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

Psychiatric Practice, Owner Agree to Pay $310,000 in FCA Settlement for Employing Doctor on OIG Exclusion List

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

On February 23, 2022, a psychiatric practice and its owner agreed to pay $310,874 to resolve allegations they improperly hired and employed a physician who was excluded from federal healthcare programs. The physician who was hired was on the OIG’s exclusion list, the “List of Excluded Individuals and Entities” (LEIE). As a result, the government took the position that claims for services the physician provided filed against government programs were illegal pursuant to the false Claims Act (FCA). Details were disclosed in a Press Release by the U.S. Attorney for the District of Connecticut.

Geriatric & Adult Psychiatry, LLC (GAP), along with the owner, entered into a civil settlement agreement to resolve their liability under the federal and state False Claims Acts, the U.S. Department of Justice (DOJ) said in a press release.

Past Conviction Overlooked.

In 2006, the physician had been convicted in the Southern District of Florida of conspiracy to commit healthcare fraud. Because of his conviction, the Office of the Inspector General (OIG) excluded him from all federal healthcare programs. Such an exclusion includes Medicare, Medicaid, Tricare, Veterans Administration (V.A.), and Indian Health Service (I.H.S.) programs.

When the OIG excludes an individual or entity from federal health care programs, no payments may be made for items or services furnished by that excluded individual. Additionally, the law prohibits any person or organization that receives such funds from employing or contracting with a person on the LEIE, in any way. To avoid potential liability, it advised that health care providers check the List of Excluded Individuals/Entities (LEIE) on the OIG website: http://oig.hhs.gov/exclusions.

In addition, the OIG has issued a Special Advisory Bulletin to providers who might employ or contract with an excluded individual or entity to provide guidance. To review this OIG Bulletin, click here.

For more helpful information, click here.

Despite this, to medical group hired the former physician as the clinical director in 2016 where he served in that position until 2021. During that time, both the practice and its owner billed and sought reimbursements from Medicare, Medicaid, TRICARE, and the Railroad Retirement Medicare Program. Additionally, GAP’s reimbursements were used to pay the physician’s salary and benefits.

Payment Prohibition & Civil Monetary Penalties (CMPs).

Health care providers receiving funds from federal health care programs must check to see if potential employees and contractors are excluded by searching the LEIE to ensure that person is not listed. Providers have mistakenly assumed that exclusion does not apply to an individual or entity that provides services that extend beyond direct patient care; this is wrong. Payment prohibition extends to anyone who chooses to employ or contract with an excluded individual or entity in any capacity. Providers who violate this prohibition are required to pay back all federal health care program funds inappropriately received and may also be subject to civil monetary penalties (CMPs) and action under the False Claims Act (FCA).

Furthermore, payment of an excluded individual’s salary, benefits, or expenses, directly linked to federal health care program funds is expressly prohibited. Click here to read my prior blog and learn more about this.

Little Known Fact: You Must Actively Apply to Get Taken Off the LEIE.

A little-known fact, often overlooked, is that a person or entity on the LEIE must actually apply to be removed from it, no matter how short the period of exclusion. Thus if a person is excluded and placed on the LEIE for only two years, they must apply to the OIG after that period of time, completing its detailed, notarized application, and be removed from the list. Removal is not automatic.

Contact Health Law Attorneys Experienced in Defending Against Action to Exclude an Individual or Business from the Medicare Program and Assisting in Reinstatement Applications.

The attorneys of The Health Law Firm have experience in dealing with the Office of the Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS), and defending against action to exclude an individual or business entity from the Medicare Program, in administrative hearings on this type of action, in submitting applications requesting reinstatement to the Medicare Program after exclusion, and removal from the List of Excluded Individuals and Entities (LEIE).

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:

Yankowski, Peter. “Officials: Hamden psychiatric practice to pay $310,000 settlement over employee who lost medical license.” Stamford Advocate. (February 23, 2022). Web.

Health Law Weekly. “Psychiatric Practice, Owner Pay $310K for Employing “Excluded” Individual.”American Health Law Association (AHLA). (February 25, 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 Avenue, 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.

2022-03-22T18:29:39-04:00May 6th, 2022|Categories: Nursing Law Blog|Tags: , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |0 Comments

First COVID-19 Breathalyzer Test Authorized By FDA

Author Headshot

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

On April 14, 2022, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization for the first Covid-19 diagnostic test that uses breath samples. The test, made by Texas-based company, InspectIR Systems, is authorized for those patients 18 and older.

