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Supreme Court Rules FCA Case Liability Requires Defendants’ Subjective Belief

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

On June 1, 2023, the Supreme Court handed down an opinion on the knowledge standard required in False Claims Act (FCA) cases in a precedential decision that leaves the whistleblower plaintiffs bar reeling. In a unanimous ruling, the high court said liability of defendants in FCA cases would be based on their own belief in the falsity of their claims, rather than an “objectively reasonable” interpretation of the law or regulation. This appears to set the age-old maxim of “ignorance of the law is no excuse” on its head. Now, apparently, a defendant can argue that he, she or it was ignorant of the law and win.

The case before the Supreme Court was consolidated from two lower court decisions in the cases United States ex rel. Schutte v. SuperValu Inc. and United States ex rel. Proctor v. Safeway.

When Subjective Belief is Relevant in FCA Cases.

In the cases which the Supreme Court decided, the whistleblowers accused SuperValu and Safeway of violating the FCA by overcharging Medicare, Medicaid, and the Federal Employee Health Benefits Program for prescription drugs.

According to the rules of these programs, pharmacies cannot charge the government more than the “usual and customary” price for a drug, which is the cash price charged to the general public. The plaintiffs claimed that the pharmacies overbilled the government when they started offering discounted prices to consumers under a price-match program to compete with other pharmacies. They also offered a membership discount program but did not adjust their “usual and customary” prices, continuing to charge the government more than they should have.

The Lower Court’s Ruling.

The Seventh Circuit Court of Appeals ruled in April 2022, that the pharmacies had submitted false claims by not reporting their discounted prices, which were the “usual and customary” prices. The appeals court also stated that the retailers had made reasonable interpretations of ambiguous laws without being warned against it by authoritative guidance. The circuit court referred to the Safeco standard from the Supreme Court’s 2007 Safeco Insurance Co. of America v. Burr case in its decision.

Click here to learn more about the Seventh Circuit Court of Appeal’s ruling.

The Supreme Court’s Ruling.

The Seventh Circuit’s perspective was rejected by the Supreme Court, which instead focused on the defendant’s intentions when submitting false claims. Justice Clarence Thomas, writing for a unanimous court stated, “What matters for an FCA case is whether the defendant knew the claim was false. Thus, if [the defendants] correctly interpreted the relevant phrase and believed their claims were false, they could have known their claims were false.” Read the opinion in full here.

Under this rationale, a defendant could successfully make the argument, “I didn’t know the claim was false and I never bothered to do anything to make sure of that fact.” Even objectively unreasonable claims, such as charging a million dollars for a drug which only cost one dollar, could be successfully defended.

Contact Health Law Attorneys Experienced in Handling Health Care Fraud Investigations and other Legal Proceedings.

The Health Law Firm represents healthcare providers in Medicare and Medicaid audits, and in RAC audits throughout Florida and across the U.S. We also represent health providers in civil and administrative litigation by government agencies and insurance companies attempting to recoup claims that have been paid.

The Health Law Firm’s attorneys routinely represent physicians, dentists, pharmacists, psychotherapists, medical groups, clinics, pharmacies, assisted living facilities (ALFs), home health agencies, nursing homes, group homes and other healthcare providers in Medicaid and Medicare investigations, audits and recovery actions.

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.

Sources:

Elberg, Jacob. “Supreme Court maintains focus on defendant’s subjective beliefs in False Claims Act cases.” SCOTUS Blog. (June 1, 2023). Web.

Wilson, Daniel. “Justices Say FCA Liability Hinges On Defendants’ Beliefs.” Law360. (June 1, 2023). Web.

Gaivin, Kathleen. “False Claims Act ruling by High Court a ‘clear win’ for government, expert says.” McKnights Senior Living. (June 2, 2023). 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 Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Avenue, Suite 1000, Altamonte Springs, Florida 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: [email protected] 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 © 2023. The Health Law Firm. All rights reserved.

