Medicare Revocation and the Collateral Damage It Can Cause Health Care Providers

Attorney and Author George F. Indest III HeadshotBy George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law
Many healthcare professionals are unaware of the adverse long-term collateral effects of Medicare revocation or exclusion on their careers and future employment. However, if you are a physician, dentist, nurse, mental health counselor, psychologist, pharmacist, physician assistant, nurse practitioner, massage therapist, or other licensed health professional whose license is revoked or suspended, there may still be hope.
Lasting Consequences of Medicare Revocation. 
A revocation or exclusion from Medicare is often a severe consequence of license discipline on a professional license and can devastate a provider’s career. The Centers for Medicare & Medicaid Services (CMS) can revoke a healthcare provider’s agreement to participate in Medicare. When this occurs, their Medicare billing privileges are terminated.  Their legal authority to write prescriptions, referrals or orders for tests paid by Medicare also vanishes.
Additionally, the exclusion can last for many years. This can be a career-ending move for many healthcare providers especially physicians, as Medicare revocation is reported to the National Practitioner Databank (NPDB). In addition, it can potentially affect their opportunities to work in hospitals with other Medicare providers, or on health insurance panels.
For this reason, healthcare providers need to retain a health law attorney with experience in licensing issues who can help them navigate the complex legal system Medicare presents. A skilled attorney can review the facts of the case, develop a strategy for defending the provider’s license, recommend actions to avoid or mitigate the damages, and represent them in administrative hearings or proceedings in court. In some cases, an effective legal strategy may minimize the impact of discipline or even prevent Medicare revocation or exclusion. However, the best way to protect against license discipline and its consequences is to ensure that you are in compliance with Medicare standards, regulations and procedures.

To learn more, read one of my prior blogs here.

Contact Experienced Health Law Attorneys in Healthcare Licensing Issues.

If you have had a license suspended or revoked, or you are facing imminent action against your license, it is imperative that you contact an experienced healthcare attorney to assist in defending you.  Remember, your license is your livelihood. It is not recommended that you should not attempt to pursue these matters without the assistance of an experienced health care attorney. The Health Law Firm routinely represents physicians, dentists, nurses, medical groups, clinics, and other healthcare providers in Medicare issues and in defense of actions in personal and facility licensing actions.

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:

Hollender, Allison and Wortley, Mackenzie. “Collateral Consequences of Medicare Revocations.” AHLA. (March 9, 2021). Web.

Simas, Steven. “Collateral Consequence of Healthcare License Discipline – Medicare Exclusion.” SIMAS & Associates. (October 3, 2017). Web.

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Avenue, 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 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: [email protected] 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 © 2023 The Health Law Firm. All rights reserved.
By |2024-03-14T09:59:24-04:00July 26, 2023|Categories: Pharmacy Law Blog|Tags: , , , , , , , , , , , , , , , , , , , , , , , , , , |Comments Off on Medicare Revocation and the Collateral Damage It Can Cause Health Care Providers

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.

 

Medications and Other Substances that Mimic Prohibited Drugs on Urinalysis Drug Tests (Part 1 of a Blog Series)

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law
In representing nurses and other licensed health professionals, we constantly discuss positive drug screenings, usually from employer-ordered drug testing, with our clients.  These clients include nurses, pharmacists, dental professionals, mental health counselors, therapists, etc.  Often these individuals need to remember that if they apply for a job with a new employer or are working for a large corporation or the government, they are subject to employer-ordered drug screenings.  Most problems arise when the professional has applied to a hospital or a placement agency for work in a hospital and they must submit to a pre-employment drug test.
The client often contends that the result is a false positive and that some other substance must be responsible for it.

A positive result for any drug for which you do not have a valid prescription from a physician, including marijuana, will cause you to be eliminated from consideration for a new job or terminated from a current position and a complaint against your professional license, which could cause you to lose it.  We are routinely called on to defend such situations.

Series of Blogs to Discuss Substances that Can Mimic Prohibited Drugs on Drug Tests.

In the years I have been doing this, I have encountered many cases in which other substances have caused a positive result for a prohibited substance on a drug screening test.

