Additional Negative Consequences for Discipline on Your Professional License, Part 1 of 2

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

Do you have a medical, pharmacist, counselor, or nursing license in more than one state?  Do you have a license in more than one profession?  Have you been notified that an investigation has been opened against your professional license?  Are you thinking about resigning your professional license or voluntarily relinquishing (giving up) your license?  Then you should be aware of some important facts you may not have known.

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  A resignation is considered to be a “disciplinary relinquishment” and is treated the same as if your license had been revoked on disciplinary grounds.

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

Protect Your License from These Types of Adverse Actions.

Following is a list of some of the adverse actions you can expect to be taken after discipline on your license (or if you give up your license after receiving notice of investigation):

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

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

3. Any other states or jurisdictions in which the professional has a license will also initiate an investigation and possible disciplinary action against him or her in that jurisdiction.  (Note:  I have had two clients who had licenses in seven or more other states; even states where the license was no longer active initiated action).

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

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

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

c.  Additionally, if this happens, your state is required to terminate you “for cause” from the state Medicaid Program.  In many states, this will also be an additional ground for revocation of your license.

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

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

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

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

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

What Should and Shouldn’t You Do?

If you find yourself notified that you are under investigation, don’t take the easy way out by immediately relinquishing your license. Don’t hide your head in the sand by thinking the case will just go away on its own. Do not request an informal hearing or a settlement agreement in which you admit the facts alleged against you are all true.  If you do this, you are “pleading guilty.” If you are innocent of the charges, request a formal hearing and contest the charges; defend yourself.

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

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

Professional Liability Insurance.

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

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

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

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

To learn more, visit our Video Q&A section on our website and watch our video titled, “Should I voluntarily relinquish my professional license because I am being investigated?” Additionally, click here to read one of our prior blogs for even more information on how to fight back against adverse NPBD reports.

Contact Health Law Attorneys Experienced with Investigations of Healthcare Professionals.

The attorneys of The Health Law Firm provide legal representation to medical professionals in Department of Health (DOH) investigations, licensing matters, and other types of investigations of health professionals and providers. To contact The Health Law Firm, please call (407) 331-6620 or Toll-Free at (888) 331-6620 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 Avenue, Suite 1000, Altamonte Springs, FL 32714, Phone: (407) 331-6620 or Toll-Free: (888) 331-6620.

“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 © 2022 The Health Law Firm. All rights reserved.

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Out-of-State Compounding Pharmacies May Need a Permit To Do Business in Florida

Lance Leider headshotBy Lance O. Leider, J.D., The Health Law Firm

Beginning on October 1, 2014, out-of-state compounding pharmacies may be required to hold a compounded sterile product permit. That’s because the Regulated Industries Committee of the Florida Senate voted on March 13, 2014, to approve a bill increasing the restrictions on out-of-state compounding pharmacies that ship medications into Florida. These increased regulations would apply to around 300 compounding pharmacies shipping medicine to Florida.

The bill was introduced to increase standards for compounding pharmacies that create medications that are tailored to the needs of individual patients. Currently the bill is out for reference review. Considering that this is a hot issue in Florida and nationally, we expect the bill to pass.

Click here to read the entire bill.

Requirements Under the New Bill.

The bill requires out-of-state compounding pharmacies to hold a compounded sterile product permit to ship medications into Florida. Applications for the permit would be provided by the Board of Pharmacy. The bill also requires pharmacies to meet or exceed Florida’s sterile compounding standards. Under the bill, the Florida Department of Health (DOH) is responsible for inspecting out-of-state compounding pharmacies for compliance. The DOH would hold the authority to punish or revoke an out-of-state compounding pharmacy’s license for noncompliance. The pharmacy would be responsible for reimbursing the cost of the inspection.

If the bill passes, compounding pharmacies already shipping compounded sterile products into Florida may continue to do so, as long as the pharmacy receives a permit before January 31, 2015.

Permit Law for Florida Pharmacies that Compound Sterile Products.

