When the DEA Comes Knocking: 15 Tips For a “Routine” DEA Inspection

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

As the United States continues to open back up from the COVID-19 shutdown, the Drug Enforcement Agency (DEA) is resuming on-site routine inspections.  Therefore, healthcare professionals must ensure compliance and regulatory efforts are in place.

This is part 1 of a 2-part blog series. Check back for part 2 of this blog series soon!

DEA Inspections and Site Visits:  Subpoenas.

DEA agents are often pushy, demanding, and intimidating.  They will try to use subpoenas (which are merely requests for documents that afford you at least ten days to produce the requested documents) as search warrants.  THEY ARE NOT.  They will try to use an administrative subpoena to obtain documents and get your testimony immediately. YOU DO NOT HAVE TO PRODUCE THEM RIGHT AWAY. A copy of a sample subpoena used by the DEA is on our website for reference here.

Not Just a Routine Audit, Inspection, or Investigation.

Beware the “Notice of Inspection of Controlled Premises” (DEA Form 82).   Although the DEA often treats it as one, it is not a search warrant.  Also, it is probably NOT a “Routine Inspection.”  IT WILL NOT TAKE ONLY 15 TO 20 MINUTES.

We have had several clients who have had to close down their businesses all day to try to accommodate the demands of the agents performing their “routine inspection.”  The DEA should not cause you to shut down or should not cause you to turn away patients.  It should not interfere with your patient services or your ability to provide them.  You can ask them to come back at a later date.

The DEA often refers to “routine audits” as “Accountability Investigations” and requires the pharmacy or registrant to be given certain rights in connection with it. For example, DEA Form 82 states you are given the following rights:

1.    The constitutional right not to have an administrative inspection without an Administrative Inspection Warrant (AIW),
2.    Has the right to refuse consent to such an inspection,
3.    Presented with a Notice of Inspection,
4.    Given consent voluntarily, without threats of any kind,
5.    May withdraw consent at any time during the course of the inspection, and
6.    Incriminating evidence may be seized and used in criminal prosecution.

Although the DEA agent may tell you that the site visit is “completely random,” do not believe it.  If the DEA agent has brought a list of records to obtain from you, try to keep a copy of it, as your lawyer may find it very useful later when they are defending you.


What to Do When Confronted with a DEA Inspection or Site Visit.

1.    Notify the owner right away.  If you are not the owner, don’t sign anything, give permission, or agree to anything. You probably have no authority to do so.

2.    Call your health lawyer and get them over immediately.  This is an emergency!

3.    Yes, you have the right to consult with your attorney;  do not believe them if they say you can’t (which they may do, believe it or not).

4.    Request photo identification from everyone to ensure the individuals are who they say they are.  No identification? No access. Federal agents, including DEA agents, will always have their photo ID.

5.    Obtain a business card from each person present.  DEA agents always carry business cards.  If they do not have one, you will have to write all contact information for that agent from their photo id card (or photocopy, if they will allow you to do so).

6.    Do the same as the above for anyone else the DEA brings, whether they claim to be a federal or state investigator, Department of Health investigator, or local police. Please note that our experience has been that the DEA and state agencies contend that they don’t go on joint inspections or investigations (however, we don’t believe this to be true).  Therefore, get all parties’ information at the very start, or you may never get it until they testify against you.

7.    DO NOT SIGN A VOLUNTARY AGREEMENT TO RELINQUISH YOUR DEA REGISTRATION.  Agents may try to pressure and intimidate you into signing one by telling you it will be easier if you sign it. They might even try to scare you by warnings of criminal prosecution unless you sign it.  Yes, you have the right to consult with an attorney before deciding whether or not to sign it (they may falsely tell you that you don’t). However, once you sign it, it is gone.  If you are a prescribing physician or health professional, your authority to prescribe is gone forever.  If you are a pharmacy/pharmacist, your ability to order or fill any controlled substances is forever gone. So go ahead and put a sign on the door that says “CLOSED-Out of Business.”

8.    Before the inspection begins, you should be given a form to read and sign. If not, request it. It will usually be a DEA Form 82 “Notice of Inspection of Controlled Premises” Form. Before the inspection, it should be read, explained, agreed to, and signed, not during or after.

9.    Read the form carefully. You have the right to fax it, scan and e-mail it, or call and read it to your attorney before you sign it. If it says you have the right to refuse the inspection, consider putting it off until a later date. Especially if you are busy and have patients you must serve.

10.    Obtain a copy of the form (inspection form or subpoena) at the beginning and keep it.  You will need this later.

11.    Obtain a complete, detailed receipt for any documents, prescriptions, or other items taken by the agents. Again, since this is not a search warrant, the DEA does not have the authority to take your only originals and leave you without a copy.

12.    You may or may not be in serious trouble and subject to future criminal charges or administrative action to revoke your DEA registration. Your attorney should be able to evaluate this and advise you. Don’t bother to ask the agents, as they will not tell you what is in your own best interest to know.

13.    If you don’t have an attorney who is experienced in health law and DEA defense,  get one NOW.  You should begin preparing now.  It often takes the DEA a year or more to work up charges against you.  Once you are served with charges, you will only have a very short time to prepare your defense.  It is a completely unfair system for the subject of charges as the government will have longer to prepare its case against you than you have to prepare your defense.  Take advantage of the time you have. Do not waste it.

14.    Be polite and do not argue with a DEA agent.

15.    Do not volunteer information, but never tell a lie. Making a false statement to any federal agent is a felony criminal offense. A subpoena for documents is not an authorization to interrogate you.  A search warrant is not an authorization to interrogate you.

Lastly, don’t forget to check back to read part 2 of this blog series.

Please remember: This blog’s statements are opinions based on our experience.  If you do not agree with it, then you are probably the DEA.

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

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

To contact The Health Law Firm, please call (407) 331-6620 or (888) 331-6620 and visit our website at www.TheHealthLawFirm.com.

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave. Suite 1000, Altamonte Springs, FL 32714, Phone: (407) 331-6620 or Toll-Free: (888) 331-6620.


Current Open Positions with The Health Law Firm.  The Health Law Firm always seeks qualified individuals interested in health law.  Its main office is in the Orlando, Florida, area.  If you are a current member of The Florida Bar or a qualified professional who is interested, please forward a cover letter and resume to: PAlexander@TheHealthLawFirm.com or fax them to (407) 331-3030.


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“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 © 2022 The Health Law Firm. All rights reserved.

