U.S. Patients Could See Lower Drug Prices From Normalization Of Business Relations With Cuba

7 Indest-2008-4By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

On October 14, 2016, the Obama administration declared its decision to lift a long-standing restriction on importing Cuban pharmaceuticals into the U.S.  If the policy change is approved by the Food and Drug Administration (FDA), this could bring Cuba’s low-cost, creditable medicines to the United States.  This presents an interesting side effect for the normalization of business relationships that we have not seen examined before.  That is, will patients be able to obtain drugs at the much lower prices that Cuba pays for them by importing them from Cuba?

Benefits Of A Policy Change.

This policy change could allow American researchers the chance to lead joint research with Cuba’s researchers and the opportunity for Cuba’s care-delivery models. These models are known worldwide for their essential care and conveying solid results in spite of their lack of resources.  According to Dr. Pedro Greer, a Cuban-American who is associate dean for community engagement at the Herbert Wertheim College of Medicine at Florida International University, Cuban vaccines are recognized for being high quality.

According to the Cuba Business Report, multiple Cuban drugs have already been approved or trialed in countries like Europe, Asia and Canada. Click here to read the full report.

What Are The Changes?

The Obama administration’s changes would also include legalizing imported Cuban merchandise such as alcohol and cigars. The administration feels that this change would open a world of business, as well as research opportunities, for American manufacturers and academic institutions.  Dr. Greer said that the Cuban biotech industry is mature and ready for a joint venture with a U.S. company or even an academic institute.

Dr. Ross McKinney, chief scientific officer at the Association of American Medical Colleges believes this policy change could be an opportunity to gain knowledge from one of the most cultured healthcare delivery and training programs in Latin America.

Dr. McKinney said, in terms of research, Cuban academics have a lot of knowledge to provide Americans, especially when it comes to vector-borne illness such as the Zika virus.  Dr. McKinney predicts U.S. medical researchers will want to engage in joint clinical trails with Cuba, as they have already done so with Caribbean islands such as Puerto Rico and the Bahamas.

Contact Experienced Health Law Attorneys.

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

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

Sources:
Rubenfire, Adam. “Cuban Pharmaceutical Imports To U.S. Could Lead To Lower Drug Prices. “Vital Signs. (October 26, 2016). Web.

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

KeyWords:  U.S. Food and Drug Administration (FDA), Obama administration lifting ban on Cuban imported pharmaceuticals, The Health Law Firm, Cuban imports of medical products and equipment, complex health care business transaction attorneys, defense of pharmacy and pharmacists attorney, reviews of The Health Law Firm, The Health Law Firm attorney reviews, consumer reports of Cuban medical business, consumers reducing prices of medications, legal representation for pharmaceutical companies, legal representation for FDA investigations, doing business with Cuba legal counsel, legal counsel for research studies, medical research defense attorney, legal opinion on complex medical business transactions, legal opinion on complex health care business transactions

“The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.
Copyright © 2016 The Health Law Firm. All rights reserved.

Pharmacist Pled Guilty To $2.4 Million Prescription Fraud Scheme, Including Using Foreign Drugs

4 Indest-2009-3By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

On November 17, 2016, Walter Beich, an Illinois pharmacist, pled guilty to defrauding Medicare, Medicaid and several private insurers out of $2.4 million by submitting false reimbursement requests for prescriptions he had filled with counterfeit drugs or did not fill at all. Beich faces up to 12 years in prison.

Beich, 63, is the owner of Corwin Pharmacy in Lockport, Illinois. He admitted on Thursday, November 17, 2016, that he was using patients’ names to submit false insurance claims for prescriptions to insurers like Humana, Blue Cross Blue Shield of Illinois, Medicare and several others.

Patient Information Used For Reimbursement.

Prosecutors said that between January 2010 and 2013, Beich used his patients’ information to submit reimbursement claims for drugs like Levaquin, Advair and Abilify. It is reported that more than ten of Beich’s patients received non-FDA-approved, foreign-made drugs instead of the ones they were actually prescribed.

Employees Were Unaware Of The Scheme.

Beich was allegedly able to get his employees to unknowingly falsify pharmacy records by telling them he had received phone-in orders from physicians. According to his plea agreement, only one of Beich’s employees knew what was really going on. To cover this fraud scheme, Beich falsified signature logs and prescriptions.