Similarly, the Florida Board of Pharmacy promulgated a rule requiring a permit for pharmacies that compound sterile products in Florida. Effective September 23, 2013, Rule 64B16-28.100(8), Florida Administrative Code (F.A.C.), requires most pharmacies that engage in the preparation of sterile compounded products in Florida to obtain a Special Sterile Compounding Permit.

Click here to read more on this permit.

New Standards Most Likely Triggered by Tainted Compounded Medications.

These new standards are being implemented after a nationwide outbreak of fungal meningitis linked to contaminated drugs made by a compounding pharmacy in Massachusetts. Florida is no stranger to allegations of tainted compounded products. In May 2012, Franck’s pharmacy in Ocala, Florida, was accused of distributing eye medications that contained a fungal infection. Click here for the first blog and here for the second blog.

It’s likely these new permits are a direct result of the recent issues with compounded medications and compounding pharmacies. The goal of these permits is to help authorities, such as the DOH and U.S. Food and Drug Administration (FDA), track pharmacies compounding sterile products.

Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.

The Health Law Firm represents pharmacists and pharmacies in DEA, DOH and FDA 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 bill to increase restrictions on out-of-state compounding pharmacies that ship medications into Florida? Please leave any thoughtful comments below.

Sources:

The News Service of Florida. “Pharmacy Bill, FL Budge Taking Shape.” WUSF News. (March 14, 2014). From: http://wusfnews.wusf.usf.edu/post/pharmacy-bill-fl-budget-taking-shape

Palombo, Jessica. “After Federal Compounding Pharmacy Crackdown, Fla. Panel Passes Extra Restrictions.” WFSU News. (February 12, 2014). From: http://news.wfsu.org/post/after-federal-compounding-pharmacy-crackdown-fla-panel-passes-extra-restrictions

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 Ave., Altamonte Springs, Florida 32714, Phone: (407) 331-6620.

 

“The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.
Copyright © 1996-2014 The Health Law Firm. All rights reserved.

Drug Enforcement Administration (DEA) Agents May Surprise You at Florida Board of Pharmacy Meeting

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

At several recent Florida Board meetings, after hearings at which disciplinary cases were considered by the Board, Drug Enforcement Administration (DEA) agents approached the health professional. Even in instances where the pharmacist was represented by an attorney and the attorney was there, the DEA agents confronted the professional involved.

What Were the DEA Agents Trying to Do?

In the cases where The Health Law Firm’s attorneys were there representing clients, the professional received some type of discipline on his or her license. Some of these were Settlement Agreements. The DEA Agent approached the professional and urged the professional to sign a voluntary relinquishment of DEA registration.

It seems that this is happening to professionals where there is some type of serious or long-term discipline is being taken against their licenses, such as long-term probation, suspension or revocation. Also, if the charges against the health professional involved, drugs, over-prescribing, abuse of narcotics, operation of a “pill mill,” selling or illegally dispensing or prescribing narcotics, drug diversion or abuse, being impaired from use of drugs, and other similar misconduct. These are often grounds for the revocation, suspension or revocation of the DEA number.

This action by DEA agents has occurred at Board of Medicine meetings and hearings, Board of Osteopathic Medicine meetings and hearings, Board of Dentistry meetings and hearing and Board of Pharmacy meetings and hearings. If you are a professional who has a DEA registration and number, you are, apparently, fair game.

Don’t Be Surprised; Be Prepared and Don’t Make a Rash Decision.

It is unusual to see federal agents of this type “cruising” state professional board meetings like we have seen lately. But, it seems to make sense, from the DEA’s point of view. If you can take several minutes and convince, surprise or intimidate a health professional into relinquishing his or her DEA registration voluntarily, then you may save the government hundreds of hours of time and thousands of dollars in expenses in having to investigate and have a separate administrative hearing (which the health professional may win), if he or she voluntarily relinquishes the DEA registration.

Immediately consult with an experienced health law attorney who has dealt with the DEA before.

Remember Your Rights; Yes, You Have Rights!

