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Common Errors We See in Pharmacy Inspections and How to Avoid Them

George Indest HeadshotBy 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

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

Inspections may be routine and simply to confirm compliance with the law. Annual inspections by the Florida DOH are examples of these. However, inspections can also be triggered by a fear of imminent danger to the public health, safety, and welfare; a formal complaint; or the belief that a specific violation of law by the pharmacy or pharmacist has occurred or may occur.

Common Errors Found During Inspections.

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

Here are some common deficiencies often found during pharmacy inspections:

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

2.  Pharmacy technicians not supervised by pharmacist;

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

4.  Controlled substances not accurately recorded on appropriate forms;

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

6.  Failure to maintain a biennial inventory;

7.  Controlled substance records (including invoices, inventories and logs) not properly maintained for required number of years;

8.  Not having an accurate count for all controlled substances on hand;

9.  Required DEA forms not maintained, accurate or complete;

10.  Inadequate security measures (cameras, alarms, etc.);

11.  Failure to control access to secured areas;

12.  Proper pre-hire screenings not in place (background checks, references, etc.);

13.  Proper computer security measures not in place;

14.  Not properly identifying suspect controlled substance prescriptions;

15.  No corrective measures in place to ensure legitimacy of a controlled substance
prescription;

16.  Not knowing the requirements for filling a legitimate controlled substance
prescription;

17.  Refrigerator not being maintained at the appropriate temperature; and

18.  Food or other non medications (e.g., lab samples) being kept in refrigerator with medications.

Be Aware: All Pharmacies Are Subject to Inspections.

We are constantly writing blogs on pharmacies that, after inspections, get served with immediate suspension orders (ISO), emergency suspension orders (ESO), or have their controlled substance registrations revoked. This is not happening to just the smaller independent stores, but to the big chain pharmacies as well.

In a prior case, the DEA revoked the controlled substance licenses from two CVS pharmacies in Sanford, Florida. (Click here to read that blog.) This is why it is imperative for all pharmacies and pharmacists to know the state and federal laws and regulations.

Your Best Defense.

In our opinion, your best defenses are the following:

1.  Know the laws and rules and be sure they are fully implemented and followed, always, by everyone in the store.
2.  Maintain good professional liability insurance that includes coverage for legal defense of administrative complaints and complaints against your pharmacy license and your pharmacist license.  Cover should be at least $25,000 for legal defense expenses at the very minimum. Contact Lloyd’s of London or Healthcare Providers Service Organization (HPSO) if your agent can’t locate this insurance for you.

3.  Contract with a good pharmacy consultant and have him/her make frequent visits and “mock investigations.”

Talk to an Experienced Attorney Before You Talk to an Investigator.

In Florida, you do not have any duty to cooperate with any investigator who is investigating you. This extends to DOH investigators, DEA special agents, police officers, sheriffs’ deputies or criminal investigators of any type. Our advice is to always contact an experienced health law attorney before making a statement to an investigator. Click here to read a previous blog on the best practice tips for dealing with investigators.

Never voluntary relinquish your DEA registration or your pharmacy license without speaking to an experienced health law attorney first. Click here to read a blog on why this is so important.

Contact Health Law Attorneys Experienced with Investigations of Pharmacies and Pharmacists.

The attorneys of The Health Law Firm provide legal representation to pharmacies, pharmacists 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.

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.

KeyWords: Pharmacy defense lawyer, representation for pharmacies, pharmacy law defense attorney, representation for pharmacy inspections, representation for Drug Enforcement Administration (DEA), DEA investigation lawyer, DEA pharmacy investigation attorney, Food and Drug Administration (FDA) representation, FDA investigation lawyer, FDA pharmacy investigation representation, Florida Board of Pharmacy lawyer, representation for Board of Pharmacy inspections, Department of Health (DOH) representation DOH defense lawyer, DOH inspections, DOH investigators, common deficiencies in pharmacy inspection, health law defense attorney, administrative law representation,  legal defense for administrative complaints,  Florida defense attorney, Florida defense lawyer, The Health Law reviews, reviews of 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.

OIG Exclusion: Do You Know if You’re on the List?

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

Have you ever faced a disciplinary action against your professional license? Have you ever been arrested or convicted of a criminal offense? If yes, then you may have also been terminated from the federal Medicare Program or your state Medicaid Program.

Many health care professionals don’t think about the repercussions that an exclusion action by the Office of the Inspector General (OIG) can have on their professional career. Whether you are a physician, nurse, dentist, psychologist or other health professional, if you allow yourself to be excluded from the Medicare Program, devastating economic results may follow.

First, Check the List.

The first step is to check if you are on the federal government’s List of Excluded Individuals and Entities (LEIE). You can check that list here: http://exclusions.oig.hhs.gov/.

