his discovery motion, the attorney cited phone records between the subinformant and the defendants in his case and in two other methamphetamine cases, U.S v. Parra, 03-CR- 121, and U.S. v. Corcuera, 03-CR-24. In the three cases, the subinformant had regular and frequent contact with the defendants, but the informant had very little or no contact with the defendants before the arrests.

Cooper agreed that the informant used an underling to keep the defense from analyzing the details of the drug deal. According to Cooper, using an intermediary to do the actual work assigned to the informant, allows the DEA to protect itself from inspection and from any charges of improper conduct.

“A law enforcement agency must not be allowed to shield itself from accountability by hiring someone outside of law enforcement who is free to violate citizens’ rights.” U.S. v. Alvarez, 02-CR-355.

With a subinformant, there is no requirement to monitor their actions. The DEA doesn’t tape, keep records or provide discovery for subinformants. The DEA has a history of failing to regulate its informants, including the nationwide Andrew Chambers scandal. An internal investigation launched by the DEA in 2000 revealed that Chambers repeatedly lied under oath over a 16-year period in which he earned almost $2 million to help bust drug felons.

However, even if informants were regulated it wouldn’t prevent subinformants from negotiating the transactions that entrap individuals.

These investigative measures by the DEA are also being used in operations directed at Florida pain clinics. In an effort to rid the state of pill mills, the DEA is using every tool to bust clinics, physicians and pharmacists that might be involved in a suspicious pain clinic.

For more information about legal matters concerning pain clinics, visit www.TheHealthLawFirm.com.

By The Health Law Firm|2024-03-14T10:00:26-04:00June 1, 2018|Categories: Health Care Industry, In the News, Pain Management, Pharmacy, The Health Law Firm Blog|Tags: attorney, dea, florida, informants, pain clinic, pill mills|Comments Off

Florida’s Pill Mills Still a Target

Last week, the DEA announced the results of enforcement efforts directed at Florida’s illegal prescription drug distributors.

According to the DEA, more than 100 individuals have been arrested in operations targeting pill mills in Florida, and the DEA, as well as Florida law enforcement, will continue to investigate and prosecute pain clinics, pharmacies and physicians who are contributing to Florida’s prescription drug trafficking epidemic.

Operation Pill Nation I, initiated in February 2011 in South Florida, has resulted in the arrest of 47 people, including 17 doctors and five clinic owners, and the seizure of more than $18.9 million in cash and assets. Furthermore, over 70 doctors, six pharmacy owners and five DEA Registered Controlled Substance Distributors have been stripped of their DEA registrations.

Operation Pill Nation II has resulted in enforcement actions against 22 individuals and one pharmacy allegedly involved in the illegal distribution of prescription drugs.

The DEA also announced the addition of a third Tactical Diversion Squad in Florida. Based in Orlando, this new group will be responsible for investigating prescription drug diversion in Central Florida.

According to the Orlando Sentinel, this new squad was created solely to investigate the illegal use and distribution of prescription drugs in the Orlando area. Currently, the Orlando squad is investigating doctors and pharmacies, their first case involves a Winter Park pharmacy.

Howell Branch Road’s The Medicine Shoppe is under investigation. It’s pharmacist is accused of providing more than 15,000 oxycodone pills that were illegally distributed.

Coinciding with the DEA’s announcements, was the investigation of Tampa pill mills. DEA agents, and Florida state and local law enforcement executed six search warrants and served two immediate suspension orders to a doctor and a pharmacy in Tampa. Immediate suspension orders revoke authority to dispense or prescribe controlled substances.

Earlier this year, the DEA commissioned a pill mill hotline in Florida. This 24-hour pill mill tip line and e-mail address allow the public to provide information on suspicious pain clinics. Additionally, laws targeting pill mills were passed that makes it much more difficult to dispense narcotics at a clinic. However, the DEA’s raids will continue in order to eradicate Florida’s pill mill problem.

For more information on Florida pain clinics and the laws and legal matters that impact them, visit www.TheHealthLawFirm.com.

George Indest is an attorney, board certified by the Florida Bar in Health Law, who represents health care professionals and providers, including pain management clinics and pain management physicians.

Doctor or Nurse, Please, Please, Please: Talk to an Attorney Before You Talk to an Investigator

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

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

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

However, in cases where you might have your medical license revoked or have your nursing license revoked or have your DEA number revoked or lose your Medicare provider status or your Medicaid provider status, the investigator is not required to advise you of your rights.