Yes, you do have rights, Constitutional rights. Use them! That is what they are there for.

You have the right to consult with counsel before making a decision. Don’t believe it if a DEA agents tells you that you don’t.

You have the right not to sign any forms or make any statements. Don’t sign anything. Don’t make any statements except for getting the agent’s card and telling them you will have your attorney contact them.

You have the right to take time to consider the matter and consult with others. You do not have to make a decision right away.

The Consequences of Voluntary Relinquishment are Serious and Long-Lasting.

Your voluntary relinquishment are serious and long lasting. It will be treated the same as a revocation of your DEA number. We have consulted with physicians and pharmacists who have never been able to get it back after they relinquished it.

You will probably be terminated from any health insurance panels you are on if this happens.

You will probably have action taken against your clinical privileges if you have clinical privileges at any hospital, nursing home or ambulatory surgical center (ASC).

You may be terminated from the Medicare or Medicaid Program.

There are many other consequences that may result.

Therefore, you and your attorney should be aware that this may happen and you and your attorney should be prepared if it does happen.

For more tips on how to prepare, click here to read my prior blog.

Don’t Wait Too Late; Consult with an Experienced Health Law Attorney Early.

Do not wait until action has been taken against you to consult with an experienced attorney in these matters. Few cases are won on appeal. It is much easier to win your case when there is proper time to prepare and you have requested a formal hearing so that you may actually dispute the facts being alleged against you.

The lawyers of The Health Law Firm are experienced in both formal and informal administrative hearings and in representing pharmacists, pharmacies and pharmacy technicians in investigations and at Board of Pharmacy hearings. Call now or visit our website www.TheHealthLawFirm.com.

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

Keywords: Administrative hearing attorney, representation for administrative hearings, administrative complaint defense attorney, Board of Pharmacy representation, Board of Pharmacy attorney, Board of Pharmacy defense attorney, representation for Board of Pharmacy investigations, representation for Board of Pharmacy complaints, DEA hearing defense attoreny, DEA investigation attorney, DEA hearing representation, DEA investigation representation, pharmacist attorney, health care professional defense attorney, representation for health care professionals, professional licensure defense attorney, professional licensure representation, licensure defense attorney, representation for licensure issues, representation for pharmacists, representation for pharmacies, pharmacy attorney, review of The Health Law Firm, The Health Law Firm attorney 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.

 

 

 

 

DEA Offers New Prescription Drug Return Policy

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

Looking to improve the prescription drug abuse epidemic in the United States, the Drug Enforcement Administration (DEA) announced September 8, 2014, that it would permit patients to return their unused prescription medications to pharmacies. This new rule, covering all types of prescription drugs, will give patients the option of mailing unused prescriptions to an authorized collector using packaging provided by the pharmacy.

Hopefully this will help to eliminate many of the problematic situations that pharmacists and physicians found themselves in when they accumulated returned or unused medications from patients for destruction.

This move intends to address the rising number of injuries and deaths associated with controlled substance drugs, particularly opioids. Reducing the stockpile of unneeded prescription drugs from American homes will limit teenagers’ accessibility to their parents’ medications and reduce burglaries for such substances. According to The New York Times, this demographic is known to be the most prevalent abuser of such controlled substances.

To read the full story from The New York Times, click here.

Prior Methods of Prescription Drug Disposal.

Under the Controlled Substances Act, patients were only allowed to dispose of unused drugs themselves or surrender them to law enforcement. Personal disposal of controlled substances typically means flushing pills down a toilet or throwing them in the trash. Because this can pose a risk toward animals and clean drinking water, these methods are frowned upon by environmentalists and the Environmental Protection Agency (EPA).

Drug “take back” programs are another option when it comes to disposing of unused prescription drugs. These events are organized by the DEA and are held twice a year at local police departments across the country. During these programs, citizens can anonymously drop off any unused prescription drugs. According to The Wall Street Journal, the Department of Justice (DOJ) reported that a nationwide event in April 2014 brought in 390 tons of prescription drugs at more than 6,000 sites. In the past four years, these collection events have removed from circulation more than 4.1 million pounds of prescription medication from across the country.

