Department of Health

Florida Pharmacy Allegedly the Cause of Eye Infection Outbreak

The Centers for Disease Control (CDC) has allegedly traced a rare fungal infection to an Ocala pharmacy, according to media reports. As reported, Franck’s Compounding Lab is believed to be at least partially responsible for spreading a rare fungal eye infection to over 30 patients across the U.S.

The CDC reports that eye drops and injections traced back to the lab caused the infections. These ophthalmic products contained multiple fungal and bacterial species, according to the CDC. The products have now been recalled, but were in use for over a year before the recall. The CDC has also issued a warning to avoid any product labeled sterile from Franck’s.

The patients impacted by the contaminated products had all undergone some type of eye procedure in which the Franck’s products were used. 23 patients have allegedly suffered some vision loss as a result of the infection.

The Florida Department of Health (DOH) has stated that it cannot divulge if Franck’s or any other pharmacy is being investigated at this time. If the pharmacy is believed to pose an immediate threat to patient safety, the DOH could issue an emergency suspension order (ESO) to immediately suspend the pharmacy’s license.

Franck’s has released a statement saying that the pharmacy is fully cooperating with the DOH and FDA. Franck’s says it is currently cooperating to conduct product recalls and will assist in post-recall inspections to prevent future occurrences.

This is not the first time that this Central Florida pharmacy has made headlines. In 2009, the pharmacy was blamed for the deaths of over twenty polo horses in south Florida. This was also allegedly caused by a contaminated compound. Because of this case, the FDA tried to stop Franck’s from compounding veterinary products.

However, Franck’s won in U.S. District Court when United States v. Franck’s Lab, Inc. was decided in December 2011. In this case, the federal court ruled that the FDA does not have the authority to regulate the practice of pharmacists compounding veterinary prescriptions from bulk substances. The decision in favor of the pharmacy can be found here.

The Health Law Firm represents pharmacists and pharmacies in investigations, regulatory matters, licensing issues, litigation, inspections and audits. It’s attorneys include those who are board certified by The Florida Bar in Health Law as well as licensed health professionals who are also attorneys.

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

Sources Include:

Associated Press. “CDC Links Eye Infections to Troubled Florida Pharmacy.” Fox News.com. (May 04, 2012). From
http://www.foxnews.com/health/2012/05/04/cdc-links-eye-infections-to-troubled-florida-pharmacy/#ixzz1tvHCA4yg

CBS News Staff. “Rare Fungal Eye Infections Tied to Fla. Pharmacy, CDC Warns.” CBS News. (May 04, 2012). From:
http://www.cbsnews.com/8301-504763_162-57427915-10391704/rare-fungal-eye-infections-tied-to-fla-pharmacy-cdc-warns/

Medina, Carlos E. “Eye Infections Linked to Ocala’s Franck’s Compounding Lab.” The Gainesville Sun. (May 03, 2012) From
http://www.gainesville.com/article/20120503/ARTICLES/120509811?tc=ar

United States v. Franck’s Lab, Inc., No. 5:10-cv-147-Oc-32TBS (M.D. Fla., Sept. 12, 2011).

WFTV. “Ocala Pharmacy Blamed for Dozens of People Suffering Vision Loss.” WFTV.com. (May 04, 2012). From
http://www.wftv.com/news/news/local/ocala-pharmacy-blamed-dozens-people-suffering-visi/nNWCR/

American Hospital Association (AHA) Sues U.S. Government for Denied Medicare Payments by RACs, ZPICs and Other Auditors

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

On November 1, 2012, the American Hospital Association (AHA) filed a lawsuit against the U.S. Department of Health and Human Services (HHS) claiming that private auditors hired to crack down on improper Medicare payments are denying hospitals millions of dollars in medically necessary care, this is according to a number of sources. The AHA is seeking a court order declaring the practice invalid, saying it violates the Medicare Act.

Four hospital systems in Michigan, Missouri and Pennsylvania have joined the AHA as plaintiffs in the suit. The suit has been filed in federal court in Washington, D.C.

To read the AHA complaint against the HHS, click here.

AHA Wants Doctors to Be Able to Focus on Patient Care.

The lawsuit alleges Recovery Audit Contractors (RACs), private auditors used by the HHS, forced hospitals to repay Medicare for the costs of in-patient services by determining that Medicare beneficiaries should have been treated as out-patients instead of being admitted into hospitals as in-patients. The services provided to out-patients are much less, of course, and the bills for out-patient services are usually much lower.

In the official press release AHA argues when patients need treatment, the first step for a doctor is to decide whether to admit the patient to the hospital or to provide care in an out-patient facility. AHA believes doctors’ decisions are often more complicated for Medicare beneficiaries because the doctor is routinely second-guessed by RACs months or even years later. The president and CEO of AHA said this practice is “indefensible.”

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

Neither the Centers for Medicare and Medicaid (CMS) nor the Department of HHS has commented on the pending litigation.

AHA Fed Up with Redundant Audits that Drain Time, Funding and Patient Care.

