Miami Medicare Fraud Fugitive Returns After Hiding in Cuba

6 Indest-2008-3By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law
On Friday, a Miami pharmacy owner charged in a Medicare fraud scheme, surrendered to U.S. authorities after hiding in Cuba for over two years. Sandy De La Fe, was charged in 2013 with unlawfully pocketing $2.8 million in taxpayer-funded Medicare payments through his former business Goldenway Pharmacy Discount.

False Claims for Prescription Drugs.

According to the indictment, De La Fe submitted false claims for prescription drugs by using Medicare beneficiaries’ ID numbers. He also forged doctors’ signatures for medication that was either unnecessary or not provided at all. The scheme ran between 2011 and 2013, and according to the U.S. Attorney, is hardly unique. The U.S. Attorney’s Office has increasingly made cases against South Florida Pharmacy offenders who steal from the Medicare Part D drug program. To read a previous blog I wrote on the fraud and abuse plaguing the Medicare Part D program, click here.

Goldenway Pharmacy Discount Scheme.

De La Fe is also charged with conspiring with his business associates Jose Teijeiro and Michael Gonzalez Cabral, to pay recruiters to bring in Medicare beneficiaries. Both business associates have already plead guilty to fraud charges and are serving nine-year and five-year jail sentences. De La Fe had his first court appearance on Monday, since turning himself in. The prosecutor in the case plans to recommend no bail, arguing the defendant is a flight risk. Click here to read a previous blog I wrote on a similar case of Medicare fraud.

Voluntary Surrender.

In the case of Medicare fraud and fugitives, an estimated 150 South Florida defendants are at large in Cuba, Mexico and other countries. Normally, fugitives are stopped on federal arrest warrants or upon trying to enter the United States. A defendant voluntarily surrendering is highly unusual in cases like this. Apparently, De La Fe didn’t like life on the lam, and sources say that he missed his young son whom he left behind in the states.

De la Fe purchased his own plane ticket to Miami International Airport, where U.S. Marshall’s apprehended him.

Is Cuba No Longer a Safe Haven for Medicare Thieves?

We have defended physicians and other health professionals who have had their Medicare numbers and identities stolen by those seeking to use them to submit false bills to Medicare. Often in such cases, at least here in Florida, the perpetrator of such crimes has fled with the illegal proceeds. We suspect, in many cases, that they have gone to Cuba. With the relaxation of the relationship between the U.S. and Cuba, this may mean that Cuba is no longer a safe haven for such criminals. It is yet to be seen whether Cuba is likely to allow the extradition of such criminals or cooperate with government officials in the return of stolen funds. However, such may well be the case.

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

The attorneys of The Health Law Firm represent healthcare 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.

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

Comments?

As a pharmacy owner, pharmacy employee or health care facility owner, what do you think of the increased effort to find fraud? Do you think all facilities, not just pharmacies, are under the microscope? Please leave any thoughtful comments below.

Sources:

“Miami Pharmacy Owner Charged in Medicare Fraud Scheme Returns After Hiding in Cuba.” AHLA. (January 14, 2016). Web.

Weaver, Jay. “Miami Medicare-fraud fugitive returns from Cuba.” Miami Herald. (January 14, 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: Medicare fraud, Centers for Medicare and Medicaid Services (CMS), pharmacy, Florida pharmacy investigation, false claims, Office of Inspector General (OIG), Department of Health (DOH), U.S. Department of Health and Human Services (HHS), pharmacy raid, defense attorney, defense lawyer, pharmacist defense, Medicare fraud defense lawyer, Legal counsel for pharmacists, Goldenway Pharmacy Discount, Florida pharmacy defense attorney, Florida health care attorney, Florida health care 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 © 1996-2016 The Health Law Firm. All rights reserved.

FDA’s Agenda for 2016: Biggest Issues on Agency’s Calendar for the New Year

PS 4 Indest-2009-3By: George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law
The Food and Drug Administration (FDA) has great influence on a vast array of issues impacting the medical industry in the U.S. The decisions it makes in 2016 will have a significant impact for health care providers and on the lives of many Americans. Here is a look at the top issues on the agency’s agenda in 2016.

