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Need Last Minute Deposition or Hearing Representation? Call The Health Law Firm

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

Our office often takes phone calls from pharmacies and pharmacists needing short-notice representation at a Board of Pharmacy hearing or at a deposition related to a health care matter.

In our experience, many other law firms refuse to represent clients at hearings unless the firm is given plenty of advance notice. We always prefer to have sufficient time to obtain documents, review files, interview witnesses, conduct research and prepare, in order to provide the best possible representation to our client. However, we realize that in certain cases, the alternative is that the client either gets legal representation on little or no advance notice or has to suffer the consequences of having no legal representation.

Administrative Proceedings Can be Complex.

In some cases, individuals may be fooled into believing that they can effectively represent themselves. They later find out that they have gotten in over their heads. Laypersons (meaning, in this case, nonlawyers) who are not aware of such complex matters as the Administrative Procedure Act, the Rules of Civil Procedure, the Rules of Evidence, the Florida Administrative Code (F.A.C.) Rules which the Board of Pharmacy and the Department of Health (DOH) have enacted, may quickly be confused.

The inexperienced individual, or even the inexperienced attorney, in these matters, can fall into a number of procedural traps that damage an effective defense. This can be advising the individual to talk to the DOH investigator, filing an unnecessary answer to an Administrative Complaint, forgetting or not knowing that the client’s right to be free of self-incrimination applies in this type of case and many, many others.

Procedural Mistakes Can Be Damaging To Your Legal Defense.

Often you will find that merely having an experienced attorney to represent you at a hearing or Board meeting will assist you in avoiding mistakes that damage your case and assist you in preserving your rights for an appeal. In other cases, it may even be possible to obtain a change in the forum to obtain a better result. For example, many laypersons do not know that if you elect an informal hearing before the Board of Pharmacy, you have waived your right to prove you are innocent by contesting the facts alleged against you.

What few know or think of in the heat of the moment is that you can ask at the informal hearing before the Board of Pharmacy to contest the facts, to prove you are not guilty of the charges, and to have the hearing converted to a formal hearing. A formal hearing will be in front of a neutral Administrative Law Judge (ALJ), and you have a great many more procedural rights than you have at an informal hearing. However, we still recommend that you have an experienced health lawyer represent you at a formal hearing.

Professional Liability Insurance May Pay Legal Fees for Deposition Coverage.

If you are a pharmacist or pharmacy that has professional liability insurance, these often provide legal coverage for depositions. This is primarily because the outcome of the deposition may include having you named as a defendant in a professional liability or negligence lawsuit or having disciplinary charges filed against you.

One of the first things you should do if you receive a subpoena or a notice of a deposition is to contact your professional liability insurance carrier and see if it will pay for an attorney to represent you. For example, Healthcare Providers Service Organization (HPSO), CPH & Associates, Nurses Service Organization (NSO), Dentists Advantage and many other malpractice insurance companies provide excellent deposition coverage.

The second thing you should do is to call an experienced attorney and schedule a consultation. Even if you cannot afford to retain the services of the attorney for the actual deposition, a consultation may assist you in properly preparing. Click here to read our blog on this matter and learn more.

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

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

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

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

KeyWords: Florida Board of Pharmacy, Legal Defense for Pharmacists, Pharmacist, Pharmacy and tagged Administrative Law Judge, administrative procedure act, administrative proceeding, ALJ, Board of Pharmacy, Board of Pharmacy hearing, defense attorney, defense lawyer, Department of Health, deposition coverage, disciplinary charges, disciplinary complaint, FAC, final hearing, Florida Administrative Code, formal hearing, health law firm, health professional, hearing representation, Informal hearing, last-minute deposition coverage, legal representation, legal representation for pharmacist, legal representation for pharmacy, local deposition coverage, negligence lawsuit, noticed of a deposition, pharmacist, pharmacy, professional liability insurance, rights for an appeal, Rules of Civil Procedure, Rules of Evidence, short notice of representation of pharmacy, short notice representation of pharmacist, subpoena, The Health Law Firm

“The Health Law Firm” is a registered fictitious business name of and a registered service mark of The Health Law Firm, P.A., a Florida professional service corporation, since 1999.
Copyright © 2019 The Health Law Firm. All rights reserved.

