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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.

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.

New Professional Liability Insurance Benefits for Health Professionals

2 Indest-2009-1By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

I have been pleasantly surprised recently to discover that several professional liability insurance companies have raised their coverage amounts and added coverage in areas sorely needed by health professionals.  I’m referring to coverage for incidents not necessarily related to malpractice or professional liability.

I do note that Healthcare Providers Service Organization (HPSO) Insurance has increased its basic policy limits from a cap of $3,000,000 in the aggregate per year to $5,000,000 aggregate per year for counselors on professional liability coverage.

However, we have always maintained that the most important coverage for any licensed health professional is professional licensure legal defense coverage.  This is probably the most used type of coverage and the most beneficial for a health professional.

HPSO Insurance and Nurses Service Organization (NSO) Insurance, as well as several other insurers now provide up to $25,000 coverage.  If an employer whether it’s a hospital, nursing home, assisted living facility (ALF), home health agency (HHA), medical group or public health clinic or a patient complains about you to the state Department of Health (DOH) or state licensing authority, you could face investigation and hearings that would cost you tens of thousands of dollars to have properly defended by an experienced attorney.  If you don’t have the funds to pay for this, you could be forced to accept discipline on your license which could result in a number of unexpected additional adverse actions against you.

Although I would prefer to see this coverage increased to $50,000, and there are several companies that provide this much in coverage, $25,000 will go a long way toward defending you against meritless or unprovable complaints.

New HPSO Insurance and NSO Coverages.

Representation During a Deposition – A patient is injured at the facility where you work. You are not named in the lawsuit, but you receive a subpoena for testimony. Your coverage through HPSO Insurance will pay up to $10,000 per deposition with a $10,000 annual aggregate for you to be represented at the deposition by an attorney.

Information Privacy Coverage (added upon request) – People today are very conscious about their privacy. Most are aware of the protection they receive under the new Health Insurance Portability and Accountability Act (HIPAA) laws. This optional endorsement extends your coverage to pay for HIPAA fines and penalties arising from a HIPAA proceeding, subject to a $25,000 aggregate limit.

Sexual Misconduct – In the past, while your coverage through HPSO Insurance would pay to defend you against allegations of sexual misconduct related to your professional services, there was no coverage for a settlement. This new endorsement provides you with a $25,000 aggregate sublimit for covered sexual misconduct claims.

Reimbursement for Rendering First Aid – This benefit provides reimbursement up to $10,000 for expenses you incur while rendering first aid to a person other than yourself. For example, this could include supplies from your personal first aid kit that you used to help a victim of an automobile accident.

Accidental Injury to Others – If someone was hurt by something like a slip and fall at your residence or your workplace and required medical attention, they can receive reimbursement for their expenses up to $10,000 per incident with a $100,000 annual aggregate. It must be an accidental injury, not a medical incident.

Service to Animals (added for pharmacists, physical therapists (PTs), massage therapists and counselors) – In the course of providing professional services to an animal, if they are injured and the owner files suit, the new service to animals endorsement provides $25,000 aggregate coverage. (Added upon request for all others.)

Accidental Damage to Others’ Property – While you are providing care at a patient’s home what if you accidentally break something? No worries. Your policy pays for unintentional damage you cause to someone else’s property while at your personal residence or workplace. This coverage provides up to $10,000 per incident with a $10,000 aggregate.

Other Coverages Added to Professional Liability Insurance Policies.

In addition to the coverages I have discussed above, there have been some other coverages added to many professional liability insurance policies that could pay off for damages or injuries the individual health professional incurs, as well.

Workplace Violence Counseling – While your assault coverage pays for the medical expenses resulting from an attack, this new endorsement broadens your coverage to include $25,000 aggregate limits for the payment of any emotional counseling needed as a result of a covered incident.

Coverage If You are Assaulted – Violence in the workplace is a sad reality. Should you be the victim of a violent action at work or on your way to or from work, this coverage will pay up to $25,000 per incident with a $25,000 aggregate for medical expenses you incur or for damage to your personal belongings.

Reimbursement for Defendant Expenses – Regardless of its outcome, a malpractice suit will likely cost you money and could mean thousands of dollars out of your pocket. Your policy through HPSO Insurance will reimburse you up to $1,000 per day, up to $25,000 aggregate for lost wages, travel and other covered expenses.