In some situations, Beich would bill the insures for pricey over-the-counter drugs, knowing that he has actually dispensed things like vitamins, fish oil, or a cheap, foreign-made drug to patients. He would also bill insurers for drugs he gave to his friends and family members who had no prescriptions. He went as far as submitting claims for drugs he had received as samples.

Court Appearance and Sentencing.

Beich appeared in court before the U.S. District Judge Amy St. Eve to plead guilty to two of the 12 counts of his indictment. He entered his plea to one count of health care fraud and one count of identity theft. There is a mandatory minimum sentence of two years that comes with the identity charge, which must be served consecutively following any other sentence Beich receives for the fraud charge. He will be enforced to pay $2.4 million in restitution.

Beich is expected to be sentenced in front of the U.S. District Court Judge John Darrah on March 29, 2017.

Consult With An Attorney Experienced in the Representation of Dentists.

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

The lawyers of The Health Law Firm are experienced in both formal and informal administrative hearings and in representing dentists and dental hygienists and other health professionals in investigations and at Board of dentistry hearings and other legal matters. Call now or visit our website www.TheHealthLawFirm.com.

Sources:

Jones, Diana Novak. “Pharmacist Admits Running $2.4M Prescription Fraud Scheme.” Law360.(November 17, 2016. Web.

“Lockport Pharmacist Accused of $2.4M Health Care Fraud Scheme.” Chicago Sun Times. (May, 26, 2015). Web.

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

KeyWords: Medicare audit defense attorney, Medicaid audit defense lawyer, legal representation for pharmacists, legal representation for pharmacies, pharmacy defense lawyer, Board investigation defense lawyer, Board of Pharmacy defense attorney, Board of Health investigation defense attorney, The Health Law Firm Reviews, New England Compounding Center (NECC), health defense lawyer for pharmacists, The Health Law Firm, reviews of The Health Law Firm, Food and Drug Administration (FDA) defense attorney, Drug Enforcement Administration (DEA) defense counsel, pharmacy audit defense counsel, pharmacy investigation defense lawyer, pharmacist defense attorney, department of health investigation defense counsel, compounding pharmacy defense legal representation, complex litigation attorney

“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 © 2016 The Health Law Firm. All rights reserved.

Does This Drug Make People Irresponsible Zombies?

2 Indest-2009-1By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

The smoking-cessation drug Chantix has come into the spotlight and allegedly played a crucial role in a second violent crime. On August 8, 2016, a Maryland man was reported to have been found not criminally responsible for shooting his wife in their home in 2014 because he was found to be suffering from “involuntary intoxication” due to the drug Chantix. His wife survived.

In 2015, an Army soldier, who brutally stabbed another soldier to death in 2008, won a new hearing because the judge in his original trial refused to let him put on an involuntary intoxication defense. The soldier claimed that he was so neurologically disturbed by the drug Chantix that he was not aware of what he was doing. A military court then reduced his sentence from life without parole to 45 years. Quite the victory!

See my prior blog in which I discuss the hypnotic and mind altering effects of some sleeping medications from both first hand experience and from watching “The Simpsons.” Click here.

Involuntary Intoxication?

The idea of involuntary intoxication is not a new defense, and not every state or court agrees with it as a defense. The defense did not work in Fairfax County, Virginia, where a man who had invaded another lawyer’s home, took the lawyer and his wife hostage and then stabbed and shot them. He later claimed that his prescribed cocktail of pain and psychiatric medications made him involuntarily intoxicated. A jury disagreed, convicted Andrew Schmuhl and sentenced him to two life sentences plus 98 years. He probably wished he could get that one reduced to a mere 45 years!

Walking Zombies?

Pfizer, the maker of the anti-smoking drug Chantix, has denied that the drug has any neuropsychiatric effects that turn people into essentially walking zombies. We really cannot weigh the scientific evidence here and that is not the purpose of this blog, anyway. But McClatchy News Service reported in 2014 that more than 2,000 people had joined in lawsuits against Pfizer for various psychiatric problems, including suicide and suicidal thoughts. Pfizer has reportedly settled most of them for an estimated total of at least $299 million, McClatchy reported.