In October 2012, prior to the lawsuit, the executive vice president of the AHA wrote a letter to the Office of Inspector General (OIG) in response to the Work Plan for Fiscal Year 2013. In the work plan the OIG reviewed the effectiveness of various Medicare contractors, including RACs, Medicare Administrative Contractors (MACs) and Zone Program Integrity Contractors (ZPICs).

The letter states that these programs auditing payment accuracy are well intentioned, but hospitals are fed up with the RACs’ inaccuracy in determining whether the hospital received any overpayments. The letter also claims that hospitals are overwhelmed by the significant overlap and duplication of efforts between the RACs, MACs and ZPICs. These redundant audits drain time, funding and attention to patient care, according to the AHA.

According to the OIG review, hospitals reported appealing more than forty percent (40%) of all RAC denials, with a seventy-five percent (75%) success rate in the appeals process.

Click here to read the letter from the AHA to the OIG.

How to Take Action Once a Notice of a Medicare Audit Has Been Received.
When a physician, medical group or other healthcare provider receives a notice of an audit and site visit from a RAC, MAC or ZPIC, things happen fast with little opportunity to prepare. To help, read our checklist of what to do when notified of a Medicare or ZPIC audit. Click here for part one and click here for part two.

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

The attorneys of The Health Law Firm represent healthcare providers in Medicare audits, ZPIC audits and RAC audits throughout Florida and across the U.S. They also represent physicians, medical groups, nursing homes, home health agencies, pharmacies, hospitals and other healthcare providers and institutions in Medicare and Medicaid investigations, audits, recovery actions and termination from the Medicare or Medicaid Program.

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

Comments?

What you think about the lawsuit again the HHS? Do you support AHA’s decision to question the RACs’ auditing system? Please leave any thoughtful comments below.

Sources:

Mitchell, Alicia. “Hospitals Sue Federal Government for Unfair Medicare Practices.” American Hospital Association. (November 1, 2012). Press Release from: http://www.thehealthlawfirm.com/uploads/AHA%20Sues%20Govnt%20PR.pdf

Pollack, Richard. “Letter: AHA Supports OIG Review of Effectiveness of Medicare Contractors, Including RACs, In 2013 Work Plan.” American Hospital Association. (October 24, 2012). Letter from: http://www.thehealthlawfirm.com/uploads/AHA%20letter%20to%20OIG%20on%20RACs.pdf

Morgan, David. “Hospitals Sue Government Over Private Medicare Audits.” Reuters. (November 1, 2012). From: http://uk.reuters.com/article/2012/11/01/us-usa-healthcare-medicare-idUKBRE8A01BZ20121101

Harris, Andrew. “American Hospital Association Sues U.S. Over Medicare.” Bloomberg. (November 1, 2012). From: http://www.bloomberg.com/news/print/2012-11-01/american-hospital-association-sues-u-s-over-unpaid-medicare.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.

Some Providers Billing PIP Claims No Longer Exempt From Health Care Clinic Act

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

Some health care providers that were previously exempt from the requirements of the Health Care Clinic Act are now required to obtain a Health Care Clinic license in order to bill for care provided to their patients injured in car accidents.

The original purpose of the Health Care Clinic Act was to regulate health care entities that were not owned by licensed health care providers. Entities that were owned by licensed health care providers were exempt from the Health Care Clinic license requirements because those health care providers were already regulated by the Department of Health (DOH).

Effective January 1, 2013, the law changed so that every health care provider that bills personal injury protection (PIP) insurance carriers is now required to obtain a Health Care Clinic license unless the provider is exempt from that requirement under the PIP statute. The only health care providers that are still exempt under the PIP statute are medial doctors, osteopathic doctors, chiropractic doctors, and dentists. Physical therapists, nurse practitioners and doctors of podiatry must be licensed as Health Care Clinics in order to bill PIP insurance carriers. Acupuncture doctors and massage therapists are now completely prohibited from billing PIP insurance carriers.

Additional Requirements on Health Care Clinics.

The PIP statute also imposes additional requirements on Health Care Clinics before those clinics can bill PIP insurance carriers. In order to bill PIP, a Health Care Clinic must be:

A health care clinic licensed under Part X of Chapter 400, Florida Statutes, and is accredited by an accrediting organization whose standards incorporate comparable regulations required by this state, or

1. Has a medical director licensed under chapter 458, chapter 459, or chapter 460;
2. Has been continuously licensed for more than three years or is a publicly traded corporation that issues securities traded on an exchange registered with the United States Securities and Exchange Commission as a national securities exchange; and
3. Provides at least four of the following medical specialties:

a. General medicine
b. Radiography
c. Orthopedic medicine
d. Physical medicine
e. Physical therapy
f. Physical rehabilitation
g. Prescribing or dispensing outpatient prescription medication
h. Laboratory services.

Click here to read 627.736(1)(a)2e, Florida Statutes.

PIP Insurance Carriers Might Deny Claims.

The Florida PIP statute also provides that a physical therapist can provide follow-up care upon the referral by a physician, which conflicts with the new Health Care Clinic license requirements in other parts of the statute. Several PIP insurance carriers are denying provider claims and demanding refunds based upon their own interpretations of these changes. A health care provider that receives denials, or demands for refunds should immediately contact an attorney experienced in these matters.