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

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

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

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

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

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

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

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

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

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

Hint: If it is a Department of Health Quality Assurance Investigator or Medical Malpractice Investigator, they are probably only investigating possible disciplinary action against your license that could result in large administrative fines or revocation of your license.

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

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

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

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

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

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

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

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

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

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

For more information about investigations and other legal matters, visit www.TheHealthLawFirm.com.

By The Health Law Firm|2024-03-14T10:00:27-04:00June 1, 2018|Categories: Department of Health, Health Care Industry, Medicaid, Medicare, Nurses, The Health Law Firm Blog|Tags: attorney, dea, dentist, doh, fdle, investigation, investigators, license, nurse, physician, psychologist|Comments Off

Florida’s Strike Force Raids Pain Management Physicians

Florida is reported to have one of the worst prescription drug abuse problems in the country. Because of this issue, pain management physicians have been under increasing scrutiny and attack by federal and state agencies. If you are a pain management physician or you work in a pain a management clinic, you need to be aware of the measures that state and federal agencies are taking against doctors who practice pain management and the owners of pain management clinics.

A news release sent out by the Florida Department of Health (DOH) this summer discusses “inspections” of physicians’ offices across the state, allegedly to ensure compliance with Florida’s new prescription drug law (House Bill 7095). However, many of these may be more aptly termed as “raids.” These raids, under the guise of being inspections, have resulted in a massive quantity of narcotics being seized from clinics and physicians’ offices by the Strike Force. It is claimed that no search warrants are necessary as the Strike Force states it is performing an “administrative inspection.” The pain management physicians targeted by these inspections are identified based on their purchasing, prescribing and dispensing levels.

Often these “inspections” will include Department of Health Investigators, Florida Department of Law Enforcement Special Agents, local police and law enforcement agents, and Drug Enforcement Administration (DEA) Special Agents.

Our primary concern and warning to the physician or owner is to not talk to any investigators or inspectors, but call your personal attorney immediately. Have the investigator or inspector talk to your attorney. All communications should be with and through your attorney.
If you are requested to “voluntarily” relinquish (give up) your DEA registration or your medical license or other professional license, do not do this. It will not help you and it will make every aspect of your case more difficult to defend.
Do not make any statement (oral or written) or allow yourself to be interviewed.
Obtain the complete names, addresses, titles and agencies for each agent there. Obtain their business cards (which they should have).
Do not volunteer up any documents, items or information.

To read more about inspections from the document released by the Florida Department of Health click here.

If your office has been “inspected” and you need legal representation, you may call and speak to one of our health attorneys at (407) 331-6620 or (850) 439-1001.

By The Health Law Firm|2024-03-14T10:00:28-04:00June 1, 2018|Categories: Department of Health, Health Care Industry, Pain Management, Pharmacy, The Health Law Firm Blog|Tags: attorney, doh, florida, inspections, pain management, physicians, raids|Comments Off

National Practitioner Data Bank (NPDB) Update

On March 23, 2010, President Barack Obama signed into law the Patient Protection and Affordable Care Act (PPACA). This legislation made many reforms to the American health care system and with it came many changes that will affect both health care providers and consumers alike. One such change brought about by this legislation was the elimination of the independent Health Integrity and Protection Data Bank (HIPDB), and its merger with the National Practitioner Data Bank (NPDB). This will not affect the purpose of the federal government’s clearing house for disciplinary and malpractice information, but will forever change how the information is disseminated.

To understand the changes, one must first know the history of the NPDB. The NPDB was established by Title IV of Public Law 99-660, of the Health Care Quality Improvement Act of 1986. Its purpose was to improve the quality of health care by encouraging State licensing boards, hospitals and other health care entities, and professional societies to identify and discipline those who engage in unprofessional behavior. The NPDB has been expanded and revised a number of times, but its greatest expansion came on January 28, 2010, when the U.S. Department of Health and Human Services issued a final rule implementing Section 1921 of the Social Security Act.

Prior to this the NPDB dealt only with licensure and malpractice reports of physicians, dentists, and health care entities. This new regulation expanded the information collected and disseminated through the NPDB to include reports on all licensure actions taken against all health care practitioners.