Supreme Court Rules FCA Case Liability Requires Defendants’ Subjective Belief

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

On June 1, 2023, the Supreme Court handed down an opinion on the knowledge standard required in False Claims Act (FCA) cases in a precedential decision that leaves the whistleblower plaintiffs bar reeling. In a unanimous ruling, the high court said liability of defendants in FCA cases would be based on their own belief in the falsity of their claims, rather than an “objectively reasonable” interpretation of the law or regulation. This appears to set the age-old maxim of “ignorance of the law is no excuse” on its head. Now, apparently, a defendant can argue that he, she or it was ignorant of the law and win.

The case before the Supreme Court was consolidated from two lower court decisions in the cases United States ex rel. Schutte v. SuperValu Inc. and United States ex rel. Proctor v. Safeway.

When Subjective Belief is Relevant in FCA Cases.

In the cases which the Supreme Court decided, the whistleblowers accused SuperValu and Safeway of violating the FCA by overcharging Medicare, Medicaid, and the Federal Employee Health Benefits Program for prescription drugs.

According to the rules of these programs, pharmacies cannot charge the government more than the “usual and customary” price for a drug, which is the cash price charged to the general public. The plaintiffs claimed that the pharmacies overbilled the government when they started offering discounted prices to consumers under a price-match program to compete with other pharmacies. They also offered a membership discount program but did not adjust their “usual and customary” prices, continuing to charge the government more than they should have.

The Lower Court’s Ruling.

The Seventh Circuit Court of Appeals ruled in April 2022, that the pharmacies had submitted false claims by not reporting their discounted prices, which were the “usual and customary” prices. The appeals court also stated that the retailers had made reasonable interpretations of ambiguous laws without being warned against it by authoritative guidance. The circuit court referred to the Safeco standard from the Supreme Court’s 2007 Safeco Insurance Co. of America v. Burr case in its decision.

Click here to learn more about the Seventh Circuit Court of Appeal’s ruling.

The Supreme Court’s Ruling.

The Seventh Circuit’s perspective was rejected by the Supreme Court, which instead focused on the defendant’s intentions when submitting false claims. Justice Clarence Thomas, writing for a unanimous court stated, “What matters for an FCA case is whether the defendant knew the claim was false. Thus, if [the defendants] correctly interpreted the relevant phrase and believed their claims were false, they could have known their claims were false.” Read the opinion in full here.

Under this rationale, a defendant could successfully make the argument, “I didn’t know the claim was false and I never bothered to do anything to make sure of that fact.” Even objectively unreasonable claims, such as charging a million dollars for a drug which only cost one dollar, could be successfully defended.

Contact Health Law Attorneys Experienced in Handling Health Care Fraud Investigations and other Legal Proceedings.

The Health Law Firm represents healthcare providers in Medicare and Medicaid audits, and in RAC audits throughout Florida and across the U.S. We also represent health providers in civil and administrative litigation by government agencies and insurance companies attempting to recoup claims that have been paid.

The Health Law Firm’s attorneys routinely represent physicians, dentists, pharmacists, psychotherapists, medical groups, clinics, pharmacies, assisted living facilities (ALFs), home health agencies, nursing homes, group homes and other healthcare providers in Medicaid and Medicare investigations, audits and recovery actions.

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.

Sources:

Elberg, Jacob. “Supreme Court maintains focus on defendant’s subjective beliefs in False Claims Act cases.” SCOTUS Blog. (June 1, 2023). Web.

Wilson, Daniel. “Justices Say FCA Liability Hinges On Defendants’ Beliefs.” Law360. (June 1, 2023). Web.

Gaivin, Kathleen. “False Claims Act ruling by High Court a ‘clear win’ for government, expert says.” McKnights Senior Living. (June 2, 2023). 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 Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Avenue, Suite 1000, Altamonte Springs, Florida 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: [email protected] 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 © 2023. The Health Law Firm. All rights reserved.

Supreme Court Rules FCA Case Liability Requires Defendants’ Subjective Belief

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

On June 1, 2023, the Supreme Court handed down an opinion on the knowledge standard required in False Claims Act (FCA) cases in a precedential decision that leaves the whistleblower plaintiffs bar reeling. In a unanimous ruling, the high court said liability of defendants in FCA cases would be based on their own belief in the falsity of their claims, rather than an “objectively reasonable” interpretation of the law or regulation. This appears to set the age-old maxim of “ignorance of the law is no excuse” on its head. Now, apparently, a defendant can argue that he, she or it was ignorant of the law and win.