Although these events prove successful, many healthcare professionals are optimistic for the bigger impact the pharmacy “take back” programs may have. Providing consumers convenient year-round access to medication disposals will be positive reinforcement to regularly dispose of unused prescription medications. This method is believed to be more likely to accomplish the mission of shrinking the pool of unused and potentially fatal controlled substances in American homes.

To read the full article from The Wall Street Journal, click here.

Ironing Out Details of the New Plan.

There are many logistics to consider to ensure these pharmaceutical “take back” programs will be successful. The programs will not be mandatory, as the decision to take part will be the under the sole discretion of each company. The pharmacies must voluntarily choose to register with the DEA in order to start receiving the leftover prescriptions. In the past, pharmacies have not generally wanted to accept the hassle of offering such a program. However, the DEA expects many pharmacies to jump on the bandwagon to showcase good-faith effort of keeping drugs out of the wrong hands.

DEA-approved organizations collecting the unused drugs will include hospital pharmacies, narcotic treatment programs, and companies contracted by other collectors to destroy controlled substances.

There are concerns circling the initiative. Some pharmacies do not have the resources required to accommodate incinerators, thus limiting the locations available to consumers. In addition, professionals are concerned with the lack of regulations listed in the new plan. There are no set requirements on how the prescriptions should be destroyed. The rules simply mandate that the drugs are altered into a permanent, irreversible state.

The burden of payment has also not been discussed or outlined in the new plan. Who will cover the cost of packaging and disposal has yet to be decided. Also, to be considered is the challenge of keeping the returned prescriptions safe until destruction. An unsecured, unmonitored return site containing stock piles of addictive drugs would be a gold mine for many addicts and criminals. Should a theft occur at one of these drop-off receptacles, who would be held liable? The American Pharmacists Association has already expressed concern of pharmacy legal liability.

The biggest obstacle of all, however, may be convincing the general public that returning unused pills is a necessary moral obligation.

Comments?

Would you participate in this type of prescription drug return program? As a pharmacist or someone who works at a pharmacy, what are your concerns with this take back program? Please leave any thoughtful comments below.

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

We routinely provide deposition coverage to pharmacists, pharmacies and other health professionals being deposed in criminal cases, negligence cases, civil cases or disciplinary cases involving other health professionals. We can review business referral arrangements and provide legal counsel on whether they are not in violation of federal and state anti-referral laws. The lawyers of The Health Law Firm are experienced in both formal and informal administrative hearings and in representing physicians, physician assistants and other health professionals in investigations and at Board of Pharmacy hearings.

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

Sources:

Barrett, Devlin. “U.S. to Allow Pharmacies to Take Back Unused Prescription Drugs.” The Wall Street Journal. (September 08, 2014). From: http://online.wsj.com/articles/u-s-to-allow-pharmacies-to-take-back-unused-prescription-drugs-1410186602

Saint Louis, Catherine. “D.E.A. to Allow Return of Unused Pills to Pharmacies.” The New York Times. (September 08, 2014). From: http://www.nytimes.com/2014/09/09/health/unused-pills-return-to-pharmacies.html?_r=0

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 © 1996-2014 The Health Law Firm. All rights reserved.

Florida Board of Pharmacy Approves Change to Destruction of Controlled Substances Rule

Lance Leider headshotBy Lance O. Leider, J.D., The Health Law Firm

At its meeting held in Orlando, Florida, on February 12, 2014, the Florida Board of Pharmacy approved final changes to Rule 64B16-28.303, Florida Administrative Code. This rule governs the destruction of controlled substances by Class II Institutional Pharmacies.

The focus of the new rule changes is to ensure that either the prescription department manager (PDM) or the consultant pharmacist of record signs off on all destruction of controlled substances. Further, the rule requires that a copy of the destruction documents be mailed to the Drug Enforcement Administration (DEA) within one business day of destruction.