Ready or Not, It’s Irregular Behavior Season Once Again…

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

Every year, our firm receives calls from panicked medical students and residents about a recent letter they have received, alleging irregular behavior on standardized medical examinations.

This letter may come from the National Board of Medical Examiners (NBME), the United States Medical Licensing Examination (USMLE), or the Educational Commission for Foreign Medical Graduates (ECFMG). No matter the organization, if you receive a letter alleging irregular behavior, it will typically say the following:

A bulletin or policy related to the exam stating that Irregular Behavior is not permitted.

The facts alleging irregular behavior in this case.

You have an opportunity to respond to the allegations, in person, with counsel.

Often there is a very short window of time to respond to such allegations. While this is important because it is urgent that you get your results test results, it also gives a limited time to prepare to defend yourself.

What is Irregular Behavior?

Although irregular behavior is not the same thing as cheating, it is often thought of as the same by medical school officials and residency program directors. A notice of irregular behavior may hold up and delay your entry into a residency program, your graduation from medical school, and your job opportunities. Your examination scores will be held up while the matter is reviewed by a USMLE Committee on irregular behavior or until a hearing can be held.

What Should You Do?

Once you receive an irregular behavior letter, begin to compile documents to defend yourself. Write out your version of events in order to recall what happened. Collect character reference letters from professors and administrators that attest to your integrity.

Place the personal appearance date listed in your letter on your calendar. It is of upmost importance that you attend in person, preferably with representation. Hearings are usually held in Philadelphia, Pennsylvania, so plan accordingly.

Why Hiring an Attorney Matters.

An attorney can provide the following services to someone accused of irregular behavior:
Review documents, videos, photographs, and all other information that pertains to your case.

Recommend other documents that you should obtain in your defense.

Prepare you for a personal appearance before the respective board or committee making the allegations, and will also make a personal appearance with you at hearing.

Prepare you to answer questions under pressure and on the day of your hearing.

The takeaway message is that retaining an attorney to represent you against irregular behavior allegations could be the difference between a clear record and a mark that will follow you for the rest of your career. Don’t risk jeopardizing your future as a healthcare practitioner. Consult with an attorney as soon as you receive notice of allegations against you regarding irregular behavior.

Consequences of an Irregular Behavior Finding.

If a finding of irregular behavior is made against you, then this usually means that your best score is voided, and you must retake it. The USMLE Committee may require you to wait a year or more to retake the examination. This can prevent you from obtaining or entering a residency program or it may delay you from graduating. Furthermore, the notation that you were found to have committed irregular behavior will be placed on your Step exam transcript. This will be reported out when your test scores are reported.

As indicated above, many medical decision makers view this as similar to cheating. It may disqualify you for many jobs or residency programs that you would otherwise be considered for. If you are accused of irregular behavior, immediately consult with an attorney who has actual experience in dealing with this matter. You can find more information about irregular behavior by clicking here to watch our informational video blog. Click here to read one of my prior blogs on USMLE.

Contact Experienced Health Law Attorneys For Irregular Behavior or USMLE Issues Today.

The attorneys of The Health Law Firm provide legal representation to medical students, residents, interns and fellows in academic disputes, graduate medical education (GME) hearings, contract negotiations, license applications, board certification applications and hearings, credential hearings, and civil and administrative litigations.
To contact The Health Law Firm, please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.

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.

Keywords: National Board of Medical Examiners (NBME), medical students, medical resident, irregular behavior, United States Medical Licensing Examination (USMLE), Examination Committee for Foreign Medical Graduates (ECFMG), cheating, USMLE preparation course , USMLE hearings, USMLE appeals, defense attorney, defense lawyer, legal representation, medical student lawyer, medical student attorney, medical resident lawyer, medical resident attorney, medical intern lawyer, medical intern attorney, accused of irregular behavior, The Health Law Firm reviews

“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 © 2018 The Health Law Firm. All rights reserved.