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Appellate Court Reverses Nursing Board’s Revocation of License For Florida Nurse; “Due Process Rights Violated” Says Court of Appeal

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

On September 22, 2022, Florida’s First District Court of Appeal reversed a final administrative order from the Board of Nursing, saying that the state agencies engaged in “a game of bait and switch” when revoking a Florida nurse’s license. As a result, the discipline imposed on the nurse, revocation of her nursing license, is reversed. The appeals court said that the Florida Board of Nursing violated the nurse’s due process rights by imposing a penalty for violating patient confidentiality when she was only charged with having her license suspended in another state.

Details About the Case.

In 2018, the Florida Department of Health (DOH) filed a complaint and an amended complaint against the nurse. According to the DOH, she violated section 464.018(1)(b) by having her license to practice nursing in another state suspended. However, the Florida state nursing board issued a final order permanently revoking her Florida license, a punishment that was not within the regulatory guidelines that the Board of Nursing had previously adopted for the offense with which she was charged.

Also, the nurse had originally requested a formal hearing. She was allegedly informed she was not entitled to a formal hearing and was not notified she should appear when the Board of Nursing held the informal hearing on her case.

The nurse claimed the actions by the Florida DOH and the Florida Board of Nursing deprived her of her right to due process of law according to the U.S. Constitution’s Fifth Amendment, as applied to the states through the Fourteenth Amendment. The appellate court agreed.

State Agencies Not Communicating?

According to the court opinion, the Board and the DOH engaged in a “bait and switch game.” The state’s DOH allegedly failed to notify her of all the alleged violations that later led to the permanent revocation of her nursing license. The opinion of the appellate court stated: “More egregious than this, there was no mention in the amended complaint of an alleged violation of section 464.018(1)(h), [of Florida Statutes,] pertaining to her allegedly unprofessional conduct. In essence, the Board punished Appellant [the nurse] for this uncharged violation.”

Moreover, the appellate court said that the DOH applied the wrong disciplinary guideline for the uncharged violation. The applicable guideline only authorized a fine of up to $500 and probation as the maximum penalty. See Rule 64B9-8.006(3)(f)3, Florida Administrative Code (2012).

Based on these findings, the three-judge appellate panel reversed the revocation order, remanding it for further proceedings. Read the entire Florida court opinion on our website.

Click here to read our blog to learn more about state and DOH investigations that could help save your professional license.

Contact Health Law Attorneys Experienced in Board of Nursing Cases.

The Health Law Firm’s attorneys routinely represent nurses in Department of Health investigations, before the Board of Nursing, in appearances before the Board of Nursing in licensing matters, in formal and informal administrative hearings, and in appeals of Final Orders.

To contact The Health Law Firm please call (407) 331-6620 or toll free (888) 331-6620 and visit our website at www.TheHealthLawFirm.com.

Sources:

Dunn, Allison. “State Agencies Engaged in ‘Game of Bait-and-Switch’ When Revoking Nursing License, Florida Appeals Court Rules.” Daily Business Review. (September 22, 2022). Web.

Pazanowski, Mary Ann. “Florida Nurse Gets New Hearing in License Revocation Dispute.” Bloomberg Law. (September 21, 2022). 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. Suite 1000, Altamonte Springs, FL 32714, Phone: (407) 331-6620 or toll-free (888) 331-6620.

Attorney Positions with The Health Law Firm. The Health Law Firm is always looking for qualified attorneys interested in health law practice. Its main office is in the Orlando, Florida, area. If you are a member of The Florida Bar and are interested, forward a cover letter and your resume to: PAlexander@TheHealthLawFirm.com or fax to: (407) 331-3030.

“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 © 2022 The Health Law Firm. All rights reserved.

 

New Jersey Appeals Court Says Plaintiffs Don’t Need Affidavit to Sue LPN in Medical Malpractice Cases

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

In a precedent-setting case, on November 9, 2022, for the first time, a New Jersey appeals court ruled that plaintiffs in medical malpractice cases do not need an affidavit of merit before filing a claim against a licensed practical nurse (LPN). In many states, Florida included, licensed practical nurses (LPNs) and registered nurses (RNs) are included in coverage by the state’s medical malpractice pre-suit screening act. This requires a plaintiff to conduct a pre-suit screening and obtain an affidavit of expert opinion from a similar expert witness that states that the nurse has committed malpractice that harmed the patient. without such an affidavit, the suit is not permitted.

No distinction is usually made between the rights of a licensed practical nurse and a registered nurse. After all, they both are required to have licenses from the state.

In this case, the Superior Court of New Jersey,  Appellate Division, said that an LPN is not included in the “licensed person” definition under the state’s affidavit of merit statute. Additionally, the court’s opinion stated that an LPN could not use the lack of such an affidavit to dodge a medical malpractice suit. In this case, the malpractice suit was brought by a widower who says his wife died due to bad advice given by the LPN about how to treat his wife’s pain.

The Details of the Lawsuit.

The plaintiff claimed that the defendant (an LPN) responded to his complaints about his wife being in pain and unable to eat following her colon surgery by blaming the issue on “post-operative gas. “After ignoring numerous messages he left regarding her condition, the LPN allegedly told the husband (plaintiff) to give his wife, Pepto Bismol. The following day, his wife died, according to the lawsuit.

In July 2020, the plaintiff filed a medical malpractice claim as his wife’s estate administrator. The lawsuit originally named as defendants the doctor, Virtua Surgical Group, and an unknown nurse. Following discovery in the case, the plaintiff dismissed the claims against the other defendants and named only the LPN as a defendant. According to the appellate opinion, he alleged that the defendant was negligent in providing medical advice and failing to consult with her doctor.

You can view the court’s opinion in full here on our website.

Is a Licensed Practical Nurse a “Licensed Person” Covered by the Statute?

In New Jersey professional negligence cases, plaintiffs must file an “affidavit of merit,” or AOM, signed by a licensed medical professional with training or credentials similar to those of the professional to be sued. This comes from a tort reform law passed by the state government in 1995. The statute was originally designed to provide a balance between reducing frivolous lawsuits and permitting injured plaintiffs recovery for meritorious claims. It is similar to requirements that exist in many states.

According to the appellate court’s opinion, a plaintiff claiming “malpractice or negligence by a licensed person” must file an “affidavit of an appropriate licensed person” who can attest that there is a “reasonable probability” that defendant’s conduct “fell outside acceptable professional or occupational standards or treatment practices.” This is required before an actual suit is allowed.

The defendant argued that since the nursing portion of the statute defines “the practice of nursing” for “a registered professional nurse,” the Legislature intended for licensed practical nurses to be included. However, the appeals court held that the tort reform package would not protect her from the lawsuit because she did not fall within the definition in the law. She was not a registered professional nurse. Instead, she was a different type of nurse.