Reigning in E-Cigarettes.

The use and health of electronic cigarettes (e-cigarettes) have been hot topics between Americans for years and big changes are on the way in 2016. The FDA’s proposal for 2016 will grant the agency permission to oversee e-cigarettes. The proposal, called the “deeming rule,” will give the agency authority to regulate and require pre-market reviews for e-cigarettes. This process will be used to determine which products are safe and which could be potentially dangerous to consumers.

In addition, the FDA seeks to ban e-cigarette sales to minors and require all packages to have a warning label stating that the product contains nicotine. To read more on the FDA’s regulations on e-cigarettes and other tobacco products, click here.

Regulating Drug Marketing and Advertising.

Until recently, drug manufacturers were required to prove that their products were safe and effective before they could be marketed or advertised to treat a specific ailment. Off-label prescribing is nothing new in this industry, but companies are usually careful not to encourage unapproved uses.

Recently, a significant case involving Amarin Pharma Inc., and the availability of information for unapproved uses, caused the FDA to revamp its rules. In this case, Amarin Pharma Inc. won an injunction against the FDA’s ban on off-label marketing. To read our previous blog on this case, click here.

Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, wrote that the agency’s front-burner priorities for 2016 included reevaluating regulations for drug advertising and promotion. To read further on off-label marketing, click here.

The Backlog of Generic Drugs.

Escalating drug prices have become a serious drain on consumers’ wallets and lawmakers are looking to generic drugs as an alternative. Currently, about 4,300 applications for generic drugs are waiting approval or rejection by the FDA. The FDA blames drug manufacturers for careless and incomplete applications that slow the process, but the availability of generic drugs to the consumer is the bottom line.

Sometimes referred to as copycat drugs, generic brand drugs are between 30 and 80 percent cheaper than brand-name drugs. Generic drugs account for 88 percent of all prescriptions in the United States, but only 28 percent of the cost, according to the Generic Pharmaceutical Association.

In the year 2016, the FDA looks to finalize a rule that would permit generic drug companies to update labels with important safety information without prior FDA approval. This rule however, comes with a catch: increased liability in the case of safety problems. To read more on this problem from the American Pharmacists Association, click here.

Fees for Services.

While the FDA is charged with regulating drug manufacturers, it also relies on these companies for its continued operation. It charges fee to companies that manufacture generic drugs in order to offset the costs of regulating them and fees for other aspects of its operations.

Congress approved several important measures for 2016, which require reauthorization every five years. First, the Prescription Drug User Fee Act (PDUFA), authorizes the FDA to collect money from companies that produce certain human drug products. These measures have been enacted to force manufacturers to pay fees to offset the costs of regulating generic drugs.

As part of these new measures, the FDA has agreed to certain performance goals. These goals include: increased patient participation in drug development and review, expansion of the FDA’s Sentinel program to strengthen oversight of post-marketing safety, and the ability to use funds to hire and retain top talent.

New Year, New Decisions.

Not only does the FDA face several significant decisions in 2016 that greatly impact the lives of many Americans, but the industry is pushing for “real-world” evidence outside of clinical trials. The FDA has jurisdiction over some 20 to 25 cents out of every consumer dollar. In short, the decisions the FDA makes matter, big time.

Comments?

What are your thoughts on the FDA’s biggest issues in 2016? Do you agree with the tactics the FDA is using to tackle these issues? Is there an important issue that you think should be added?

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 and visit our website at www.TheHealthLawFirm.com.

Sources:

Kaplan, Sheila. “E-cigarettes. Generic Drugs. A guide to the FDA in 2016.” STAT. (January 4, 2016). Web.

U.S. Food and Drug Administration. “Electronic Cigarettes (e-Cigarettes).” Public Health Focus. (January 10, 2016). Web.