The case before the Supreme Court was consolidated from two lower court decisions in the cases United States ex rel. Schutte v. SuperValu Inc. and United States ex rel. Proctor v. Safeway.

When Subjective Belief is Relevant in FCA Cases.

In the cases which the Supreme Court decided, the whistleblowers accused SuperValu and Safeway of violating the FCA by overcharging Medicare, Medicaid, and the Federal Employee Health Benefits Program for prescription drugs.

According to the rules of these programs, pharmacies cannot charge the government more than the “usual and customary” price for a drug, which is the cash price charged to the general public. The plaintiffs claimed that the pharmacies overbilled the government when they started offering discounted prices to consumers under a price-match program to compete with other pharmacies. They also offered a membership discount program but did not adjust their “usual and customary” prices, continuing to charge the government more than they should have.

The Lower Court’s Ruling.

The Seventh Circuit Court of Appeals ruled in April 2022, that the pharmacies had submitted false claims by not reporting their discounted prices, which were the “usual and customary” prices. The appeals court also stated that the retailers had made reasonable interpretations of ambiguous laws without being warned against it by authoritative guidance. The circuit court referred to the Safeco standard from the Supreme Court’s 2007 Safeco Insurance Co. of America v. Burr case in its decision.

Click here to learn more about the Seventh Circuit Court of Appeal’s ruling.

The Supreme Court’s Ruling.

The Seventh Circuit’s perspective was rejected by the Supreme Court, which instead focused on the defendant’s intentions when submitting false claims. Justice Clarence Thomas, writing for a unanimous court stated, “What matters for an FCA case is whether the defendant knew the claim was false. Thus, if [the defendants] correctly interpreted the relevant phrase and believed their claims were false, they could have known their claims were false.” Read the opinion in full here.

Under this rationale, a defendant could successfully make the argument, “I didn’t know the claim was false and I never bothered to do anything to make sure of that fact.” Even objectively unreasonable claims, such as charging a million dollars for a drug which only cost one dollar, could be successfully defended.

Contact Health Law Attorneys Experienced in Handling Health Care Fraud Investigations and other Legal Proceedings.

The Health Law Firm represents healthcare providers in Medicare and Medicaid audits, and in RAC audits throughout Florida and across the U.S. We also represent health providers in civil and administrative litigation by government agencies and insurance companies attempting to recoup claims that have been paid.

The Health Law Firm’s attorneys routinely represent physicians, dentists, pharmacists, psychotherapists, medical groups, clinics, pharmacies, assisted living facilities (ALFs), home health agencies, nursing homes, group homes and other healthcare providers in Medicaid and Medicare investigations, audits and recovery actions.

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.

Sources:

Elberg, Jacob. “Supreme Court maintains focus on defendant’s subjective beliefs in False Claims Act cases.” SCOTUS Blog. (June 1, 2023). Web.

Wilson, Daniel. “Justices Say FCA Liability Hinges On Defendants’ Beliefs.” Law360. (June 1, 2023). Web.

Gaivin, Kathleen. “False Claims Act ruling by High Court a ‘clear win’ for government, expert says.” McKnights Senior Living. (June 2, 2023). 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 Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Avenue, Suite 1000, Altamonte Springs, Florida 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: [email protected] 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 © 2023. The Health Law Firm. All rights reserved.

Supreme Court Rules FCA Case Liability Requires Defendants’ Subjective Belief

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

On June 1, 2023, the Supreme Court handed down an opinion on the knowledge standard required in False Claims Act (FCA) cases in a precedential decision that leaves the whistleblower plaintiffs bar reeling. In a unanimous ruling, the high court said liability of defendants in FCA cases would be based on their own belief in the falsity of their claims, rather than an “objectively reasonable” interpretation of the law or regulation. This appears to set the age-old maxim of “ignorance of the law is no excuse” on its head. Now, apparently, a defendant can argue that he, she or it was ignorant of the law and win.

The case before the Supreme Court was consolidated from two lower court decisions in the cases United States ex rel. Schutte v. SuperValu Inc. and United States ex rel. Proctor v. Safeway.