In this series of blogs, I intend to discuss some of the substances scientifically shown to cause false positives on employer-ordered drug screening tests.  This is the second in the series. Remember to read Part 2 and Part 3 of this blog series! Part 2 deals with substances that may cause a false positive for cocaine. Part 3 deals with Marijuana and THC Imposter Substances.


Over-the-Counter Medications Mimicking Amphetamines on Drug Tests.

Following is a discussion of substances that can cause a false positive for amphetamines on a urinalysis drug test.  This material comes from an article in Case Reports in Psychiatry published in 2013. (Ref. 1)
Many prescription pharmaceuticals and over-the-counter (OTC) medications have been previously reported in the literature to cause a false-positive result for amphetamines on urine drug screens. Many OTC medications have been reported in scientific literature to produce false positives for amphetamines on urine drug screenings, chiefly antihistamines.
The OTC medications that have been documented to and are well known as causing false positives for amphetamines on drug tests include nasal decongestants, Vicks inhaler, MDMA (3,4-Methylenedioxy methamphetamine;  commonly known as ecstasy, molly, mandy or X), and pseudoephedrine.  (Refs. 1-5)  Some of these are prohibited medications that cannot be prescribed and are only available as “street drugs” such as MDMA.

Prescription Medications Documented as Mimicking Amphetamines.

Prescription medications known to have mimicked amphetamines on testing include antipsychotics and antidepressants.  (Refs. 1 & 2)
The prescription medications known to cause false-positive amphetamine urine drug screen include fluoxetine, selegiline, ranitidine, trazodone, nefazodone, brompheniramine, phenylpropanolamine, chlorpromazine, promethazine, ephedrine, methamphetamine, and labetalol.  (Refs. 2-5)  However, the fact that the individual taking the drug test might have a prescription for one of these might cause the employer to disqualify the employee or potential employee from consideration for the job.
Bupropion (an atypical antidepressant that inhibits norepinephrine and dopamine re-uptake), is a drug used to treat depression and smoking cessation, but may also be used off-label to treat ADHD.  It has also been documented as causing false positive results for amphetamines on drug screenings.  (Ref. 6)
The drug atomoxetine has metabolites that are similar to those of amphetamines (phenylpropan-1-amine verses phenyl-propan-2-amine).  This could also result in a false positive on a urine drug screen.  (Ref. 1)

 

Other Discussions in Future Blogs.

In this series of blogs, I intend to discuss some of the substances scientifically shown to cause false positives on employer-ordered drug screening tests. Remember to read Part 2 and Part 3 of this blog series! Part 2 deals with substances that may cause a false positive for cocaine. Part 3 deals with Marijuana and THC Imposter Substances.

Contact Experienced Health Law Attorneys in Matters Involving PRN or IPN.

The Health Law Firm’s attorneys routinely represent physicians, dentists, nurses and other health professionals in matters involving PRN or IPN. Our attorneys also represent health providers in Department of Health investigations, before professional boards, in licensing matters, and in administrative hearings.
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.

References:

1. Fenderson JL, Stratton AN, Domingo JS, Matthews GO, Tan CD. Amphetamine positive urine toxicology screen secondary to atomoxetine. Case Rep Psychiatry. 2013;2013:381261. doi: 10.1155/2013/381261. Epub 2013 Jan 30. PMID: 23424703; PMCID: PMC3570929.
(Accessed on May 20, 2023.)
2. Brahm NC, Yeager LL, Fox MD, Farmer KC, Palmer TA. Commonly prescribed medications and potential false-positive urine drug screens. Am J Health Syst Pharm. 2010 Aug 15;67(16):1344-50. doi: 10.2146/ajhp090477. PMID: 20689123.
3. Vincent EC, Zebelman A, Goodwin C, Stephens MM. Clinical inquiries. What common substances can cause false positives on urine screens for drugs of abuse? J Fam Pract. 2006 Oct;55(10):893-4, 897. PMID: 17014756.
4. Rapuri SB, Ramaswamy S, Madaan V, Rasimas JJ, Krahn LE. ‘Weed’ out false-positive urine drug screens. Current Psychiatry. 2006;5(8):107–110. [Google Scholar]
5. Moeller KE, Lee KC, Kissack JC. Urine drug screening: practical guide for clinicians. Mayo Clin Proc. 2008 Jan;83(1):66-76. doi: 10.4065/83.1.66. Erratum in: Mayo Clin Proc. 2008 Jul;83(7):851. PMID: 18174009.
6. Reidy L, Walls HC, Steele BW. Crossreactivity of bupropion metabolite with enzyme-linked immunosorbent assays designed to detect amphetamine in urine. Ther Drug Monit. 2011 Jun;33(3):366-8. doi: 10.1097/FTD.0b013e3182126d08. PMID: 21436763.