Next, to see if you are on Florida’s list of individuals and entities who have been terminated from Florida’s Medicaid Program, click here.

Collateral Consequences to OIG Exclusion or Termination.

Termination or exclusion can have many collateral consequences about which most health care professionals and providers are not aware. These Include:

– Termination for cause from all state Medicaid Programs.

– Loss of state professional licenses in other states and jurisdictions.

– Loss of hospital, ambulatory surgical center (ASC), and nursing home clinical privileges.

– Removal from the provider panels of health insurers.

– Loss of ability to contract or work for any individual or entity that contracts with the Medicare Program in any capacity. This includes physicians, medical groups, hospitals, healthcare systems, ambulatory surgical centers, skilled nursing facilities, health insurance companies, etc.

– Placement on the General Services Administration (GSA) Exclusions List (or “Debarred” List) from government contracting.

– Loss of ability to contract or work for any individual or entity that contracts with the federal government in any capacity.

To learn more on the consequences of being excluded, click here.

You’re On the List, Now What?

So, you just found yourself on a state’s excluded or terminated list or on the federal LEIE, don’t panic! All is not lost. There are ways to become reinstated.

The OIG exclusion list is a complicated regulatory program which requires experience and perseverance to navigate. It is highly recommended that you do not attempt to handle removal without qualified assistance. If your application is denied, even for hyper-technical reasons, you may be barred from reapplying for one full calendar year. Therefore, it is crucial that your application is complete and correct, and you are fully eligible for removal. To read a past blog about reinstatement after OIG removal, click here.

Contact Attorney Experienced in Defending Against Action to Exclude an Individual or Business from the Medicare Program and Assisting in Reinstatement Applications.

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 Program, 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.

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

KeyWords:  Office of Inspector General, OIG, OIG exclusion list, OIG reinstatement representation, representation for physicians, representation for physician reimbursement, licensure defense attorney, professional license representation, licensure defense representation, representation for health care professionals, investigations analyst, applying for reinstatement, application for reinstatement, Medicare exclusion attorney, OIG hearing, request for reinstatement, removal from list of excluded individuals and entities (LEIE), application to OIG, Medicare reinstatement representation, Medicaid reinstatement representation, healthcare fraud lawyers, Medicare defense attorney, Medicaid defense lawyer, Florida defense attorney, Florida defense lawyer, The Health Law Firm reviews, health law blog, OIG Exclusion, healthcare fraud,

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

OIG Exclusion: What You Need to Know if You’re on the List

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

Have you ever had disciplinary action against your license as a health care professional? Have you ever been arrested or convicted of a criminal offense? Have you ever been convicted of fraud or patient neglect? If so, then you may have also been terminated or excluded from the federal Medicare Program or your state Medicaid Program.

Many health professionals don’t understand the significant repercussions that an exclusion action by the Office of the Inspector General (OIG) can have on their career and employment. Whether you are a physician, nurse, dentist, psychologist or other health professional, if you allow yourself to be excluded from the Medicare Program, devastating economic results may follow.

Check the List.

To check if you are on the federal government’s List of Excluded Individuals and Entities (LEIE), click here.

To see if you are on Florida’s list of individuals and entities who have been terminated from Florida’s Medicaid Program, click here.

Collateral Consequences to OIG Exclusion or Termination.

Termination or exclusion can have many collateral consequences about which most health care providers are not aware. These Include:

– Termination for cause from all state Medicaid Programs.

– Loss of state professional licenses in other states and jurisdictions.

– Loss of hospital, ambulatory surgical center (ASC), and nursing home clinical privileges.

– Removal from the provider panels of health insurers.

– Loss of ability to contract or work for any individual or entity that contracts with the Medicare Program in any capacity (officer agent, shareholder, director, employee or independent contractor, even for non-Medicare products and services such as office supplies, building and construction services, software and systems support, etc.), including physicians, medical groups, hospitals, healthcare systems, ambulatory surgical centers, skilled nursing facilities, health insurance companies, etc.

– Placement on the General Services Administration (GSA) Exclusions List (or “Debarred” List) from government contracting.

– Loss of ability to contract or work for any individual or entity that contracts with the federal government in any capacity (officer agent, shareholder, director, employee or independent contractor, even for such services as construction projects, janitorial contracts, computer equipment and software services, real estate brokers on federally underwritten housing loans, sales of motor vehicles, products and services to the government, etc.

To learn more on the consequences of being excluded, click here.

You’re on the List, Now What?

If you find yourself on a state’s excluded or terminated list or if you find yourself on the federal LEIE, all is not lost. There are ways to become reinstated.