Contact Experienced Health Law Attorneys.

The Health Law Firm routinely represents pharmacists, pharmacies, physicians, nurses and other health providers in investigations, regulatory matters, licensing issues, litigation, denials and demands for repayment from insurance companies, 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.

Comments?

Were you aware for the changes to the Health Care Clinic Act? Were you previously exempt and now required to obtain a Health Care Clinic license? Please leave any thoughtful comments below.

About the Author: 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. http://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 © 1996-2014 The Health Law Firm. All rights reserved.

In Florida You Have Fifth Amendment Rights in a Department of Health Investigation of Your License

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

If you are contacted by a Florida Department of Health investigator, did you know that you are not required to make a statement or give any information that can be used against you?  If you are being investigated you have a right to refuse to speak with an investigator pursuant to the Fifth Amendment of the U.S. Constitution and the equivalent rights given by the Florida Constitution, Article 1, Section 9.  However, because the Miranda decision does not apply to administrative proceedings, including licensure investigations, the DOH investigator does not have to inform you of this.

In some states other than Florida, the state’s law is such that a nurse, physician, dentist or other licensed health care professional is required to “cooperate” with the investigation, even though he or she may be punished or lose their license as a result.  THIS IS NOT THE CASE IN FLORIDA.

Florida Licensing Investigations Are Considered to Be “Penal” or “Quasi-criminal” in Nature.

Florida licensing investigations are considered to be “penal” or “quasi-criminal” in nature.  In Florida, a professional’s license is considered to be a property right.  So you also have the constitutional right not to be deprived of it without due process of law.  Due Process of law is guaranteed not only by the Florida and U.S. constitutional provisions cited above, but also by the Fourteenth Amendment of the U.S. ConstitutionDue process of law includes the right to be represented by an attorney in any proceedings that might be initiated that may result in your losing your license.

In Florida, a long history of legal cases has resulted in the common law rule that administrative proceedings that may result in loss of a license must afford all of the protections that a criminal defendant would have in a criminal case.

Case Law in Florida.

In a 2004 case involving the Florida Department of Health, the Florida First District Court of Appeal stated:

Initially, it should not be forgotten that because professional disciplinary statutes are penal in nature, they must be strictly construed with any ambiguity interpreted in favor of the licensee. See Ocampo v. Dep’t of Health, 806 So. 2d 633, 634 (Fla. 1st DCA 2002);  Elmariah v. Dep’t of Prof. Reg., Board of Med., 574 So. 2d 164 (Fla. 1st DCA 1990).

Cone v. Dep’t of Health, 886 So. 2d 1007, 1011 (Fla. 1st DCA 2004).

The Florida Supreme Court confirmed that a licensee could assert a Fifth Amendment right in administrative proceedings in the 1973 case of State ex rel. Vining v. Florida Real Estate Commission, 281 So.2d 487 (1973).

In Vining a real estate broker was charged by the Florida Real Estate Commission of violating the Real Estate License Law.  Id. at 488.  The broker filed a sworn answer, as he was required to do under Florida Statute Section 475.30(1).  Id.  The broker later argued that the Florida statute violated his right against self-incrimination as guaranteed by the Fifth Amendment to the U.S. Constitution and Article I, Section 9 of the Florida Constitution.  Id.

The Florida Supreme Court agreed, holding that “the right to remain silent applies not only to the traditional criminal case, but also to proceedings ‘penal’ in nature in that they tend to degrade the individual’s professional standing, professional reputation or livelihood.”  Id. at 491 (citing Spevack v. Klein, 385 U.S. 511, 87 S.Ct. 625, 17 L.Ed.2d 574 (1967);  Stockham v. Stockham, 168 So. 2d 320 (Fla. 1964)).  More recently, courts have reaffirmed that Vining remains good law in Florida.  See Best Pool & Spa Service Co., Inc. v. Romanik, 622 So. 2d 65, 66 (Fla. 4th DCA 1993);  Scott v. Department of Professional Regulation, 603 So. 2d 519, 520 (Fla. 1st DCA 1992).

In Best Pool & Spa Service Co., Inc. v. Romanik, 622 So. 2d 65, 66 (Fla. 4th DCA 1993), for example, the Court of Appeal reiterated the ability of a defendant to claim the Fifth Amendment privilege in an administrative proceeding.  Best Pool involved a pool owner filing actions for negligence and breach of contract against a pool maintenance contractor and its president.  The circuit court required the president to answer questions at his deposition about his certifying to the county, in an application for license, that the contractor had liability insurance.  The Court of Appeal ruled that the president was allowed to assert his Fifth Amendment privilege with regard to questions on this issue.  The court stated in Best Pool: “requiring Kassover, the president, to answer these questions does violate his right against self incrimination, which applies not only to criminal matters but also administrative proceedings such as licensing.  Id. at 66.

There are many other cases which have held the same.

