Category Archives: Health care Law

A Prescription for Love Fraud

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

In May of 2015, Tricare began screening all compound medication prescriptions to ensure approval of each ingredient with the Food and Drug Administration (FDA). This decision came after a finding of a significant increase in compound drug prescriptions reimbursed by Tricare over the last year.

In April 2015, just four months into the fiscal year, it was already determined that total costs for compound drug prescriptions filled for Tricare recipients were likely to come close to $1 billion. If the trend continues, the Defense Health Agency expects it may need to reallocate funds at the end of this year to cover the prescription drug benefit, which is currently set at $8.25 billion.

For more on this new screening process and its effect on compound medication prescriptions, click here.

With prescription drug costs at an all-time high, the government is cracking down on health care fraud. This includes the implementation of data mining for fraud detection and prevention.

It was during one of these routine mining expeditions of reimbursement data that the United States Attorney’s Office identified MediMix, a compounding pharmacy in Jacksonville, Florida, as the top-biller of compounding pain prescriptions. More importantly, upon further investigation, it was found that Ankit Desai, M.D. was the top referring physician for MediMix.

The significance in the correlation between the two is that, according to reports, Dr. Desai happens to be married to one of the top executives (Senior Vice President) of Medimix.

To read the press release on this story, click here.

When Marriage and Money Clash.

Health care providers are generally prohibited from referring patients to another medical-related business in which they hold a financial interest of some kind, if there are payments made with federal funds.

The prohibition on certain physician referrals is established under Section 1395nn, 42 United States Code (otherwise known as the Stark Law). The Stark Law states in pertinent part:

“…if a physician (or an immediate family member of such physician) has a financial relationship with an entity specified in paragraph (2), then–

(A) the physician may not make a referral to the entity for the furnishing of designated health services for which payment otherwise may be made under this subchapter, and

(B) the entity may not present or cause to be presented a claim under this subchapter or bill to any individual, third party payor, or other entity for designated health services furnished pursuant to a referral prohibited under subparagraph (A).” Section 1395nn (a)(1)(A)(B), 42 United States Code.

Paragraph (2) of Section 1395nn (a), 42 United States Code, defines “a financial relationship of a physician (or an immediate family member of such physician) with an entity specified in this paragraph” as:

(A) except as provided in subsections (c) and (d) of this section, an ownership or investment interest in the entity, or

(B) except as provided in subsection (e) of this section, a compensation arrangement (as defined in subsection (h)(1) of this section) between the physician (or an immediate family member of such physician) and the entity.

An ownership or investment interest described in subparagraph (A) may be through equity, debt, or other means and includes an interest in an entity that holds an ownership or investment interest in any entity providing the designated health service.” Section 1395nn (a)(2)(A)(B), 42 United States Code.

The Stark Law was specifically enacted to place limitations on physician referrals so as to avoid:

(1) conflicts of interests;

(2) self-referrals;

(3) overutilization of services;

(4) increased health care costs;

(5) a limit on competition by other medical providers;

(6) to prevent ineffective and unsafe treatment; and, ultimately-

(7) fraudulent practices.

Click here for more information on the most common Federal fraud and abuse laws in health care.

 

Tricare Regulations Similar to Stark and Anti-Kickback Regulations.

In support of its position, the United States Attorney’s Office relied on Section 199.9, 32 Code of Federal Regulations, which provides “administrative remedies for fraud, abuse, and conflict of interest.” More specifically, Section 199.9(c)(12) defines fraud as:

“Arrangements by providers with employees, independent contractors, suppliers, or others which appear to be designed primarily to overcharge the [Tricare program] through various means (such as commissions, fee-splitting, and kickbacks) used to divert or conceal improper or unnecessary costs or profits.”

Furthermore, due to the application of this more open-ended regulation, whistleblowers that may come forward as a result of the allegations made in this False Claims Act (FCA) case, may be granted more latitude in making arguments. Alternatively, under the Stark Law, the same arguments might have been moot as a result of its explicit exceptions not found in Tricare regulations.

We’ll Call it the Honeymoon Fund.

MediMix reached a settlement agreement with the government which has avoided a determination of liability. However, the Jacksonville-based compounding pharmacy did not get off without a significant penalty. The settlement will cost MediMix an impressive $3,775,458.

Click here to read more about the government cracking down on what they determine to be “a significant threat to the [Department of Defense] DoD healthcare system.”

Avoiding the”Dog House.”

The FCA has been highly effective in exposing fraudulent practices of pharmaceutical companies. Whistleblower cases brought under the FCA have assisted the government in recovering more than $19 billion in stolen funds due to varying pricing, billing and marketing schemes.

Here are the most common pharmaceutical practices that may land you in the “dog house” for a FCA violation:

(1) Off-label marketing of drugs;

(2) Illegal kickbacks;

(3) Inflating the price of pharmaceuticals;

(4) Best price fraud; and

(5) Pharmaceutical benefits manager fraud.

Click here to read more information about these common pharmaceutical schemes and how to identify and consequently avoid them.

If you find yourself in a tricky situation with possible allegations of a FCA violation, it’s best to contact an experienced health attorney immediately to properly evaluate your case and inform you of your rights.

For more about your right to consult with a lawyer prior to speaking with an investigator, please read one of our previous blogs here.

Comments?
Are you currently engaged in a questionable financial relationship? Do you agree with the law on prohibiting certain referrals in which there is a financial interest? Why or why not?

Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.

The Health Law Firm represents pharmacists and pharmacies in DEA, DOH and FDA investigations, qui tam and whistleblower cases, regulatory matters, licensing issues, litigation, administrative hearings, inspections and audits. The firm’s 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.


