Tag Archives: pharmacist

Florida Nursing Home Owner Arrested for Alleged $395,000 Medicaid Fraud Scheme

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

A Miami-Dade nursing home owner was arrested for allegedly committing $395,000 worth of Medicaid fraud. The Florida Attorney General (AG) accused the nursing home owner of using the billing names of non-existent businesses to submit fraudulent invoices. The fake invoices were then allegedly paid with Medicaid funds. The nursing home owner was arrested on October 17, 2013, by the AG’s Medicaid Fraud Control Unit (MFCU) and the Miami-Dade Police Department.

To read the press release from the AG, click here.

Nursing Home Owner Allegedly Pocketed Medicaid Money.

According to the AG, the nursing home owner recorded forty-seven (47) fraudulent operating expense charges and submitted the cost report to the Agency for Health Care Administration (AHCA). The owner is accused of then writing checks to these phony businesses to “pay” the expense charges. The AG alleges that the nursing home owner was just paying himself. AHCA referred the case to the MFCU.

If convicted, the nursing home owner faces up to 90 years in prison and more than $1.9 million in fines.

MFCU and State and Federal Auditing Agencies.

The MFCU receives referrals from many other state and federal agencies. Often, matters that could be resolved as simple billing errors get escalated to criminal charges when Medicaid providers are interviewed and give evidence against themselves. Admitting to any misconduct, no matter how slight, may lead to far more serious criminal charges.

Click here for tips on how to respond to a Medicaid audit.

Take Fraud Charges Seriously.

In many cases those subject to Medicaid or Medicare fraud audits and investigations refuse to acknowledge the seriousness of the matter or they decide not to spend the money required for a top quality attorney to defend them.

If you are accused of Medicare or Medicaid fraud, realize that you are in the fight of your life. Your liberty, life and profession are at stake. Do not delude yourself. This is extremely serious. Be prepared to give up whatever you have if you can avoid a conviction.

Contact Health Law Attorneys Experienced in Handling Medicaid Audits, Investigations and other Legal Proceedings.

Medicaid fraud is a serious crime and is vigorously investigated by the state MFCU, the Agency for Health Care Administration (AHCA), the Zone Program Integrity Contractors (ZPICs), the FBI, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (DHHS). Often other state and federal agencies, including the U.S. Postal Service (USPS), and other law enforcement agencies participate. Don’t wait until it’s too late. If you are concerned of any possible violations and would like a confidential consultation, contact a qualified health attorney familiar with medical billing and audits today. Often Medicaid fraud criminal charges arise out of routine Medicaid audits, probe audits, or patient complaints.

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.

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

Comments?

Have you heard of the MFCU? Would you know how to properly respond to a Medicaid audit? Please leave any thoughtful comments below.

Source:

Ray, Whitney. “Miami-Dade Nursing Home Owner Arrested for $395,000 in Medicaid Fraud.” My Florida Legal. (October 17, 2013). From: http://www.myfloridalegal.com/newsrel.nsf/newsreleases/F652FC98C9E1BA0C85257C0700530C42
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.

 

“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 © 1996-2012 The Health Law Firm. All rights reserved.

New Requirements Released for Physician Medical Records Related to Compounded Medications

MLS Blog Label 2By Michael L. Smith, R.R.T., J.D., Board Certified by The Florida Bar in Health Law and George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

On September 5, 2013, the Florida Board of Medicine and the Florida Board of Osteopathic Medicine published new requirements for medical record documentation related to compounded medications administered to patients in an office setting.  These standards become effective September 9, 2013. The standards are contained in Florida Administrative Code Rules adopted by each board.

We believe the updated requirements are a result of the recent recalls of tainted compounded medications that have spread across the country and infected thousands of patients. These new standards will make it easier for health care professionals to trace drug reactions and spot tainted batches of medications quickly. The new changes apply to the exact documentation required anytime a compounded medication is administered to a patient.

For the Florida Board of Medicine this is an update to Rule 64B8-9.003, Florida Administrative Code. For the Florida Board of Osteopathic Medicine this is an update to Rule 64B15-15.004, Florida Administrative Code.

New Medical Records Standards.

According to the Florida Board of Medicine and the Florida Board of Osteopathic Medicine, when compounded medications are administered to a patient in the office the medical record documentation must contain, at a minimum:

1.  The name and concentration of medication administered;
2.  The lot number of the medication administered;
3.  The expiration date of the medication administered;
4.  The name of the compounding pharmacy or manufacturer;
5.  The site of administration on the patient;
6.  The amount of medication administered; and
7.  The date the medication was administered.

New Standards Most Likely Triggered by Tainted Compounded Medications.

These new standards are being implemented about a year after a nationwide outbreak of fungal meningitis linked to contaminated drugs made by a compounding pharmacy in Massachusetts. Click here to read our previous blog. Florida is no stranger to allegations of tainted compounded products. In May 2013, Franck’s pharmacy in Ocala, Florida, was accused of distributing eye medications that contained a fungal infection. Click here for the first blog and here for the second blog on this.