You Must Be Extremely Cautious When Dealing with a DOH Investigator or Any Investigator.

If you receive notice that a DOH disciplinary investigation has been opened against you, you may not even realize it or understand how serious the consequences may be.  The notice comes in the form of a simple letter or, more often nowadays, a phone call, followed by a letter.  The letter will be on Florida Department of Health letterhead and will, in most cases,  be signed by a person whose job title is “Medical Malpractice Investigator,” “Quality Assurance Investigator” or some other title that might throw you off.

If you think you are giving information to be used in connection with a true quality assurance matter, such as would be confidential and privileged in a hospital or health institution, think again.  This is an investigation that could result in your having to pay thousands of dollars in fines, thousands of dollars in investigative costs and suspension or loss of your license.  Worse yet are the other consequences that having discipline on your professional license will bring, including difficulty in obtaining employment, reports being made to national data banks, etc.  Please see some of the other articles we have on our blog and on our website about all of the unforeseen consequences of discipline on your license.

Have You Been Told the Investigation Is Not Aimed at You?  Watch Out!

Even if the investigator attempts to ensure you that the investigation is not aimed at you, watch out!  It may not be aimed at you today, but it may be aimed at you tomorrow.  Additionally, even if the particular investigation that you are being questioned about is not directed against you, there may be another investigation that has been opened against you.  Your statement can and will be sued against you in that other investigation.

I was told by a DOH investigator one time that my clients (who were a director of nursing (DON), assistant director of nursing (ADON), an administrator and a medical director) were not being investigated, but that another health professional was.  My clients cooperated and gave statements for use in the investigation of the other person.  A short time later, additional investigations were opened against all of them, too.  Fortunately we eventually had all of the charges against all of them dismissed.  But I have not trusted investigators since then.

Don’t Wait Until it is Too Late; Consult with a Health Law Attorney Experienced in Representing Health Professionals Now.

The lawyers of The Health Law Firm routinely represent nurses, ARNPs, CRNAs, physicians, dentists, pharmacists, psychologists, mental health counselors, social workers, massage therapists, medical groups, clinics, pharmacists, pharmacies, home health agencies, nursing homes, assisted living facilities, and other healthcare providers in licensing investigations, regulatory matters, in board actions and in administrative hearings.  Call now at (407) 331-6620 or (850) 439-1001 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 the Orlando, Florida, area.  www.TheHealthLawFirm.com  The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone:  (407) 331-6620.

Disclaimer: Please note that this article represents our opinions based on our many years of practice and experience in this area of health law. You may have a different opinion; you are welcome to it. This one is mine.  This article is for informational purposes only; it is not legal advice.

Fake Pharmacist Sentenced to Prison for Working in Central Florida Pharmacies

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

On November 2, 2012, a former Altamonte Springs resident was sentenced to three and a half years in federal prison for fraudulently working as a Central Florida pharmacist from 2000 to 2009, according to the Department of Justice (DOJ).

Click here to read the press release from the DOJ.

I previously blogged about this story when the fake pharmacist pleaded guilty. Click here to read that blog.

Phony Pharmacist Worked at Central Florida Pharmacies Including CVS and Walgreens.

According to an article in the Orlando Sentinel, the man worked at pharmacies throughout Central Florida, including a CVS and a Walgreens. While working at one of the pharmacies, he allegedly gave a customer the incorrect medication, causing that person to suffer a stroke.

Man Will Spend Time in Prison and Must Change His Name.

Allegedly, the man fraudulently obtained a pharmacy license in September of 2000

from the Florida Department of Health (DOH) by using the name, date of birth, Social Security number and pharmacy education information of a licensed pharmacist in Arizona. In 2004 the man actually changed his legal name by fraud to the name of the licensed pharmacist.

Along with his prison sentence, the fake pharmacist was ordered to change his name back to his legal name.

Fun with Alliteration.

Pardon my alliteration, but I just love all of those “F” sounds like I used in the title for this blog. For comparison, see my blog on Franck’s Pharmacy fungus case.

Look for More Stories on Phony and Fraudulent Health Professionals to Come.

In the near future on this blog we will include additional articles on fake doctors and health professionals, some old, some new.

To see a recent blog on a fake dentist in Miami, click here. You can also read the story of a fake plastic surgeon in New York by clicking here.

Contact Health Law Attorneys Experienced with Representing Pharmacists and Pharmacies.

The attorneys of The Health Law Firm provide legal representation to pharmacists and pharmacies in Department of Health (DOH) investigations, Drug Enforcement Administration (DEA) investigations, FBI 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?

What do you think of all the fake health provider stories? Please leave any thoughtful comments below.

Sources:

FBI.gov. “Pharmacist Impersonator Sentenced to Prison and Ordered to Change His Name.” FBI, Tampa Division. (November 1, 2012). From Press Release: http://www.fbi.gov/tampa/press-releases/2012/pharmacist-impersonator-sentenced-to-prison-and-ordered-to-change-his-name

Pavuk, Amy. “Fake Pharmacist Sentenced to Federal Prison.” Orlando Sentinel. (November 1, 2012). From: http://www.orlandosentinel.com/news/local/breakingnews/os-fake-pharmacist-prison-20121101,0,4565731.story
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.