New System for Patients to Report Medical Mistakes in the Works

By Danielle M. Murray, J.D.

According to the New York Times, the government wants to implement a new system that would allow patients to report medical mistakes and unsafe practices by health care providers to a central reporting organization. This includes doctors, hospitals, pharmacists, and all other professionals or entities that provide medical treatment. While it is only an idea at this point, the government envisions patients reporting problems through a website or a phone number by answering a short questionnaire.

Federal officials believe that medical mistakes frequently go unreported and patients could have useful information that could be used to identify health care providers and facilities where errors are made.

A Tool to Help Doctors and Hospitals Learn from Mistakes.

Hospitals and some doctors like the idea. They argue that it would allow them to better understand the prevalence and characteristics of medical errors and learn how to better prevent those errors.

However, some suggest that these reports need to be matched with a patient’s medical records and taken with a grain of salt. Health care providers believe patients may perceive something as an adverse event that is actually not a problem or is common with the procedure they received. The example used in the New York Times article is that a patient with a hip replacement surgery may report a dislocated hip when the patient hears or feels a popping sensation, but this is a normal sensation after this type of procedure.

System Will Monitor Quality.

Health care providers are already under scrutiny by the government through Medicare and Medicaid. This would be another tool used to monitor doctors’ ability to give care. It’s great for patients, but what will the effect be on providers? It’s too soon to say. The American Medical Association did not comment for the New York Times article, stating that it needed to study the details.

To read the New York Times article, click here.

Comments?

As a provider, do you agree with this proposed system? Leave a comment below.

How Patient Complaints Can Impact Your License.

As many health professionals are aware, patient complaints are a frequent cause of problems for your license. When a patient complains to the Department of Health (DOH), the DOH will hold a hearing, called a probable cause panel, to determine, based on the complaint, if there is enough information to proceed against your license. If there is, the DOH will file an administrative complaint against your license, and ask you to voluntarily relinquish your license.

When you receive the first correspondence from the DOH that there is a pending investigation, do not sit idly. Call an experienced health law attorney, such as those available at The Health Law Firm, to evaluate your case and let you know what your options are. Do not speak with any investigator or DOH representative, and do not voluntarily relinquish your license. Your career and livelihood are at stake.

For a list of the 25 biggest mistakes health professionals make when notified of a DOH investigation, click here.

Contact Health Law Attorneys Experienced in Representing Health Care Providers in DOH 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 DOH, contact an experienced health law attorney immediately.

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

Source:

Pear, Robert, “New System for Patients to Report Medical Mistakes.” The New York Times, (September 22, 2012). From: ttp://www.nytimes.com/2012/09/23/health/new-system-for-patients-to-report-medical-mistakes.html?emc=tnt&tntemail0=y&_r=1

 

About the Author: Danielle M. Murray 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

“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.

University of Miami Employee Allegedly Caught Red Handed Stealing More Than $14 Million in Cancer Drugs

By Michael L. Smith, J.D., R.R.T., Board Certified by The Florida Bar in Health Law

For three years, hundreds of life-saving cancer drugs disappeared from the shelves of the University of Miami’s (UM) Sylvester Comprehensive Cancer Center. A pharmacy technician at the center was arrested in connection to the thefts in May of 2011, and is accused of stealing more than $14 million in cancer drugs, according to the Miami Herald. The pharmacy tech faces four counts of grand theft, two counts of trafficking in contraband prescription drugs and one count of dealing in stolen property.

To read the entire article from the Miami Herald, click here.

Pharmacy had No System in Place to Keep Track of Supplies.

According to the Miami Herald, UM’s chief financial officer and a board member admitted that there were no controls at the cancer pharmacy to keep track of supplies. The pharmacy technician was apparently able to walk to refrigerators in the pharmacy and slip packages of Neulasta, a drug used by cancer patients, into his lab coat. Each box of Neulasta runs about $2,600 per dose. It’s obviously worth more than its weight in gold.