It’s likely these updated requirements are a direct result of the recent issues with compounded medications and compounding pharmacies. In the event a health care professional’s office receives a batch of tainted compounded medicine, these medical record standards will help the health care professional track which patients received the tainted medications. Also, authorities, such as the Department of Health (DOH) and U.S. Food and Drug Administration (FDA), will be able to easily track and send recalls to the offices that receive tainted compounded medications.

Contact Health Law Attorneys Experienced in the Representation of Health Professionals and Providers.

The attorneys of The Health Law Firm provide legal representation to physicians, nurses, nurse practitioners, CRNAs, pain management doctors, dentists, pharmacists, psychologists and other health providers in Department of Health (DOH) investigations, Drug Enforcement Administration (DEA) investigations, FBI investigations, Medicare investigations, Medicaid investigations and other types of investigations of health professionals and providers.

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

Comments?

Had you heard of these updates? Do you think these requirements will help officials track tainted medications? Please leave any thoughtful comments below.

About the Authors: Michael L. Smith, R.R.T., J.D., is Board Certified by The Florida Bar in Health Law. He is an attorney with 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.

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.

“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 © 1996-2012 The Health Law Firm. All rights reserved.

Orlando Health’s Restructuring Efforts Might Mean Pay Cuts and Layoffs for Employees

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

Many employees at Orlando Health might be getting hit hard in the wallet with pay cuts schedule for later this year. According to the Orlando Sentinel, the eight-hospital health system notified its night-shift workers that their differential pay would be trimmed by several dollars an hour. For some employees that could be a twenty percent (20%) reduction in salary. The differential pay cuts are scheduled to take effect on September 8, 2013.

Meanwhile the hospital allegedly raised prices in the cafeteria, reduced the tuition reimbursement benefit, cut some workers hours and made a number of layoffs, according to the Orlando Sentinel. According to Orlando Health officials, this is all part of a restructuring effort that began in November 2012. The cutbacks will affect all eight hospitals and all departments.

Anyone who has eaten in the cafeteria at Orlando Regional knows what a bargain the food was. Now this will be the subject of reminiscence as when us old codgers fondly think back on 5 cent Coca Colas and 10 cent loaves of bread.

To read the Orlando Sentinel article, click here.

Night-Shift Workers Feel Under Paid and Under Appreciated.

Some Orlando Hospital employees spoke to the Orlando Sentinel about the pay cuts. According to the Orlando Sentinel, night-shift workers receive incentive pay on top of their base salary for their willingness to work night shifts. One worker interviewed explained the incentive pay is given to them because no one wants to work the overnight shift. Workers also get differential pay for weekend and holiday hours.

On top of the pay cuts, workers are seeing their hours drop, as well as layoffs around the hospital. In the November 2012, restructuring announcement, Orlando Health said 300 to 400 employees’ jobs were on the chopping block, according to WFTV. Some people were previously let go, while more layoffs will be coming. Hospital officials would not say how many people have been laid off so far.

To read more from WFTV, click here.

Orlando Health’s Statement.

Orlando Health reported an $8.1 million loss last quarter. That’s on top of losing money for the last four out of five quarters, according to the Orlando Sentinel. Hospital officials said the change in differential pay puts Orlando Health in line with the pay of other hospitals in the Southeast. On August 13, 2013, Orlando Health sent out an official statement, click here to read the full statement.

Petition to Block Pay Cuts Gaining Momentum.

A petition filed on August 9, 2013, on Change.org, is requesting the Orlando Health CEO block the pay cuts to the night shift workers. The petition was started by a registered nurse at Winnie Palmer Hospital for Women and Babies and is quickly picking up steam. As of August 15, 2013, the petition had more than 2,700 signatures, although not all are local. To view the petition, click here.

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

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.

Comments?

What do you think of the cutbacks at Orlando Health? Are these steps necessary? If you are an Orlando Health employee, how will these changes affect you? Please leave any thoughtful comments below.

Sources:

Jameson, Marni. “Orlando Health Workers Concerned by Cutbacks in Hours and Pay.” Orlando Sentinel. (August 9, 2013). From: http://www.orlandosentinel.com/health/os-orlando-health-cutbacks-20130809,0,5234963.story?dssReturn

Hughes, Ryan. “Orlando Health Confirms Second Round of Layoffs.” WFTV. (August 2, 2013). From: http://www.wftv.com/news/news/local/orlando-health-confirms-second-round-layoffs/nZCjC/

Lewis, Kena. Orlando Health Statement. Orlando Business Journal. (August 13, 2013). From: http://www.bizjournals.com/orlando/blog/2013/08/orlando-health-pay-cuts-to-save-18m.html?page=all

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.

“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 © 1996-2012 The Health Law Firm. All rights reserved.