When Subjective Belief is Relevant in FCA Cases.

In the cases which the Supreme Court decided, the whistleblowers accused SuperValu and Safeway of violating the FCA by overcharging Medicare, Medicaid, and the Federal Employee Health Benefits Program for prescription drugs.

According to the rules of these programs, pharmacies cannot charge the government more than the “usual and customary” price for a drug, which is the cash price charged to the general public. The plaintiffs claimed that the pharmacies overbilled the government when they started offering discounted prices to consumers under a price-match program to compete with other pharmacies. They also offered a membership discount program but did not adjust their “usual and customary” prices, continuing to charge the government more than they should have.

The Lower Court’s Ruling.

The Seventh Circuit Court of Appeals ruled in April 2022, that the pharmacies had submitted false claims by not reporting their discounted prices, which were the “usual and customary” prices. The appeals court also stated that the retailers had made reasonable interpretations of ambiguous laws without being warned against it by authoritative guidance. The circuit court referred to the Safeco standard from the Supreme Court’s 2007 Safeco Insurance Co. of America v. Burr case in its decision.

Click here to learn more about the Seventh Circuit Court of Appeal’s ruling.

The Supreme Court’s Ruling.

The Seventh Circuit’s perspective was rejected by the Supreme Court, which instead focused on the defendant’s intentions when submitting false claims. Justice Clarence Thomas, writing for a unanimous court stated, “What matters for an FCA case is whether the defendant knew the claim was false. Thus, if [the defendants] correctly interpreted the relevant phrase and believed their claims were false, they could have known their claims were false.” Read the opinion in full here.

Under this rationale, a defendant could successfully make the argument, “I didn’t know the claim was false and I never bothered to do anything to make sure of that fact.” Even objectively unreasonable claims, such as charging a million dollars for a drug which only cost one dollar, could be successfully defended.

Contact Health Law Attorneys Experienced in Handling Health Care Fraud Investigations and other Legal Proceedings.

The Health Law Firm represents healthcare providers in Medicare and Medicaid audits, and in RAC audits throughout Florida and across the U.S. We also represent health providers in civil and administrative litigation by government agencies and insurance companies attempting to recoup claims that have been paid.

The Health Law Firm’s attorneys routinely represent physicians, dentists, pharmacists, psychotherapists, medical groups, clinics, pharmacies, assisted living facilities (ALFs), home health agencies, nursing homes, group homes and other healthcare providers in Medicaid and Medicare investigations, audits and recovery actions.

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.

Sources:

Elberg, Jacob. “Supreme Court maintains focus on defendant’s subjective beliefs in False Claims Act cases.” SCOTUS Blog. (June 1, 2023). Web.

Wilson, Daniel. “Justices Say FCA Liability Hinges On Defendants’ Beliefs.” Law360. (June 1, 2023). Web.

Gaivin, Kathleen. “False Claims Act ruling by High Court a ‘clear win’ for government, expert says.” McKnights Senior Living. (June 2, 2023). 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 Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Avenue, Suite 1000, Altamonte Springs, Florida 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: [email protected] 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 © 2023. The Health Law Firm. All rights reserved.

Supreme Court Says FCA Case Liability Requires Defendants’ Subjective Belief

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

On June 1, 2023, the Supreme Court handed down an opinion on the knowledge standard required in False Claims Act (FCA) cases in a precedential decision that leaves the whistleblower plaintiffs bar reeling. In a unanimous ruling, the high court said liability of defendants in FCA cases would be based on their own belief in the falsity of their claims, rather than an “objectively reasonable” interpretation of the law or regulation. This appears to set the age-old maxim of “ignorance of the law is no excuse” on its head. Now, apparently, a defendant can argue that he, she or it was ignorant of the law and win.

The case before the Supreme Court was consolidated from two lower court decisions in the cases United States ex rel. Schutte v. SuperValu Inc. and United States ex rel. Proctor v. Safeway.

When Subjective Belief is Relevant in FCA Cases.

In the cases which the Supreme Court decided, the whistleblowers accused SuperValu and Safeway of violating the FCA by overcharging Medicare, Medicaid, and the Federal Employee Health Benefits Program for prescription drugs.