Kaplan. Sheila. “Backlog of unapproved generic drugs helps boost drug prices.” STAT. (December 29, 2015). 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: Food and Drug Administration (FDA), FDA guide for 2016, FDA significant decisions in 2016, crackdown on electronic cigarettes (e-cigarettes), “deeming rule”, drug advertising and promotion, off-label prescribing, drug advertising and promotion of off-label use, backlog of generic drugs, approval of generic drugs, reauthorization of the Prescription Drug User Fee Act (PDUFA), pharmacist defense attorney, The Health Law Firm, health law firm, pharmaceutical company lawyer, pharmacy defense attorney, legal representation for pharmacists, health law attorney

“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 © 1996-2016 The Health Law Firm. All rights reserved.

2015 Proved to Be a Good Year in Medicine as FDA Approvals of First-Of-A-Kind Drugs Continued to Escalate

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

It’s been 19 years since anyone has seen the approval of more first-of-a-kind drugs by the U.S. Food and Drug Administration (FDA).  2015 proved to be a year of satisfactory innovation for medicine.  With the approval of 45 drugs formulated with never-before-sold ingredients, the FDA came close to surpassing its previous all-time record of 53 first-of-a-kind drug approvals in 1996.

The increase in newly formulated drugs is a reflection of the industry’s shift in focus to a greater availability of treatments for rare and hard-to-treat diseases.  This expansion is also a good indicator of the government’s acquired efficiency in reviewing new therapies and heightened scientific understanding of diseases that once eluded the medical community.

However, such progress is not without its challenges.  The increased specialty drug approvals may be a further catalyst in the ongoing political debate over rising prescription drug costs.  Furthermore, most pharmaceutical companies still struggle with timely research and development (R&D) turnarounds, sufficient returns on investment (ROI), and effective marketing launches for new drugs competing with their more affordable generic counterparts.

For a full listing of the FDA’s press announcements for first-of-a-kind drugs approved in 2015, click here.

As Innovation Rises So Do Prescription Drug Costs.

Innovative new drugs for rare and hard-to-treat diseases often come with problems of their own that need curing.  In addition to streamlined reviews and extra patent protections, one of the inconveniences attributed to innovation in medicine is the higher price tag associated with the up-and-coming prescription drugs.  This issue has created such a stir among the pharmaceutical industry and consumers alike that it is even a hot topic in the current presidential campaign.  Some candidates have even proffered outlined proposals meant to bridle the rising costs.

Presently, the FDA is restricted from considering prices during the drug approval process.  This results in the anonymous approval of drugs carrying a price tag in excess of hundreds of thousands of dollars for a year’s supply.  One of the most expensive drug approvals of 2015, was Vertex Pharmaceuticals’ Orkambi, formulated to treat cystic fibrosis and costing $259,000 annually.

Pharmaceutical Industry Faces Its Own Cost-Related Difficulties.

Whether or not the running price for improved lung function is set at $259,000, is perhaps debatable.  However, it is known that big pharmaceutical companies can spend billions of dollars each year on R&D and struggle to obtain a decent ROI.  Several factors contribute to a lackluster ROI for drug makers.

The time it takes to research and develop one new drug averages 14 years.  This is an increase from past projections of 11 years in the 1990s.  This escalation in turnaround time is due to more complex drug trials and health insurers’ requests for increased data stores.

Furthermore, new medicines frequently possess dismal sales forecasts.  Additionally, they are pitched alongside a growing list of their cheaper generic formulations.

Still, It’s Not All Bad.

It was reported by Reuters and The Associated Press (AP), that the trend in heightened innovation in medicine will continue in 2016.  AP reported that “IMS Health predicts 225 new drugs will be approved worldwide between 2016 and 2020.”  Furthermore, Reuters publicized analysts’ belief that 2016 will also bring “further advances in cancer treatments […] and significant progress in drugs for autoimmune diseases.”

That’s certainly good news for the pharmaceutical industry and medical community alike as we enter a new year!

Comments?

What are your thoughts on the increased FDA approvals of first-of-a-kind drugs?  Are you excited about the prospect of further advancements in medicine in 2016?

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 and visit our website at www.TheHealthLawFirm.com.

Sources:

Hirschler, Ben.  “Drug Approvals at 19-Year High Belie Industry Challenges.”  Reuters: 4 Jan. 2015.  Web.  5 Jan. 2015.