Terrible Things That Can Happen after Discipline on Your Professional License or Resignation of a License after Notice of Investigation

Patricia's Photos 013By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

Do you have a medical, pharmacy or nursing license in several different states?  Do you have a license in more than one health profession?  Have you been notified that an investigation has been opened against you?  Are you thinking about resigning your professional license or voluntarily relinquishing such a license?  Then you must be aware of the following.

First, you should never voluntarily relinquish or resign your license after you know that an investigation has been opened or that disciplinary action has been taken against you.  Such a resignation is considered to be a “disciplinary relinquishment” and is treated the same as if your license had been revoked on disciplinary grounds.

Second, this will be reported out to other states, agencies, to the National Practitioner Data Bank (NPDB), to any certifying bodies for certifications you have and to other reporting agencies (such as the National Council of State Board of Nursing, the National Association of Boards of Pharmacy or the American Board of Internal Medicine).  Other states and other professional boards will most likely initiate disciplinary action based upon the first one.

Protect Your License from These Adverse Actions.

The following is a list of some of the adverse actions that you can expect to be taken against you after discipline on your license or after you resign your professional license after receiving notice of investigation:

1.  A mandatory report to the National Practitioner Data Base (NPDB) which remains there for 50 years. Note: The Healthcare Integrity and Protection Data Bank or HIPDB recently merged into the NPDB.

2.  Must be reported to and included in the Department of Health (DOH) profile that is available to the public online (for those having one), and remains for at least ten years.

3.  Any other states or jurisdictions in which the nurse has a license will also initiate an investigation and possible disciplinary action against him or her in that jurisdiction.  (Note:  I have had two clients who had licenses in seven other states and all, even ones that were inactive or not renewed years ago, initiated action).

4.  The Office of the Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS) will take action to exclude the provider from the Medicare Program.  If this occurs (and most of these offenses require mandatory exclusion) the provider will be placed on the List of Excluded Individuals and Entities (LEIE) maintained by the HHS OIG.

a.  If this happens, you are prohibited by law from working in any position in any capacity for any individual or business, including hospitals, nursing homes, home health agencies, physicians, medical groups, insurance companies, etc., that contract with or bill Medicare or Medicaid.  This means, for example, you are prohibited from working as a janitor in a nursing home that accepts Medicare or Medicaid, even as an independent contractor.

b.  If this happens, you are also automatically “debarred” or prohibited from participating in any capacity in any federal contracting, and you are placed on the U.S. General Services Administration’s (GSA) debarment list.  This means you are prohibited by law from working in any capacity for any government contractor or anyone who takes government funding.  This applies, for example, to prevent you from being a real estate agent involved in selling property financed by a government backed loan, prohibited from working for an electrical company that bids on contracts for government housing projects, working as a school teacher in a public school, etc.

c.  If this happens, your state Medicaid Program is required to terminate you “for cause” from the state Medicaid Program.  In many states, this is also grounds for revocation of your license.

5.  Any profile or reporting system maintained by a national organization or federation (e.g., NURSYS profile maintained by the National Council of State Boards of Nursing, American Medical Association physician profile, or the Federation of State Board of Physical Therapy profile) will include the adverse action in it, generally available to the public.

6.  If you are a nurse practitioner or other professional with clinical privileges at a hospital, nursing home, HMO or clinic, action will be taken to revoke or suspend the clinical privileges and staff membership if you have such. This may be in a hospital, ambulatory surgical center, skilled nursing facility, staff model HMO or clinic.  This will usually be for physicians, physician assistants (PAs), advance registered nurse practitioners (ARNPs), certified registered nurse anesthetists (CRNAs), nurse midwives or certified nurse anesthetists (CNAs), podiatrists, clinical psychologist or clinical pharmacists.

7.  Third party payors (health insurance companies, HMOs, etc.) will terminate the professional’s contract or panel membership with that organization.

8.  The U.S. Drug Enforcement Administration (DEA) will act to revoke the  professional’s DEA registration if he or she has one.

9.  Many employers will not hire you or will terminate your employment if they discover your license has been disciplined in another state.

What Should You Do?

-  Don’t take the easy way out by immediately relinquishing your license if you are notified you are under investigation.

-  Don’t hide your head in the sand by thinking the case will just go away on its own.

-  Don’t take the easy way out.  If you are innocent of the charges, request a formal hearing and contest the charges; defend yourself.

-  Do not request an informal hearing or a settlement agreement in which you admit the facts alleged against you are all true.  If you do this, you are “pleading guilty.”

-  Do immediately seek the advice of an attorney who has experience in such professional licensing matters and administrative hearings.  They are out there, but you may have to search for one.  Do this as soon as you get notice of any investigation and especially before you have talked to or made any statement (including a written one) to any investigator.