According to the rules of these programs, pharmacies cannot charge the government more than the “usual and customary” price for a drug, which is the cash price charged to the general public. The plaintiffs claimed that the pharmacies overbilled the government when they started offering discounted prices to consumers under a price-match program to compete with other pharmacies. They also offered a membership discount program but did not adjust their “usual and customary” prices, continuing to charge the government more than they should have.

The Lower Court’s Ruling.

The Seventh Circuit Court of Appeals ruled in April 2022, that the pharmacies had submitted false claims by not reporting their discounted prices, which were the “usual and customary” prices. The appeals court also stated that the retailers had made reasonable interpretations of ambiguous laws without being warned against it by authoritative guidance. The circuit court referred to the Safeco standard from the Supreme Court’s 2007 Safeco Insurance Co. of America v. Burr case in its decision.

Click here to learn more about the Seventh Circuit Court of Appeal’s ruling.

The Supreme Court’s Ruling.

The Seventh Circuit’s perspective was rejected by the Supreme Court, which instead focused on the defendant’s intentions when submitting false claims. Justice Clarence Thomas, writing for a unanimous court stated, “What matters for an FCA case is whether the defendant knew the claim was false. Thus, if [the defendants] correctly interpreted the relevant phrase and believed their claims were false, they could have known their claims were false.” Read the opinion in full here.

Under this rationale, a defendant could successfully make the argument, “I didn’t know the claim was false and I never bothered to do anything to make sure of that fact.” Even objectively unreasonable claims, such as charging a million dollars for a drug which only cost one dollar, could be successfully defended.

Contact Health Law Attorneys Experienced in Handling Health Care Fraud Investigations and other Legal Proceedings.

The Health Law Firm represents healthcare providers in Medicare and Medicaid audits, and in RAC audits throughout Florida and across the U.S. We also represent health providers in civil and administrative litigation by government agencies and insurance companies attempting to recoup claims that have been paid.

The Health Law Firm’s attorneys routinely represent physicians, dentists, pharmacists, psychotherapists, medical groups, clinics, pharmacies, assisted living facilities (ALFs), home health agencies, nursing homes, group homes and other healthcare providers in Medicaid and Medicare investigations, audits and recovery actions.

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.

Sources:

Elberg, Jacob. “Supreme Court maintains focus on defendant’s subjective beliefs in False Claims Act cases.” SCOTUS Blog. (June 1, 2023). Web.

Wilson, Daniel. “Justices Say FCA Liability Hinges On Defendants’ Beliefs.” Law360. (June 1, 2023). Web.

Gaivin, Kathleen. “False Claims Act ruling by High Court a ‘clear win’ for government, expert says.” McKnights Senior Living. (June 2, 2023). 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 Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Avenue, Suite 1000, Altamonte Springs, Florida 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: [email protected] 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 © 2023. The Health Law Firm. All rights reserved.

The Most Common Cases The Health Law Firm Takes

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

One of the most common questions we get asked by doctors and lawyers alike, is about the types of cases our firm takes. They often mistake the practice of health law as medical malpractice defense. However, this is an incorrect assumption. Likewise, if we had a penny for every time we have heard “Yikes, an attorney! I hope I never need you,” we could close our doors and all retire.

As a general health law practice, we concentrate on both proactive and defensive legal issues and clients involved in the health care industry. To a certain extent our law firm does practically everything a physician, medical group, health facility or health care professional could need in the legal arena.

The types of cases we most commonly see are the following:

1. Sales, mergers and acquisitions of medical practices, health care clinics, and health facilities. We represent buyers, sellers and lenders at any stage of the process.

2. Contracts for medical and health care transactions. We prepare contracts, review contracts, negotiate contracts, help to terminate or break contracts, and we litigate contracts. We can be on either side of these transactions. Our litigation can take place in state court or federal court. We review and analyze quite a few employment contracts for medical residents and fellows going to new positions.

3. We research and prepare complex legal opinion letters on proposed health care transactions. The health care industry is the most regulated industry in the United States. There are complex layers of both federal and state laws and regulations as well as numerous federal and state agencies regulating it. Often, legal opinion letters are sought by purchasers and lenders for healthcare transactions for these reasons. We have several board certified health lawyers in our firm who have written dozens of these.