Perrone, Matthew.  “First-Of-A-Kind Drug Approvals Continued Rise in 2015.”  The Associated Press: 4 Jan. 2016.  Web.  5 Jan. 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: research and clinical trials defense lawyer, health attorney, pharmacist defense attorney, The Health Law Firm, health law firm, Food and Drug Administration (FDA) drug approvals, pharmaceutical company lawyer, pharmacy defense attorney, legal representation for pharmacists, research and development in pharmaceutical industry, FDA approval of first-of-a-kind drugs, innovation in pharmaceutical industry

“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 © 1996-2016 The Health Law Firm. All rights reserved.

OIG Issues Favorable Advisory Opinion 15-14 Involving 501(c)(3) Charitable Organization Funded by Pharmaceutical Manufacturers

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

A nonprofit organization (Requestor) requested an advisory opinion from the Office of the Inspector General (OIG).  The organization is dedicated to helping financially needy patients, including those covered by Medicare and Medicaid, with a single disease state (Disease State) obtain magnetic resonance imaging (MRI) (altogether, “Arrangement”).  Specifically, the Requestor sought the OIG’s opinion as to the legality of its funding for the Arrangement.

The Arrangement is funded by persons and corporations, primarily pharmaceutical manufacturers, as well as foundations and other entities.  The Requestor asked the OIG whether the Arrangement constituted violations of any of the following:

(a)    the civil monetary penalty provision of the Social Security Act (Act) prohibiting inducements to beneficiaries at section 1128(a)(5);

(b)    the exclusion authority of the Act at section 1128(b)(7); or

(c)    the civil monetary penalty provision at section 1128A(a)(7) of the Act

as each of those sections relate to section 1128B(b) of the Act, otherwise known as the federal Anti-Kickback Statute (AKS).

The OIG issued a favorable opinion on November 13, 2015, Advisory Opinion 15-14, concluding that the Arrangement does not constitute grounds for the imposition of civil monetary penalties and that it would not impose sanctions in connection with the AKS with respect to the Arrangement.

OIG’s Analysis of the Arrangement.

In its analysis of the Arrangement, the OIG noted its longstanding guidance permitting stakeholders to contribute to the health care safety net for financially needy patients.  This guidance is inclusive of federal health care program beneficiaries.  OIG’s Supplemental Special Advisory Bulletin on Independent Charity Patient Assistance Programs states “that pharmaceutical manufacturers can effectively contribute to the safety net by making cash donations to independent, bona fide charitable assistance programs.”  It states further, “…we recognize that bona fide independent charities may reasonably focus their efforts on patients with particular diseases (such as cancer or diabetes) and that, in general, the fact that a pharmaceutical manufacturer’s donations to an independent charity are earmarked for one or more broad disease funds should not significantly raise the risk of abuse.”

To read the full OIG’s Supplemental Special Advisory Bulletin on Independent Charity Patient Assistance Programs, click here.

The OIG further relied on its Special Advisory Bulletin on Patient Assistance Programs for Medicare Part D Enrollees in its overall assessment of the risks imposed by the Arrangement.  The referenced bulletin states in pertinent part, “…cost-sharing subsidies provided by bona fide, independent charities unaffiliated with pharmaceutical manufacturers should not raise anti-kickback concerns, even if the charities receive manufacturer contributions…This, we believe lawful avenues exist for pharmaceutical manufacturers and others to help ensure all Part D beneficiaries can afford medically necessary drugs.”

To read the OIG’s Special Advisory Bulletin on Patient Assistance Programs for Medicare Part D Enrollees in its entirety, click here.

OIG’s Conclusive Assessment for Fraud and Abuse Risk.

OIG concluded that the Arrangement presented minimal risk of donors’ (including pharmaceutical manufacturers) contributions influencing direct or indirect referrals by the Requestor due to the following determinations:

(1)    No donor or donor affiliate exerts direct or indirect control over the Requestor or the program because the Requestor is an independent, nonprofit, tax-exempt charitable organization that operates independently and autonomously from donors and donors’ contributions;

(2)    Although the Requestor matches “full-pay” patients* with contracted MRI providers for MRI’s covered under the Arrangement, all patients are free to choose their health care providers, practitioners, suppliers and insurance plans, and the Requestor does not refer to or recommend donors or donor affiliates;

(3)    The Requestor does not provide the donors with any data that would enable a donor to correlate its donations with the amount or frequency of the use of its drugs or devices; and

(4)    No donor or donor affiliate directly or indirectly influences the identification or delineation of the Disease State fund.