InspectIR expects to produce approximately 100 testing instruments per week, which can each be used to evaluate approximately 160 samples per day. At this level of production, testing capacity using the InspectIR COVID-19 Breathalyzer is expected to increase by about 64,000 samples per month, according to the FDA’s statement.

The Testing Requirements.

The test can only be performed in environments where the patient’s specimen is collected and analyzed, such as doctor’s offices, hospitals, and mobile testing sites.

Additionally, the test must be performed by a qualified, trained operator under the supervision of a licensed health care provider or authorized by state law to prescribe tests. The test detects chemicals associated with the virus that causes the disease in a breath sample in less than three minutes. If it’s positive, it should be followed up by a molecular test, the agency said in a statement.

“Today’s authorization is yet another example of the rapid innovation occurring with diagnostic tests for Covid-19,” Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said.

Read the FDA’s press release and get even more information.

Contact Health Law Attorneys Experienced in Representing Health Care Professionals and Providers.

At the Health Law Firm, we provide legal services for all health care providers and professionals. This includes physicians, nurses, dentists, psychologists, psychiatrists, mental health counselors, home health agencies, hospitals, ambulatory surgical centers, pain management clinics, nursing homes, and any other healthcare provider. It also includes medical students, resident physicians, and fellows, as well as medical school professors and clinical staff. We represent health facilities, individuals, groups, and institutions in contracts, sales, mergers, and acquisitions. The lawyers of The Health Law Firm are experienced in complex litigation and both formal and informal administrative hearings. We also represent physicians accused of wrongdoing, patient complaints, and in Department of Health investigations.

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

Sources:

Helsel, Phil. “FDA authorizes first Covid-19 breath test.” NBC News. (April 14, 2022). Web.

Muller, Madison. “Breathalyzer Test for Covid-19 Wins Approval From FDA.” Bloomberg. (April 14, 2022). Web.

Mckinney, Jim. “Coronavirus (COVID-19) Update: FDA Authorizes First COVID-19 Diagnostic Test Using Breath Samples.” U.S. Food and Drug Administration. (April 14, 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 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.

 

COVID Uninsured Provider Relief Fund Expected To Run Out of Money Soon If Congress Doesn’t Act

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

In 2020, the U.S. Department of Health and Human Services (HHS) created the “Provider Relief Fund” (PRF) to help support healthcare providers in the battle against the COVID-19 pandemic. The federal program has served as a lifeline to frontline healthcare workers who’ve experienced revenue losses and increased demand for their services during the pandemic.

To date, it has allocated more than $178 billion in payments to over 410,000 providers across the United States. Click here to learn more.

COVID-19 Uninsured Relief Fund.

Let’s start with some good news: Under the COVID-19 relief funding, HHS created the “uninsured relief fund.” This program provides claims reimbursement to health care providers for testing, treating, diagnosis, and administering vaccines to uninsured individuals for COVID-19. It has paid out more than $17 billion throughout the pandemic. It has paid out more than $17 billion throughout the pandemic.

Of the $17 billion, HHS has distributed nearly $10 billion for testing, more than $6 billion reimbursed for treatment, and the remainder covered vaccinations. Read more on the statistics here.

Running Out of Money.

Now for the bad news: According to an HHS spokesperson, there’s only $7.6 billion left, and the money will run out in the coming months. Congress isn’t currently considering making more funding available, meaning providers and patients are likely to have soon to bear the costs themselves.

Therefore, many hospitals and healthcare organizations urge Congress to replenish the PRF. “One of the most helpful and patient-oriented uses of the PRF was to help those people who for whatever reasons are uninsured and suffer from COVID-19,” said Federation of American Hospitals CEO Chip Kahn. “It meant that no one should have any reluctance to go to the hospital if they have COVID but no insurance.”

Additionally, on February 9, 2022, the American Hospital Association released a statement urging readers to contact lawmakers to get Congress to provide another $25 billion for the PRF in the government funding package. Read the AHA’s action alert here.

As we approach nearly two years since HHS declared COVID-19 a national public health emergency, PRF has been a lifeline to hospitals, health systems, and medical professionals. It has been helping to keep doors open during the pandemic to continue providing essential care to patients and communities. However, if the program runs out of money and Congress doesn’t appropriate more, hospitals could be left footing the bill, which will hurt both providers and patients in the end.

Read one of my previous blogs on a similar case regarding a Florida Dentist’s COVID-19 Business Interruption Insurance Claim to learn even more.

Contact Health Law Attorneys Experienced in Representing Health Care Professionals and Providers.