 

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.

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.
By |2024-03-14T09:59:25-04:00July 18, 2023|Categories: Pharmacy Law Blog|Tags: , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |Comments Off on Medications and Other Substances that Mimic Prohibited Drugs on Urinalysis Drug Tests (Part 1 of a Blog Series)

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

Previously published on April 19, 2022
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.

 

 

By |2024-03-14T09:59:26-04:00July 8, 2023|Categories: Pharmacy Law Blog|Tags: , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |Comments Off on Psychiatric Practice to Pay $310,000 in FCA Settlement for Employing Doctor on OIG Exclusion List

Florida Man Gets 15 Years in Prison for HIV Drug Fraud Scheme;  $230 Million Lost to Fraud

author headshot standing in dark suit with arms crossedBy George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law
On June 15, 2023, a United States District Judge sentenced a Florida man to 15 years in prison for his role in an HIV prescription drug fraud scheme that amassed more than $230 million in two years.  The defendant was initially indicted on June 17, 2022, and charged with six counts of conspiracy and money laundering.  Unlike most of the fraud convictions we report on, this one was directed against the U.S. Food and Drug Administration (FDA) and involved adulterating and misbranding drugs.  The defendant pled guilty to only two counts: conspiracy to defraud the United States and conspiracy to commit money laundering.  Click here to view the press release from the U.S. Attorney’s Office, Southern District of Florida, to learn more about the arrest


The Charges: Adulterated and Misbranded HIV Medications.

Prescription drug diversion is when prescription drugs are removed from regulated distribution channels and reintroduced into the wholesale market or otherwise illegally distributed.  These drugs can be acquired through theft, fraud, or patients who were prescribed the medication and intentionally did not consume them.
In this case, U.S. vs. Lazaro Hernandez,  the defendant would obtain prescribed drugs illegally, repackage them, falsify the documentation, and resell them to coconspirators through conspiracy wholesalers. To successfully divert the prescription medications, they got wholesale drug distributor licenses for LLC’s in Florida, New Jersey, Connecticut, and New York. These conspiracy wholesalers would purchase the diverted, adulterated, and misbranded drugs and documentation and sell them to pharmacies.
Adulteration occurs when any substance is added to or substituted, in part or in whole, or mixed with an approved drug.  Misbranding of a drug occurs when someone places a label on it that is false or misleading in any way, as defined in Title 21 U.S. Code sections 351(d) and 352 (a)(1).  In this case, the pharmacies billed health care benefit programs and dispensed adulterated and misbranded drugs to patients.  The pharmacies paid $232,800,000 for the diverted drugs between April 2019 and at least October 2021.
The six counts that the defendant was initially charged with include conspiracy to introduce adulterated and misbranded drugs and to defraud the United States, conspiracy to traffic pre-retail medical products with false documentation, conspiracy to commit money laundering, and three counts of money laundering.  The false documentation and money laundering charges were later dropped in the plea deal.

The Sentencing.

The government recommended a sentence of 188 to 235 months, which aligns with the defendant’s criminal history and total offense level (calculated in accordance with federal statutes and regulations), while the defense argued for a lesser amount of time due to the allegedly “secondary” role the defendant played in the fraud.  The judge sentenced the defendant to 180 months. Also included in the sentence was a forfeiture of all proceeds from the scam and restitution in an amount that has yet to be determined.
This lower-than-recommended prison sentence came after the defendant spoke about his gambling addiction, which allegedly led him to participate in the fraud. Also, two of his 47 character references addressed the court in person.  The judge was swayed to give him a lower sentence as a result. View the indictment in the case in full here.