In his written opinion for the court, New Jersey Superior Court Judge Robert J. Gilson considered whether a licensed practical nurse is a “licensed person” covered under the AOM statute. “The AOM statute expressly uses the term ‘a registered professional nurse.’ Yet, nowhere in that definition of a registered professional nurse is there a reference to a licensed practical nurse,” he added.

Gilson stated in the opinion that the New Jersey Legislature was aware that it had separately defined the two different types of nurses. Therefore, the statute did not apply to or protect the LPN, and the plaintiff was allowed to pursue claims without an AOM. Nevertheless, the court said, the plaintiff must still prove the defendant’s negligence to succeed.

Click here to view the opinion in full.

Click here to read one of our related blogs about legal issues LPNs often face.

The New Jersey Case is Probably Not a Precedent for Most States.

Usually, the test for whether or not malpractice or professional negligence has been committed for legal purposes is whether or not the individual is a member of a learned profession. This is usually indicated by the requirement of a professional license to practice that profession. Using this definition, both a licensed practical nurse and a licensed registered nurse are considered professionals, and their “professional negligence” is considered malpractice covered by medical (nursing) malpractice laws.

Moreover, the laws in some states, such as Florida, define which professionals are covered by their medical malpractice presuit screening act by listing the licensing laws to which the medical malpractice presuit screening act applies. Thus, in Florida, Section 766.202(4), Florida Statutes refer to those licensed by Chapter 464 (Part I), Florida Statutes. Both licensed practical nurses and registered nurses are licensed in accordance with that Chapter of Florida Statutes. Thus both are covered by the Florida Medical Malpractice Presuit Screening Act.

Contact Health Law Attorneys With Experience Representing Nurses and Handling Licensing Issues.

If you are applying for a nursing or healthcare license, have had a license suspended or revoked, or are facing imminent action against your license, you must contact an experienced healthcare attorney to assist you in defending your career. Remember, your license is your livelihood. It is not recommended that you attempt to pursue these matters without the assistance of an attorney. The Health Law Firm routinely represents nurses, physicians, dentists, medical groups, clinics, and other healthcare providers in personal and facility licensing issues. If you have received a notice that a complaint has been filed against you or that you are under investigation by the department of health or your licensing board, we routinely provide legal representation in such matters; often, there may be insurance coverage that may pay for your legal defense.

To contact The Health Law Firm, call (407) 331-6620 or toll-free (888) 331-6620 and visit our website at www.TheHealthLawFirm.com.

Sources:

Karpan, Andrew. “No Affidavit Needed To Sue ‘Practical’ Nurses, NJ Court Says.” Law360. (November 9, 2022). Web.

Murphy, Colleen. “NJ Appeals Court: No Affidavit of Merit Needed for Negligence Claim Against Licensed Practical Nurse.” Law.com. (November 10, 2022). 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. Suite 1000, Altamonte Springs, FL 32714, Phone: (407) 331-6620 or Toll-Free: (888) 331-6620.

Employment with The Health Law Firm. The Health Law Firm is always seeking qualified attorneys, paralegals and legal staff interested in health law. Its main office is in the Orlando, Florida, area. If you are a current member of The Florida Bar or a qualified legal professional or secretary, who is interested, please forward your cover letter and resume to: PAlexander@TheHealthLawFirm.com or fax them to (407) 331-3030.

“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 © 2022 The Health Law Firm. All rights reserved.

Florida Nurse Wins Reversal by Appellate Court of Nursing Board’s Revocation of License; “Due Process Rights Violated” Says Court of Appeal

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

On September 22, 2022, Florida’s First District Court of Appeal reversed a final administrative order from the Board of Nursing, saying that the state agencies engaged in “a game of bait and switch” when revoking a Florida nurse’s license. As a result, the discipline imposed on the nurse, revocation of her nursing license, is reversed. The appeals court said that the Florida Board of Nursing violated the nurse’s due process rights by imposing a penalty for violating patient confidentiality when she was only charged with having her license suspended in another state.

Details About the Case.

In 2018, the Florida Department of Health (DOH) filed a complaint and an amended complaint against the nurse. According to the DOH, she violated section 464.018(1)(b) by having her license to practice nursing in another state suspended. However, the Florida state nursing board issued a final order permanently revoking her Florida license, a punishment that was not within the regulatory guidelines that the Board of Nursing had previously adopted for the offense with which she was charged.

Also, the nurse had originally requested a formal hearing. She was allegedly informed she was not entitled to a formal hearing and was not notified she should appear when the Board of Nursing held the informal hearing on her case.

The nurse claimed the actions by the Florida DOH and the Florida Board of Nursing deprived her of her right to due process of law according to the U.S. Constitution’s Fifth Amendment, as applied to the states through the Fourteenth Amendment. The appellate court agreed.

State Agencies Not Communicating?

According to the court opinion, the Board and the DOH engaged in a “bait and switch game.” The state’s DOH allegedly failed to notify her of all the alleged violations that later led to the permanent revocation of her nursing license. The opinion of the appellate court stated: “More egregious than this, there was no mention in the amended complaint of an alleged violation of section 464.018(1)(h), [of Florida Statutes,] pertaining to her allegedly unprofessional conduct. In essence, the Board punished Appellant [the nurse] for this uncharged violation.”

Moreover, the appellate court said that the DOH applied the wrong disciplinary guideline for the uncharged violation. The applicable guideline only authorized a fine of up to $500 and probation as the maximum penalty. See Rule 64B9-8.006(3)(f)3, Florida Administrative Code (2012).

Based on these findings, the three-judge appellate panel reversed the revocation order, remanding it for further proceedings. Read the entire Florida court opinion on our website.

Click here to read our blog to learn more about state and DOH investigations that could help save your professional license.

Contact Health Law Attorneys Experienced in Board of Nursing Cases.

The Health Law Firm’s attorneys routinely represent nurses in Department of Health investigations, before the Board of Nursing, in appearances before the Board of Nursing in licensing matters, in formal and informal administrative hearings, and in appeals of Final Orders.

To contact The Health Law Firm please call (407) 331-6620 or toll free (888) 331-6620 and visit our website at www.TheHealthLawFirm.com.

Sources:

Dunn, Allison. “State Agencies Engaged in ‘Game of Bait-and-Switch’ When Revoking Nursing License, Florida Appeals Court Rules.” Daily Business Review. (September 22, 2022). Web.

Pazanowski, Mary Ann. “Florida Nurse Gets New Hearing in License Revocation Dispute.” Bloomberg Law. (September 21, 2022). 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. Suite 1000, Altamonte Springs, FL 32714, Phone: (407) 331-6620 or toll-free (888) 331-6620.