According to the Board’s statement, the purpose of the rule change is to make it “easier to properly dispose of [controlled] substances while ensuring that one of the persons signing for the destruction always is either the prescription department manager or the consultant pharmacist of record, and that a copy of the destruction is timely sent to the DEA.”

Who the Rule Applies To.

Although this rule applies to all permittees, pharmacists in Class II institutional pharmacies need to be aware that the Board’s clarifications were specifically aimed at those facilities. In case you are not sure whether you work in a Class II pharmacy, those facilities are defined as pharmacies which “employ the services of a registered pharmacist or pharmacists who, in practicing institutional pharmacy, [] provide dispensing and consulting services on the premises to patients of that institution, for use on the premises of that institution.” Section 465.019(b), Florida Statutes.

More Details of the Rule.

The new rule also states that destruction shall be conducted by at least two people. One will be the PDM or the consulting pharmacist of record and the other has to be one of the following: the medical director of the facility or his/her physician designee; the director of nursing or his/her licensed nurse designee, or a sworn law enforcement officer.

Finally, the rule retains the ability of the pharmacy to destroy the drugs by way of sending them to a reverse distributor in lieu of on-site destruction.

Check our blog regularly for updates on this and other recently adopted rules and changes.

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 rule change? Will the change affect your job or business? Please leave any thoughtful comments below.

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 Ave., Altamonte Springs, Florida 32714, Phone: (407) 331-6620.

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

Copyright © 1996-2014 The Health Law Firm. All rights reserved.

CVS Blacklists Second Set of Doctors Accused of Overprescribing Painkillers

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

CVS is again stepping up its own internal efforts to combat the nation’s prescription drug abuse epidemic. According to Reuters, the second largest retail pharmacy chain announced it is cutting off access to the most powerful painkillers for more than 36 doctors and health care providers around the country. The Drug Enforcement Administration (DEA) has been keeping a close eye on CVS over the past few years. According to Reuters, CVS began revoking the dispensing privileges of certain providers back in 2011. CVS disclosed this round of suspensions on August 21, 2013.

To read the article from Reuters, click here.

CVS Closely Analyzed Prescription Practices of Health Care Providers Before Suspending Dispensing Privileges.

CVS said the suspension followed an analysis of prescriptions brought to its drugstores from March 2010 through January 2012, for painkillers such as oxycondone, hydrocodone, and methadone, according to Reuters. CVS said it first identified several dozen health care providers, from its database of nearly one million, with “extreme” patters of prescribing high-risk drugs. CVS allegedly compared their prescription rates to other providers in the same specialty and geographic region, the ages of the patients, and the number of patients paying with cash for the drugs.

After analyzing the results, CVS said the company’s stores and mail-order pharmacy will no longer dispense controlled substances for 36 providers who it said could not justify their prescribing habits, according to the Orlando Sentinel. CVS did not disclose the names or location of the physicians blacklisted this time around.

Click here to read the Orlando Sentinel article.

Second Time CVS Has Blacked Listed Specific Doctors.

In November 2011, at least 22 Central Florida doctors received an unsigned letter from CVS telling them that the company’s pharmacists would no longer fill prescriptions they write for painkillers and other powerful drugs. The letter was called a “blacklist” and was criticized as discriminatory. One Orlando doctor tried to fight back with legal action, claiming that CVS basically called him a criminal. To read more on the previous blacklist, click here to read my blog.

So far, we have not heard of any legal action pending against CVS from providers recently added to the blacklist.

DEA Previously Pulled Controlled Substance Licenses from Two Sanford, Florida, CVS Pharmacies.

As previously stated, the DEA has had its eyes on CVS for a while. You may remember that in September 2012, the DEA revoked the registrations (controlled substance licenses) from two CVS pharmacies in Sanford, Florida. I previously wrote about this, click here to read that blog.

Who is Responsible for the Prescription Drug Epidemic?