Sources:

Department of Justice, The United States Attorney’s Office, Middle District of Florida. Press release. “United States Settles False Claims Act Allegations Against Jacksonville-Based Compounding Pharmacy.” 1 June 2015. Web. 11 Sept. 2015.

Kime, Patricia. “Tricare to Start Screening Compound Medications Friday.” Military Times. A TEGNA Co., 1 May 2015. Web. 10 Sept. 2015.

“Pharmaceutical Fraud” Web blog post. False Claims Act Resource Center. Pietragallo Gordon Alfano Bosick & Raspanti, LLP, 2015. Web. 11 Sept. 2015.

Rumph, Alan, and Donna Lee Yesner. “When Referrals And Marriage Don’T Mix: MD, Pharmacy Settle Case.” Report on Medicare Compliance. Washington: Atlantic Information Services, Inc., 8 June 2015. Web. 11 Sept. 2015.

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: False Claims Act defense attorney, FCA, pharmaceutical fraud, compounding pharmacy attorney, fraudulent practices of pharmaceutical companies, whistleblowers lawyer, FCA violations, fraud detection, data mining, financial interest in physician referrals, Stark Law, Department of Defense, DoD, Tricare fraud attorney, health attorney, defense attorney, The Health Law Firm, health law firm, fraud investigations, conflict of interest in physician referrals, compound medication prescriptions, compounding pharmacy lawyer, prescription reimbursement, qui tam attorney, financial relationship with physician

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“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 © 1996-2015 The Health Law Firm. All rights reserved.

Chinese Nationals Indicted in Alleged U.S. Test-Taking Scheme

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

Fifteen Chinese citizens living in the United States reportedly conspired to take college entrance exams for others so they could obtain student visas, according to the Associated Press. The frauds allegedly took standardized exams including the Scholastic Aptitude Test (SAT), the Graduate Record Examination (GRE), and the Test of English as a Foreign Language (TOEFL).

The Test-Taking Conspiracy.

According to BBC News, the scheme reportedly took place between 2011 and 2015, mainly in western Pennsylvania. Six individuals named in the indictment were identified as students who supposedly paid up to $6,000 to have other individuals, also charged, take the tests. The test-takers purportedly “impersonated others, and those others were able to use the fraudulent test scores to obtain F1 visas,” U.S. Attorney for the Western District of Pennsylvania David Hickton told the Associated Press. The individuals allegedly used fake passports that contained the students’ personal information, but a picture of the test-taker substituted for the student.

Testing Services Cooperate with the Investigation.

Princeton, New Jersey-based Educational Testing Service and the New York-based College Board are cooperating with the investigation, according to Hickton. “Their actions are consistent with the College Board’s commitment to identify and stop illegal activity that undermines the integrity of our exams and the hard work of students around the world,” College Board vice president Stacy Caldwell told the Associated Press. Educational Testing Service administers the SAT, GRE, and TOEFL exams, while the College Board oversees SAT registration.

Offenders Expected to Receive More Than Just a Slap on the Wrist.

The charges against the suspects include conspiracy, counterfeiting passports, mail and wire fraud, BBC News reported. The defendants, both male and female ranging in age from 19 to 26, could face up to 20 years in prison if convicted. According to BBC’s report, Special Agent in Charge of Homeland Security Investigations of Philadelphia John Kelleghan believes “these students were not only cheating their way into the university, they were also cheating their way through our nation’s immigration system.”

Due to the ongoing investigation, a final number has not yet been released documenting an exact number of suspects believed to be involved in the ruse.

Is There Similar Activity Going On in Medical Testing for NBME, USMLE or ECFMG Administered Tests?

There have been somewhat similar alleged test-taking fraudulent activities involving medical testing. From time to time we are consulted by individuals who have been caught using fraudulent documents to attempt to take the USMLE Step exams. We are also aware of allegations that there have been compromises of actual examinations involving foreign nationals. For example, see the blog I wrote on the Optima scandal.

On the whole, the NBME, USMLE, and ECFMG and their testing centers do an excellent job in screening out fraudulent test takers. It would be foolish for anyone who ever hoped to be a practicing physician to try to perpetrate a fraud in taking these tests.

Comments?

What are your thoughts on these allegations? Do you feel standardized testing should be monitored more heavily to prevent test-taking fraud from occurring? Please leave any thoughtful comments below.

Contact Experienced Health Law Attorneys.

The attorneys of The Health Law Firm provide legal representation to medical, dental, chiropractic, other professional students, residents, interns and fellows in academic disputes, contract negotiations, license applications, board certification applications and hearings, credential hearings, and civil and administrative litigations.

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

Sources:

“Chinese Nationals Accused of Taking SATs for Others.” BBC News. (May 28 2015). From:

http://www.bbc.com/news/world-us-canada-32921737

Mandak, Joe. “Feds Indict 15 Chinese in Alleged College Test-Taking Scheme.” The Associated Press. (May 28, 2015). From:

http://abcnews.go.com/US/wireStory/feds-indict-15-chinese-alleged-college-test-taking-31366456

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: medical students, standardized tests, irregular behavior, fraud, defense attorney, legal representation, criminal proceeding, administrative law, health law, health care attorney, health care lawyer, defense lawyer, GME, graduate medical education, Step exams, medical interns, medical residents, ECFMG lawyer, USMLE attorney, foreign medical graduate attorney, legal counsel, legal advocate

“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 © 1996-2015 The Health Law Firm. All rights reserved.