Attorney Positions with The Health Law Firm. The Health Law Firm is always looking for qualified attorneys interested in health law practice. Its main office is in the Orlando, Florida, area. If you are a member of The Florida Bar and are interested, forward a cover letter and your resume to: PAlexander@TheHealthLawFirm.com or fax to: (407) 331-3030.

“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 © 2022 The Health Law Firm. All rights reserved.

 

DOJ Drops Charges in Appalachia Opioid Case After Supreme Court Ruling

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

On August 12, 2022, the U.S. Department of Justice (DOJ) announced that it dropped charges against the remaining defendants in a case against a former Ohio drug distributor. In 2019, Miami-Luken, two of its executives, and two pharmacists were charged with unlawfully conspiring to distribute millions of addictive painkillers across rural Appalachia.

The Original Indictment.

The DOJ issued an indictment against the five defendants in 2019 and charged all with conspiracy to distribute a controlled substance. It alleged Miami-Luken had sent millions of Class II and III narcotic painkillers to pharmacies that served rural towns in Appalachia. The indictment said that this occurred from about 2008 to 2015 when the opioid crisis was at its height.

During that time, the government alleged that Miami-Luken sent over “six million doses” of drugs to a West Virginia pharmacy and “regularly exceeded the internal threshold limit” set for that area. The charges were tied to alleged violations of the Controlled Substances Act. For more information about the charges, read the DOJ’s press release.

In a lengthy motion to dismiss, the former drug distributor said the claims were not clearly prohibited by the Controlled Substances Act and said the case was “the first time that the DOJ has relied on Drug Enforcement Administration (DEA) guidance letters interpreting a federal statute — the Controlled Substances Act — as the basis for a criminal prosecution.”

Pharmacy Fraud Cases using gavel and stethoscope with spilled opioid pills

As an aside, I note that the DEA (and when DOJ is representing it, DOJ adopts the same tactic) routinely engages in what I call “bean counting” to exaggerate the perception of the seriousness of the matter. They do this by counting the number of individual pills prescribed or dispensed when, overall, it really is not that significant. Let’s say a hypothetical patient suffering from chronic pain

is prescribed 20 mg of a narcotic medication thrice daily. Such prescriptions are normally written for a thirty (30) day supply. The DEA (and sometimes the DOJ) will multiply these out and allege the doctor prescribed 90 pills X 12 months or 1,080 pills. If the pharmacists did not have 20 mg size pills and filled it with 10 mg pills (doubling

the number of pills, but not the dosage), this doubles the number of pills to 2,160. It sounds like a tremendous number, but it is actually the average that would be prescribed for such a patient.

And then, when one considers that a pharmacy probably has thousands of patients each month who get their prescriptions filled, this greatly magnifies the number of individual pills. Then take it a step further, and consider a medical distributor that may be distributing medications to a hundred different individual drug stores. This multiplies out the number to a much greater one. Using a figure such as “six million pills distributed” sounds much more terrible than “three thousand patients received an average dosage of pills that were distributed through the drug distribution company.” Defense attorneys must do everything possible to eliminate or reduce the impact of such “bean counting” or “pill counting” in such cases.

In March 2021, U.S. District Judge Matthew W. McFarland of the Southern District of Ohio refused to toss the case, saying the motion was “premised on the mischaracterization of the crime.”

Unopposed Motion to Dismiss the Charges.

This time, Surprisingly, there was a motion by the DOJ to dismiss the case. Judge McFarland granted the government’s unopposed motion to dismiss the charges against the remaining defendants, including former Miami-Luken President Anthony Rattini, who died last year. Another former Miami-Luken executive had accepted a plea deal in December 2021.

View the government’s motion to dismiss the indictment without prejudice and stipulation.

View Judge McFarland’s order granting the motion to dismiss the indictment.

It’s important to note that the government did not specify why the charges were dropped; however, the move came shortly after a U.S. Supreme Court ruling that made such cases harder to prove. The decision in Ruan v. U.S. said that prosecutions under the Controlled Substances Act for excessive prescribing of opioids and other addictive drugs must show that doctors knew they lacked a legitimate medical purpose.

Click here to read my previous blog to learn more about this topic.

Contact Health Law Attorneys Experienced in the Representation of Health Professionals and Providers.

The Health Law Firm and its attorneys have represented physicians, pharmacists, nurses, clinics, dentists, pharmacies, health facilities, and other health care providers in cases involving allegations of over-prescribing narcotics and pain medications. These include criminal investigations by local police and law enforcement authorities, investigations by the U.S. Drug Enforcement Agency (DEA), U.S. Department of Justice (DOJ), complaints against professional licenses by the Florida Department of Health, investigations, and prosecutions by the Medicaid Fraud Control Units (MFCU), and other types of cases. Having attorneys familiar with the medical standards of care and guidelines for prescribing narcotics and having access to expert medical and pharmacy professionals who can testify as expert witnesses in such cases is also crucial. We have represented professionals in administrative investigations and hearings at state and federal levels.

To contact The Health Law Firm, please call (407) 331-6620 or Toll-Free (888) 331-6620 and visit our website at www.TheHealthLawFirm.com.

Sources:

Weld, Elliot. “Appalachia Opioid Charges Dropped After High Court Ruling.” Law360. (August 12, 2022). Web.

Raymond Nate. “Opioid distributor Miami-Luken, execs seek dismissal of indictment.” Reuters. (May 1, 2020). Web.

Overley, Jeff. “DOJ Indicts Opioid Distributor, Execs Over Painkiller Sales.” Law360. (July 18, 2019). 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. Suite 1000, Altamonte Springs, FL 32714, Phone: (407) 331-6620 Toll-Free: (888) 331-6620

Attorney Positions with The Health Law Firm. The Health Law Firm is always looking for qualified attorneys interested in the practice of health law. Its main office is in the Orlando, Florida, area. If you are a member of The Florida Bar and are interested, forward a cover letter and your resume to: PAlexander@TheHealthLawFirm.com or fax to: (407) 331-3030.

“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 © 2022 The Health Law Firm. All rights reserved.

2022-09-07T23:39:52-04:00September 7th, 2022|Categories: Pharmacy Law Blog|Tags: , , , , , , , , , , , , , , , , , , , , , , , , , , , , |0 Comments

Additional Negative Consequences for Discipline on Your Professional License, Part 1 of 2

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

Do you have a medical, pharmacist, counselor, or nursing license in more than one state?  Do you have a license in more than one profession?  Have you been notified that an investigation has been opened against your professional license?  Are you thinking about resigning your professional license or voluntarily relinquishing (giving up) your license?  Then you should be aware of some important facts you may not have known.

First, you should never voluntarily relinquish or resign your professional license after you know that an investigation has been opened or that disciplinary action has been taken against you.  A resignation is considered to be a “disciplinary relinquishment” and is treated the same as if your license had been revoked on disciplinary grounds.