The act of prescribing powerful, and sometimes deadly, addictive drugs inappropriately for a health care provider’s personal gain has grown. It’s argued that pharmacies have a role to play in the oversight of controlled substance prescriptions. Pharmacists, as well as physicians and all health care providers, have an ethical (and legal duty) to ensure that a prescription for a controlled substance is appropriate.

Contact Health Law Attorneys Experienced with DEA Cases.

The Health Law Firm represents physicians, pharmacists, pharmacies, nurses and other health providers in investigations, regulatory matters, licensing issues, litigation, inspections and audits involving the DEA, Department of Health (DOH), and other law enforcement agencies.
If you are aware of an investigation of you or your practice, or if you have been contacted by the DEA or DOH, contact an experienced health law attorney immediately.

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

Comments?

What do you think of CVS’ ban on filling controlled substance prescriptions from certain doctors? Do you think this will help with the national prescription drug abuse epidemic? Please leave any thoughtful comments below.

Sources:

Pavuk, Amy. “CVS Cracks Down on Doctors with ‘Extreme Patters’ of Prescribing High-Risk Drugs.” Orlando Sentinel. (August 29, 2013). From: http://www.orlandosentinel.com/news/local/breakingnews/os-cvs-crackdown-doctors-20130829,0,5193527.story?dssReturn

Wohl, Jessica. “CVS Cuts Access to Opiod Pain-Killers for Suspect Doctors.” Reuters. (August 21, 2013). From: http://www.reuters.com/article/2013/08/21/us-cvscaremark-painkillers-idUSBRE97K17120130821

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.

Selling Tobacco Can Get You Penalized By Insurance Panels

Lance Leider headshotBy Lance O. Leider, J.D., The Health Law Firm

Beware: selling cigarettes could burn a hole in your pocket.

The CVS Health Corporation (CVS), the nation’s second-largest drug store, is currently in the midst of launching a tobacco-free prescription-drug network. The company announced in October 2014, that it will begin offering a tobacco-free pharmacy plan to employers, unions, and insurance companies for which its Caremark arm manages prescription benefits. CVS is slapping patients with an extra co-payment “penalty” if they purchase their medications from pharmacies that sell tobacco products, regardless of whether the patient is a tobacco user.

According to US News, by adding a variable co-payment of up to $15, CVS hopes that this new strategy, comparable to a narrow network insurance design, will perpetuate the company’s health-and-wellness based initiatives.

The new network will start in 2015. Customers will receive a list of participating pharmacies before any network change will take place.

Click here to read more from US News.

The Tobacco-Free Retail Trend.

Target and CVS have become the poster children for tobacco-free retailers. In 1996, Target spearheaded the fight against tobacco by eliminating all sales of the toxic substance. In September 2014, the CVS Corporation followed suit and completed its tobacco-free overhaul by removing all tobacco products from store shelves across the nation.

The tobacco-free pharmacy networks would include CVS and Target nationally, as well as local or regional pharmacies such as independent pharmacies that abstain from tobacco sales. Walgreens and Walmart pharmacies, two large-scale rival drug chains that sell tobacco, as well as any other grocery or community pharmacy, should expect patient penalties and negative impacts on prescription-drug revenue.

Those Participating in the Tobacco-Free Network.

According to Yahoo! Finance, CVS representatives said the network was created in a response to pharmacy benefit management (PBM) clients that indicated interest in tobacco-free pharmacies. The tobacco-free network will only be used by the PBM customers that voluntarily participate.

The first employer to sign on is the city of Philadelphia, as it promotes a tobacco-free workforce. Philadelphia officials estimate that between 150 and 200 CVS pharmacies will participate in the Philadelphia network.

To read more on this topic from Yahoo! Finance, click here.

Sincere Motives or a Monopoly in the Making?

There are a myriad of arguments regarding CVS’ genuine motive behind the tobacco-free network. Health benefit analysts argue that the network is a disguised anti-competition scheme. With the announcement of the new network plan, CVS opens itself up to criticism for appearing to steer patients to CVS pharmacies, or strong arm the competition into giving up lucrative tobacco revenue. Although the corporation denies these claims of ulterior motives, Dave Balto, a former policy director at the U.S. Federal Trade Commission argued that “…It’s really another effort to limit the ability of their rivals to effectively compete.”