Like the NPDB, the HIPDB was created to improve the quality of healthcare in America. The HIPDB was formed under the Health Insurance Portability and Accounting Act of 1996 (HIPAA) and specifically focused on combating fraud and abuse in health insurance and health care delivery, and promoting quality care. The HIPDB collected reports made by federal and state licensing agencies, federal and state prosecutors, and federal and state government agencies that had excluded a practitioner, provider or supplier from their health plan.

The NPDB and the HIPDB were created to provide a resource for state licensing boards, hospitals, and other health care entities to assist them in their investigations of the qualifications of the healthcare practitioners they sought to license or hire. These two data banks served this purpose independently of each other until the passing of PPACA on March 23, 2010.

Section 6403 of PPACA requires the Secretary of Health and Human Services (HHS) to maintain a national health care fraud and abuse data collection program for reporting certain adverse actions taken against health care providers, suppliers, and practitioners, and to submit information on the actions to the NPDB. Section 6403 further requires the Secretary to establish a process to terminate the HIPDB and ensure that the information formerly collected in the HIPDB is transferred to the NPDB.

What does this mean to you? Specifically, the NPDB has now become one large, all encompassing central data bank for all reports made against all health care professionals, whether the report deals with fraud, abuse, licensure actions, or malpractice. The HIPDB has been eliminated as an independent data bank and in its place the Secretary of Health and Human Services has implemented a process in which all fraud and abuse reports will be collected and transferred to the NPDB. Additionally, all information that was previously held in the HIPDB has been transferred to the NPDB.

For more information about the National Practitioner Data Bank and how it might impact you and your practice, visit www.TheHealthLawFirm.com.

By The Health Law Firm|2024-03-14T10:00:28-04:00June 1, 2018|Categories: In the News, The Health Law Firm Blog|Tags: attorney, doctor, florida, national practitioner data bank, npdb, physcian|Comments Off

What Does Proposed Liposuction Bill Mean For Florida Plastic Surgeons?

A new Florida bill aimed at making liposuction procedures safer is making its way through the Senate in Tallahassee. The bill was created as a result of the deaths of four South Florida mothers in their 30s during liposuction procedures, according to the Orlando Sentinel.

Present state rules say physician surgery offices must be inspected by the state Department of Health or accrediting organizations, unless the doctor performs procedures using only local sedatives that leave the patient awake. Cosmetic surgeons who perform liposuctions using local sedatives such as lidocaine do not have to have their offices inspected.

The bill says that any liposuction that removes more than 1 liter of fat can only be done in a regulated office. This would cover most liposuctions. It would force most liposuctions to be done in surgery offices inspected by the state, by doctors with life-support training, not in unregulated physician offices.

However, some doctors think that the legislation doesn’t go far enough. It does not ban liposuction in physician surgery offices, as some proposed. It does not force med-spas to be regulated, as Sobel proposed in bills that failed in the past. It does not force doctors to use an anesthetist for all liposuctions.

The bill has cleared the Senate Health Regulation Committee and now goes to the Senate Budget Committee, where it is expected to pass. A similar bill is pending in the state House and no opponents have come out against it so far.

The bill was filed by state Sen. Eleanor Sobel, D-Hollywood in reaction to four South Florida liposuction deaths since 2009.

Maria Shortall, 38, died when her bloodstream was blocked by fat sucked from her midsection and reinjected into her buttocks at an unregulated physician office. Kellee Lee-Howard, 32, died of drug interactions in the hours after a liposuction at the same office, and Rohie Kah-Orukotan, 37, died of an overdose of lidocaine given during liposuction at an unregulated medical spa. Another Miami woman was killed from a fat blockage after liposuction at a licensed surgery center.

Disciplinary action is pending against the doctor involved in the first two cases; the doctor in the third case has surrendered his medical license. No disciplinary action has been taken in the fourth case.

According to the Florida Society of Plastic Surgeons, which backs the bill, it won’t be expensive for the state to regulate these offices. Additionally, the Florida Society of Plastic Surgeons hopes inspections will detect doctors who may be using local sedatives, such as lidocaine, for extensive liposuctions that should warrant stronger sedatives and more safety measures. Those measures include advanced life-saving training and having an assistant give anesthesia.

While no one has come out vehemently opposing the bill, if passed it will have some consequences for plastic surgeons who don’t update their practice to comply.

For more information about this and other health law topics, please visit www.TheHealthLawFirm.com.