Accordingly, the OIG concluded that the Arrangement presented a low risk of fraud and abuse and was not likely to improperly influence beneficiaries’ choice of providers, suppliers, items or services due to the following determinations:

(a)    Although the Requestor matches “full-pay” patients with contracted MRI providers, the Requestor reimburses contracted providers in full and those MRI costs are not reimbursed by Medicare or Medicaid.  Additionally, the requestor does not refer to, recommend or arrange for particular providers, suppliers, drugs or insurance plans to “co-pay” patients*;

(b)    The Requestor’s determination of a patient’s qualification for assistance is based solely on financial need determined in a verifiable and consistent manner.  This determination is made without regard to the patient’s providers, suppliers, drugs or insurance plans, or any referring party or donor and the amount of the corresponding donation; and

(c)    The Requestor assists all eligible financially needy patients on a first-come first-served basis to the extent of available funds without regard for a patient’s provider, supplier or insurance plan.  Additionally, patients have already selected a provider or supplier for treatment, and the Requestor does not refer patients to, or recommend or arrange for products or services of, a donor.

*A patient is categorized as “full-pay” or “co-pay” based on their insurance status and deductible or cost-sharing obligations.  “Full-pay” patients can be either uninsured or insured with a deductible or cost-sharing obligation that exceeds the average charge for an MRI negotiated with contracted MRI providers in the program.

To read the full OIG Advisory Opinion 15-14, click here.

Comments?

Are you a Medicare or Medicaid provider with questions regarding potential risks of government health care fraud or abuse?

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

The Health Law Firm can assist organizations and individuals desiring OIG advisory opinions or declaratory statements from the Agency for Health Care Administration (AHCA), the Board of Medicine, Board of Pharmacy or other professional boards.  Its attorneys can also assist in providing legal advice and representation in complex health care business transactions and can prepare well-researched legal opinions on proposed or existing business transactions.

If litigation arises, whether defending you in actions by government regulators or in representing you as a party in civil litigation, we have experience and can assist you.  We represent shareholders, partners and owners in business disputes and we represent businesses, organizations and individuals in defense of whistleblower cases and other types of lawsuits.

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

Sources:

Demske, Gregory E.  “OIG Advisory Opinion No. 15-14.”  Office of Inspector General.  Department of Health and Human Services: Issued 13 Nov. 2015, Posted 20 Nov. 2015.  Web.  1 Dec. 2015.

Fraud and Abuse Practice Group Leadership.  “Summary of OIG Advisory Opinion 15-14.”  American Health Lawyers Association: 30 Nov. 2015.  E-mail.  1 Dec. 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: OIG, Office of the Inspector General, audit attorney, Medicare fraud defense attorney, pharmaceutical manufacturer attorney, Florida health attorney, health law attorney, Florida health lawyer, The Health Law Firm, health law defense lawyer, non-profit health care attorney, financially needy patients, patient assistance programs (PAP), civil monetary penalties lawyer, Anti-Kickback Statute (AKS), AKS attorney, illegal kickbacks attorney, illegal referrals in health care, health professional legal representation, counsel for charitable organizations in health care, health care legal opinions, OIG advisory opinion, legal opinion on health care business transactions, anti-kickback opinion, Medicare legal counsel, complex business transactions, advice of legal counsel, declaratory statement from Board of Medicine, Board of Pharmacy administrative opinions

“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.