OIG Audit Finds Federal Database of Terminated Medicaid Providers Needs Improvement

LLA Headshot smBy Lenis L. Archer, J.D., M.P.H., The Health Law Firm

The Affordable Care Act (ACA) requires the Centers for Medicare and Medicaid Services (CMS) to establish a process for sharing information about terminated Medicaid providers. The federal database, called Medicaid and Children’s Health Insurance Program State Information Sharing System (MCSIS), is designed to prevent terminated health care providers from billing another state’s program. However, an audit by the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG), released in March 2014, states the MCSIS is not working as intended.

The MCSIS is supposed to collect data from every state Medicaid program on providers that were terminated from Medicaid for cause. However, the report found that the HHS OIG is not receiving data from 17 states or the District of Columbia. It was also found that a majority of the data does not meet the ACA criteria.

To read the entire report from the HHS OIG, click here.

Specific Issues Within Database.

According to the OIG, only 27% of the 6,439 MCSIS records involve terminated Medicaid providers. The database is filled with providers who had not been terminated, but rather had died, retired, left the state or stopped working with Medicaid of their own accord. It is also reported that about one-third of the records are not related to for-cause provider terminations. A majority of the data comes from California, Pennsylvania, Illinois and New York. According to Reuters, more than half of the records submitted did not include a National Provider Identification number, which is critical to any state trying to identify a terminated provider.

Click here to read the entire article from Reuters.

Recommendations to Improve Database.

CMS is now exploring options to implement mandatory state reporting. The agency has begun requiring that states submit termination letters for each provider entered in the MCSIS, and that CMS employees review each letter to ensure the provider belongs in the system.

What This Means for Medicaid Providers.

As CMS works to improve this database, those providers who have fallen through the cracks due to the reporting lag will now face repercussions for exclusion. Exclusion from Medicaid could mean exclusion from Medicare and other federal providers. It is important that health care providers know their status regarding exclusion, and contact an experience attorneys to assist them in having their names removed from exclusion lists.

To read more on the devastating consequences of exclusion, click here for a previous blog.

Contact Attorneys Experienced in Defending Against Action to Exclude an Individual or Business from the Medicare or Medicaid Programs.

The attorneys of The Health Law Firm have experience in dealing with the Office of the Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS), and defending against action to exclude an individual or business entity from the Medicare or Medicaid  Programs, in administrative hearings on this type of action, in submitting applications requesting reinstatement to the Medicare Program after exclusion, and removal from the List of Excluded Individuals and Entities (LEIE).

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 health care provider, do you know your status regarding exclusion? Are you aware of the consequences of being excluded? Please leave any thoughtful comments below.

Sources:

Pell, M.B. “U.S Database for Tracking Medicaid Fraud Fall Short, Auditor Says.” Reuters. (March 27, 2014). From: http://www.reuters.com/article/2014/03/27/us-usa-medicaid-database-idUSBREA2Q08D20140327

Levinson, Daniel. “CMS’s Process for Sharing Information About Terminated Providers Needs Improvement.” Department of Health and Human Service Office of Inspector General. (March 2014). From: http://oig.hhs.gov/oei/reports/oei-06-12-00031.pdf

About the Author: Lenis L. Archer is as 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 © 1996-2014 The Health Law Firm. All rights reserved.

The 25 Biggest Mistakes Physicians Make After Being Notified of a Department of Health Complaint

The investigation of a complaint which could lead to the revocation of a physician’s license to practice medicine and the assessment of tens of thousands of dollars in fines, usually starts with a simple letter from the Department of Health (DOH).  This is a very serious legal matter and it should be treated as such by the physician who receives it.  Yet, in many cases, attorneys are consulted by physicians after the entire investigation is over, and they have attempted to represent themselves throughout the case.  Often, the mistakes that have been made severely compromise an attorney’s ability to achieve a favorable result for the physician.

These are the 25 biggest mistakes we see in the physician cases we are called upon to defend after a DOH investigation has been initiated:

  1. Failing to keep a current, valid address on file with the DOH (as required by law), which may seriously delay the receipt of the Uniform Complaint (notice of investigation), letters, and other important correspondence related to the investigation.
  2. Contacting the DOH investigator and providing him/her an oral statement or oral interview.  (Note:  There is no legal requirement to do this.)
  3. Making a written statement in response to the “invitation” extended by the DOH investigator to do so.  (Note:  There is no legal requirement to do this.)
  4. Failing to carefully review the complaint to make sure it has been sent to the correct physician (Note:  Check name and license number).
  5. Failing to ascertain whether or not the investigation is on the “Fast Track” which may then result in an emergency suspension order (ESO) suspending the physician’s license until all proceedings are concluded.  (Note:  This will usually be the case if there are allegations regarding drug abuse, alcohol abuse, sexual contact with a patient, mental health issues, or failure to comply with PRN instructions.)
  6. Providing a copy of the physician’s curriculum vitae (CV) or resume to the investigator because the investigator requested them to do so.  (Note:  There is no legal requirement to do this.
  7. Believing that if they “just explain it,” the investigation will be closed and the case dropped.
  8. Failing to submit a timely objection to a DOH subpoena when there are valid grounds to do so.
  9. Failing to forward a complete copy of the patient medical record when subpoenaed by the DOH investigator as part of the investigation, when no objection is going to be filed.
  10. Delegating the task of providing a complete copy of the patient medical record to office staff, resulting in an incomplete or partial copy being provided.
  11. Failing to keep an exact copy of any medical records, documents, letters or statements provided to the investigator.
  12. Believing that the investigator has knowledge or experience in hospital procedures, medical procedures or the health care matters or procedures being investigated.
  13. Believing that the investigator is merely attempting to ascertain the truth of the matter and this will result in the matter being dismissed.
  14. Failing to check to see if their medical malpractice insurance carrier will pay the legal fees to defend them in this investigation.
  15. Talking to DOH investigators, staff or attorneys, in the mistaken belief that they are capable of doing so without providing information that can and will be used against them.
  16. Believing that because they haven’t heard anything for six months or more the matter has “gone away.”  The matter does not ever just go away.
  17. Failing to submit a written request to the investigator at the beginning of the investigation for a copy of the complete investigation report and file and then following up with additional requests until it is received.
  18. Failing to wisely use the time while the investigation is proceeding to interview witnesses, obtain witness statements, conduct research, obtain experts, and perform other tasks that may assist defending the case.
  19. Failing to exercise the right of submitting documents, statements, and expert opinions to rebut the findings made in the investigation report before the case is submitted to the Probable Cause Panel of your licensing board for a decision.
  20. Taking legal advice from their colleagues regarding what they should do (or not do) in defending themselves in the investigation.
  21. Retaining “consultants” or other non-lawyer personnel to represent them.
  22. Believing that the case is indefensible so there is no reason to even try to have it dismissed by the Probable Cause Panel.
  23. Attempting to defend themselves.
  24. Believing that because they know someone on the Board of Medicine, with the Department of Health or a state legislator, that influence can be exerted to have the case dismissed.
  25. Failing to immediately retain the services of a health care attorney who is experienced in such matters to represent them, to communicate with the DOH investigator for them, and to prepare and submit materials to the Probable Cause Panel.

 Bonus Point:

 26. Communicating with the Department of Health about the pending case.

Not every case will require submission of materials to the Probable Cause Panel after the investigation is received and reviewed.  There will be a few where the allegations made are not “legally sufficient” and do not constitute an offense for which the physician may be disciplined.  In other cases, an experienced health care attorney may be successful in obtaining a commitment from the DOH attorney to recommend a dismissal to the Probable Cause Panel.  In other cases (usually the most serious ones), for tactical reasons, the experienced health care attorney may recommend that you waive your right to have the case submitted to the Probable Cause Panel and that you proceed directly to an administrative hearing.  The key to a successful outcome in all of these cases is to obtain the assistance of a health care lawyer who is experienced in appearing before the Board of Medicine in such cases and does so on a regular basis.

For more information, on how to respond to a DOH investigation, or other legal matters, visit our website.

Florida Cardiologist Receives Emergency Suspension Order Linked to Stem Cell Treatments

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

A Florida cardiologist recently had his medical license emergently suspended by the Florida Department of Health (DOH) for allegedly performing stem cell treatments on a patient. According to the emergency suspension order (ESO), the DOH had previously warned the doctor to stop performing these treatments in 2011. Now, his license is at risk of being revoked. To view the ESO click here.

Doctor’s License Suspended by the DOH for Allegedly Performing Stem Cell Treatments.

The DOH ordered the emergency suspension of the cardiologist’s medical license in March 2012. He is being accused of violating an emergency restriction order (ERO) against using stem cell treatments in Florida. He is also being accused of causing the death of a patient.

We want to be perfectly clear that these are just allegations being made by the DOH at this point in time. All persons are presumed to be innocent until found guilty in a court of law (or, in DOH licensure cases, in an administrative final order).

Stem Cell Treatment Allegedly Contributed to Patient’s Death.

According to the ESO, the doctor performed a stem cell treatment on a patient who had both pulmonary hypertension and pulmonary fibrosis. Both of these conditions restrict blood flow to the heart. According to the ESO, the stem cell treatment included harvesting adipose tissue from the patient’s abdomen and concentrating stem cells from the tissue in a lab. The concentrated stem cells were then infused into the patient’s bloodstream to help treat the patient’s pulmonary hypertension and pulmonary fibrosis. Allegedly, the cardiologist’s patient suffered a cardiac arrest and died during the treatment.

Doctor Now Awaits Administrative Hearing.

An administrative hearing regarding the doctor’s license suspension is scheduled for June 2012.

To view the administrative complaint issued by the DOH, click here.

To see a diagram or flow chart of the procedures followed by the Florida Department of Health, click here.

For an explanation of the differences between a formal administrative hearing and an informal administrative hearing under the Florida Administrative Procedure Act, Chapter 120, Florida Statutes, click here.