-  Do purchase professional liability insurance that includes legal defense coverage for any professional license investigation against you, whether it is related to a malpractice claim or not.  This insurance is cheap and will provide needed legal assistance at the time when you may be out of a job and not have money to hire an attorney.  Beware of the insurance policy that only covers professional license defense if it is related to a malpractice claim.

Professional Liability Insurance.

We strongly encourage all licensed health professionals and facilities to purchase their own, independent insurance coverage.  Make sure it covers professional license defense under all circumstances.  Make sure you have enough coverage to actually get you through a hearing. $25,000 coverage for just professional licensure defense is the absolute minimum you should purchase;  $50,000 may be adequate but $75,000 or $100,000 may be what you really need in such a situation.  For a few dollars more (and I do mean only a few) you can usually purchase the higher limits.

Also, I will repeat, make sure it covers your legal defense in an administrative disciplinary proceeding against your license, even if there is no malpractice claim filed against you or likely to be filed against you.

We also recommend that you purchase coverage through an insurance company that allows you to select your own attorney and does not make you use one that the insurance company picks for you.

Companies we have encountered in the past who provide an inexpensive top quality insurance product for professional license defense costs include:  CPH & Associates Insurance, Nurses Service Organization (NSO) Insurance, Healthcare Providers Organization (HPSO) Insurance and Lloyd’s of London Insurance.

Contact Experienced Health Law Attorneys.

The Health Law Firm routinely represents physicians, nurses, pharmacists, pharmacies, dentists, mental health counselors, massage therapists and other health providers in investigations, regulatory matters, licensing issues, litigation, inspections and audits involving the Drug Enforcement Administration (DEA), Federal Bureau of Investigation (FBI), 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.

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.

“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 © 1996-2012 The Health Law Firm. All rights reserved.

Supreme Court Rules that Government Regulators Can Sue Over Pay-for-Delay Agreements Between Brand and Generic Drug Manufacturers

George F. Indest III, Board Certified by The Florida Bar in Health Law

George F. Indest III, Board Certified by The Florida Bar in Health Law

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

The U.S. Supreme Court ruled on June 17, 2013, that pay-for-delay agreements between brand name and generic drug manufacturers are subject to anti-trust scrutiny. These pay-for-delay agreements, or reverse payments, are usually a form of settlement between the two manufacturers in patent litigation. The Supreme Court decided that each instance must be considered on a case-by-case basis. This verdict rewrites the rules governing the release of generic drugs. It is likely to increase the number of generic drugs in the marketplace and reduce the price of generic drugs.

To read a previous blog on pay-for-delay agreements, click here.

What is a Pay-for-Delay Agreement?

Pay-for-delay agreements came as the result of the Drug Price Competition and Patent Term Restoration Act of 1984, also known as the Hatch-Waxman Act. The Hatch-Waxman Act gives generic drug manufacturers an incentive to challenge brand name drug patents because the first generic drug manufacturer to received U.S. Food and Drug Administration (FDA) approval to launch a generic copy of a brand name drug can receive a 180-day marketing exclusivity period for the product. The FDA cannot approve any other generic applications for the same drug until the first-to-file generic manufacturer has sold its product for 180 days or has given up its exclusivity period. Click here to read the Hatch-Waxman Act.

Brand name manufacturers often challenge generic drug manufacturers who try to sell their product prior to patent expiration. This results in litigation to determine whether the generic manufacturer is violating the brand name manufacturer’s patents.

Instead of going to court over this, brand name manufacturers often choose to pay a settlement to the generic drug manufacturers for agreeing to delay the launch of its competing product.

Why the Supreme Court Overruled Court of Appeals Decision.

The 5-3 vote overruled the 11th Circuit Court of Appeals decision that said pharmaceutical companies can’t be sued unless the patent litigation is a sham or a generic drug maker agrees to delay introduction of a generic drug into the market even after the patent has expired.

A Med Page Today article lists the Supreme Court’s five reasons why the appellate court made a mistake in giving blanket immunity to pay-for-delay agreements from the decision written by Justice Stephen Breyer:

-  “A reverse payment, where large and unjustified, can bring with it the risk of significant anticompetitive effects.”

-  “One who makes such a payment may be unable to explain and to justify it.”

-  “Such a firm or individual may well possess market power derived from the patent.”

-  “A court, by examining the size of the payment, may well be able to assess its likely anticompetitive effects along with its potential justifications without litigating the validity of the patent.”

-  “Parties may well find ways to settle patent disputes without the use of reverse payments.”

Click here to read the entire Med Page Today article.

Pay-for-Delay Agreements Allegedly Cost Patients Millions of Dollars a Year.

According to Bloomberg, the high court’s decision may discourage brand name and generic pharmaceutical companies from reaching settlements. It’s been found that pay-for-delay agreements can delay a generic drug almost 17 months before it can be put on the market. In the meantime, patients must pay higher prices for the brand name version. This also impacts Medicare and Medicaid programs. The Federal Trade Commission (FTC) claims pay-for-delay agreements cost consumers $3.5 billion a year in the form of higher drug prices.