Pfizer’s Wyeth Pharmaceutical Inc. Claims Whistleblower Cannot Prove Alleged Promotion of Off-Label Prescribing in Federal Court Case

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

Two whistleblowers brought suit against Pfizer’s Wyeth Pharmaceutical Inc. (Wyeth) alleging violations of the False Claims Act (FCA).  Relator Lauren Kieff alleged the company encouraged physicians to prescribe its acid reflux drug, Protonix, off-label.  This is in addition to allegations that Wyeth offered Protonix in oral and intravenous forms as a bundling deal to offer both drugs at a discount to physicians and hospitals.  This same deal was reportedly not offered to Medicare and Medicaid thereby overcharging the government programs by not paying an alleged hundreds of millions of dollars in rebates due to them.

Wyeth told a Massachusetts federal court on Thursday, November 12, 2015, that a whistleblower cannot prove that the company encouraged physicians to prescribe Protonix off-label.  Wyeth argued that it would be near impossible to determine causation acknowledging a plethora of outside resources physicians could have relied on including their own independent judgment in deciding to prescribe the drug off-label.

However, Kieff claims that Wyeth’s own internal records show that physicians gained much of their knowledge on Protonix IV through the pharmaceutical company’s sales representatives.  Furthermore, she points out that there have been no clinical studies about off-label uses of Protonix for physicians to rely upon.

To read the full complaint of the United States, click here.

Off-Label Prescribing.

Physicians can generally prescribe drugs off-label.  However, off-label use of drugs previously approved by the Food and Drug Administration (FDA) for a certain medical condition is not regulated and is considered “experimental” or “investigative.”  The FDA does not regulate the practice of medicine.  Therefore once the FDA has approved the drug, physicians are free to use their professional judgment in prescribing the drug.

For more information on off-label prescribing, click here.

Due to the risks involved in off-label prescribing, most insurance companies are reluctant to reimburse such prescriptions since its use may be entirely ineffective in treating the patient or even detrimental.

Off-Label Promotion of Drugs by Pharmacies.

The promotion of utilizing drugs off-label constitutes a violation of the FCA when it results in billing to a government health care program such as Medicaid and Medicare.  State programs explicitly prohibit coverage for off-label prescription usage.  The theory behind this prohibition is that using a drug in a way it has not been medically accepted (or approved by the FDA) results in waste of government funds on assumed ineffective treatments.

Centers for Medicare and Medicaid Services issued some guidelines for recognizing the various forms of unlawful off-label promotion, to include:

(1)    Paying incentives to sales representatives based on sales for off-label use;

(2)    Paying kickbacks to physicians to prescribe drugs for off-label use;

(3)    Disseminating misleading posters promoting off-label use;

(4)    Paying physicians:

(a)    To pretend to be the authors of articles about off-label uses when the articles were actually written by manufacturers’ agents;

(b)    To serve as members of “advisory boards” promoting off-label use;

(c)    To travel to resort locations to listen to promotions about off-label use; or

(d)    To give promotional lectures in favor of off-label use to fellow practitioners;

(5)    Providing advice to prescribers on how to code their claims and document their medical records to support payment for off-label uses not covered by Medicaid;

(6)    Publicizing studies showing efficacy of off-label uses while suppressing studies showing no efficacy; and

(7)    Making false representations directly to Medicaid to influence decisions about payment for drugs used off-label.

To read more about off-label pharmaceutical marketing, click here.

Comments?

Are you facing allegations of off-label promotion?  Do you suspect your company may be involved in the unlawful promotion of off-label prescribing?
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 http://www.TheHealthLawFirm.com.

Sources:

American Cancer Society.  “Off-Label Drug Use.”  Cancer.Org.: 17 Mar. 2015.  Web.  19 Nov. 2015.

Centers for Medicare and Medicaid Services.  “Off-Label Pharmaceutical Marketing: How to Recognize and Report It.”  Fact Sheet: Oct. 2015.  Web.  20 Nov. 2015.

Kass, Dani.  “Wyeth Rejects Claim That it Promoted Off-Label Prescribing.”  Law360.  Portfolio Media Inc.: 13 Nov. 2015.  Web.  16 Nov. 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. http://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, off-label promotions, fraudulent practices of pharmaceutical companies, whistleblowers lawyer, FCA violations, fraud detection, health attorney, defense attorney, The Health Law Firm, health law firm, fraud investigations, qui tam attorney, physician off-label prescribing, overcharging Medicare and Medicaid, Medicare fraud attorney, Medicaid fraud lawyer, marketing drugs off-label, unlawful off-label promotion, Food and Drug Administration (FDA), pharmaceutical company lawyer, overcharging government programs, false claims attorney

“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.