Pfizer spokesman Steven Danehy said Tuesday, “There is no reliable scientific evidence that Chantix causes serious neuropsychiatric events. In fact, the largest global clinical trial of smoking cessation medications, including varenicline, bupropion and nicotine replacement patch, which was ordered by the FDA and recently published in The Lancet also ‘did not show a significant increase in serious neuropsychiatric adverse events attributable to varenicline compared to placebo and nicotine replacement patch.”

Despite what Pfizer says, the Food and Drug Administration (FDA) issued a “black box” warning on Chantix because of its potential for “serious neuropsychiatric” problems. It is the most serious warning a medication can carry and still be sold.
Of course, we feel that any drug with such properties is one which might possibly be used to instill zombie-like characteristics into normal people. Next thing you know, the government will be using it to create zombie troops who will follow orders to attack and kill without questioning them. I think some police departments may already be doing this!

Contact Experienced Health Law Attorneys.

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

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

Source:

Jackman, Tom. “The stop-smoking pill made me do it’: Man found not criminally responsible for shooting wife.” The Washington Post. (August 9, 2016). 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., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

KeyWords: Involuntary intoxication defense, smoking-cessation drug Chantix, neuropsychiatric adverse side effects, pharmacy defense attorneys, board of pharmacy legal defense attorney attorneys, pharmaceutical class action litigation attorneys, The Health Law Firm reviews, complex health litigation attorneys, medicated walking zombies, reviews for The Health Law Firm Attorneys, Health Providers Service Organization (HPSO) insurance attorney, HPSO legal defense counsel, The Health Law Firm, the ambien effect, zombie lawyers

“The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.
Copyright © 2016 The Health Law Firm. All rights reserved.

Feds Reach Deal With Florida Compounding Pharmacy Owners, Agree to Pay Almost $7.8 Million to Settle FCA Suit

8 Indest-2008-5By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

On September 14, 2016, co-owners of a Maitland, Florida, compounding pharmacy agreed to pay $7.75 million to the federal government to resolve False Claims Act (FCA) allegations. QMedRx reached the settlement in connection with alleged fraudulent billing practices for services that weren’t eligible for reimbursement through federal health care programs, prosecutors said.

The U.S. attorney’s office for the Middle District of Florida sought penalties and fines for Andy Miller, Tracy Miller and the Healthmark Investment Trust, who are partial owners of QMedRx and allegedly participated in the fraud scheme.

“Deceptive” Prescriptions.

According to prosecutors, from January 2013 to January 2014, QMedRx knowingly billed federal health care programs for prescriptions that weren’t qualified for reimbursement. Under the federal Anti-Kickback Statute, the exchange of money or goods for federal health care program referrals is illegal.

“The United States Attorney’s Office is committed to protecting TriCare and other federal health care programs from fraud,” U.S. Attorney A. Lee Bentley III said in a statement. “Those who violate the Anti-Kickback Statute to generate business will be held accountable.”

 

The Federal Government’s Ongoing Battle.

Unfortunately, these types of elaborate fraud schemes have been seen many times before.
For example, this case stemmed from an ongoing investigation to unearth improper claims submitted to the TriCare program, a health care program that provides benefits for United States military personnel.

To read more on this ongoing health care fraud investigation, click here.

At The Health Law Firm, we have experience with FCA, whistle-blower/qui tam cases and allegations, click here to read a press release from one of our cases in 2015.

Consult with a Health Law Attorney Experienced in Medicare and Medicaid Issues Now.

The attorneys of The Health Law Firm represent pharmacies and pharmacists in defending investigations, defending False Claims Act and whistleblower cases, defending against actions by the Drug Enforcement Agency (DEA) and the Department of Health (DOH), and in licensing, regulatory and corporate matters. They also represent health care providers in Medicare audits, ZPIC audits and RAC audits throughout Florida and across the U.S. They also represent physicians, medical groups, nursing homes, home health agencies, pharmacies, hospitals and other healthcare providers and institutions in Medicare and Medicaid investigations, audits, recovery actions and termination from the Medicare or Medicaid Program. They represent companies in buying and selling health care businesses and prepare contracts.

For more information please visit our website at www.TheHealthLawFirm.com or call (407) 331-6620 or (850) 439-1001.