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

The attorneys of The Health Law Firm provide legal representation to pharmacists, pharmacy facilities, physicians, nurse practitioners, CRNAs, dentists, psychologists, mental health professionals, nurses, and other health providers in Department of Health (DOH) investigations and hearings, Drug Enforcement Administration (DEA) investigations, audits and hearings, Food and Drug Administration (FDA) investigations and hearings, FBI investigations, Medicare/Medicaid investigations, audits and hearings, and many other actions involving defense 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.

Sources:

Minsky, David. “Fla. Man Sentenced To 15 Years In Prison Over HIV Drug Fraud.” Law360. (June 16, 2023). Web.
Becker, Zoey. “In fraud case targeting HIV meds, Florida man gets 15 years in prison.” FiercePharma. (June 21, 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 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.

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.
By |2024-03-14T09:59:27-04:00June 26, 2023|Categories: Pharmacy Law Blog|Tags: , , , , , , , , , , , , , , , , , , , , , , , |Comments Off on Florida Man Gets 15 Years in Prison for HIV Drug Fraud Scheme;  $230 Million Lost to Fraud

Supreme Court Rules FCA Case Liability Requires Defendants’ Subjective Belief

Author and attorney headshot leaning with hands folded in frontBy 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.

Walmart Announces Pay Raise For Thousands of Pharmacists and Opticians

Author and Attorney headshot standing with arms crossed in front of dark backgroundBy George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

On May 31, 2023, Walmart announced it is raising wages for 7,700 U.S. pharmacists and opticians in a nationwide plan to expand healthcare services. The retailer said about 3,700 pharmacists would get a bump in pay, bringing their total average pay to more than $140,000 annually. Additionally, more than 4,000 opticians will receive pay raises, with their average hourly pay rising to more than $22.50. The company also said it plans to start a program in which associates who work in its Vision Center could receive certification and licensing to move into higher-paying positions.

Currently, Walmart employs 16,000 pharmacists and 12,000 opticians overall.

Competitive Pay in a Competitive Market.

According to the Bureau of Labor Statistics, the mean annual wage for a pharmacist in the United States is $129,410 (https://www.bls.gov/oes/current/oes291051.htm), and the mean hourly wage for opticians is $21.58 (https://www.bls.gov/oes/current/oes292081.htm).

The retail giant’s decision to increase wages for workers across its business is a way to compete for talent in a competitive market.

In 2022, the company also increased wages for 36,000 Pharmacy technicians. “As our Health & Wellness business continues to grow, we’re serious about being an employer of choice for talented individuals in these fields,” said Kevin Host, Senior Vice President of Walmart Health & Wellness, Pharmacy, in a press release.

To read the press release on Walmart’s website and learn more, click here.

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 pharmacists, optometrists, physicians, nurses, dentists, psychologists, psychiatrists, mental health counselors, Durable Medical Equipment suppliers, medical students and interns, hospitals, ambulatory surgical centers, pain management clinics, nursing homes, and any other healthcare provider. We represent facilities, individuals, groups, and institutions in contracts, sales, mergers, and acquisitions.

The lawyers of The Health Law Firm are experienced in both formal and informal administrative hearings and in representing physicians in investigations and at Board of Medicine and Board of Osteopathic Medicine hearings. We represent physicians accused of wrongdoing, in patient complaints and in Department of Health investigations.

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:

Holman, Jordan. “Walmart Raises Wages for Some Pharmacists and Opticians.” The New York Times. (May 31, 2023). Web.

“Walmart announces raise for pharmacists and opticians, new optician training program.” 5NewsOnline. (May 31, 2023). Web.

Diaz, Naomi. “Walmart Health to add 28 new clinics by 2024.” Becker’s Hospital Review. (March 2, 2023). Web.

Cavale, Siddharth. “Walmart is raising wages for pharmacists, opticians in healthcare push.” Reuters. (May 31, 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 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.

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.

CMS Using Medicare Termination to Squash Doctors Involved in Overprescribing Opioids

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

Recently it has come to our attention that there may be a nationwide effort by the Centers for Medicare and Medicaid Services (CMS) Medicare Administrative Contractors (MACs) to squelch physicians who prescribe opioids and other narcotic medications. We have seen letters sent out by CMS MACs to physicians notifying them that their Medicare program billing privileges have been terminated because CMS has identified them as a provider who is overprescribing.