4. We represent health professionals and health facilities in Medicare audits, including fraud audits by the Zone Program Integrity Contractors (ZPICs) and by Recovery Audit Contractors (RACs). This includes representation in the appellate process, including requests for reconsideration, request for redetermination, and federal administrative law judge hearings. Preparation of the response to the audit request, completion of the audit questionnaire, response to the preliminary audit report (PAR), and defense of any repayments demanded, through administrative hearings before federal administrative law judges and appeals if necessary.

5. We represent health professionals and health facilities in Medicaid audits, including fraud audits by the zone program integrity contractors (ZPICs). This includes preparation of the initial response to the audit request, completion of the audit questionnaire, response to the preliminary audit report (PAR), and defense of any repayments demanded, through administrative hearings and appeals if necessary.

6. If there has been an action by the Centers for Medicare & Medicaid Services (CMS) to terminate the Medicare provider’s billing privileges, we aggressively represent them to have the decision reversed and have them reinstated. This includes filing requests for reconsideration and corrective action plans (CAPs). We have been very successful in obtaining relief for our clients.

7. We have represented a number of clinical investigators, primarily physicians, and defensive charges of research fraud, misconduct in science, manipulation of data, manipulating outcomes, in research investigations, and other similar proceedings brought by their institutions or and investigation review board. Whether it is at the initiation of such an investigation or in later hearings and appeals, we have navigated a number of principal investigators through these processes.

8. Our firm has represented a number of medical students, residents and fellow, including foreign medical graduates, in cases brought by the National Board of Medical Examiners (NBME), the United States Medical Licensing Examination (USMLE), and the Educational Commission for Foreign Medical Graduates (ECFMG) in cases where there is an allegation of “irregular behavior” and rules violations through the hearing process and in appeals as necessary.

9. We represent physicians and other health professionals in hospital medical staff peer review proceedings and hearings. Whether it’s the initial application for clinical privileges and medical staff membership or action being taken to revoke or limit clinical privileges, we have been involved representing physicians and other health professionals at all levels. We have also done similar work for physicians in actions initiated by HMOs, professional associations, certification bodies, and other organizations. This is an area where a physician truly needs a health lawyer experienced in this type of proceeding.
10. “Disruptive physician” defense is another area where a doctor really needs an attorney who knows what he or she is doing. When your hospital or medical staff is attempting to place the label on you “disruptive physician,” you are really in trouble. This is an area in which careful navigation is required to prevent actions that result in such a label. Other wise, the physician can be pigeon-holed for life, placed into disruptive physician programs requiring years, if not a lifetime, of close monitoring and can even have discipline commenced against his or her medical license. We can assist you in taking actions to avoid having this happen.

11. When you receive a Medicare, Department of Health and Human Services (HHS), or Office of the Inspector General (OIG) subpoena or civil investigative demand (CID), you know there is serious trouble for someone in the works. We help you to respond promptly and professionally and attempt to keep you from becoming the target of serious federal investigations.

12. We represent physicians, nurses, dentists, psychologists and other licensed health professionals in responding to Department of Health (DOH) letters of investigation. Many physicians, nurses, dentists and other licensed health professionals do not understand that when they receive a letter from the Department of Health complaints advising them that they are under investigation for a complaint that is been made against them, this is a very serious matter. There is nothing that is “routine” about this. This means that there is an investigation that has been opened against your license that could ultimately result in disciplinary action being taken against you. Any disciplinary action taken against you will be on your license forever. This is the time to obtain an attorney. This is not a time to attempt to represent yourself. You should not ever speak with the investigator or provide a statement to the investigator; this is something only your attorney should do and only if it is determined to be advisable considering the facts of the case. We have represented hundreds of licensed health professionals in such investigations and in subsequent disciplinary hearings.

13. We also represent health professionals and others who have been excluded from the Medicare program and placed on the Office of Inspector General (OIG) List of Excluded Individuals and Entities (LEIE). We have represented a number of healthcare professionals in completing and submitting applications to be removed from the LEIE and reinstated to the Medicare program.