To read the Bloomberg article, click here.

The Case of the FTC v. Solvay Pharmaceuticals.

The Supreme Court case center around AndroGel, a treatment for low testosterone in men, made by Solvay Pharmaceuticals, Inc. The FTC sued Solvay and three generic drug companies. According to Bloomberg, the FTC said that a payment made by Solvay, the holder of a patent on AndroGel, to the generic drug manufacturers represented an unlawful restraint of trade because it was intended to keep cheaper, generic versions of AndroGel off the market until 2020.

FTC Enthusiastic About the Decision.

In a statement, the FTC Chairwoman said the Supreme Court’s decision is a “significant victory for American consumers, American taxpayers and free market.” She also stated, “The court made it clear that pay-for-delay agreements are subject to antitrust scrutiny.”

Click here to read the full statement from the FTC.

Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.

The Health Law Firm represents pharmacists and pharmacies in investigations, regulatory matters, licensing issues, litigation, 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.

Comments?

What do you think of the Supreme Court’s ruling? Do you agree or disagree? What effect do you think it will have on the pharmaceutical industry? Please leave any thoughtful comments below.

Sources:

Stohn, Greg. “Drugmakers Opened to ‘Pay for Delay’ Suits by High Court.” Bloomberg. (June 17, 2013). From: http://www.bloomberg.com/news/2013-06-17/drugmakers-opened-to-pay-for-delay-suits-by-high-court.html

Frieden, Joyce. “Supreme Court Split on Pharma ‘Pay for Delay’ Deals.” Med Page Today. (June 17, 2013). From: http://bit.ly/18SfhKb

Kaplan, Peter. “Statement of FTC Chairwoman Edith Ramirez of the U.S. Supreme Court’s Decision in FTC v. Actavis, Inc.” (June 17,2 013). From: http://www.ftc.gov/opa/2013/06/actavis.shtm

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.

“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 © 1996-2012 The Health Law Firm. All rights reserved.

Healthcare Providers Service Organization (HPSO) Attorneys, Lawyers and Defense Council in Florida

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

Often we learn after the fact that a health professional such as a mental health counselor, psychologist, or pharmacist has received Healthcare Providers Service Organization (HPSO) insurance, has had a legal problem, and has not been able to locate an attorney or law firm that accepts this type of insurance. We have offices in Florida and Colorado, but we have attorneys licensed in Florida, Colorado, Louisiana, the District of Columbia, Virginia and other states.

Additionally, we can provide legal advice and representation in license investigations and administrative proceedings in many other states.

If you have HPSO Insurance, do not go without an attorney or with a lawyer that has little or no experience where you need it. Contact us, and we will help you.

Don’t Worry About Legal Bills While Your Case is Going On.

Call us first. We can assist you in determining if your legal problem is covered by your insurance, and we can help you file a claim to have your legal defense expenses and costs covered. In most cases, we will accept the assignment of your insurance so that you do not have to worry about legal bills while your case is going on.

Contact Experienced Health Law Attorneys That Will Work with Insurance Companies.

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.

In cases in which the health care professional has professional liability insurance or general liability insurance which provides coverage for such matters, we will seek to obtain coverage by your insurance company and will attempt to have your legal fees and expenses covered by your insurance company. We will agree to take an assignment of your insurance policy proceeds in order to be able to submit our bills directly to your insurance company, if your insurance company will allow this. Many of these insurers will pay our firm to represent you in the legal defense of an investigation or complaint against your professional (nursing, medical, dental, psychology, mental health counselor) license or for an administrative hearing involving professional discipline.

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.

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 © 1996-2012 The Health Law Firm. All rights reserved.

Two Separate Lawsuits Against Novartis Pharmaceuticals Corporation Allege Illegal Kickbacks and False Claims

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

Novartis Pharmaceuticals Corporation (NPC) is currently fielding two different lawsuits, filed just days apart from each other, by the U.S. Department of Justice (DOJ). The first lawsuit was filed on April 23, 2013, alleging the company gave illegal kickbacks to pharmacists. A second lawsuit was filed on April 26, 2013, alleging illegal kickbacks were paid by NPC to health care providers. According to the DOJ, the government’s complaint seeks damages and civil penalties under the False Claims Act, and under the common law for paying kickbacks to doctors to induce them to prescribe NPC products that were reimbursed by federal health care programs.

Click here to read the entire press release from the DOJ.

NPC Accused of Treating Health Care Professionals to Expensive Dinners, Product Discounts and Fishing Trips.

Both lawsuits allege NPC violated the Anti-Kickback Statute. In the April 23, 2013, complaint against NPC the lawsuit alleges the company gave kickbacks, in the form of rebates and discounts to pharmacies in exchange for the pharmacies’ cooperation in switching patients from competitors’ drugs to NPC products.