The fact that the pharmacy was missing hundred of syringes of drugs did not even get noticed until May 2011 when a pharmacy buyer at UM noticed something was off when she reviewed a new computer program that tracked drugs. The system showed hundreds of syringes full of Neulasta were missing from inventory. Since the new software was not reliable, the pharmacy buyer decided to hand-count the syringes. This was the first time anyone at the pharmacy noticed that drugs were missing.

Pharmacy Technician Used Lab Coat to Smuggle Drugs Out of the Pharmacy.

On June 1, 2011, hidden video surveillance cameras were installed in the pharmacy to view the refrigerators. On two separate occasions the cameras allegedly caught the pharmacy technician pocketing several boxes of Neulasta.

To see the security camera footage, click here.

The second time the pharmacy technician was allegedly captured on video, he was confronted and forced to hand over his lab coat containing the cancer drugs. He immediately confessed to selling the drugs and allowed investigators to search his home. There investigators found 163 doses of Neulasta and other cancer-fighting drugs. All together the drugs found had a value of more than $700,000, according to the Miami Herald.

It is currently unknown whether he will ever get his lab coat back. He may have to exchange it for a striped one or an orange jump suit.

Security and Controls Now Up To Par.

As soon as the theft was confirmed, security and inventory controls of pharmaceuticals at Sylvester were reviewed and strengthened, according to the Miami Herald. A follow up audit found that the pharmacy’s inventory controls are now sufficient.

The pharmacy is seeking reimbursement for losses from the employee and the pharmacy’s insurance.

Recent Article on Employee Embezzlement.

George F. Indest, another health attorney with our firm, recently wrote several articles on prevention of employee embezzlement. Although the articles are written for smaller health care providers than universities, many of the general principles contained in these would apply to larger employers, as well.

To see the Medical Economics article, click here.

Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.

The Health Law Firm represents pharmacists and pharmacies in DEA investigations, 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.

Comments?

What do you think of this story? What do you think of the fact that it took the university so long to find out the inventory was missing? Have you heard of people stealing drugs from pharmacies before? Please leave any thoughtful comments below.

Sources:

Dorschner, John. “How Did $14 Million in Drugs Vanish from a UM Pharmacy?” Miami Herald. (August 6, 2012). From: http://www.miamiherald.com/2012/08/06/2936916/how-did-14-million-in-drugs-vanish.html

Creamer, Alyssa. “University of Miami Employee, Manuel Pacheco, Allegedly Looted Pharmacy For Over $14 Million In Cancer Drugs.” Huffington Post. (August 9, 2012). From: http://www.huffingtonpost.com/2012/08/09/um-employee-steals-14-million-cancer-drugs_n_1760155.html?view=print&comm_ref=false

About the Author: Michael L. Smith, J.D., R.R.T., 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.

“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.

Osceola County Authorities Nab 29 People in Phony Prescription Ring

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

A sting on a prescription fraud ring netted 29 arrests in Osceola County, Florida. On December 13, 2012. Osceola County Investigative Bureau (OCIB) agents, along with the Osceola County Sheriff’s Office, Kissimmee Police Department and St. Cloud Police Department conducted an operation nicknamed “Rx Printshop,” according to a press release from the Osceola County Sheriff’s Department.

Click here to read the entire press release from the Osceola County Sheriff’s Department.

Alleged Criminals Getting Phony Prescriptions Filled at Legitimate Pharmacies.

According to the Osceola County Sheriff’s Department, operation “Rx Printshop” targeted a group of people who printed fake prescriptions for painkillers, including oxycodone. The individuals involved would fill the prescriptions at legitimate pharmacies. The pills would then be sold illegally on the streets, according to the sheriff’s department. The people filling the phony prescriptions would be paid with the fraudulently obtained pills for their roles in pretending to be patients.

Those filling the prescriptions are nicknamed “smurfs.” They are usually hired by a drug ring. They return the pills from the prescriptions they get filled back to the ring-leaders. To read a blog on a similar raid in Polk County, click here.

29 People Arrested – More to Come.

According to CF News 13, the phony prescriptions were written using the DEA numbers of unknowing physicians. The physicians apparently have nothing to do with the scheme.