Independent pharmacies are also questioning the industry benefits of such a plan. Small, local pharmacies that have not carried tobacco products for years may be overlooked by the consumers knowingly aware of CVS as a tobacco-free drug store. These mom-and-pop pharmacies will be forced to spend a pretty penny on increased marketing to stand on their own two feet against these mass retail chains.

The Narrow Network Comparison.

Many critics argue that the new CVS plan could be considered a narrow network strategy. A narrow network applies to any health insurance plan that places constraints on doctors and hospitals that are available to their beneficiaries. Typically plans will not cover medical services received out-of-network or they will increase co-payments.

These designs are becoming more common for insurance companies and pharmacy benefit managers. By limiting the choices, insurers say they can better focus on the quality of medical care that is delivered to plan customers.

Comments?

What is your opinion of the new CVS tobacco-free network plan? Do you think it will be beneficial for overall community health or more detrimental to the livelihood of small pharmacies? Please leave any thoughtful comments below.

Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.

The Health Law Firm represents pharmacists and pharmacies in DEA, DOH and FDA 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 http://www.TheHealthLawFirm.com.

Sources:

Silverman, Ed and Ziobro, Paul. “CVS Plays Hardball with Rival Drug Chains.” (October 20, 2014). From: http://finance.yahoo.com/news/cvs-plays-hardball-rival-drug-231400764.html

Murphy, Tom. “CVS Health Stretches Anti-tobacco Push to New Prescription Drug Network.” (October 21, 2014). From: http://www.usnews.com/news/business/articles/2014/10/21/cvs-develops-tobacco-free-prescription-network

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 Ave., Altamonte Springs, Florida 32714, Phone: (407) 331-6620.

“The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.
Copyright © 1996-2014 The Health Law Firm. All rights reserved.

Florida Toughens Up Drug Compounding Law for Out-of-State Pharmacies

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

A new, stricter law on Florida’s compounding pharmacy industry took effect October 1, 2014.
The new law increases the restrictions for out-of-state compounding pharmacies and outsourcing facilities that ship medications into Florida. The law also gives the Florida Board of Pharmacy and Florida Department of Health (DOH) more power to oversee and penalize these companies. Click here to read the new law.

The law was enacted to increase the standards for compounding pharmacies that create medications that are supposed to be tailored to the needs of individual patients. In an effort to prevent another nationwide outbreak of fungal meningitis, similar efforts to tighten control on compounding pharmacies have been implemented by other states across the country. Click here to read a prior blog on the fungal meningitis outbreak.

The Lowdown on the New Law.

The bill requires an out-of-state compounding pharmacy or an outsourcing facility to obtain a nonresident sterile compounding permit before shipping products into Florida. Any currently-registered nonresident pharmacies must be permitted by February 28, 2015. However, all compounded sterile products shipped, mailed, delivered, or dispensed into the Sunshine State must meet Florida’s standards for sterile compounding.

The law establishes application and inspection requirements for the nonresident sterile compounding permit, as well as increased responsibilities for the Florida DOH and the Board of Pharmacy.

Under the law, the Florida DOH and Board of Pharmacy are given enhanced oversight for these out-of-state compounding pharmacies, including the authority to inspect a pharmacy or sterile compounding permittee; the cost of which is picked up by the pharmacy or permittee. The Board is authorized to discipline a nonresident pharmacy for conduct which causes or could cause serious injury, without waiting 180 days for the resident state to act. The Board is also authorized to discipline nonresident pharmacies and sterile compounding permittees for specified acts of noncompliance.

New Standards Triggered by Tainted Compounded Medications.

These new standards are being implemented two years after a nationwide outbreak of fungal meningitis linked to contaminated drugs made by a compounding pharmacy in Massachusetts. Florida is no stranger to allegations of tainted compounded products. In May 2012, Franck’s pharmacy in Ocala, Florida, was accused of distributing eye medications that contained a fungal infection. To read more: click here for the first blog and here for the second blog.