Sources:

Kang, Peter. “Fla. Pharmacy Owners to Pay $7.8M to Settle FCA Suit.” Law360. (September 14, 2016). Web.

Jacobson, Susan. “Feds reach deal on pharmacy fraud case.” Orlando Sentinel. (September 15, 2016). Print.

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

KeyWords: Florida compounding pharmacy defense attorney, False Claims Act (FCA) defense counsel, improper billing practices, knowingly submitting fraudulent claims, federal Anti-Kickback Statute, qui tam whistleblower defense attorney, legal representation for whistleblower and qui tam cases, legal representation for pharmacies, Medicare and Medicaid fraud defense attorney, health care fraud defense lawyer, whistleblower/qui tam attorney, reviews for The Health Law Firm attorneys, The Health Law Firm reviews, The Health Law Firm, Board of Pharmacy attorney, Department of Health (DOH) defense lawyer, Drug Enforcement Administration (DEA) defense counsel, Food and Drug Administration (FDA) defense lawyer

“The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999. Copyright © 2016 The Health Law Firm. All rights reserved.

New Florida Rules Shorten Required Hours For Community Pharmacies and Change Start of Business Requirements

6 Indest-2008-3By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

The Florida Board of Pharmacy (BOP) amended its rules regarding community pharmacies following a request for relief by industry health care professionals. The amended rules include shortening community pharmacy hours of operation from 40 to 20 hours per week, pharmacy delays to open business after the receipt of a permit and changes regarding ownership. Rules promulgated by The Florida BOP are published in the Florida Administrative Code (FAC).

Community Pharmacies May Delay Opening After Application is Approved.

The rule changes allow community pharmacies to delay the opening of business after receipt of the pharmacy permit. The BOP acknowledged that a delay may exist between the time a pharmacy receives a permit and when the pharmacy commences operations. For example, the delay in receiving the Drug Enforcement Administration (DEA) registration would make it difficult to structure an asset purchase. Ordinarily the pharmacy would have to obtain a new pharmacy permit and then obtain its DEA registration in an asset purchase transaction. Once the pharmacy permit has been received under prior rules, the pharmacy had to start operations (then 40 hours a week), but could not dispense controlled substances or obtain insurance contracts without the DEA registration.

Under the new rules, the BOP must be given notice (within 15 days) if the pharmacy is delaying its opening and give its reason. When it does open for business, the Board must be notified within two days. If the permittee delays commencement of operations, it must:

Display a sign in block letters not less than one inch in height at the main entrance of the establishment stating that the pharmacy is not yet open for business and that medicinal drugs may not be dispensed or sold nor prescriptions filled or dispensed; and

Within two business days of commencement of operations the permittee must notify the Board in writing that the permittee has commenced to operate and the date of such commencement.

Additionally, it is important to know that any pharmacy which does not commence operations within six months of the date of receipt of its permit, must provide a written statement to the Board that includes the reason(s) that the pharmacy has failed to commence operations, the efforts the pharmacy has made to commence to operate, the exact date the pharmacy expects to commence operations.

Changes in Ownership.

The BOP also amended the rules regarding changes of ownership and clarified that transfers of ownership in business entities (i.e., a corporation, limited liability company, limited partnership, etc.) holding pharmacy permits do not constitute “changes of ownership” when such entity continues to hold the permit without change in identity (purchase of stock or membership interests for example). Upon the transfer of ownership interests in the business entity, the following steps must also be taken:

Within fifteen days of closing the transfer, the permittee must notify the BOP of the transfer of ownership; and

All persons, members, partners, officers, directors, and agents having an ownership or other financial interest of greater than five percent and all persons who directly or indirectly manage, oversee, or control the operation of the business entity must file their fingerprints with the BOP.

The rule amendments, especially the reduction in community pharmacy operating hours from 40 per week to 20 per week, may give pharmacies the leeway for new opportunities and to try new business ventures, without incurring the expense of having to pay a full-time pharmacist.

Whether opening a new establishment, changing locations or changing owners, it is important to be aware of the licensing requirements and rules, process, fees and statutes.

A pharmacy permit is required prior to operating in the State of Florida. To learn about the changes and important information on obtaining a community pharmacy permit, click here to visit the Florida Board of Pharmacy.