At the Health Law Firm, we provide legal services for all health care providers and professionals. This includes physicians, nurses, dentists, psychologists, psychiatrists, mental health counselors, home health agencies, hospitals, ambulatory surgical centers, pain management clinics, nursing homes, and any other healthcare provider. It also includes medical students, resident physicians, and fellows, as well as medical school professors and clinical staff. We represent health facilities, individuals, groups, and institutions in contracts, sales, mergers, and acquisitions. The lawyers of The Health Law Firm are experienced in complex litigation and both formal and informal administrative hearings. We also represent physicians accused of wrongdoing, patient complaints, and in Department of Health investigations.

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

Sources:

Hellmann, Jessie. “HHS running out of money to pay providers for treating uninsured COVID-19 patients.” Modern Healthcare. (February 8, 2022). Web.

HRSA. “Covid Uninsured Claim.” Health Resources & Services Administration. (February 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 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.

“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.

Psychiatric Practice to Pay $310,000 in FCA Settlement for Employing Doctor on OIG Exclusion List

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

On February 23, 2022, a psychiatric practice and its owner agreed to pay $310,874 to resolve allegations they improperly hired and employed a physician who was excluded from federal healthcare programs. The physician who was hired was on the OIG’s exclusion list, the “List of Excluded Individuals and Entities” (LEIE). As a result, the government took the position that claims for services the physician provided filed against government programs were illegal pursuant to the false Claims Act (FCA). Details were disclosed in a Press Release by the U.S. Attorney for the District of Connecticut.

Geriatric & Adult Psychiatry, LLC (GAP), along with the owner, entered into a civil settlement agreement to resolve their liability under the federal and state False Claims Acts, the U.S. Department of Justice (DOJ) said in a press release.

Past Conviction Overlooked.

In 2006, the physician had been convicted in the Southern District of Florida of conspiracy to commit healthcare fraud. Because of his conviction, the Office of the Inspector General (OIG) excluded him from all federal healthcare programs. Such an exclusion includes Medicare, Medicaid, Tricare, Veterans Administration (V.A.), and Indian Health Service (I.H.S.) programs.

When the OIG excludes an individual or entity from federal health care programs, no payments may be made for items or services furnished by that excluded individual. Additionally, the law prohibits any person or organization that receives such funds from employing or contracting with a person on the LEIE, in any way. To avoid potential liability, it advised that health care providers check the List of Excluded Individuals/Entities (LEIE) on the OIG website: http://oig.hhs.gov/exclusions.

In addition, the OIG has issued a Special Advisory Bulletin to providers who might employ or contract with an excluded individual or entity to provide guidance. To review this OIG Bulletin, click here.

For more helpful information, click here.

Despite this, to medical group hired the former physician as the clinical director in 2016 where he served in that position until 2021. During that time, both the practice and its owner billed and sought reimbursements from Medicare, Medicaid, TRICARE, and the Railroad Retirement Medicare Program. Additionally, GAP’s reimbursements were used to pay the physician’s salary and benefits.

Payment Prohibition & Civil Monetary Penalties (CMPs).

Health care providers receiving funds from federal health care programs must check to see if potential employees and contractors are excluded by searching the LEIE to ensure that person is not listed. Providers have mistakenly assumed that exclusion does not apply to an individual or entity that provides services that extend beyond direct patient care; this is wrong. Payment prohibition extends to anyone who chooses to employ or contract with an excluded individual or entity in any capacity. Providers who violate this prohibition are required to pay back all federal health care program funds inappropriately received and may also be subject to civil monetary penalties (CMPs) and action under the False Claims Act (FCA).

Furthermore, payment of an excluded individual’s salary, benefits, or expenses, directly linked to federal health care program funds is expressly prohibited. Click here to read my prior blog and learn more about this.

Little Known Fact: You Must Actively Apply to Get Taken Off the LEIE.

A little-known fact, often overlooked, is that a person or entity on the LEIE must actually apply to be removed from it, no matter how short the period of exclusion. Thus if a person is excluded and placed on the LEIE for only two years, they must apply to the OIG after that period of time, completing its detailed, notarized application, and be removed from the list. Removal is not automatic.

Contact Health Law Attorneys Experienced in Defending Against Action to Exclude an Individual or Business from the Medicare Program and Assisting in Reinstatement Applications.

The attorneys of The Health Law Firm have experience in dealing with the Office of the Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS), and defending against action to exclude an individual or business entity from the Medicare Program, in administrative hearings on this type of action, in submitting applications requesting reinstatement to the Medicare Program after exclusion, and removal from the List of Excluded Individuals and Entities (LEIE).

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:

Yankowski, Peter. “Officials: Hamden psychiatric practice to pay $310,000 settlement over employee who lost medical license.” Stamford Advocate. (February 23, 2022). Web.