For the Florida Administrative Procedure Act, Chapter 120, Florida Statutes, click here.

Contact Health Law Attorneys Experienced with Emergency Suspensions and DOH Actions.

The attorneys of The Health Law Firm are experienced in handling all types of DOH cases, including emergency suspensions, administrative complaints, investigations, administrative hearings, investigations, licensing issues, settlements and more. If you are currently facing adverse action by the DOH contact one of our attorneys by calling (407) 331-6620 or (850) 439-1001. You can also visit our website for more information at http://www.thehealthlawfirm.com/.

Sources:

Fitzpatrick, David and Drew Griffin. “Florida Suspends Doctor Accused of Illegal Stem Cell Therapy.” CNN. (Mar. 8, 2012). From: http://www.cnn.com/2012/03/08/health/stem-cell-doctor-suspension/index.html

Miller, Reed. “Flouting Warning, Florida Stem-Cell Cardiologist has License Suspended.” theheart.org. (Mar. 8, 2012). From: http://www.theheart.org/article/1368039.do

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

Advice for All Massage Therapists: Please Talk to a Lawyer Before You Talk to the Department of Health (DOH) Investigator

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

Massage therapists, I beseech you: please do not talk to a Department of Health (DOH) investigator until you have talked to a health lawyer who is experienced with DOH investigations and board licensing complaints.  Do not answer or respond to even the most basic questions about where you work now, what your address is or if you know patient x, until consulting with counsel.

Admitting to Anything May Hurt Your Case.

We are routinely consulted by massage therapists and other healthcare providers for representation after they have discussed the case and after it is too late to undo the damage they have caused to themselves. Often they do not understand the seriousness of the matter or the possible consequences, until it is too late. Admitting to even the most basic facts causes damage to any possible defense.

Administrative Licensure Investigations are “Semi-Criminal.”

The vast majority of massage therapists and even most attorneys do not realize that DOH investigations concerning complaints against a massage therapist’s license are considered to be “penal” or “quasi-criminal” proceedings.  This means the same laws and constitutional rights apply to them as apply to criminal investigations.  However, since they are also administrative proceedings and not strictly criminal proceedings, investigators do not need to advise you of your Miranda rights or tell you you have the right to remain silent, the right to an attorney, etc.

In any criminal investigation a good criminal defense attorney would always tell you “Do not talk to the investigator” and “Tell the investigator you have a lawyer.”

How Investigators Try to Get You to Not Talk to an Attorney.

DOH investigators, police investigators, FBI investigators and other law enforcement officers, are well trained in investigative techniques and how to get information out of suspects.  Often the approach used is to catch you by surprise before you even know there is an investigation and the investigation is of you.  Another technique used is to lull you into a false sense of security that the investigation is about someone or something else and not you.  Another investigative technique is to convince you that you need to “Tell your side of the story” so that the investigation is accurate.  Yet another is that “Things will go much better for you if you cooperate.”  None of these things are true.

However, if it is truly in your best interest to cooperate or to make a statement, after you consult with your attorney, your legal counsel will surely advise you to do this.  The investigator should not mind waiting until you consult your attorney.  However, many will go to extremes to convince you that you don’t need an attorney and shouldn’t get an attorney.

Consult an Experienced Health Law Attorney.

The attorneys of The Health Law Firm are experienced in dealing with DOH investigators, AHCA surveyors, Drug Enforcement Administration (DEA) agents, FBI agents, police and sheriff’s office investigators, OIG special agents (S/As) and Medicaid Fraud Control Unit (MFCU) investigators. 

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.

Disclaimer: Please note that this article represents our opinions based on our many years of practice and experience in this area of health law. You may have a different opinion; you are welcome to it. This one is mine.

Note: This article is for informational purposes only; it is not legal advice.

“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.

In Brief: Florida Pain Management Clinic Laws

Every health profession has its own set of rules and regulations. This week, we’re examining Florida laws under which pain management clinics operate.

Because Florida has one of the worst drug trafficking problems in the country, law enforcement is making sure that punishments for any violations are severe. For example, if a patient dies of drug overdose and the prescriber is found to be responsible, he or she can be charged with homicide, which was the case for a Palm Beach County pain management physician (see this New York Times article).

The DEA, Florida Department of Health and Florida law enforcement are watching pain management clinics very closely in order to keep Florida’s drug trafficking problem under control. Make sure that your clinic abides by the following legislation, in order to prevent any interference with your practice.

The 2011 Florida Statutes

Section 458.3265, F.S.:

Definition of Pain Management Clinic:

Pain-management clinic” or “clinic” means any publicly or privately owned facility:
(I) That advertises in any medium for any type of pain-management services; or
(II) Where in any month a majority of patients are prescribed opioids, benzodiazepines, barbiturates, or carisoprodol for the treatment of chronic nonmalignant pain.