Nationwide Effort to Run “Pill Mills” Out of Business.

We are well aware of efforts by the various law enforcement authorities at the state and federal level to prosecute and put out of business physicians identified as “pill mills” and the pharmacies that fill their prescriptions.  These include surprise audits and inspections, followed by administrative actions or criminal prosecutions, by the Drug Enforcement Administration (DEA), the state Attorney General’s Office, the Department of Health, statewide task forces, and local sheriff’s offices and police departments.

However, this new heavy-handed tactic hits physicians in the pocketbook. It takes advantage of an arcanely-complex system of administrative appeals that is heavily weighted in favor of the government.

If You Receive a Letter from CMS Regarding Termination of Your Medicare Billing Privileges, Act Immediately.

Do not hesitate or wait if you receive a letter notifying you that CMS is terminating your billing privileges. You must get an experienced health care attorney to represent you right away and appeal the decision through a “request for reconsideration.”  You must also ask that the termination not go into effect while the appeal is pending and provide reasons why it should not.  Often you only have a few days to do this.

In Truth, There May Be No Oversprescribing.

In one recent case, we represented a physician who received such a letter stating she was terminated from Medicare. She was not a pain management physician, and she had over 2,000 patients. She only prescribed a handful (literally, less than ten) of these patients opioids, but the medical necessity was present and well-documented. However, because Medicare was aware of the prescriptions, it terminated her because it was paying for them.

Consequences of a Medicare Privileges Termination.

There are many, many seriously adverse consequences of a termination of Medicare privileges. Often we refer to this as a “death sentence.” It could be the death of your medical practice and possibly your medical career.

Consequences include:

1.    A waiting period of ten (10) years before you can even reapply.

2.    Placement on the OIG’s List of Excluded Individuals and Entities (LEIE).

3.    Having to notify hospitals and other health facilities where you are on the staff so that your medical staff privileges can be terminated.

4.    Being terminated from your state’s Medicaid Program.

5.    Being placed on the exclusion list for all federal contracts and contractors.

6.    Being terminated from the provider panels of all health insurers.

7.    Being excluded from any job or any position, including contractor or subcontractor for any organization that receives and government funding.

8.    Possible loss of medical license or non-renewal of medical license because of #1, #2 and #4 above (in most states).

 

Act Fast; Don’t Delay!

Act fast if you receive such a letter. Do not delay.  Retain the services of a health lawyer experienced in Medicare appeals and federal administrative hearings.

Don’t Wait Too Late; Consult with a Health Law Attorney Experienced in Medicare and Medicaid Issues Now.

The lawyers of The Health Law Firm routinely represent physicians, medical groups, clinics, pharmacies, durable medical equipment (DME) suppliers, home health agencies, nursing homes and other healthcare providers in Medicare and Medicaid investigations, audits and recovery actions. They also represent them in preparing and submitting corrective action plans (CAPs), requests for reconsideration, and appeal hearings, including Medicare administrative hearings before an administrative law judge. Attorneys of The Health Law Firm represent health providers in actions initiated by the Medicaid Fraud Control Units (MFCUs), in False Claims Act cases, in actions initiated by the state to exclude or terminate from the Medicaid Program or by the HHS OIG to exclude from the Medicare Program.

Call now at (407) 331-6620 or Toll-Free (888) 331-6620 or visit our website 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 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.

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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.

By |2024-03-14T09:59:31-04:00May 8, 2023|Categories: Pharmacy Law Blog|Comments Off on CMS Using Medicare Termination to Squash Doctors Involved in Overprescribing Opioids

Court Rules NY Doctor Can Subpoena Yelp for User Info in Defamation Suit

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

On October 7, 2021, the United States District Court for the Southern District of New York ruled that Yelp is subject to a subpoena to reveal the names of anonymous users who left negative reviews for a doctor and his medical practice. The federal court judge found that the statements in the reviews made on Yelp contained factual claims that the doctor did have a legal right to contest in court. This is a factor that is usually missing in such cases. Accordingly, a motion for expedited discovery filed by the plaintiff physician was granted by the federal judge.

A Litigious History of Lawsuits.