To learn more on how we can help you or your practice if such a situation arises, click here to read one of my prior blogs.

Consult With A Health Law Attorney Experienced in the Representation of Pharmacists and Pharmacies.

We routinely provide deposition coverage to pharmacists, pharmacies and other health professionals being deposed in criminal cases, negligence cases, civil cases or disciplinary cases involving other health professionals.

The lawyers of The Health Law Firm are experienced in both formal and informal administrative hearings and in representing physicians, physician assistants and other health professionals in investigations and at Board of Pharmacy hearings. Call now or visit our website www.TheHealthLawFirm.com.

Source:

Akerman LLP. “The Board of Pharmacy’s 40 Hour Rule is Dead! Long live the 20 Hour Rule! Community Pharmacy Ownership Rule Change Creates new Opportunities.” Lexology. (August 30, 2016). 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., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

KeyWords: The Florida Board of Pharmacy (BOP) attorneys, pharmacy hours of operation, reduced daily operating hours for pharmacies, community pharmacies may delay opening of business after receipt of permit, Drug Enforcement Administration (DEA) registration lawyers, community pharmacy permit, legal representation of pharmacies and pharmacists, pharmacy and pharmacist defense attorney, The Health Law Firm attorney reviews, reviews of The Health Law Firm attorneys, The Health Law Firm, pharmacy law attorney, change in ownership application

“The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.
Copyright © 2016 The Health Law Firm. All rights reserved.

 

Health Care Providers: PLEASE Talk to an Attorney Before You Talk to an Investigator!

5 Indest-2008-2By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

At The Health Law firm, we often receive calls from new clients and from potential clients, after they have already spoken to and made critical harmful admissions against their own interests to investigators. It is imperative to know that in Florida, you do not have any duty to cooperate with any investigator who is investigating you. This extends to Department of Health (DOH) investigators (who are sometimes titled “Medical Quality Assurance Investigators” or “Medical Malpractice Investigators”), Drug Enforcement Administration (DEA) special agents, police officers, sheriff’s deputies, or criminal investigators of any type.

If you are being investigated, you will NOT be better off making a statement. You will NOT be better off explaining your side of the story. The investigator is NOT your friend. The investigator is NOT on your side.

You have a right under the U.S. Constitution to not make any statement that may be used against you. This is so important that in criminal cases government investigators are required to advise you of this by reciting to you your Miranda rights. To learn more about your Miranda rights, click here to read one of our prior blogs.

Know Your Rights.

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

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

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

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

You Cannot Talk Your Way Out Of It.

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

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

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

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

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

Hint: If it is a Department of Health Quality Assurance Investigator or Medical Malpractice Investigator, they are probably only investigating possible disciplinary action against your license that could result in large administrative fines or revocation of your license.
Do not believe for a second that you are smarter than the investigator. Do not believe for a second that you will convince the investigator (or anyone else) that there is a legal or medical justification for what you did or what they allege. If it were as simple as that, then why would there be an investigation and why would you be the one being investigated?

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

Keep Silent.

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

Far too often the health professional only calls us after he has given a statement. This is usually too late to avoid much of the damage that will have been be caused. Everything above applies to oral statements or written statements. Do not make either. Contact a lawyer as soon as possible, preferably before making any statement, no matter how simple, defensive, self-serving or innocuous you may think it to be.

Contact Health Law Attorneys Experienced in Representing Health Care Professionals in Criminal Matters and Professional Licensing Matters.

If you have been arrested, it is strongly recommended that you retain an experienced attorney who can advise you on the criminal proceeding, your rights and how it may affect you. Most important to a physician, dentist, nurse, pharmacist or other health professional are what consequences may follow this. Consequences may include loss or suspension of hospital privileges, loss or suspension of your professional license, exclusion from the Medicare Program, termination from the state Medicaid Program, termination from health care insurance panels and other severe consequences.

The attorneys of The Health Law Firm routinely represent physicians, pharmacists, nurses, and other healthcare practitioners in criminal defense matters. We frequently consult with criminal defense attorneys regarding defense strategies tailored to minimizing criminal sanctions while preserving the practitioner’s license.