The April 26, 2013, lawsuit accuses NPC of paying doctors to speak about certain drugs at events that were allegedly social occasions. Many of the programs were allegedly held in circumstances in which it would be impossible to have a presentation. According to the DOJ, this included fishing trips off the Florida coast and meetings in Hooters restaurants. NPC is also accused of treating health care professionals to expensive dinners. The payments and dinners were apparently kickbacks to the doctors for writing prescriptions for NPC drugs.

Florida Doctors Involved.

The lawsuit alleges at least six Florida doctors of participating in the bogus conferences and taking thousands of dollars in kickbacks, according to the Tampa Bay Times. The doctors are not named or charged in the civil lawsuit.

To read the allegations listed in the lawsuit against Florida doctors, click here for the Tampa Bay Times article.

NPC Denies All Claims.

In a press release, NPC disputes all of the government’s allegations. The pharmaceutical company states that discounts and rebates by pharmaceutical companies are a customary and legal procedure, as recognized by the government. It also addresses the physician speaker programs by saying the programs are also acceptable practices designed to inform physicians about the uses of different types of medicines. Click here to read the entire press release from NPC.

The Law Against Using Bribes in Exchange for Selling a Drug or Service.

For years drug companies have paid doctors to speak about new drugs at educational conferences with other health care professionals. The practice is legal, but considered questionable.

Under the Anti-Kickback Statute, it’s a felony for health care professionals to accept bribes in exchange for recommending a drug or service covered by Medicare, Medicaid, TRICARE or the Department of Veterans Affairs health care program.

Whistleblowers Who Report Fraud and False Claims Against the Government Stand to Receive Large Rewards.

The original complaint against NPC was allegedly filed under the qui tam, or whistleblower, provisions of the False Claims Act by a former sales representative.

Individuals working in the health care industry, whether for hospitals, pharmacies, nursing homes, medical groups, home health agencies or others, often become aware of questionable activities. Often they are even asked to participate in it. In many cases the activity may amount to fraud on the government.

In a two-part blog series on whistleblower/qui tam lawsuits I explain types of false claims, the reward programs for coming forward with a false claim, who can file a whistleblower/qui tam lawsuit, and more. Click here to read the first part of this blog, and click here for the second part.

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

Attorneys with The Health Law Firm represent plaintiffs, patients, health care professionals and health facilities in qui tam or whistleblower 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.

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

Comments?

What do you think of these lawsuits? Please leave any thoughtful comments below.

Sources:

Masow, Julie. “Novartis Pharmaceuticals Corporation Disputes Allegations in Two US Government Lawsuits and Looks Forward to a Fair Discussion of the Facts.” Novartis Pharmaceuticals. (April 26, 2013). From: http://www.pharma.us.novartis.com/newsroom/pressreleases/137176.shtml

Davis, Brittany Alana. “Lawsuit: Pharmaceutical Company Gave Kickbacks to Florida Doctors.” Tampa Bay Times. (May 3, 2013). From: http://www.tampabay.com/news/courts/lawsuit-pharmaceutical-company-gave-kickbacks-to-florida-doctors/2119133

Department of Justice. “United States Files Complaint Against Novartis Pharmaceuticals Corp. for Allegedly Paying Kickbacks to Doctors in Exchange for Prescribing Its Drugs.” Department of Justice. (April 26, 2013). From: http://www.justice.gov/opa/pr/2013/April/13-civ-481.html

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.

 

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 © 1996-2012 The Health Law Firm. All rights reserved.

Two More Compounding Pharmacies Recall Drugs

CCS Blog LabelBy Carole C. Schriefer, R.N., J.D., The Health Law Firm and George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

Two different compounding pharmacies have recently recalled products due to concerns from the Food and Drug Administration (FDA). The New Jersey compounding pharmacy, Med Prep Consulting, and Clinical Specialties Compounding in Georgia, both recalled products between March 17, 2013 and March 20, 2013.

The recalls were issued as the FDA and state agencies step up regulation on compounding pharmacies across the country. These agencies are trying to prevent another widespread outbreak, like the fungal meningitis outbreak in the fall of 2012, which is responsible for 50 deaths.

Recall Upgraded in New Jersey.

Med Prep Consulting first issued a recall on March 17, 2013, for all lots of magnesium sulfate for injections after a hospital reported seeing visible particles in the containers. Three days later, the compounding pharmacy recalled all of its compounded products. Med Prep Consulting has halted production, processing and shipping. The FDA reported products distributed through March 15, 2013, in New Jersey, Pennsylvania, Delaware and Connecticut need to be returned to the company. Click here to see all the recalled products from Med Prep Consulting.

Eye Infections from Georgia Compounding Pharmacy Products.

According to Modern Healthcare, at least five people have acquired serious eye infections associated with the use of the cancer drug Avastin packaged in syringes from Clinical Specialties Compounding. At the company’s facility in Georgia the FDA raised concerns about the lack of sterility assurance. Products covered under the recall were distributed nationwide, between October 19, 2012 and March 19, 2013. Until further notice, healthcare providers are asked to stop using all of these sterile products and return them to the company. Click here to read the press release on the recall from the FDA.