The OIG exclusion list is a complicated regulatory program which requires experience and perseverance to navigate. It is highly recommended that you do not attempt to handle removal without qualified assistance. If your application is denied, even for hyper-technical reasons, you may be barred from reapplying for one full calendar year. Therefore, it is crucial that your application is complete and correct, and you are fully eligible for removal. To read a past blog about reinstatement after OIG removal, click here.

Contact Attorney Experienced in Defending Against Action to Exclude an Individual or Business from the Medicare Program and Assisting in Reinstatement Applications.

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 Program, 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.

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

KeyWords: Exclusion list, Office of Inspector General, OIG, OIG exclusion list, OIG reinstatement representation, representation for physicians, representation for physician reimbursement, licensure defense attorney, professional license representation, licensure defense representation, representation for health care professionals, investigations analyst, applying for reinstatement, Application for Reinstatement, Medicare Exclusion attorney, OIG Hearing, Request for Reinstatement, Removal from List of Excluded Individuals and Entities (LEIE), Application to OIG, Medicare Reinstatement representation, Medicaid Reinstatement representation, healthcare fraud lawyes, Medicare defense attorney, Medicaid defense lawyer, Florida defense attorney, Florida defense lawyer, The Health Law Firm reviews

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

Health Care Professionals Need to be Compliant with Anti-Fraud Laws

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

The federal government has several tools available to help combat Medicare fraud. Among those are the Stark Act, Anti-Kickback laws and Civil Monetary Penalty Laws. Each of these typically focuses on a particular type of behavior that is prone to abuse by health care providers.

The Stark laws exist to combat the problems that can arise from physician self-referrals. Self-referrals are cases in which a physician orders a test or service and refers the patient to a provider in which the referring physician has a financial interest. This second provider will then bill Medicare for the service, essentially allowing the referring physician to cash in twice.

The concern is that if physicians are permitted to benefit from referring to an entity, they will be prone to order tests and services that are not medically necessary. I previously wrote an article on the legal ramifications of unnecessary tests, which was published in Medical Economics. Click here to read that article.

Obligations for Compliance.

Stark compliance is a two-way street. Not only is the physician prohibited from referring to an entity in which he has a non-exempt financial interest, the provider receiving the referral is prohibited from accepting it.

Medicare conditions payment of a claim upon the certification by the claimant that it is in compliance with the Stark law. What this means is that there is an obligation on the recipient of a referral to make sure that it is proper.

In the complicated world of healthcare business entities, it is incumbent upon the management of a supplier of Designated Health Services (DHS) to know who all of its owners, investors, and stakeholders are so that it can remain in compliance and avoid any charges of impropriety.

Exceptions to Stark Law.

Like many other regulatory frameworks, the Stark law have exceptions. The law provides a number of exceptions to the rules which allow otherwise impermissible referral arrangements to pass muster.

Because the exceptions are numerous and often subject to change, it is highly recommended that any new business arrangement, or substantial change to an existing one, is reviewed by a health law attorney experienced in the area of Stark law.

Contact Health Law Attorneys Experienced in Handling Stark Compliance.

If you are involved in referring or providing DHS it is crucial that your arrangements are reviewed for compliance with Stark and other anti-fraud laws.

Violations of these laws can carry severe financial and criminal penalties. One of the best ways to avoid these sanctions is to have your current or potential arrangement reviewed by an attorney who is experienced in these matters.

The Health Law Firm routinely advises healthcare providers on Stark compliance issues for practitioners and providers of all types of DHS. We can advise you on the legality of a particular arrangement and can assist with remedying any perceived compliance issues.

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.

KeyWords: Medicare representation, Medicare fraud representation, Medicare fraud defense lawyer, Medicare audit representation, Medicare fraud prevention, Stark Law attorney, Stark Law representation, Anti-Kickback representation, AKS defense lawyer, representation for healthcare fraud, health care fraud compliance, representation for health care professionals, health law defense attorney, health care fraud lawyer, Florida defense attorney, Florida defense lawyer, heath law attorney, health law lawyer, representation for health care professionals, The Health Law Firm reviews, reviews of The Health Law Firm attorneys, Florida health law defense attorney, protecting your professional license

“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.

Tuomey Healthcare System Ordered to Pay a Reduced $238 Million in Damages for Allegedly Violating Stark Law and False Claims Act

LOL Blog Label 2Lance 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

On September 30, 2013, a federal judge ordered Tuomey Healthcare System in Sumter, South Carolina, to pay $238 million in penalties and fines. The hospital system is accused of paying doctors to refer Medicare patients for treatments at the hospital, according to a number of media sources. The judge granted the government’s request to impose Stark law penalties and False Claims Act fines. The lawsuit against Tuomey was initially filed in 2005, by a whistle-blowing physician.