Second, this will be reported to other states, professional agencies, the National Practitioner Data Bank (NPDB), and to any certifying bodies for certifications you have. It will also be reported to other national professional bodies (such as the National Council of State Boards of Nursing, the National Association of Boards of Pharmacy, or the American Board of Internal Medicine).  Other states and other professional boards will most likely initiate disciplinary action based on the report of the first one.

Protect Your License from These Types of Adverse Actions.

Following is a list of some of the adverse actions you can expect to be taken after discipline on your license (or if you give up your license after receiving notice of investigation):

1. A mandatory report to the National Practitioner Data Base (NPDB) which remains there for 50 years. Note: The Healthcare Integrity and Protection Data Bank HIPDB have now merged into the NPDB.

2. The action must be reported to and included in the Department of Health (DOH) profile that is available to the public online (for those having one) and remains for at least ten years.

3. Any other states or jurisdictions in which the professional has a license will also initiate an investigation and possible disciplinary action against him or her in that jurisdiction.  (Note:  I have had two clients who had licenses in seven or more other states; even states where the license was no longer active initiated action).

4. The Office of the Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS) will take action to exclude the provider from the Medicare Program.  If this occurs (and many of these offenses require mandatory exclusion) the provider will be placed on the List of Excluded Individuals and Entities (LEIE) maintained by the HHS OIG.

a.  Note that if this happens, you are prohibited by law from working in any position in any capacity for any individual or business, including hospitals, nursing homes, home health agencies, physicians, medical groups, insurance companies, etc., that contract with or bill Medicare or Medicaid.  This means, for example, you are prohibited from working as a janitor in a nursing home that accepts Medicare or Medicaid, even as an independent contractor.

b.  Also, if this happens, you are also automatically “debarred” or prohibited from participating in any capacity in any federal contracting, and you are placed on the U.S. General Services Administration’s (GSA) debarment list.  This means you are prohibited by law from working in any capacity for any government contractor or anyone who takes government funding.  This applies, for example, to prevent you from being a real estate agent involved in selling property financed by a government-backed loan, prohibited from working for an electrical company that bids on contracts for government housing projects, working as a school teacher in a public school, etc.

c.  Additionally, if this happens, your state is required to terminate you “for cause” from the state Medicaid Program.  In many states, this will also be an additional ground for revocation of your license.

5. Any profile or reporting system maintained by a national organization or federation (e.g., NURSYS profile maintained by the National Council of State Boards of Nursing, American Medical Association physician profile, or the Federation of State Board of Physical Therapy profile) will include the adverse action in it, generally available to the public.

6. If you are a nurse practitioner or other professional with clinical privileges at a hospital, nursing home, HMO, or clinic, action will be taken to revoke or suspend the clinical privileges and staff members if you have such. This may be in a hospital, ambulatory surgical center, skilled nursing facility, staff model HMO, or clinic.  This will usually be for physicians, physician assistants (PAs), advanced registered nurse practitioners (ARNPs), certified registered nurse anesthetists (CRNAs), nurse midwives, or certified nurse anesthetists (CNAs), podiatrists, clinical psychologists or clinical pharmacists.

7. Third-party payors (health insurance companies, HMOs, etc.) will terminate the professional’s contract or panel membership with that organization.

8. The U.S. Drug Enforcement Administration (DEA) will act to revoke the professional’s DEA registration if he or she has one.

9. Many employers will not hire you or will terminate your employment if they discover your license has been disciplined in another state.

What Should and Shouldn’t You Do?

If you find yourself notified that you are under investigation, don’t take the easy way out by immediately relinquishing your license. Don’t hide your head in the sand by thinking the case will just go away on its own. Do not request an informal hearing or a settlement agreement in which you admit the facts alleged against you are all true.  If you do this, you are “pleading guilty.” If you are innocent of the charges, request a formal hearing and contest the charges; defend yourself.

Do immediately seek the advice of an attorney who has experience in such professional licensing matters and administrative hearings.  They are out there, but you may have to search for one.  Do this as soon as you get notice of any investigation and especially before you have talked to or made any statement (including a written one) to any investigator.

Do purchase professional liability insurance that includes legal defense coverage for any professional license investigation against you, whether it is related to a malpractice claim or not.  This insurance is cheap and will provide needed legal assistance at the time when you may be out of a job and not have money to hire an attorney.  Beware of the insurance policy that only covers professional license defense if it is related to a malpractice claim.

Professional Liability Insurance.

We strongly encourage all licensed health professionals and facilities to purchase their own, independent insurance coverage.  Make sure it covers professional license defense under all circumstances.  Make sure you have enough coverage to actually get you through a hearing. $25,000 coverage for just professional licensure defense is the absolute minimum you should purchase;  $50,000 may be adequate but $75,000 or $100,000 may be what you really need in such a situation.  For a few dollars more (and I do mean only a few) you can usually purchase the higher limits.

Also, I will repeat, make sure it covers your legal defense in an administrative disciplinary proceeding against your license, even if there is no malpractice claim filed against you or likely to be filed against you.

We also recommend that you purchase coverage through an insurance company that allows you to select your own attorney and does not make you use one that the insurance company picks for you.

Companies we have encountered in the past that provide an inexpensive top quality insurance product for professional license defense costs include CPH & Associates Insurance, Nurses Service Organization (NSO) insurance, Healthcare Providers Organization (HPSO) Insurance, and Lloyd’s of London Insurance.

To learn more, visit our Video Q&A section on our website and watch our video titled, “Should I voluntarily relinquish my professional license because I am being investigated?” Additionally, click here to read one of our prior blogs for even more information on how to fight back against adverse NPBD reports.

Contact Health Law Attorneys Experienced with Investigations of Healthcare Professionals.

The attorneys of The Health Law Firm provide legal representation to medical professionals in Department of Health (DOH) investigations, licensing matters, and other types of investigations of health professionals and providers. To contact The Health Law Firm, please call (407) 331-6620 or Toll-Free at (888) 331-6620 and visit our website at www.TheHealthLawFirm.com.

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Avenue, Suite 1000, Altamonte Springs, FL 32714, Phone: (407) 331-6620 or Toll-Free: (888) 331-6620.

“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 © 2022 The Health Law Firm. All rights reserved.

2022-07-11T18:21:32-04:00July 11th, 2022|Categories: Dental Law Blog|Tags: , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |0 Comments

Supreme Court Explores Doctor Intent in “Pill Mill” Criminal Prosecutions Under the Controlled Substances Act

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

Physicians and other healthcare professionals usually have broad scope to prescribe most drugs, including potentially dangerous ones. However, over the past decade, many limits, often imposed arbitrarily through criminal prosecutions or drastic administrative sanctions, have been used to impose limits.