Agents allegedly arrested 29 suspects on felony warrants. Most of them will be charged with conspiracy to traffic drugs, in addition to obtaining prescriptions by fraud, according to CF News 13. Agents are still looking for four suspects who have similar arrest warrants outstanding.

Click here to see a list of those arrested in operation “Rx Printshop,” and those suspects still on the run.

Contact Health Law Attorneys Experienced with Representing Pharmacists and Pharmacies.
The attorneys of The Health Law Firm provide legal representation to physicians, pharmacists and pharmacies in Department of Health (DOH) investigations, Drug Enforcement Administration (DEA) investigations, FBI investigations, administrative hearings and other actions involving 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?

As a pharmacist, how do you verify prescriptions you receive are legitimate? As a physician, how do you keep your DEA number safe? Please leave any thoughtful comments below.

Sources:

CF News 13. “29 People Busted in Fake Prescription Sting.” CF News 13. (December 14, 2012). From: http://www.cfnews13.com/content/news/cfnews13/news/article.html/content/news/articles/cfn/2012/12/14/_29_people_busted_in.html

Weiner, Jeff. “Fake-Prescription Ring Busted in Sting.” Orlando Sentinel. (December 15, 2012). From: http://articles.orlandosentinel.com/2012-12-14/news/os-prescription-sting-arrests-osceola-20121214_1_prescription-fraud-fraudulent-prescriptions-oxycodone-and-other-drugs

Osceola County Sheriff’s Office. “OCIB Arrests 29 in Operation Rx Printshop.” Osceola County Sheriff’s Office. (December 14, 2012). From: http://www.osceolasheriff.org/sheriff/113-22016-0/ocib_arrests_29_in_operation_rx_printshop.cfm

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.

Government Discovers Extensive Overbilling of Cancer Drug to Medicare

Lance Leider headshotBy Lance O. Leider, 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

It’s no surprise that the government is aggressively pursuing Medicare fraud. Recently, the Department of Health and Human Services (HHS), Office of Inspector General (OIG), made a surprising discovery. An audit uncovered that more than three-quarters (3/4) of all Medicare claims for the breast-cancer drug Herceptin were billed incorrectly, according to Modern Healthcare. This was found during an audit conducted on physicians and hospitals from around the country between January 1, 2008, and December 31, 2010.

To read the entire Modern Healthcare article, click here.

Audit Results from Around the Country.

Three different audits were released to the public by the HHS OIG. All of these audits showed roughly the same information. Health care providers have been billing Medicare for full multiuse vials of the drug Herceptin, when patients actually only need a smaller portion. Medicare does not pay healthcare providers for any part of the drug that is discarded, because it can be preserved for up to 28 days and reused. The auditors suggest that payment from Medicare for an entire multiuse vial is likely to be incorrect. We saw a similar situation with the drug Avastin and Lucentis being used by ophthalmologists several years ago.

The results of the audits were released in January 2013. One audit found eighty-five percent (85%) of 1,073 Herceptin vials used in Ohio and Kentucky were billed incorrectly. In Illinois, Indiana, Michigan and Wisconsin, the government auditors found that seventy-eight (78%) of 713 claims investigated were wrong. The overpayment amount was around $682,000, for these audits.

Florida’s District Found to Have Overcharged 78% of Bills.

According to the report, HHS auditors found overcharges in seventy-eight percent (78%) of bills for 1,330 vitals of Herceptin submitted to First Coast Service Options, Inc. This company serves as the Medicare Administrative Contractor (MAC) for HHS District Nine, which primarily includes providers in Florida, Puerto Rico, and the U.S. Virgin Islands. The overcharges for Herceptin were $1,325,409.

In the report, the government recommends that First Coast Service Options, Inc., do a number of things. The first is to recover the more than one million dollars in overpayments. It’s also recommended that First Coast Service Options, Inc., implement system edits that review multiuse vial drugs that are billed with units of service equivalent to the dosage of an entire vial. The government also suggests that these audit results be used as an educational tool for teaching correct billing practices to physicians and hospitals.