This corrected fine actually lowers the amount originally ordered by the federal judge, reducing it by $39 million. The original judgement was for approximately $277 million. The reduction in the damages was an acknowledgment that there was an error in the calculation of damages by the judge in the case, who awarded more than the government asked for.

Click here to read the entire ruling from the federal judge.

After the judge announced the fines, Tuomey began preparing to file an appeal, according to an article on Modern Healthcare. It is alleged that the hospital may be looking to settle.

Judge Ordered Hospital System to Pay Fines for Violating Stark Law and False Claims Act.

In a 2005 federal whistleblower or qui tam lawsuit, a Tuomey physician stated that a series of 19 deal contracts with specialty physicians in the area violated the federal ban on compensating doctors based on the volume and value of patient business they refer, according to Modern Healthcare. This is considered to be a financial conflict, illegal under federal laws.

The hospital has twice lost its case in U.S. District Court. A 2010, jury came to a $45 million split verdict that was overturned on appeal. In May 2013, a second jury found the hospital responsible for more violations than in the first trial, deciding that the hospital violated the Stark law and the False Claims Act.

It’s alleged that between 2005 and 2009, Tuomey collected $39 million in fraudulent Medicare claims.

To read the Modern Healthcare article, click here.

Open to Settlement.

According to WLTX, the CBS affiliate in Sumter, South Carolina, Tuomey is filing a notice of appeal. It is expected the hospital system is open to settle. According to a former attorney with the Department of Health and Human Services’ (HHS) Inspector General’s Office (OIG), it will be up to the government if they will settle. The former attorney also stated that with most of the civil litigation division on furlough it might take some time.

Complying with Stark and Other Anti-Fraud Laws.

The federal government has several tools in its toolbox to combat Medicare fraud. Among those are the Stark Act, Anti-Kickback laws, and Civil Monetary Penalty Laws. Each of these typically focuses on a particular type of behavior that is prone to abuse by health care providers.

Primarily, the Stark laws exist to combat the problems that can arise from physician self-referrals. Self-referrals are cases in which a physician orders a test or service and refers the patient to a provider in which the referring physician has a financial interest. This second provider will then bill Medicare for the service, essentially allowing the referring physician to cash in twice. Click here to read our previous blog on compliance with the Stark law.

Paying Kickbacks or Providing Things of Value in Exchange for Patient Referral Now Recognized as Basis for False Claims Act Cases.

U.S. v. Tuomey is just one of several different cases that has recently been decided that allows qui tam or whistleblower recoveries based on providing kickbacks for patient referrals. “Kickbacks” can include any thing or service of value. It can include, for example, tickets to ball games, free meals, sets of surgical scrubs, gift cards, appliances and free medical supplies. A “referral” can include an actual referral of a patient, a consultation to another physician, an order for x-rays, labs or other diagnostic testing, a prescription for medication, medical equipment or other supplies or services, an order for home health or nursing home services or other medical services.

It is the giving of something of value in exchange for the referral that violates the Stark Act and, many times, state laws. The theory is that this unnecessarily increases the amount of medical services that the government pays for without there being any actual medical need for them.

Now, under the decision in Tuomey and other cases, the claims for medical services (and equipment) that were submitted when the services (and equipment) were based on kickbacks, are considered to be false claims. Whistleblowers (qui tam plaintiffs or “relators”) can now file False Claims Act suits based on these theories and share in the government’s recovery. For example, and by way of demonstration only, if the person who filed the qui tam case in Tuomey received only 20% of the amount awarded to the government, that individual would receive approximately $47.6 million as their share. This is still big money to some of us.

Contact Health Law Attorneys Experienced in Handling Stark Compliance.

If you are involved in referring or providing DHS it is crucial that your arrangements are reviewed for compliance with Stark and other anti-fraud laws.

Violations of these laws can carry severe financial and criminal penalties. One of the best ways to avoid these sanctions is to have your current or potential arrangement reviewed by an attorney who is experienced in these matters.

The Health Law Firm routinely advises healthcare providers on Stark compliance issues for practitioners and providers of all types of DHS. We can advise you on the legality of a particular arrangement and can assist with remedying any perceived compliance issues.

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 ruling? Please leave any thoughtful comments below.

Sources:

Calson, Joe. “Out-of-Court Settlement for Tuomey may be in te Works Following Ruling Against the System.” Modern Healthcare. (October 1, 2013). From: http://bit.ly/15Lj2uF

United State of America ex rel Michael L. Drakeford, M.D. vs. Tuomey d/b/a Tuomey Healthcare System, Inc. Case Number 3:05-cv-02858-MBS. Federal Judge Order and Opinion. September 30, 2013. From: http://www.thehealthlawfirm.com/uploads/Toumey%20Case.pdf

Santaella, Tony. “Tuomey Healthcare Ordered to Pay $276 Million.” WLTX. (October 1, 2013). From: http://www.wltx.com/news/story.aspx?storyid=251321

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.