14. We routinely counsel and represent physicians, dentists, psychologists, mental health counselors, and other health professionals in referrals to the Professionals Resource Network (PRN) for evaluation. We have found that often the health professional will not actually have any type of substance abuse problem or mental health issue. However, one referred for an evaluation to the PRN can wind up in a five year contract or even a lifetime contract for monitoring containing many mandatory requirements in order to continue practicing his/her profession and a lot of expenses associated with meeting such requirements.

15. We also routinely counsel and represent nurses and nurse practitioners (ARNPs), including certified registered nurse anesthetists (CRNAs) in similar referrals to the Intervention Project for Nurses (IPN). We have found that often the nurse will not actually have any type of substance abuse problem or mental health issue. However, one referred for an evaluation to the IPN can wind up in a five year contract or even a lifetime monitoring contract containing many mandatory requirements in order to continue practicing his/her profession and a lot of expenses associated with meeting such requirements.

16. We have been involved in a number of qui tam or whistle blower cases, either representing the whistle blower or representing an employer or institution that is being accused of wrongdoing. Whether this is pursuant to the Federal False Claims Act (FCA), a state false claims act or a private whistle blower act, we are experienced in investigating, prosecuting, defending, and litigating such cases in state or federal court.

17. Our firm represents physicians, pharmacists, health professionals and health facilities in administrative litigation against the Drug Enforcement Administration (DEA), the Food and Drug Administration (FDA), the Centers for Medicare and Medicaid Services (CMS), the Agency for Health Care Administration (AHCA) and the Department of Health, among other agencies. Whether the government agency is seeking to recover civil monetary penalties (CMP), attempting to recover large Medicare overpayments, seeking to revoke your DEA registration or seeking to discipline your medical license, we have experience in litigating such matters in these administrative tribunals. This can make the difference between a favorable outcome or a devastating outcome.

18. We represent Veterans Administration (VA) physicians, Army physicians, Navy physicians, Air Force physicians, and Indian Health Service physicians, in employment disputes, peer review investigations and hearings, clinical privileging investigations and hearings, and decisions to report to the National Practitioner Data Bank (NPDB).

19. Reporting a conviction for Driving under the influence (DUI) or some other criminal offense is required by most state licensing agencies. We are experienced in making such reports when required and in such a manner that a subsequent investigation and discipline on the professional license is often avoided.

20. Complex litigation involving health professionals is another area in which we routinely practice. Whether the matter involves a dispute between the shareholders of a medical clinic or practice, restraints on trade, allegations of false claims and fraud, the enforcement or avoidance of restrictive covenants (or covenants-not-to-compete), employment, pay and bonus disputes, ownership of practices or facilities, or any other of a number of different situations, we represent either side in state court or federal court.

21. Because of our experience in mental health law, we have come to represent individuals who have been incorrectly confined in mental health facilities in Florida because of allegations of impairment, drug abuse, mental health issues and other issues in which the person is initially though to be a threat to himself or to others. Both law enforcement authorities and medical personnel are being trained to take fewer chances with an individual acting unusual who may tend to hurt herself or someone else. They often tend to err to the side of ordering confinement under the Florida Mental Health Act (also known as the “Baker Act”). When this happens, the individual may be set for a long stay unless he or she has assistance in navigating the way out. We help doing this as quickly and expeditiously as possible.
22. We routinely representing physicians, pharmacists, nurses, dentists and other licensed health professionals in attempting to avoid or in disputing or in appealing adverse National Practitioner Data Bank (NPDB) Reports. There are only limited grounds for doing this so the professional needs to obtain counsel as early in the process as possible.

23. Any type of subpoena or search warrant from a government agency or law enforcement organization seeking your patient records can herald an investigation into false claims, over-prescribing, or other serious possible charges, criminal, civil or administrative. Our representation seeks to determine the reasons for this as early in the process as feasible and to protect your rights and limit your exposure as much as possible.

24. There are many, many other types of cases which we have experience with. To see some of these others, please visit our website.

As the business of health care grows, our law firm also grows. We are always seeking to expand our areas of practice within the health law field. Be sure to check back regularly for updates.

For more information on various health law topics and how The Health Law Firm can help you, visit our YouTube page to watch our video blogs.

Contact Experienced Health Law Attorneys.

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

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

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

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