Click here to read the entire report on District Nine.

How to Respond to a Medicare Audit.

Remember, there is no such thing as a “routine” Medicare audit. The fact is that if you find yourself or your practice at the center of a Medicare audit, there is some item you have claimed as a Medicare provider or the amount of claims Medicare has paid in a certain category that has caused the audit. We’ve come up with a list of actions that we use and recommend you take when responding to a Medicare audit. Click here to view that list.

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

The best time to respond to and defeat an allegation of overpayment is at the very beginning. That is why it is essential that you obtain qualified counsel to help you through the process. 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?

Why do you think hospitals and physicians incorrectly bill for Herceptin? Are audits like these necessary? Please leave any thoughtful comments below.

Sources:

Carlson, Joe. “OIG Finds Widespread Herceptin Overcharges.” Modern Healthcare. (January 21, 2013). From: http://www.modernhealthcare.com/article/20130121/NEWS/301219959/oig-finds-widespread-herceptin-overcharges

Jarmon, Glorida. “The Medicare Contractor’s Payments to Providers in Jurisdiction 9 for Full Vials of Herceptin were often Incorrect.” Office of Inspector General (January 2013). From: http://www.thehealthlawfirm.com/uploads/Herceptin%20FL%20Overcharges.pdf

About the Authors: Lance O. Leider 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.

Medical Negligence – An Accidental Overdose of Prescription Pain Pills Can Lead to Lawsuits

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

In February 2009, a 30-year-old male patient was prescribed, all together, 180 pills of Dilaudid and Xanax from a South Florida pain clinic. Sometime within the next 24 hours the patient died of what medical examiners ruled an overdose. According to the American Association for Justice, the patient’s family then sued the pain management clinic alleging the clinic’s physician prescribed a lethal overdose of the drugs and the defendant was liable for damages resulting from the patient’s murder. In the lawsuit, the jury awarded the plaintiff more than $5.33 million.

Physicians and Business Owners Liable for Medical Negligence.

According to an article in American Medical News, of the pharmaceutical-related overdoses in 2010, seventy-four percent (74%) were unintentional. As prescription drug overdoses rise across the country, we are seeing some physicians and business owners held liable for medical negligence.

For example, in May 2012, an Alabama jury ruled a widower to receive $500,000 after he sued his wife’s physician. His wife died of an accidental overdose after being prescribed a number of narcotic pain medications. In April 2012, a woman was awarded $1.9 million after she sued her family physician claiming he over prescribed her methadone, which led to brain damage after she stopped breathing, according to American Medical News.

Click here to read the entire article from American Medical News.

Protecting Your Business and License.

Health care professionals need to pay close attention to patients who request pain medication. Being proactive about prescription management can also deter lawsuits or help in doctors’ defense if they are sued. Physicians must make sure their records meet all requirements of state laws and regulations. In cases where a patient has been “doctor-shopping” in order to abuse pain pills, we see state disciplinary investigations initiated against each physician who prescribed that individual medication. In most cases, these physicians were unaware of the other prescribers. Disciplinary actions such as these can often be defended when the physician has taken the proper safeguards.

Click here to read legal tips for physicians to manage pain patients.

Drug Monitoring Programs are Here to Stay.

The growing epidemic has some states developing drug monitoring programs to track drug seekers.

In Florida, a bill that would require doctors to check with the state’s drug database before writing a prescription for addictive medications passed in a House panel on March 19, 2013. Recently, legislators in California, Pennsylvania and Kentucky are contemplating moves to tighten monitoring and prescribing of controlled substances. Click here to read a blog on the possible new actions in these states.

Health professionals should take note, these prescription drug monitoring programs can, and will be, used as a prosecution tool.

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, 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?

Do you think physicians and business owners should be held liable for medical negligence in cases of an accidental overdose? Please leave any thoughtful comments below.