Appeals Court Upholds Medical Malpractice Law Changes

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

On July 21, a state appeals court in Tallahass2 Indest-2009-1ee upheld the constitutionality of a controversial change in Florida’s medical malpractice law. It ruled that some privacy rights are waived when patients pursue medical malpractice lawsuits. A federal appeals court last year also upheld the change in Florida’s law.

The decision by a three-judge panel of the First District Court of Appeal resulted from a 2013 change in the medical malpractice law. The Republican-controlled Florida Legislature passed the amendments to the laws after a lobbying dispute between groups like doctors and plaintiffs’ attorneys.

Ex Parte Communications Play a Major Role.

The disputes in whether the changes were constitutionally valid centered around what is known as “ex parte communications.” The amended statute allowed doctors being sued for malpractice (or their attorneys) to speak with the patients’ other physicians, whether the patient consents or not. The new law also requires patients to sign forms authorizing the release of medical information before filing malpractice claims.

Ex parte communications allow a patient’s personal health information be obtained and used in a case. Other doctors who have treated the patient could provide the information. Additionally, without the patient’s knowledge or the patient’s attorney present, a disclosure of medical information could occur.

This Ruling Stemmed From a 2013 Case in Escambia County.

In 2013, Emma Gayle Weaver of Escambia County, Florida wanted to file a medical-malpractice lawsuit against a physician. According to court documents, her concern was about the constitutionality of the ex parte provision of the law. She challenged having to disclose her medical information to the other physician she was suing in order to bring her case.

The challenge raised legal questions about privacy rights given to all citizens by the Florida Constitution. But the panel of appeal judges disagreed that the ex parte provision violates her privacy rights.

The appeal decision, written by Judge James Wolf, stated: “It is well-established in Florida and across the country that any privacy rights that might attach to a claimant’s medical information are waived once that information is placed at issue by filing a medical malpractice claim. Thus, by filing the medical malpractice lawsuit, the decedent’s medical condition is at issue.”

To read more about the Weaver v. Myers decision, click here.

Another Issue Was Addressed.

Another issue questioned whether the ex parte change violated the constitutional separation of powers. The contention dealt with whether the Legislature overstepped the role of the Florida Supreme Court. But the appeals court ruled that the change was not procedural but rather was “integral to the substantive pre-suit notice” requirements that are in the law and mandated before the filing of a medical malpractice case.

The Federal Appeals Court Also Said the Law Doesn’t Violate HIPAA.

Last year, the 11th U.S. Circuit Court of Appeals upheld the ex parte change in a ruling that focused on whether the 2013 law violates the federal Health Insurance Portability and Accountability Act (HIPAA), which prevents disclose of personal medical information. The federal appeals court said the law did not violate HIPAA, a decision also cited in the First District Court of Appeal’s decision.

Comments?

Do you agree the court’s ruling? Do you think this provision violates privacy rights? Please leave any thoughtful comments below.

Consult With a Health Law Attorney Experienced in the Representation Health Care Professionals.

The attorneys of The Health Law Firm provide legal representation to physicians, nurses, nurse practitioners, CRNAs, dentists, pharmacists, psychologists and other health providers in academic disputes, contract negotiations, license applications, board certification applications and hearings, credential hearings and civil and administrative litigations.

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

Source:

Saunders, Jim. “Appeals court upholds waiver of privacy rights in malpractice cases.” (July 22, 2015). Palm Beach Post. From: http://www.palmbeachpost.com/news/news/state-regional-govt-politics/florida-appeals-court-backs-controversial-medical-/nm48m/

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

KeyWords: Medical malpractice, medical malpractice defense attorney, medical malpractice defense lawyer, Florida defense attorney, Florida defense lawyer, health law attorney, health law lawyer, privacy rights, privacy rights violation, appeals court, Health Insurance Portability and Accountability Act, HIPAA, health law, The Health Law Firm

“The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.
Copyright © 1996-2015 The Health Law firm. All rights reserved.

CVS Possibly Under Investigation for Medicare Fraud

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

The Office of Inspector General (OIG) for the U.S. Department of Health and Human Services (HHS) has reportedly launched an investigation into CVS’ practice for refilling prescriptions. According to an article in the Los Angeles Times, authorities are looking into reports that CVS has been refilling prescriptions and submitting insurance claims without patients’ permission. The Los Angeles Times article, released October 12, 2012, names an official with knowledge of this matter as the source.