Business Owner Coverage Extension (added upon request) – The ‘named insured’ on a policy for a healthcare firm is typically the business name. If the business owner volunteers or moonlights there is always the chance they could be named in a malpractice suit under their individual name. This new extension provides protection for the owner if sued under their personal name.

HPSO Insurance Also Provides Coverage For:

   Students (Health Professional Students)
   Counselors
   Interns (Health Professional Interns)
   Physician Extenders
   Physicians
   Fitness Professionals
   Integrated Health Practitioners
   Massage Therapists
   Nurse Practitioners
   Occupational Therapists
   Pharmacists
   Physical Therapists (PTs)
   Physician Assistants (PAs)
   Radiologist Assistants
   Radiology Practitioner Assistants
   Social Workers
Healthcare Businesses:

   Assisted Living Facilities (ALFs)
   Nurse Registries
   Home Health Agencies (HHAs)
   Pharmacies
   Physical Therapy Practices
   Occupational Therapy Practices
   Outpatient Therapy Clinics

There is no time like the present, when you have the funds and can afford it, to purchase professional liability insurance.  It is surprisingly inexpensive.  Every professional should carry it.  If you don’t buy it before you need it, when you do really need it, it will be too late.

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

Our firm regularly represents physicians, dentists, nurse practitioners, pharmacists, massage therapists, mental health counselors, registered nurses (RNs), assisted living facilities (ALFs), home health agencies (HHAs), nurse practitioners, lab technicians, occupational therapists, physical therapists (PTs), 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.

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.

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.

Speech Therapist Arrested for Billing Medicaid $500,000 for Work at Florida Day Care Centers While Living in Illinois

6 Indest-2008-3By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

A speech therapist was arrested on March 29, 2013, for allegedly billing Medicaid more than $500,000 for services that she did not provide, according to the Florida Office of the Attorney General (AG). The speech therapist now faces charges of Medicaid fraud and grand larceny.

Click here to read the press release from the AG.

Billed Medicaid for Services Provided in Florida, While Living in Illinois.

According to an article in The Palm Beach Post, authorities began investigating the speech therapist when they received a tip that she was overbilling for services provided. During the investigation it was found that while the speech therapist reported to Medicaid she lived in Florida, she has been allegedly living in Illinois for the past eight years. The speech therapist allegedly employed two unlicensed speech therapists to work for her in two Florida day care centers. From January 2008 until February 2013, the speech therapist billed Medicaid for services she allegedly did not administer.

To read the entire article from The Palm Beach Post, click here.

Speech Therapist Faces Restitution and Prison Time.

The Florida AG’s Medicaid Fraud Control Unit (MFCU) and the West Palm Beach Police Department made the arrest. If convicted, the speech therapist faces up to $20,000 in fines, 60 years in prison and restitution.

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

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

Faced with an Medicaid Audit? Contact Health Law Attorneys Experienced in Handling Medicaid Audits.

Medicaid fraud is a serious crime and is vigorously investigated by the state MFCU, the Agency for Healthcare Administration (AHCA), the Zone Program Integrity Contractors (ZPICs), the FBI, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (DHHS). Often other state and federal agencies, including the U.S. Postal Service (USPS), and other law enforcement agencies participate. Don’t wait until it’s too late. If you are concerned of any possible violations and would like a confidential consultation, contact a qualified health attorney familiar with medical billing and audits today. Often Medicaid fraud criminal charges arise out of routine Medicaid audits, probe audits, or patient complaints.
The Health Law Firm’s attorneys routinely represent physicians, medical groups, clinics, pharmacies, assisted living facilities (AFLs), home health care agencies, nursing homes, group homes and other healthcare providers in Medicaid and Medicare investigations, audits and recovery actions.

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

Comments?

How did the speech therapist get away with this for so long? What are your thoughts on this story? Please leave any thoughtful comments below.

Sources:

Seltzer, Alexandra. “Authorities: Woman billed Medicaid $500,000 for working at West Palm Beach day care centers while in Illinois.” The Palm Beach Post. (March 28, 2013). From: http://www.palmbeachpost.com/news/news/crime-law/authorities-she-billed-medicaid-500k-for-working-a/nW6ht/

Meale, Jenn. “Medicaid Fraud Control Unit Arrests Speech Therapist for $500,000 of Medicaid Fraud.” Florida Office of the Attorney General. (March 29, 2013). From: http://www.myfloridalegal.com/newsrel.nsf/newsreleases/AE5D612364AD29C285257B3D004BE6B5

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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