Registration:

Every pain-management clinic must register with the Florida Department of Health UNLESS:

1. That clinic is licensed as a facility pursuant to chapter 395;

2. The majority of the physicians who provide services in the clinic primarily provide surgical services;

3. The clinic is owned by a publicly held corporation whose shares are traded on a national exchange or on the over-the-counter market and whose total assets at the end of the corporation’s most recent fiscal quarter exceeded $50 million;

4. The clinic is affiliated with an accredited medical school at which training is provided for medical students, residents, or fellows;

5. The clinic does not prescribe controlled substances for the treatment of pain;

6. The clinic is owned by a corporate entity exempt from federal taxation under 26 U.S.C. s. 501(c)(3);

7. The clinic is wholly owned and operated by one or more board-certified anesthesiologists, physiatrists, or neurologists; or

8. The clinic is wholly owned and operated by one or more board-certified medical specialists who have also completed fellowships in pain medicine approved by the Accreditation Council for Graduate Medical Education, or who are also board-certified in pain medicine by a board approved by the American Board of Medical Specialties and perform interventional pain procedures of the type routinely billed using surgical codes.

Physician Responsibilities:

1. A physician may not practice medicine in a pain-management clinic, if the pain-management clinic is not registered with the department. Any physician who qualifies to practice medicine in a pain-management clinic pursuant to rules adopted by the Board of Medicine as of July 1, 2012, may continue to practice medicine in a pain-management clinic as long as the physician continues to meet the qualifications set forth in the board rules. A physician who violates this paragraph is subject to disciplinary action by his or her appropriate medical regulatory board.

2. A person may not dispense any medication on the premises of a registered pain-management clinic unless he or she is a physician licensed under this chapter or chapter 459.

3. A physician, a physician assistant, or an advanced registered nurse practitioner must perform a physical examination of a patient on the same day that the physician prescribes a controlled substance to a patient at a pain-management clinic. If the physician prescribes more than a 72-hour dose of controlled substances for the treatment of chronic nonmalignant pain, the physician must document in the patient’s record the reason for prescribing that quantity.

4. A physician authorized to prescribe controlled substances who practices at a pain-management clinic is responsible for maintaining the control and security of his or her prescription blanks and any other method used for prescribing controlled substance pain medication. The physician shall comply with the requirements for counterfeit-resistant prescription blanks in s. 893.065 and the rules adopted pursuant to that section. The physician shall notify, in writing, the department within 24 hours following any theft or loss of a prescription blank or breach of any other method for prescribing pain medication.

5. The designated physician of a pain-management clinic shall notify the applicable board in writing of the date of termination of employment within 10 days after terminating his or her employment with a pain-management clinic that is required to be registered. Each physician practicing in a pain-management clinic shall advise the Board of Medicine, in writing, within 10 calendar days after beginning or ending his or her practice at a pain-management clinic.

6. Each physician practicing in a pain-management clinic is responsible for ensuring compliance with facility and physical operations requirements

Inspection:

1. The department shall inspect the pain-management clinic annually, including a review of the patient records, to ensure that it complies with this section and the rules of the Board of Medicine.

2. During an onsite inspection, the department shall make a reasonable attempt to discuss each violation with the owner or designated physician of the pain-management clinic before issuing a formal written notification.

3. Any action taken to correct a violation shall be documented in writing by the owner or designated physician of the pain-management clinic and verified by followup visits by departmental personnel.

Penalties and Enforcement:

1. The department may impose an administrative fine on the clinic of up to $5,000 per violation for violating the requirements of this section; chapter 499, the Florida Drug and Cosmetic Act; 21 U.S.C. ss. 301-392, the Federal Food, Drug, and Cosmetic Act; 21 U.S.C. ss. 821 et seq., the Comprehensive Drug Abuse Prevention and Control Act; chapter 893, the Florida Comprehensive Drug Abuse Prevention and Control Act; or the rules of the department. In determining whether a penalty is to be imposed, and in fixing the amount of the fine, the department shall consider the following factors:

  • The gravity of the violation, including the probability that death or serious physical or emotional harm to a patient has resulted, or could have resulted, from the pain-management clinic’s actions or the actions of the physician, the severity of the action or potential harm, and the extent to which the provisions of the applicable laws or rules were violated.
  • What actions, if any, the owner or designated physician took to correct the violations.
  • Whether there were any previous violations at the pain-management clinic.
  • The financial benefits that the pain-management clinic derived from committing or continuing to commit the violation.

2. Each day a violation continues after the date fixed for termination of the violation as ordered by the department constitutes an additional, separate, and distinct violation.

3. The department may impose a fine and, in the case of an owner-operated pain-management clinic, revoke or deny a pain-management clinic’s registration, if the clinic’s designated physician knowingly and intentionally misrepresents actions taken to correct a violation.

4. An owner or designated physician of a pain-management clinic who concurrently operates an unregistered pain-management clinic is subject to an administrative fine of $5,000 per day.

5. If the owner of a pain-management clinic that requires registration fails to apply to register the clinic upon a change of ownership and operates the clinic under the new ownership, the owner is subject to a fine of $5,000.

For more information about Florida pain management clinics, visit www.TheHealthLawFirm.com.

Load More Posts
Go to Top