Florida Compounding Pharmacy in Hot Water Due to Fungal Growth.
We have previously blogged about the problems encountered by Franck’s pharmacy in Ocala, Florida. It has been accused of distributing eye medications that contained a fungal infection. Click here for the first blog and here for the second blog on this.

Harsher Regulations on Compounding Pharmacies.

Since the widespread fungal meningitis outbreak, compounding pharmacies have fallen under heightened scrutiny. The FDA is beefing up their oversight of compounding, and, according to Modern Healthcare, the FDA and state Department of Health (DOH) agencies have been paying surprise visits to compounding pharmacies. Click here to read more from Modern Healthcare.

Common Deficiencies We See in Pharmacy Inspections.

Pharmacies and pharmacists are subject to many types of inspections. These inspections are necessary to determine whether the business and its employees are complying with state and federal laws and regulations. Administrative agencies, such as the Drug Enforcement Administration (DEA), FDA and DOH, have the authority to inspect pharmacies.

With our experience working with pharmacists and pharmacies we’ve seen a number of different inspection deficiencies. These errors may result in a complaint being filed and the beginning of the administrative law process regarding investigations and hearings.

Here are some common deficiencies often found during pharmacy inspections:

1. Pharmacy technicians not properly identified with name tags and identified as
pharmacy technicians (as opposed to pharmacists);

2. Pharmacy technicians not supervised by pharmacist;

3. Medication on shelves not properly labeled (including exact number of pills remaining in bottle);

4. Controlled substances not accurately recorded on appropriate forms; and

5. Not keeping schedule II inventory and dispensing records separate from schedule III-V records.

Click here to read a recently blog listing more deficiencies and your best defense to protect your pharmacy license and pharmacist license.

Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.

The Health Law Firm represents pharmacists and pharmacies in investigations, regulatory matters, licensing issues, litigation, 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.

Comments?

What do you think of the harsher regulations compound pharmacies are now facing? Please leave any thoughtful comments below.

Sources:

Meinhardt, Jane. “Compounding Pharmacies Set to Navigate Potential Regulations.” Tampa Bay Business Journal. (January 25, 2013). From: http://www.bizjournals.com/tampabay/print-edition/2013/01/25/compounding-pharmacies-set-to-navigate.html?s=print

Blesch, Gregg. “Georgia Compounding Pharmacy Widens Recall.” Modern Healthcare. (March 22, 2013). From: http://www.modernhealthcare.com/article/20130322/NEWS/303229959/#

Clinical Specialties. “Clinical Specialties Compounding Pharmacy Announces Voluntary Nationwide Recall of All lots of Sterile Products Repackaged and Distributed by Clinical Specialties Compounding Due to Lack of Sterility Assurance.” Food and Drug Administration. (March 20, 2013). From: http://www.fda.gov/Safety/Recalls/ucm344786.htm

About the Authors: Carole C. Schriefer is an attorney with The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Avenue, Altamonte Springs, Florida 32714, Phone: (407) 331-6620.

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.

 

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 © 1996-2012 The Health Law Firm. All rights reserved.

Florida Pharmacy Owner Accused of Medicare Fraud

00011_RT8By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

A family that owns a number of South Florida pharmacies is allegedly under investigation for Medicare fraud, according to a number of sources. On January 17, 2013, federal authorities raided one pharmacy location in Naples, Florida. Drug Enforcement Administration (DEA) agents removed boxes of documents and computers from the pharmacy, according to Naples News. The pharmacy owner and his mother are allegedly being investigated by the U.S. Office of Inspector General (OIG) of the Department of Health and Human Services (HHS).

Click here to read the entire Naples News article.

Pharmacy Owner and Mother Allegedly Submitted False Claims to Medicare, Medicaid and Tricare.

According to NBC2, a South Florida television station, the pharmacy owner and his mother were both allegedly part of a scheme that defrauded Medicare. The family allegedly submitted claims to Medicare Part D after beneficiaries had died. This information came from a letter sent to Medicare Part D providers from the Centers for Medicare and Medicaid Services (CMS) on October 17, 2012. The letter was obtained by NBC2. The scheme allegedly also involved submitting false claims to Medicaid and Tricare.

Click here to watch the NBC2 news story.

Investigation is Ongoing.

The pharmacy that was raided is part of a chain of stores owned by the same family. So far, only the pharmacy located on Rattlesnake-Hammock Road in Naples is being investigated. That location is reportedly still closed, but the other pharmacy locations are open.

Neither the DEA nor the OIG of the HHS has released a press release on this investigation.

As in all media reports, please remember that all persons are presumed to be innocent until proven guilty in a court of law.

Pharmacies Are Being Raided and Shutdown  All Over the State.