Pill-Mill Crackdown Hurting Patients With Legitimate Pain

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

Florida has been plagued for years with the reputation of being the “pill mill capital of the country.” Lawmakers needed to do something about prescription painkiller abuse. But, the crackdown on pill mills has produced unintended consequences. Since 2011, there have been strict regulations on doctors and pharmacies when it comes to dispensing controlled substances. Click here to read about Attorney General of Florida Pam Bondi’s Pill Mill Initiative.

Additionally, state and federal law enforcement authorities have acted to arrest and prosecute pharmacists and physicians involved in prescribing and dispensing pain medication.

Real Headache for Hurting Patients.

These challenges for pain patients come after federal and state officials acted to combat an epidemic of prescription drug abuse in Florida. While the concentrated effort has made a reduction in the number of deaths related to prescription drugs, patients who suffer from legitimate pain are often caught in the middle. According to the Orlando Sentinel, many pharmacists refuse to fill pain medicine prescriptions, which causes physicians to feel as though they are being second guessed. To read more from the Orlando Sentinel, click here.

Patients in legitimate pain often feel targeted and put on trial when trying to get pain medication. Many physicians have become too scared to write prescriptions for pain medications. When they do, many pharmacists either cannot or will not fill the prescriptions. Those who really need pain medications, for example terminally ill cancer patients, maybe forced to go without it.

Has It Gone Too Far?

Many doctors, pharmacists and patients are wondering if it has gone too far in the wrong direction. The pain is real. The prescriptions are legal. So, why can’t patients get the medications that they need? The solution to this problem is not an easy task. To read a previous blog I wrote on the DEA crackdown, click here.

To read a prior blog I wrote on what physicians can do to avoid charges of being pill mill physicians, click here.

Comments?

What do you think about the war on prescription drugs in Florida? Do you think the DEA has created a problem for patients in legitimate pain? As a pharmacist, how do you verify that prescriptions you receive are legitimate? Please leave any thoughtful comments below.

Contact a Health Law Attorney Experienced in DEA Cases.

The Health Law Firm 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.

If you are aware of an investigation of you or your practice, or if you have been contacted by the DEA or DOH, contact an experienced health law attorney immediately.

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

Sources:

Kam, Dara. “Pill-mill crackdown a pain for the catastrophically ill.” Orlando Sentinel. (September 20, 2015). Print

Crawford, Heather. “Florida’s pill mill crackdowns hurting those in real pain.” First Coast News. (November 1, 2013). From: http://www.firstcoastnews.com/news/article/333761/10/Pill-mill-crackdowns-hurting-those-in-real-pain

Swisher. Skylar. “Florida’s pill mill crackdown makes getting meds difficult for ‘legitimate pain’ patients.” Daytona Beach News Journal. (March 29, 2015). From: http://www.news-journalonline.com/article/20150328/NEWS/150329436?template=printart

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: pill mill, doctor, pharmacist, defense attorney, pain management lawyer, license defense attorney, legal counsel, DEA defense attorney, board of medicine attorney, board of pharmacy attorney, Department of Health investigations, pain clinics, over prescribing, pain management, Florida prescription drug crackdown, Florida prescription drug abuse, prescription drug trafficking, Drug Enforcement Agency (DEA), DEA investigation, Health law, health law attorney, health care lawyer, The Health Law Firm

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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.

Florida Compounding Pharmacy Pays $3.7 Million in Tricare False Claims Settlement

2 Indest-2009-1By 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.

Anti-Fraud Laws Prohibit Certain Physician Referrals.

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 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.

The Stakes are High for Non-Compliance.

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.”

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.

To read more about the importance of complying with Stark and other anti-fraud laws, read one of our previous blogs here.

Avoiding False Claims Violations.

Here are the most common pharmaceutical practices that can result in allegations of FCA violations:

(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.

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? Please leave any thoughtful comments below.

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

“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.