The question was recently put before the U.S. Supreme Court as to how far a physician’s judgment can be allowed to go in the context of prescribing controlled substances before it becomes criminal. This was in the context of criminal prosecution of a physician for allegedly over-prescribing.

On March 1, 2022, the U.S. Supreme Court confronted the question of whether good faith is a defense for a doctor criminally prosecuted for unlawful distribution of controlled substances. For nearly 90 minutes, the Supreme Court heard oral arguments from both sides, struggling with the exact wording of the Controlled Substances Act (CSA), the clarity of the relevant federal regulation, and the proposition that a doctor who lacked subjective criminal intent could nevertheless go to jail for a substantial period of time, up to life imprisonment.

The two physicians whose cases are being considered are Xiulu Ruan, who was sentenced to 21 years in prison in 2017 for allegedly running a “pill mill,” and Shakeel Kahn, who was sentenced to 25 years in prison in 2019 for crimes including drug distribution of controlled drugs resulting in the death of a patient. The court consolidated their cases for the Supreme Court’s hearing.

Controversial Legal Standards Used to Convict.

The legal standard in question centers heavily on a disputed sentence in the Controlled Substances Act (CSA) that says, “Except as authorized by this subchapter, it shall be unlawful for any person knowingly or intentionally” to distribute controlled substances. The central question is how juries should assess the intentions of a doctor accused of prescribing narcotic painkillers outside “the usual course of his professional practice.”

The U.S. Department of Justice (DOJ) argued that the criminal intent standard is an objective one — or an “honest effort” to comply with professional norms. On the other hand, the attorneys for the doctors who were prosecuted argue that the standard must be subjective; that is did the doctor subjectively believe they were not prescribed for a legitimate medical purpose. This distinction gives rise to whether there is merely a violation of regulation as opposed to a crime having been committed.

Throughout the oral arguments, various justices seemed to cast doubt on whether deviating from mainstream standards on opioid prescribing is sufficient to throw physicians in jail, which could result in years or life in prison. In some states, this might even result in a death sentence, pretty drastic for what would otherwise be medical negligence.

How This Ruling Will Impact Future Prosecutions.

This case and the upcoming ruling raise alarms for healthcare providers and advocates for pain patients. Many fear that the ruling could enable even more aggressive prosecutions of opioid prescribers. They warn that such a decision could discourage doctors from providing opioids even when they’re fully warranted. In addition, the outcome could affect civil litigation accusing large pharmaceutical companies of recklessly selling prescription narcotics.

After hearing the oral arguments, the Supreme Court seemed likely to demand more substantial proof of intentional wrongdoing when the DOJ prosecutes opioid prescribers. A decision from the High Court is expected by late June 2022. The cases are Ruan v. U.S., case number 20-1410, and Kahn v. U.S., case number 21-5261, in the Supreme Court of the United States.

We will definitely keep you posted on the outcome of this case.

Click here to read one of my blogs about controlled substances and compliance.

Contact Health Law Attorneys Experienced in the Representation of Health Professionals and Providers.

The Health Law Firm and its attorneys have represented physicians, pharmacists, nurses, clinics, dentists, pharmacies, health facilities, and other health care providers in different cases involving allegations of over-prescribing narcotics and pain medications. These include criminal investigations by local police and law enforcement authorities, investigations by the U.S. Drug Enforcement Agency (DEA), U.S. Department of Justice (DOJ), complaints against professional licenses by the Florida Department of Health, investigations, and prosecutions by the Medicaid Fraud Control Units (MFCU), and other types of cases. Having attorneys familiar with the medical standards of care and guidelines for prescribing narcotics and having access to expert medical and pharmacy professionals who can testify as expert witnesses in such cases is also crucial. We have represented professionals in administrative investigations and administrative hearings at both the state and federal levels.

To contact The Health Law Firm, please call (407) 331-6620 or Toll-Free (888) 331-6620 and visit our website at www.TheHealthLawFirm.com.

Sources:

Overley, Jeff. “High Court Poised To Make DOJ’s Job Harder In Opioid Cases.” Law360. (March 1, 2022.) Web.

Gluck, Abby. “In opioids “pill mill” case, justices grapple with physician intent.” SCOTUS Blog. (March 2, 2022). Web.

Joseph, Andrew. “Fight over opioid prescribing — and when it turns criminal — heads to Supreme Court.” STAT News. (February 28, 2022). 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. Suite 1000, Altamonte Springs, FL 32714, Phone: (407) 331-6620 Toll-Free: (888) 331-6620

“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 © 2022 The Health Law Firm. All rights reserved.

2022-06-24T16:22:15-04:00June 24th, 2022|Categories: Pharmacy Law Blog|Tags: , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |0 Comments

Fight Back in National Practitioner Data Bank Disputes and Appeal Adverse Reports

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

The National Practitioner Data Bank (NPDB), created in 1986, was part of the Health Care Quality Improvement Act (HCQIA). Its purpose is to improve the quality of health care by encouraging state licensing boards, hospitals, health care entities, and professional societies to report into a national data bank those physicians and health professionals who demonstrate substandard skills or engage in unprofessional behavior.  In part, it is used to make sure that incompetent physicians do not move from one state to another in order to avoid the consequences.

Adverse Reports Stay in the NPDB for Life.

How long does an adverse NPDB report stay in the Data Bank?  I have received two (2) different answers to this question from different authorities.  I was originally informed that adverse NPDB reports are for life, and believed that for my first 25 or so years of practice.  However, more recently I have been informed that they only stay in the Data Bank for 50 years.  However, there is little difference whether it is actually 50 years or for life.  For most physicians 50 years is a lifetime for a medical career.

A Negative NPDB Report Has the Ability to Ruin Your Career.

All reports in the NPDB on an individual can and are queried by state licensing boards, hospitals, and other health care facilities to assist in investigating adverse incidents and disciplinary actions that may have been taken against a physician applying for a license or clinical privileges. Therefore, adverse NPDB reports can have long-lasting, devastating effects on the career of a health care provider.

Additionally, the real-world consequences of being the subject of an NPDB report include possible exclusion from the panels of health plans and independent physician organizations, termination for cause from state Medicaid programs, loss of medical staff privileges at hospitals and health facilities, increases in professional liability insurance premiums, exclusion from the Medicare Program, and additional licensing investigations and potential discipline by other organizations and states.

If you are the subject of an adverse NPDB report, there are several actions you should take to correct any errors, provide your side of the facts, and possibly have the adverse report removed or corrected.

What Happens If You Disagree With Your Report?