Sources:

Department of Justice. “Thirty-Two Indicted in Broward and Palm Beach Counties in Second Coordinated Pill Mill Takedown.” Department of Justice. (August 23, 2011). From: http://www.justice.gov/usao/fls/PressReleases/110823-04.html

Gallegos, Alicia. “Physician Liability: When an Overdose Brings a Lawsuit.” American Medical News. (March 4, 2013). From: http://www.thehealthlawfirm.com/uploads/AMN_Overdose%20Lawsuits.PDF

LaMendola, Bob. “Pain Clinic Boss Jeffrey George Pleads Guilty to Murder.” Sun Sentinel. (August 29, 2011). From: http://articles.sun-sentinel.com/2011-08-29/health/fl-hk-jeff-george-pleads-guilty-20110829_1_pain-clinic-cynthia-cadet-george-twins

About the Authors: 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.

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.

 

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.

New York-Based MRI Company to Pay $3.57 Million Settlement to Resolve False Claims Act Allegations in Whistleblower/Qui Tam Case

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 August 27, 2013, the Department of Justice (DOJ) announced a settlement between the government and New York-based Imagimed LLC, its former owners and its former chief radiologist. This $3.57 million settlement resolves whistleblower/qui tam allegations of false reimbursement claims for radiology scans. The payment also settles accusations that the company violated the Stark Law and the Anti-Kickback Statute.

Click here to read the press release from the DOJ.

Imagimed owns and operates 15 magnetic resonance imaging (MRI) facilities under the name Open MRI.

MRI Company Accused of Not Following Proper Safety Precautions and Committing Health Care Fraud.

According to the DOJ, from July 2001 through April 2008, Imagimed, the company’s former owners and the former chief radiologist submitted claims to Medicare, Medicaid and TRICARE for MRI scans performed with a contrast dye without the direct supervision of a qualified doctor, as required by federal regulations.

The DOJ also alleges that from July 2005 to April 2008, Imagimed also had sham on-call arrangements with, and gave improper gifts to referring physicians, which is in violation of the Stark Law and the Anti-Kickback Statute.

Local Radiologist Blew Whistle and Receives a Cut of the Settlement.

According to the Associated Press, a local radiologist filed the lawsuit against Imagimed under the False Claims Act. The radiologist will receive $565,500 for coming forward. To read the Associated Press article, click here.

Whistleblowers stand to gain substantial amounts, sometimes as much as thirty percent (30%), of the amount the government recovers under the False Claims Act (31 U.S.C. Section 3730). Such awards encourage employees and contractors to come forward and report fraud. To learn more on whistleblower cases, read our two-part blog. Click here for part one, and click here for part two.

Most Qui Tams Filed by Doctors, Nurses and Employees.

From our review of qui tam cases that have been unsealed by the government, it appears most of these are filed by physicians, nurses or hospital staff employees who have some knowledge of false billing or inappropriate coding taking place. Normally the government will want to see some actual documentation of the claims submitted by the hospital or other institution. Usually physicians, nurses or staff employees have access to such documentation. Whistleblowers are urged to come forward as soon as possible. In many circumstances, documentation that shows the fraud “disappears” or cannot be located once it is known that a company is under investigation.

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

Attorneys with The Health Law Firm also represent health care professionals and health facilities in qui tam or whistleblower cases both in defending such claims and in bringing such claims. We have developed relationships with recognized experts in health care accounting, health care financing, utilization review, medical review, filling, coding, and other services that assist us in such matters. We have represented doctors, nurses and others as relators in bringing qui tam or whistleblower cases, as well.

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

Comments?

Individuals working in the health care industry 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. Has this ever happened to you? Please leave any thoughtful comments below.

Sources:

Department of Justice. “MRI Diagnostic Testing Company, Imagimed LLC, and Its Former Owners and Chief Radiologist to Pay $3.57 Million to Resolve False Claims Allegations.” Department of Justice. (August 27, 2013). From: http://www.justice.gov/opa/pr/2013/August/13-civ-958.html

Associated Press. “Federal Authorities Settle MRI Case for $3.75M.” The Wall Street Journal. (August 29, 2013). From: http://online.wsj.com/article/APcf5d7d677786468bb9d446b6c3082e5d.html?KEYWORDS=medicare

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.