We want to emphasize that this is from an unconfirmed news story. The government rarely announces investigations of specific subjects ahead of time.

Click here to read the entire article from the Los Angeles Times.

CVS Has Not Been Contacted By the Government About an Investigation.

A related article in Reuters states that CVS said it has not been contacted by the government about the investigation. The pharmacy also said, as a policy, the company does not condone unauthorized refills. Officials said to allow unauthorized prescription refills could be considered insurance fraud, especially if insurers were not refunded for any drugs rejected by patients.

The probe might be, in part, related to the programs offered by many drugstores that allows a pharmacy to refill prescriptions even before a refill request has been made by the patient.

Click here to read the entire article from Reuters.

So far there is no news from the OIG for the HHS officially confirming this investigation.

Cause for Investigation?

It is unclear to me why there would be any cause to investigate CVS, if Medicare was not being billed until the customer actually picked up the prescription. If the customer fails to pickup the prescription, every drug store I know of restocks the medication after a short period and no one is ever billed for it. It seems that it would be a quick and simple matter for the OIG to check this.

Furthermore, it could also be argued that CVS  is actually promoting good health by this practice. Patients may forget to renew or refill their prescriptions or may fail to notice they are running low.

Two Sanford, Fla., CVS Stores Make Headlines.

On September 12, 2012, the U.S. Drug Enforcement Administration (DEA) revoked the registrations (controlled substance licenses) from two CVS pharmacies in Sanford, Florida. The two pharmacies are no longer able to fill prescriptions for drugs such as oxycodone, Dilaudid, Vicodin, Ritalin and Xanax. This decision was in response to a government crackdown on the distribution of painkillers. Click here to read a blog on this story.

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? Do you think CVS is doing anything wrong? How is this any different from the practice of many managed care plans mailing out 90 days of medications to its patients at a time? Please leave any thoughtful comments below.

Sources:

Lazarus, David. “CVS Caremark Prescription Refills Under Scrutiny, Source Says.” Los Angeles Times. (October 12, 2012). From: http://www.latimes.com/business/la-fi-lazarus-20121012,0,1032269.column

Alawadhi, Neha, Wohl, Jessica, and Morgan, David. “CVS Unaware of Any Government Prescription Refill Probe.” Reuters. (October 12, 2012). From: http://www.reuters.com/assets/print?aid=USBRE89B19520121012

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.

The Importance of Complying with the Stark Law and Other Anti-Fraud Laws

By Lance O. Leider, J.D.

The federal government has several tools in its toolbox to combat Medicare fraud.  Among those are the Stark Act, Anti-Kickback laws, and Civil Monetary Penalty Laws.  Each of these typically focuses on a particular type of behavior that is prone to abuse by healthcare providers.

The following focuses on the Stark law and what is prohibited by it.  Primarily, the Stark laws exist to combat the problems that can arise from physician self-referrals.  Self-referrals are cases in which a physician orders a test or service and refers the patient to a provider in which the referring physician has a financial interest.  This second provider will then bill Medicare for the service, essentially allowing the referring physician to cash in twice.

The concern is that if physicians are permitted to benefit from referring to an entity that they have a financial interest in, they will be prone to order tests and services that are not medically necessary. Our President and Managing Partner George F. Indest recently wrote an article on the legal ramifications of unnecessary tests, which was published in Medical Economics. Click here to read that article.

Know the History Behind the Stark Law.

There are essentially two Stark laws.  The first one is often referred to as “Stark I” and dealt primarily with physician referrals for clinical laboratory testing.  This law was in effect from January 1, 1992, to December 31, 1994.

The second Stark law, known as “Stark II,” took effect on January 1, 1995.  This law greatly expanded the types of prohibited referrals.  Instead of focusing on clinical laboratory testing, Stark II expanded the prohibition to “designated health services.”

A List of the Designated Health Services (DHS).

According to the Stark laws, designated health services (DHS) refers to the following services:

(i) clinical laboratory services;

(ii) physical, occupational, and speech-language pathology services;

(iii) radiology and certain other imaging services;

(iv) radiation therapy services and supplies;

(v) durable medical equipment and supplies;

(vi) parenteral and enteral nutrition and supplies;

(vii) prosthetics, orthotics, and prosthetic devices and supplies;

(viii) home health services;

(ix) outpatient prescription drugs; and

(x) inpatient and outpatient hospital services.

To see the complete statutory definition, click here.

It should also be noted that the regulation states that it only applies to DHS that are payable in whole or in part by Medicare.  While there are no Stark prohibitions on self-referral for non-Medicare reimbursed services, many states have their own laws that prohibit these referrals.

Stark Compliance.