Reports to the NPDB are, for all practical purposes for life, as explained above.  But healthcare professionals may appeal adverse reports through a dispute resolution process involving the Secretary of the Department of Health and Human Services (HHS). You can dispute reports if you disagree with factual accuracy of the report or if the event reported are not proper under NPDB guidelines.  For example, getting fired from a job or having a contract terminated for cause are not proper events to cause an adverse NPDB report. We have had to represent physicians in the past having these types of reports removed from the NPDB.

It’s important to note that entering the report into dispute status does not automatically trigger a review. When in dispute status, you have to notify the reporting organization.  The reporting organization can correct, void, or choose to leave the report unchanged. If after 60 days you have received no response from the reporting organization, or you are unsatisfied with the response you received, you can elevate the report to dispute resolution (appeal).

Visit the NPDB website here for more details on this process.

For more reference, you can see what a successful voided NPDB report looks like here. This example results from The Health Law Firm’s recent successful appeal of an adverse NPDB report for a client.

Your Career May Depend On Having Legal Counsel Who Understands the NPDB.

If you have received a negative National Practitioner Data Bank report and wish to appeal it, contact The Health Law Firm. Our attorneys routinely represent physicians, dentists, and other healthcare professionals in disputing and appealing NPDB reports. To learn more, click here to read one of my prior blogs.

Don’t Wait Until It’s Too Late, Contact Experienced Health Law Attorneys.

The Health Law Firm attorneys routinely represent physicians, physician assistants (PAs), nurses, nurse practitioners (NPs), dentists, and other health professionals in dealing with reports being made to the NPDB, disputing NPDB reports and appealing NPDB reports, hospital clinical privileges hearings, medical staff fair hearings, medical staff peer reviews. 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 Toll-Free (888) 331-6620 and visit our website at www.TheHealthLawFirm.com.

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620 or Toll-Free: (888) 331-6620.

“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 © 2022 The Health Law Firm. All rights reserved.

NPDB Disputes and Appeals: Fight Back Against Adverse Reports

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

The National Practitioner Data Bank (NPDB), created in 1986, was part of the Health Care Quality Improvement Act (HCQIA). Its purpose is to improve the quality of health care by encouraging state licensing boards, hospitals, health care entities, and professional societies to report into a national data bank those physicians and health professionals who demonstrate substandard skills or engage in unprofessional behavior. In part, it is used to make sure that incompetent physicians do not move from one state to another in order to avoid the consequences.

Adverse Reports Stay in the NPDB for Life.

How long does an adverse NPDB report stay in the Data Bank? I have received two (2) different answers to this question from different authorities. I was originally informed that adverse NPDB reports are for life, and believed that for my first 25 or so years of practice. However, more recently I have been informed that they only stay in the Data Bank for 50 years. However, there is little difference whether it is actually 50 years or for life. For most physicians, 50 years is a lifetime for a medical career.

 

A Negative NPDB Report Has the Ability to Ruin Your Career.

All reports in the NPDB on an individual can and are queried by state licensing boards, hospitals, and other health care facilities to assist in investigating adverse incidents and disciplinary actions that may have been taken against a physician applying for a license or clinical privileges. Therefore, adverse NPDB reports can have long-lasting, devastating effects on the career of a health care provider.

Additionally, the real-world consequences of being the subject of an NPDB report include possible exclusion from the panels of health plans and independent physician organizations, termination for cause from state Medicaid programs, loss of medical staff privileges at hospitals and health facilities, increases in professional liability insurance premiums, exclusion from the Medicare Program, and additional licensing investigations and potential discipline by other organizations and states.

If you are the subject of an adverse NPDB report, there are several actions you should take to correct any errors, provide your side of the facts, and possibly have the adverse report removed or corrected.

What Happens If You Disagree With Your Report?

Reports to the NPDB are, for all practical purposes for life, as explained above. But healthcare professionals may appeal adverse reports through a dispute resolution process involving the Secretary of the Department of Health and Human Services (HHS). You can dispute reports if you disagree with factual accuracy of the report or if the event reported are not proper under NPDB guidelines. For example, getting fired from a job or having a contract terminated for cause are not proper events to cause an adverse NPDB report. We have had to represent physicians in the past having these types of reports removed from the NPDB.

It’s important to note that entering the report into dispute status does not automatically trigger a review. When in dispute status, you have to notify the reporting organization. The reporting organization can correct, void, or choose to leave the report unchanged. If after 60 days you have received no response from the reporting organization, or you are unsatisfied with the response you received, you can elevate the report to dispute resolution (appeal).

Visit the NPDB website here for more details on this process.

For more reference, you can see what a successful voided NPDB report looks like here.  This example results from The Health Law Firm’s recent successful appeal of an adverse NPDB report for a client.

Your Career May Depend On Having Legal Counsel Who Understands the NPDB.

If you have received a negative National Practitioner Data Bank report and wish to appeal it, contact The Health Law Firm. Our attorneys routinely represent physicians, dentists, and other healthcare professionals in disputing and appealing NPDB reports. To learn more, click here to read one of my prior blogs.

Don’t Wait Until It’s Too Late, Contact Experienced Health Law Attorneys.

The Health Law Firm attorneys routinely represent physicians, physician assistants (PAs), nurses, nurse practitioners (NPs), dentists and other health professionals in dealing with reports being made to the NPDB, disputing NPDB reports and appealing NPDB reports, hospital clinical privileges hearings, medical staff fair hearings, medical staff peer reviews. 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 Toll-Free (888) 331-6620 and visit our website at http://www.TheHealthLawFirm.com.

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620 or Toll-Free: (888) 331-6620.

“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 © 2022 The Health Law Firm. All rights reserved.

 

Civil and Criminal Enforcement of HIPAA Privacy and Security Regs on the Rise

George Indest Headshot

Attorney George F. Indest III, The Health Law Firm

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

The Office of Civil Rights (OCR), a division within the U.S. Department of Health and Human Services (HHS), is the federal organization responsible for investigating complaints and enforcing the Privacy and Security Regulations implementing the Health Insurance Portability and Accountability Act, commonly referred to as “HIPAA.”

As the COVID-19 pandemic seems to be leveling off and more employees are going back to the office, and into the field, HIPAA complaint investigations will definitely pick up. Furthermore, criminal prosecutions for violations of HIPAA have recently been on the rise as well.

OCR’s Investigations and Enforcement Actions.

OCR enforces the HIPAA Privacy and Security Regulations in several ways:

The first method it has is the receiving and investigating of HIPAA violation complaints. These can easily be filed online by going to https://www.hhs.gov/hipaa/filing-a-complaint/.