The embattled physician has reportedly filed other lawsuits against reviewers for defamation. The doctor himself says he’s won or reached settlements with three of the negative reviewers, forcing them to take down their “false” reviews and paying an undisclosed amount of money.

Most recently, the physician filed suit in November 2020 against nine anonymous Yelp account-holders. According to the complaint, from November 2019 to August 2020, the users posted several reviews that contained statements that harmed his practice by making untrue and libelous comments.

In the present case we are discussing filed against the Yelp reviewer, the judge found that statements such as the physician “diluted” injectables and deceived patients about pricing to be factual statements. (The physician is apparently one who performs cosmetic procedures on patients like using botox and fillers.) Therefore, if they were false statements, as the physician alleged, this establishes a prima facie claim for defamation that courts have the authority to hear. According to the court’s order: “Because Plaintiff has alleged a prima facie case . . . and they cannot identify John Doe[s] without a court-ordered subpoena, the Court agrees that there is good cause to allow for early discovery.”  Click here to view the court’s opinion on our website.

I see this as a positive occurrence. Too often reviewers on Yelp, Google, Glass Door, and other such websites post egregious comments amounting to character assassination and libel, because they believe they can remain anonymous. And the owners of the websites fight tooth and toenail to avoid any liability and to avoid any co-operation when justice is sought by those harmed by their actions. We have had a number of cases we have handled where a “reviewer” uses a phony name and creates a phony user account just for the purpose of making a libelous, damaging review. Then, if caught, they just create a new phony account and re-post the same thing again. If the major carriers and websites like Yelp, Google, Bing, AOL, and Glass Door, want to remain free of liability, then they should co-operate when a person has to hire a lawyer and pursue legal action in order to obtain justice.

Is This Abusing the Legal System in An Effort to Stifle Free Speech?

Yelp reportedly warns users of the physician’s previous attempts to sue over negative reviews in a “Consumer Alert” pop-up notice on the doctor’s review page. Additionally, it reminds users, “reviewers who share their experiences have a First Amendment right to express their opinions on Yelp.”

Unlike a newspaper or television outlet, Yelp, Google, Glass Door, and other Internet carriers and websites enjoy immunity from liability for what they allow to be posted because of a federal law that protects them. Why are they given such a big advantage over more traditional media outlets? Why should they be?

In a separate lawsuit, a judge denied the effort by the same doctor to reveal the anonymous reviewer who wrote: “Cheap product and he’s absolutely not experienced nor does he care!!!!!” Yelp argued that the review is not defamatory as there is no statement of fact that can be proven true or false. The court agreed and found that the review used a “loose, figurative tone,” suggesting that the author expressed opinions rather than facts based on a negative experience.

Therefore, according to the court, the plaintiff was not able to make “a sufficient showing of prima facie defamation.” Click here to read the judge’s order in full in that case.

I disagree with the court’s ruling, however. Whether or not the physician has any experience is certainly a fact. It can easily be proven or disproven. It seems that if a doctor hung up a sign that said “Absolutely no Experience,” this would be perceived by most reasonable people to be a negative thing. I doubt that many people would be attracted to that doctor or his practice.

Key Takeaway From the Case.

The key takeaway from this case is that contrary to what Yelp’s pop-up notice implies, Yelp’s users have “implicitly agreed” to the release of their personal data if ordered by a court.

To learn more about fighting negative reviews on websites like Yelp as a healthcare professional, click here to read my prior blog.

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, Durable Medical Equipment suppliers, medical students and interns, hospitals, ambulatory surgical centers, pain management clinics, nursing homes, and any other healthcare provider. We represent facilities, individuals, groups, and institutions in contracts, sales, mergers, and acquisitions.

The lawyers of The Health Law Firm are experienced in both formal and informal administrative hearings and in representing physicians in investigations and at Board of Medicine and Board of Osteopathic Medicine hearings. We represent physicians accused of wrongdoing, in patient complaints and in Department of Health investigations.

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

Sources:

Capriel, Jonathan. “Doc Can Subpoena Yelp User Info In Botox Defamation Suit.” Law360. (October 7, 2021). Web.

Marza, Mike. “Manhattan doctor sues over Yelp reviews he says are false.” ABC 7NY. (November 19, 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 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 © 2021 The Health Law Firm. All rights reserved.

 

 

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