Adventist Health System Settles Whistleblower Lawsuit

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

On December 18, 2013, Adventist Health System/Sunbelt Inc., the parent company of Orlando-based Florida Hospital, settled a whistleblower lawsuit, according to court documents. The whistleblower lawsuit, filed in 2010, stated that seven Adventist hospitals in Florida overbilled the federal government between 1995 and 2009, allegedly resulting in tens of millions of dollars in false claims, according to an article in the Orlando Sentinel and other sources.

Click here to read the Order of Dismissal.

Previous reports from the Orlando Sentinel stated that the lawsuit could have damages of more than $100 million, but the details of the settlement are not yet available.

Alleged Details in the Case Against Adventist Health System.

The lawsuit claims that seven Adventist hospitals in Florida allegedly used improper coding to overbill Medicare, Medicaid and Tricare. In addition, the lawsuit alleges the hospitals also overbilled for a drug used in MRI scans and billed for computer analyses that were never performed.

The plaintiffs are a bill-coding and compliance officer, and a radiologist that were either employed or affiliated with Florida Hospital Orlando between 1995 and 2009. They allege the discrepancies occurred during those years.

To read the entire False Claims Act complaint filed, click here.

Hospitals that allegedly partook in the overbilling include: Florida Hospital Orlando, Florida Hospital Altamonte, Florida Hospital East Orlando, Florida Hospital Apopka, Florida Hospital Celebration Health, Florida Hospital Kissimmee and Winter Park Memorial Hospital.

This case was scheduled to go to trial in December 2013.

Click here to read more on this case from my previous blog.

Most Qui Tam Claims Filed by Employees.

From our review of qui tam cases that have been unsealed by the government, it appears most of these are filed by physicians, nurses or hospital staff employees who have some knowledge of false billing or inappropriate coding taking place. Normally the government will want to see some actual documentation of the claims submitted by the hospital or other institution. Usually physicians, nurses or staff employees have access to such documentation. Whistleblowers are urged to come forward as soon as possible. In many circumstances, documentation that shows the fraud “disappears” or cannot be located once it is known that a company is under investigation.

To learn more on whistleblower/qui tam cases, read our two-part blog. Click here for part one, and click here for part two.

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

Attorneys with The Health Law Firm also represent health care professionals and health facilities in qui tam or whistleblower cases both in defending such claims and in bringing such claims. We have developed relationships with recognized experts in health care accounting, health care financing, utilization review, medical review, filling, coding, and other services that assist us in such matters. We have represented doctors, nurses and others as relators in bringing qui tam or whistleblower cases, as well.

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

Comments?

Individuals working in the health care industry 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. Has this ever happened to you? Please leave any thoughtful comments below.

Sources:

Aboraya, Abraham. “Adventist Health Whistleblower Lawsuit Settled.” Orlando Business Journal. (December 19, 2013). From: http://www.bizjournals.com/orlando/blog/2013/12/adventist-health-whistleblower-lawsuit.html

United States of America and State of Florida ex rel., Amanda Dittman and charlotte Elenberger, M.D. vs Adventist Health System/Sunbelt, Inc. Case No. 6:10-cv-1062-Orl-28GJK. Order of Dismissal. (December 18, 2013). From: http://assets.bizjournals.com/orlando/pdf/document.pdf

Jameson, Marni. “Whistleblower Lawsuit Alleges Florida Hospital Filed Millions in False Claims.” Orlando Sentinel. (August 8, 2012). From: http://articles.orlandosentinel.com/2012-08-08/health/os-whistleblower-lawsuit-florida-hospital-20120808_1_adventist-health-suit-claims-whistleblower-lawsuit

Amanda Dittman and Charlotte Elenberger, M.D. v. Adventist Health Systems/Sunbelt, Inc. No. 6:10-cv-01062-JA-GJK. False Claims Act Complaint. (July 15, 2010). From: http://www.thehealthlawfirm.com/uploads/whistleblower-lawsuit-adventist.pdf

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.

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