Stark II compliance is a two-way street. Not only is the physician prohibited from referring to an entity in which he has a non-exempt financial interest, the provider receiving the referral is prohibited from accepting it.

Medicare conditions payment of a claim upon the certification by the claimant that it is in compliance with the Stark law.  What this means is that there is an obligation on the recipient of a referral to make sure that it is proper.

In the complicated world of healthcare business entities, it is incumbent upon the management of a supplier of DHS to know who all of its owners, investors, and stakeholders are so that it can remain in compliance and avoid any charges of impropriety.

Exceptions to the Rules.

Like many other regulatory frameworks, the Stark law have exceptions.  The law provides a number of exceptions to the rules which allow otherwise impermissible referral arrangements to pass muster.

Because the exceptions are numerous and often subject to change, it is highly recommended that any new  business arrangement, or substantial change to an existing one, is reviewed by a health law attorney experienced in the area of Stark law.

Contact Health Law Attorneys Experienced in Handling Stark Compliance.

If you are involved in referring or providing DHS it is crucial that your arrangements are reviewed for compliance with Stark and other anti-fraud laws.

Violations of these laws can carry severe financial and criminal penalties.  One of the best ways to avoid these sanctions is to have your current or potential arrangement reviewed by an attorney who is experienced in these matters.

The Health Law Firm routinely advises healthcare providers on Stark compliance issues for practitioners and providers of all types of DHS.  We can advise you on the legality of a particular arrangement and can assist with remedying any perceived compliance issues.

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: 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.

“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.

Drug Enforcement Administration Releases Details of Investigation into Two CVS Stores in Sanford, Florida

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

In September 2012, the Drug Enforcement Administration (DEA) revoked the controlled substance licenses from two CVS pharmacies in Sanford, Florida. Details into the investigation were made public on October 12, 2012, in a final order released by the DEA.

The order explains how the stores operated, whom they prescribed painkillers such as oxycodone to, and identified Central Florida’s top-prescribing doctors.

To read the final order from the DEA, click here.

I previously wrote about the two Sanford CVS stores losing their controlled substance licenses, click here to read that blog.

Testimonies from Employees Allegedly Explained Pharmacies’ Operating System.

The final order reveals testimonies from pharmacy personnel. In a press release from the DEA the pharmacist-in-charge at one of the Sanford stores told drug agents the stores would set a limit each morning on the number of oxycodone prescriptions they would fill based on the inventory. Once the limit was reached, the pharmacy would tell customers they were “out of stock,” even when they had inventory. The pharmacist told agents the reserved inventory was for their “real pain patients.”

Warning Signs.

Employees told drug agents that their customers would ask for oxycodone using street slang such as “the M’s” or “the blues.” Oxycodone was also allegedly dispensed frequently to customers who lived out of state, obtained prescriptions from South Florida doctors, and had the prescriptions filled in Seminole County.

Click here to read the press release from the DEA.

More Stings May Be Coming.

The Walgreens distribution center in Jupiter, Florida, is currently fighting its own war with the DEA. On October 17, 2012, the biggest pharmacy retailer in Florida filed a petition

asking a federal judge to lift an immediate suspension order (ISO) banning the center from shipping controlled substances to its stores in Florida and on the East Coast. To read more on that story, 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 the DEA’s decision? As a pharmacist how to do you regulate prescriptions for painkillers? Please leave any thoughtful comments below.

Sources:

Pavuk, Amy. “Rx for Danger: DEA Blasts CVS for Ignoring ‘Red Flags’ at Sanford Stores.” Orlando Sentinel. (October 28, 2012). From: http://www.orlandosentinel.com/health/os-cvs-dea-oxycodone-ban-20121028,0,5395839.story

Drug Enforcement Administration. “Holiday CVS Final Order Reveals Gross Negligence By

Two CVS Pharmacies in Stanford, Florida.” DEA.gov. (October 15, 2012). Press Release From: http://www.justice.gov/dea/divisions/mia/2012/mia101512.shtml

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

 

“The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.

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

Locating a Healthcare Providers Service Organization (HPSO) Insurance Defense Attorney in Florida

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

We are sometimes told by the health professionals we represent especially pharmacists, licensed mental health counselors (LMHCs), advanced registered nurse practitioners (ARNPs), massage therapists and physical therapists that after they received a complaint regarding their license from the Florida Department of Health (DOH) they had difficulty finding an experienced attorney in Florida who would accept their professional liability insurance.  In this case, I am speaking specifically about Healthcare Providers Service Organization (HPSO) Insurance.

Benefits of HPSO Insurance.