By The Health Law Firm|2024-03-14T10:00:28-04:00June 1, 2018|Categories: Department of Health, Health Care Industry, The Health Law Firm Blog|Tags: attorney, florida, legislation, liposuction, plastic surgeons|2 Comments

Under Review: What You Need to Know About Clinical Privileges Hearings

The term “fair hearing” is used by different individuals and different organizations to refer to an administrative hearing or a private hearing in a hospital or professional association. There are a number of different types of proceedings that are often referred to as “fair hearings,” including clinical privileges (or peer review) hearings, which allow a physician who has had his or her clinical privileges revoked to be reviewed.

This type of hearing can also be referred to as:
• Privileges Hearing
• Fair Hearing
• Medical Review Hearing
• Credentials Hearing
• Medical Staff Hearing
• Disciplinary Hearing
• Credentials Committee Hearing or
• Ad Hoc Committee Hearing.

The physician that is subject to these hearings is not a Hospital employee, does not have a direct contract with the Hospital, is not a member of a group with an exclusive contract, but does have clinical privileges at the Hospital (based on proven clinical skills and competence to perform certain defined procedures in a hospital). When a hospital finds that a physician with clinical privileges is no longer competent (in the eyes of the hospital), a hearing will be conducted aimed at stripping the physician of his or her clinical privileges. This process (especially the litigation involved) can get ugly, and it is important for the physician in question to obtain the counsel of a health attorney who has experience in dealing with clinical privileges hearings.

Here is attorney George Indest’s basic rundown of clinical privileges hearings:

Indest’s Maxims for Hospital Peer Review Hearings

The peer review process is different in every hospital.
a. Medical staff bylaws are different.
b. Hearings are different (attorneys may not even be able to participate).
c. The burden of proof may be placed on the physician.
d. Investigation and appeals process may be different.
The hospital’s resources are virtually unlimited.
a. Hospitals may use certain experienced companies as part of the process that have a tendency to favor the hospital.
b. The hospital’s personnel and attorneys will do all of the work and provide all of the support for the medical staff and peer review committee.
c. The hospital and medical staff will have unlimited access to hospital employees and documents.
You need legal representation from the time of the first rumor you hear that a complaint has been filed or a matter is being investigated.
a. DO NOT “wait and see what happens.”
b. DO NOT think that you will be an exception.
You must be represented by an experienced, knowledgeable health care attorney during the peer review process. The hospital will be.
The “nonconformist” or “trouble maker” will be forced into a hearing situation. The guy everyone likes won’t be.
If hospital administration (including nursing staff) is out to get you, you will be gotten.
a. If the hospital administration identifies you as a “bad physician,” “troublemaker,” or “disruptive physician” you are in serious, serious trouble.
b. Your prior cases may be reviewed and scrutinized retrospectively for problems that were “overlooked.”
c. Every poor result or outcome will be analyzed.
d. You will be written up for everything that happens, even for things for which others would not be written up. Incidents where you were just “joking around” will be written up as sexual harassment.
e. Any patient complaints over insignificant matters that would have previously been handled in a routine way, will now be handled as significant events.
You will probably be offered an opportunity to resign prior to the commencement of the investigation . . .
But you will foolishly turn down the opportunity to resign.
There are many options and alternatives available early in the process, but only an experienced health care attorney will know them. Options may include:
a. Agreement not to admit, treat or perform certain procedures;
b. Taking a leave of absence;
c. Assessment by an independent organization (P.A.C.E., C.C.A.T.);
d. Agreement to undertake additional training; or
e. Resignation (prior to any proceedings being commenced).
A “fair hearing” is not fair.
a. The resources are stacked in favor of the hospital and administration.
b. Peer review proceedings are very expensive (for all parties).
c. The burden may be and can be placed on you to prove you are currently clinically skilled and competent.
d. There may be external motivations, other than quality (especially in cases of tenured professors, senior physicians and minorities). Certain motivations are economical in nature and can be identified by:
  i. Proceedings initiated by your competitors;
  ii. Complaints made by your competitors;
  iii. You allegedly bringing in too many cases (monopolizing the procedure rooms or operating rooms);
  iv. You bringing in the wrong cases (too many Medicare, etc.);
  v. One medical group controlling the whole department (in absence of an exclusive contract);
  vi. You being accused as an “overutilizer” (you use too many hospital resources);
  vii. You being accused as”cherry picking” the best cases (all non-indigent or non-Medicaid cases); or
  viii. You refusing to participate in managed care plans.
e. If suspended pending investigation/hearing and the suspension goes over 30 days, then a report to the National Practitioner Data Bank (NPDB) is required (which means there will be a report to your state medical board or licensing authority).
f. You may find the same individuals on:
  i. The Investigation Committee
  ii. The Peer Review/Hearing Committee
  iii. The Appeals Committee
  iv. The Board of Directors/Trustees (responsible for final recommendations)
g. You may have a gag order and not be allowed to talk to witnesses or potential witnesses to help you prepare for your case.
It may not matter what the peer review or fair hearing committee recommends.
a. The Board of Directors/Trustees can and will overrule the conclusions and recommendations of any peer review hearing (with the input of hospital administration and hospital attorneys).
b. The peer review committee must make solid, unequivocal findings supported by evidence, as well as, strong, precise well-reasoned conclusions and recommendations. Make sure that you ask them to do this and that you (or your attorney) present to them a proposed recommendation or report.
Those who judge you are not your peers.
a. They may be from all different specialities and some may not even by surgeons. (Try to have the hearing committee be appointed by your medical speciality association.)
The only rights you have are those in your medical staff bylaws (unless you are at a “public hospital” or in California)
The consequences to you of an adverse outcome will be lifelong and career-altering. Consequences include:
a. National Practitioner Data Bank (NPDB) Reports, which are national, on file for 50 years, very difficult to get corrected or voided and also reported to your state medical board;
b. State licensure action (in every state in which you have a license);
c. Medical specialty associations will commence proceedings if they hear of an adverse outcome;
d. You will unlikely ever get clinical privileges at another hospital;
e. You may lose medical malpractice insurance coverage;
f. You may be dropped from the panels of many HMOs, managed care plans and insurers;
g. Contracts with employers and insurers may require you to report this (so that you can be terminated).
Once a peer review proceeding is commenced, it’s not just going to go away, and none of your friends on the Executive Committee or Board of Trustees is going to make it go away.
Once a peer review proceeding is commenced against you, you will be in the most important fight of your career and possibly your life.
You have no power, no control and no leverage. Get some:
a. Assemble an experienced legal team;
b. Begin preparing early and seriously;
c. Get established, credible experts;
d. Sue the hospital and certain individuals involved, if circumstances permit;
e. Consider “political” or “public relations” avenues like letters to other physicians or patients, full page newspaper ads, getting your state or county medical society involved, or having a state legislator introduce a bill to require due process in all hospital adverse actions.
You are going to have to spend lots of money to properly defend yourself and you will not get it back if you win.
If you think you will be successful in suing in court to have an incorrect result overturned, you are probably wrong.
Court litigation can give you the leverage you need to obtain a favorable outcome on the peer review proceeding.