If  you have watched the news at all lately or have been reading our blog, you can tell there have been an increased number of raids on pharmacies, arrests of pharmacists and emergency suspension orders issued from the Department of Health (DOH).

Recently, the DEA served a Walgreens distribution center in Florida with an immediate suspension order (click here to read more on this story), and pulled the controlled substance licenses from two Central Florida CVS Pharmacies (to learn more, click here).

In my personal opinion, the recent raids and investigations at pharmacies are especially hard on the independent operators. If the large retail giants can’t survive, the small independent pharmacies stand little chance.

Talk with an Experienced Health Law Attorney About Medicare, Medicaid and Tricare 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.

What Do You Think?

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:

Freeman, Liz. “Sunshine Pharmacy in East Naples Remains Close, Day After Federal Raid.” Naples News. (January 19, 2013). From: http://www.naplesnews.com/news/2013/jan/19/sunshine-pharmacy-east-remains-closed-raid-federal/

Ritter, Rick. “Naples Pharmacy Busted for Medicare Fraud.” NBC2. (January 20, 2013). From: http://www.nbc-2.com/story/20627104/detectives-investigating-medicare-fraud-at-naples-pharmacy

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.

“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 © 1996-2012 The Health Law Firm. All rights reserved.

Update: Fake DEA Agents Calling Citizens, Claiming to Have Arrest Warrant

1 Indest-2008-1By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

Health care providers beware, there is a scam making its rounds in Central Florida. Con men are telephoning citizens, including physicians, and pretending to be Drug Enforcement Administration (DEA) agents in the hope of extorting money from them.

It’s a scam we first told you about in December 2012, but have since learned more. Click here to read my first blog on this nationwide telephone scam.

Fake DEA Agents Conning Citizens and Health Providers.

The scam starts with criminals posing as DEA agents calling victims by telephone. Frequently, just by coincidence, the victim will have purchased prescription drugs over the internet, by phone or from a foreign country. The imposters tell the victims that purchasing the drugs in this manner is illegal, and that the phony DEA agent has an arrest warrant for them. They are then advised that they can pay a cash fine and avoid arrest. We’ve heard reports that the criminals tell the victim to wire the funds to the DEA’s account, which is actually an overseas account.

If the victims refuse to send money, the phony DEA agents threaten to arrest the victims or come out and search their property.

Click here to read more on this scam from a DEA press release.

The Local Law Enforcement is Investigating.

As we stated before, this is a nationwide scam. However, we’ve recently received a report from a local health care provider that was contacted by one of these phony DEA agents. This person was told the by the con men that he was being investigated by the DEA for an outstanding warrant. The thought of being the target of a DEA investigation can be quite unnerving for anyone working in the medical field.

The real DEA is aware of the situation and is doing a thorough investigation into the scam. Until agents find the people behind this con, they want to remind you that no DEA agent will ever contact a subject by telephone. However, a DEA agent, just like any other law enforcement officer, might show up at your house early in the morning or while you are eating dinner. If you were actually going to be arrested or charged for a crime, the agents would not offer to drop the charges in exchange for money.

Call the DEA Immediately If  Criminals Call You.

Criminals are counting on the fact that they will reach a certain number of people who have actually purchased drugs over the internet and will not know for sure whether this is legal. They are counting on the fact that if they think they may have purchased drugs illegally, they will get scared and believe the false accusations. Many people have no idea whether such conduct is legal or illegal. These imposters are banking on your ignorance and fear of being arrested for a criminal act or losing your professional license to practice. They are also banking on the fact you won’t report this to the real police or DEA. If you receive a similar call from phony DEA agents, call the real DEA at 1-877-792-2873.

How Does Your Information Get into the Hands of Criminals?

Chances are they are just “cold-calling” people. There are bound to be a certain number of people (especially in Florida) they reach who have done this. However, if they seem to have your personal health information (or credit card number) report this to the police right away. Be sure to obtain a written police report. Also, you should file a Health Insurance Portability and Accountability Act (HIPAA) Privacy Complaint with the Office of Civil Rights (OCR) to begin an investigation if you believe your personal health information has been stolen by or given to someone else to use.

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

The attorneys of The Health Law Firm provide legal representation to physicians, nurses, nurse practitioners, CRNAs, dentists, pharmacists, psychologists and other health providers in Department of Health (DOH) investigations, Drug Enforcement Administration (DEA) investigations, FBI investigations, Medicare investigations, Medicaid investigations and other types of investigations of health professionals and providers.

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

Sound Off!

Have you received a call from these phony DEA agents? Please leave any thoughtful comments below.

Source:

Drug Enforcement Administration. “DEA Scam Alert – Extortion Scheme.” DEA. (November 28, 2012). From: http://www.justice.gov/dea/divisions/mia/2012/mia112812a.shtml

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.

“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 © 1996-2012 The Health Law Firm. All rights reserved.