The professionals who are covered by HPSO Insurance have excellent insurance coverage.  HPSO Insurance provides professional liability coverage that protects in the event of a lawsuit or negligence claim.  But much more often the professional receives a notice of an investigation, a subpoena for a deposition in someone else’s case, a demand because of an allegation of sexual harassment or sexual impropriety, a complaint because of a breach of medical records confidentiality or Health Insurance Portability and Accountability Act (HIPAA) Privacy complaint, or some other administrative type of action.

HPSO provides great coverage for these.  For example, HPSO currently reimburses up to $10,000 in legal fees and expenses just for representation of you at depositions.  HPSO currently reimburses up to $25,000 in legal fees and expenses for your defense in a DOH or Agency for Health Care Administration (AHCA) notice of investigation or complaint.  HPSO currently reimburses up to $25,000 in legal fees and expenses for your legal representation in defense of a complaint or investigation regarding breach of medical confidentiality.

If you are a pharmacist, own a pharmacy, are a massage therapist, own an assisted living facility (ALF), are a mental health counselor or a social worker, or you are one of the many other types of health care professionals who HPSO insures, it should be fairly easy to find experienced health lawyers to represent you, especially in Florida.

Our firm and our attorneys, including George F. Indest III, Michael L. Smith, Joanne Kenna, Carole C. Schriefer, Lance O. Leider, Christopher E. Brown and Danielle M. Murray, routinely represent licensed health care professionals, interns and students in all types of administrative investigations and hearings and in defending lawsuits and other actions that have been filed.  We also represent health facilities in license defense, survey complaints and administrative hearings.  We represent them throughout Florida, from Pensacola, to Jacksonville, to Key West.  We also occasionally represent them in other states, as well.  We accept HPSO Insurance assignments.

Free Legal Advice: Get Insurance Immediately.

It is very important for every health professional to carry insurance that covers any investigation, complaint or administrative hearing that might be filed or opened against your license.  You may think that you are covered for this by your employer, but you are not.  If your employer contradicts this, ask for a statement in writing that your employer will pay for your legal defense for any such matter arising during your employment.

What typically happens, especially in the case of a hospital employee, nursing home employee, pharmacy employee or corporate employee, is that the employer is the one who terminates the employee and then files a complaint with the DOH.  The DOH then opens an investigation against the health professional.  The employer is not going to pay your legal defense costs if the employer has reported you.

You may very well be out of work, out of money and face an investigation and complaint that could terminate your professional license and career.  You should not take this chance.  Insurance such as HPSO Insurance is inexpensive and reliable.  Buy it while you can afford it. After the actions have occurred, it is too late.

Find an Experience Health Law Attorney in the Event of an Investigation.

Also, you should immediately contact an experienced health law attorney if you are telephoned or visited by any investigator, or if you receive a letter advising you that an investigation has been opened regarding your care.  Call immediately for advice before you speak with an investigator or provide any documents or statements of any kind.

You cannot and should not seek “legal advice” on what to do from the investigator, from a DOH employee, from your professional board or from any attorney representing any of them.  They are not your friends.  They are on the side against you. You should definitely not take any advice from them.

Do Not Skimp on Insurance Coverage.

If you have good insurance, it will pay for your legal expenses from the very beginning, so use it.  However, beware of cheap insurance policies from professional associations that do not provide any coverage for disciplinary complaints and licensure investigations.  Always check to be sure this is covered.  Get it in writing.  With some companies you have to pay an extra premium to obtain this coverage.  With some insurers, they do not offer it, and you have to purchase a completely separate policy covering just this.  It is worth it!  Do it!

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

Our firm regularly represents pharmacists, massage therapists, mental health counselors, registered nurses, assisted living facilities, home health agencies, nurse practitioners, lab technicians, occupational therapists, physical therapists, social workers, physician assistants, psychologists and other health professionals in many different legal matters.

Services we provide include representation before your professional board, in DOH investigations, in administrative hearings, in civil litigation, in defense of malpractice claims, in professional licensing matters, in defense of allegations concerning HIPAA privacy violations and medical record breaches, in Drug Enforcement Administration (DEA) actions, and in many other matters.

We routinely represent physicians, dentists, nurse practitioners, and others in defending against malpractice claims, civil lawsuits, administrative complaints, peer review actions, DOH investigations, Medicare audits, Medicaid audits, and other matters. In cases in which the health care professional has professional liability insurance or general liability insurance which provides coverage for such matters, we will seek to obtain coverage by your insurance company and will attempt to have your legal fees and expenses covered by your insurance company.  If allowed, we will agree to take an assignment of your insurance policy proceeds in order to be able to submit our bills directly to your insurance company.

We also defend health professionals and health facilities in general litigation matters and business litigation matters.

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

Comments?

Do you have professional liability insurance? Why or why not. Please leave any thoughtful comments below.

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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