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

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

KeyWords: Right to remain silent, Miranda rights, criminal law defense attorney, health care investigations, investigations against health care professionals, The Department of Health (DOH) investigations, Medical Quality Assurance Investigators, Drug Enforcement Administration (DEA) investigations, medical malpractice investigators, disciplinary actions against health care professionals, health care license defense attorney, physician criminal charges, health attorney, criminal trial, criminal case defense lawyer, Fifth Amendment, plead the Fifth, administrative sanctions, administrative law judges, administrative hearing, administrative trial, administrative proceedings, The Health Law Firm

“The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.

Copyright © 2016 The Health Law Firm. All rights reserved.

Seventh Circuit Court of Appeals Declines Kmart’s Bid to Toss False Claims Act Suit

PS 3 Indest-2009-2By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

On May 27, 2016, the U.S. Seventh Circuit Court of Appeals rejected Kmart Corporation’s arguments in a False Claims Act (FCA) suit in Illinois. The court ruled against Kmart in the whistleblower action.  Kmart was arguing that the prices it charged through its generic drug discount programs should not be counted in determining what its “usual and customary” prices were for purposes of Medicare Part D reimbursement.

What is the “General Public?”

The appeals court in this case held that the “general public” included customers in its discount programs, which were not selective and had “almost nonexistent” barriers to join.

“Regulations related to ‘usual and customary’ price should be read to ensure that where the pharmacy regularly offers a price to its cash purchasers of a particular drug, Medicare Part D receives the benefit of that deal,” the appeals court said.

The Whistleblower.

The decision affirmed the U.S. District Court’s denial of Kmart’s bid for summary judgment in a July 2008 qui tam suit. The relator, James Garbe, a pharmacist previously working for Kmart,  alleged that Kmart submitted inflated bills to federal and state programs participating in Medicare Part D.  He alleged it did this while charging cash-paying customers far less for prescription drugs through its so-called retail maintenance program.  Medicare has a “most favored nations” requirement for its drug suppliers.  Under Medicare regulations Kmart is supposed to give the Medicare Program the lowest prices.  If it actually gives cash paying customers a lower price, then, DUH! it violates those regulations.  To read more on this, click here.

Fraud Enforcement and Recovery Act.

Much of the panel’s ruling hinged on the application of the Fraud Enforcement and Recovery Act (FERA), a 2009 amendment to the FCA that relaxed the requirement that a false claim be presented to “an officer or employee of the United States government or a member of the Armed Forces of the United States” in favor of the requirement a “false record or statement” be “material to a false or fraudulent claim.”

The Seventh Circuit said the whistleblower had sufficiently alleged that for any FCA claims pending on or after June 7, 2008 — FERA’s effective date of retroactivity — he could rely on the amendment to carry his FCA suit safely past the summary judgment stage.

“FERA had the effect of bringing within the FCA’s ambit false claims to intermediaries or other private entities that either implement government programs or use government funds,” wrote Circuit Judge Diane P. Wood for the panel. “There is little doubt that much of the money paid to Kmart under Medicare Part D came from government coffers.”

The Conclusion.

According to the appeals court, the relator successfully alleged that to the extent Kmart made false claims, they were material because those claims were the basis of the federal monies it received.

Lastly, the appeals court held Kmart’s lowest prices for which its drugs were widely and consistently available to the general public through its discount programs should have been counted in its calculation of usual and customary prices for the drugs. To read the court’s appeal in its entirety, click here.

Contact Health Law Attorneys Experienced with Health Care Fraud and Qui Tam or Whistleblower Cases.

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

Attorneys with The Health Law Firm also represent health care professionals and others who may desire to file a qui tam, False Claims Act or whistleblower suit. We work with physicians, nurses and other professionals to investigate, document and file such cases. We have developed relationships with recognized experts in health care accounting, health care financing, utilization review, medical review, filling, coding and other services that assist us in such matters. We have represented number of doctors and other licensed health professionals as relators in bringing qui tam or whistleblower cases. Our attorneys are also available to defend physicians, medical groups and health care providers in qui tam or whistleblower cases.

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

Sources:

“Seventh Circuit Rules Against Kmart in Whistleblower Action.” AHLA. (May 27, 2016). Web.

Suevon, Lee. “7th Circ. Allows Kmart FCA Suit Over Medicare Payments.” Law360. (June 2, 2016). 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., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

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