If you receive a notice from the OCR that it is investigating a HIPAA complaint against you, it will request a large number of various documents relating to the matter. It is crucial that you retain the services of an experienced health lawyer to assist you in responding. Often, it will not be necessary to provide all of the documents requested by OCR, if your attorney determines that certain legal grounds exist for avoiding this. Regardless, you should seek legal counsel, anyway, since both criminal and civil sanctions may result.

OCR Also Conducts Compliance Audits.

OCR conducts compliance reviews to determine if covered entities are in compliance. Covered entities include, for example, physicians, medical groups, nurse practitioners (in most cases), psychologists, mental health counselors (in most cases), pharmacists, health clinics (in most cases), assisted living facilities (ALFs), home health agencies (HHAs), hospitals, and many others.

OCR reviews the information that it gathers through its investigation or audit. In some cases, it may determine that the covered entity did not violate the Privacy Regulations or the Security Regulations. However, in the case of the covered entity’s violation, OCR may do any of the following:

Dismissing the matter or taking no further action.

Obtaining the Covered Entity’s agreement for voluntary compliance going forward.

Obtaining corrective action through a corrective action plan (CAP).

Negotiating a resolution agreement (RA).

Assessment of civil penalties (monetary fines).

Referral to the Department of Justice (DOJ) for further investigation and criminal prosecution.

Civil Violations.

In cases of noncompliance where the covered entity does not satisfactorily resolve the matter, OCR may decide to impose civil money penalties (CMPs) on the covered entity. It can then take further administrative or civil litigation action to enforce these if they are not paid.

Civil monetary penalties for HIPAA violations are determined based on a tiered civil penalty structure. The HHS secretary has discretion in determining the amount of the penalty based on the nature and extent of the violation and the nature and extent of the harm resulting from the violation. HHS is prohibited from imposing civil monetary penalties (except in cases of willful neglect) if the violation is corrected within 30 days (this time period may be extended at HHS’s discretion). So it is imperative to retain an attorney and get on top of the situation fast.

The range of penalties for civil violations.

HIPAA violation: Unknowing
Penalty range: $100 – $50,000 per violation, with an annual maximum of $25,000 for repeat violations

HIPAA violation: Reasonable Cause
Penalty range: $1,000 – $50,000 per violation, with an annual maximum of $100,000 for repeat violations

HIPAA violation: Willful neglect but corrected (violation is corrected within the required time period)
Penalty range: $10,000 – $50,000 per violation, with an annual maximum of $250,000 for repeat violations

HIPAA violation: Willful neglect, not promptly corrected (violation is not corrected within the required time period)
Penalty range: $50,000 per violation, with an annual maximum of $1.5 million

Criminal penalties for violations.

In June 2005, DOJ clarified who can be held criminally liable under HIPAA. Its clarification included officers, employees, and other principles of business entities (corporations and companies) that are covered entities, including co-conspirators, aiders, and abettors of the acts.

Criminal violations of HIPAA are investigated and prosecuted by DOJ. As with the civil penalties, there are different criminal penalties based on the level of severity of the criminal violation.

Covered entities and specified other individuals who knowingly obtain or disclose individually identifiable health information, in violation of the Administrative Simplification Regulations to the HIPAA Regulations, face a fine of up to $50,000, as well as imprisonment for up to one (1) year.

Offenses committed under false pretenses allow penalties to be increased to a $100,000 fine, with up to five (5) years in prison.

Finally, offenses committed with a profit motive, in other words, with the intent to sell, transfer, or use individually identifiable health information for commercial advantage, personal gain, or malicious harm permit fines of $250,000 and imprisonment up to ten (10) years.

What is a “Covered Entity?”

One thing to remember is that HIPAA and its enforcing regulations only apply to “covered entities” with certain minor exceptions. The following are examples of “covered entities”:

Health plans (e.g., health insurers, HMOs, PPOs)

Health care clearinghouses

Health care providers who transmit claims in electronic form (this will cover almost all health facilities and health professionals)

Medicare prescription drug card sponsors

Individuals such as directors, employees, or officers of a covered entity (where the covered entity is not an individual) may criminally liable under HIPAA per the “corporate criminal liability” theory.

 

Criminal Penalties for HIPAA Violations.

Yes, there are criminal penalties, including prison for up to ten (10) years, possible for HIPAA violations.

To read an earlier blog I wrote on criminal penalties for HIPAA violations, please click here.

What is the Definition of “Knowingly?”

The DOJ interprets the required element of “knowingly” in the criminal liability section of HIPAA as requiring only knowledge of the actions that constitute an offense. Specific knowledge that an action is a violation of HIPAA is not required.

Can a HIPAA Violation Lead to Exclusion from the Medicare Program?

HHS has the authority to exclude from participation in Medicare any covered entity that was not compliant with certain HIPAA Regulations under certain circumstances. Call your healthcare lawyer for details on this.

For information on the effects of exclusion from any government-sponsored healthcare program on a doctor, nurse, dentist, or any other health provider, visit our website’s Health Law Articles and Documents page to view the OIG’s Special Advisory Bulletin.

 

The Administrative Simplification Act Simplifies it All.

The Administrative Simplification Act sought to clarify and simplify parts of HIPAA and increase specific penalties for violations. Title 42, United States Code, Chapter 7, Subchapter XI, Part C (Administrative Simplification Act).

The Administrative Simplification Regulations authorize a fine of up to $50,000, as well as imprisonment up to one year. Offenses committed under false pretenses allow penalties to be increased to a $100,000 fine, with up to five years in prison. Finally, offenses committed with the intent to sell, transfer, or use individually identifiable health information for commercial advantage, personal gain, or malicious harm permits fines of $250,000 and imprisonment for up to 10 years.

Misuse and Disclosure of “Unique Health Identifiers.”

The wrongful use of a unique health identifier can be charged as a violation of 42 U.S.C. § 1320d–6(a)(1) and (b)(1)), the penalty provision of which is set forth in 42 U.S.C. § 1320d–6(b)(1). “Unique health identifier” includes a patient’s name, address, social security number, insurance member ID number, description of health history, and description of the patient’s symptoms.

Contact a Health Law Attorney Experienced in Defending HIPAA Complaints and Violations.

The attorneys of The Health Law Firm represent physicians, medical groups, nursing homes, home health agencies, pharmacies, hospitals, and other healthcare providers and institutions in investigating and defending alleged HIPAA complaints and violations and in preparing Corrective Action Plans (CAPs).

For more information about HIPAA violations, electronic health records or corrective action plans (CAPs) please visit our website at www.TheHealthLawFirm.com or call (407) 331-6620 or toll-free: (888) 331-6620.

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 Toll-Free: (888) 331-6620.

“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 © 2021 The Health Law Firm. All rights reserved.

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