Indest’s Recommendations for the Subject of a Hospital Peer Review Hearing

You must ensure that your medical staff bylaws contain true “due process” rights for accused physicians.
You should attempt to have state legislation passed that requires all hospitals to afford physicians certain due process rights in peer review proceeding similar to what California has done.
The Medical Staff should never allow hospital administration (or the hospital parent corporation) to force them to adopt medical staff bylaws changes which eliminate or limit the hearing rights or due process rights of a physician who may be the subject of an adverse decision.
The peer review committee (fair hearing committee) should have its own independent legal advisor in all hearings. This must be someone other than from the law firm which represents the hospital.
You must treat the peer review process like you would a civil trial against you for medical malpractice.
If you are the subject of a peer review proceeding, immediately retain experienced, knowledgeable health care counsel to represent you.
Also, immediately retain a litigation attorney who has experience in this type of civil litigation. File suit immediately if the matter is not proceeding fairly and in accordance with medical staff bylaws and state laws.
If your hearing procedures/peer review procedures are not in your medical staff bylaws, make sure that both the medical staff bylaws and the hearing procedures state that the hearing procedures have the same force and effect as the medical staff bylaws.

If you are currently the subject of a peer review or clinical privileges hearing, call (407) 331-6620 or (850) 439-1001 to speak with one of our health law attorneys. You can also visit our website at www.TheHealthLawFirm.com.

By The Health Law Firm|2024-03-14T10:00:28-04:00June 1, 2018|Categories: Health Care Industry, The Health Law Firm Blog|Tags: attorney, clinical privileges, clinical privileges hearing, fair hearing, peer review hearing, physician|Comments Off