Health Law Weekly. “Psychiatric Practice, Owner Pay $310K for Employing “Excluded” Individual.”American Health Law Association (AHLA). (February 25, 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 Avenue, 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.

 

 

2022-03-22T18:28:42-04:00April 13th, 2022|Categories: Pharmacy Law Blog|Tags: , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |0 Comments

Psychiatric Practice Reaches Settlement in FCA Suit to End Allegations of Employing Physician on OIG Exclusion List

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

On February 23, 2022, a psychiatric practice and its owner agreed to pay $310,874 to resolve allegations they improperly hired and employed a physician who was excluded from federal healthcare programs. The physician who was hired was on the OIG’s exclusion list, the “List of Excluded Individuals and Entities” (LEIE). As a result, the government took the position that claims for services the physician provided filed against government programs were illegal pursuant to the false Claims Act (FCA). Details were disclosed in a Press Release by the U.S. Attorney for the District of Connecticut.

Geriatric & Adult Psychiatry, LLC (GAP), along with the owner, entered into a civil settlement agreement to resolve their liability under the federal and state False Claims Acts, the U.S. Department of Justice (DOJ) said in a press release.

Past Conviction Overlooked.

In 2006, the physician had been convicted in the Southern District of Florida of conspiracy to commit healthcare fraud. Because of his conviction, the Office of the Inspector General (OIG) excluded him from all federal healthcare programs. Such exclusion includes Medicare, Medicaid, Tricare, Veterans Administration (V.A.), and Indian Health Service (I.H.S.) programs.

When the OIG excludes an individual or entity from federal health care programs, no payments may be made for items or services furnished by that excluded individual. Additionally, the law prohibits any person or organization that receives such funds from employing or contracting with a person on the LEIE, in any way. To avoid potential liability, it is advised that health care providers check the List of Excluded Individuals/Entities (LEIE) on the OIG website: http://oig.hhs.gov/exclusions.

In addition, the OIG has issued a Special Advisory Bulletin to providers who might employ or contract with an excluded individual or entity to provide guidance. To review this OIG Bulletin, click here.

For more helpful information, click here.

Despite this, to medical group hired the former physician as the clinical director in 2016 where he served in that position until 2021. During that time, both the practice and its owner billed and sought reimbursements from Medicare, Medicaid, TRICARE, and the Railroad Retirement Medicare Program. Additionally, GAP’s reimbursements were used to pay the physician’s salary and benefits.

Payment Prohibition & Civil Monetary Penalties (CMPs).

Health care providers receiving funds from federal health care programs must check to see if potential employees and contractors are excluded by searching the LEIE to ensure that person is not listed. Providers have mistakenly assumed that exclusion does not apply to an individual or entity that provides services that extend beyond direct patient care; this is wrong. Payment prohibition extends to anyone who chooses to employ or contract with an excluded individual or entity in any capacity. Providers who violate this prohibition are required to pay back all federal health care program funds inappropriately received and may also be subject to civil monetary penalties (CMPs) and action under the False Claims Act (FCA).

Furthermore, payment of an excluded individual’s salary, benefits, or expenses, directly linked to federal health care program funds is expressly prohibited. Click here to read my prior blog and learn more about this.

Little Known Fact: You Must Actively Apply to Get Taken Off the LEIE.

A little-known fact, often overlooked, is that a person or entity on the LEIE must actually apply to be removed from it, no matter how short the period of exclusion. Thus if a person is excluded and placed on the LEIE for only two years, they must apply to the OIG after that period of time, completing its detailed, notarized application, and be removed from the list. Removal is not automatic.

Contact Health Law Attorneys Experienced in Defending Against Action to Exclude an Individual or Business from the Medicare Program and Assisting in Reinstatement Applications.

The attorneys of The Health Law Firm have experience in dealing with the Office of the Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS), and defending against action to exclude an individual or business entity from the Medicare Program, in administrative hearings on this type of action, in submitting applications requesting reinstatement to the Medicare Program after exclusion, and removal from the List of Excluded Individuals and Entities (LEIE).

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:

Yankowski, Peter. “Officials: Hamden psychiatric practice to pay $310,000 settlement over employee who lost medical license.” Stamford Advocate. (February 23, 2022). Web.

Health Law Weekly. “Psychiatric Practice, Owner Pay $310K for Employing “Excluded” Individual.”American Health Law Association (AHLA). (February 25, 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 Avenue, 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.

 

 

2022-04-21T22:35:28-04:00April 12th, 2022|Categories: Health Facilities 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.
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