It’s likely these new permits are a direct result of the recent issues with compounded medications and compounding pharmacies. The goal of these permits is to help authorities, such as the DOH and the Board of Pharmacy, track pharmacies compounding sterile products.

Comments?

What do you think of the law to increase restrictions on out-of-state compounding pharmacies that ship medications into Florida? Please leave any thoughtful comments below.

Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.

The Health Law Firm represents pharmacists and pharmacies in DEA, DOH and FDA 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 and visit our website at www.TheHealthLawFirm.com.

Sources:

Shedden, Mary. “Tougher Compounding Rules Finally Law.” Health News Florida. (September 30, 2014). From: http://bit.ly/1xBQtS0

Florida House Bill 7077

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 © 1996-2014 The Health Law Firm. All rights reserved.

Florida Legislature Reforms Pharmacy Benefit Manager Audit Practices

1 Indest-2008-1According to the Florida Legislature, it’s time for pharmacists to focus on their patients instead of paperwork. On June 13, 2014, Florida Governor Rick Scott signed Florida Senate Bill 702 into law. This law introduces clear guidelines of acceptable audit practices of pharmacies in the Sunshine State.

There are more than 2,700 pharmacies across Florida that are routinely evaluated by Pharmacy Benefit Managers (PBMs). The purpose of these audits is to verify that certain claims are submitted and handled properly. If a PBM audit uncovers fraud or abuse, the pharmacy will be subject to penalties, including reimbursement of amounts paid. With the increase of rules regulating pharmacies, these audits have progressively become more time consuming for pharmacists.

Florida SB 702 becomes effective on October 1, 2014. To read a summary of the law, click here.

What’s the Need of the New Law?

In the United States, a PBM is most often a third party administrator of prescription drug programs. The PBM is primarily responsible for processing and paying prescription drug claims.
Currently, PBMs have broad discretion to penalize pharmacies. This means that pharmacies can be forced to pay thousands of dollars as the result of basic clerical or typographical mistakes, many of which are not the fault of the pharmacist or pharmacy staff. This law was enacted to provide reasonable standards for pharmacy audits while allowing PBMs to continue penalizing for true fraud and abuse.

Pharmacy Rights Included in New Law.

SB 702 makes common-sense auditing standards that include:

–    At least seven days advance notice before an on-site audit is conducted;
–    On-site audits scheduled after the first three days of the month;
–    A limit on the audit period of 24 months after the date claim is submitted;
–    Audits requiring clinical judgment must be conducted by or with a pharmacist;
–    Use of written practitioner records to validate pharmacy records in accordance with state and federal law;
–    Reimbursement of claims retroactively denied for clerical, typographical or computer errors unless pharmacy has a pattern of fraudulent billing;
–    Delivery of initial audit reports to pharmacists within 120 days after an audit is completed;
–    Receipt of final audit report within six months of the preliminary report;
–    Allowing 10 days for pharmacists to provide documentation to address any discrepancies found during an audit;
–    Prohibiting the use of extrapolations in auditing claims; and
–    The Office of Insurance Regulation will study pharmacy complaints of willful violations of audit provisions by PBMs.

Stipulation of Rights.

The rights listed above do not apply to audits that are based on suspicions of fraud or willful misrepresentation; audits of claims paid for by federally funded programs; or concurrent reviews or desk audits that occur within three business days after transmission where no chargeback or recoupment is demanded.

An entity that audits a pharmacy located within a Health Care Fraud Prevention and Enforcement Action Team Task Force area designated by the U.S. Department of Health and Human Services (HHS) and the U.S. Department of Justice (DOJ) is not required to provide seven days prior notice of an audit if the pharmacy has been a member of a credentialed provider network for less than 12 months.

What This Means for You.

For once there is a new law that does not make a pharmacist’s job more complicated. This law may actually alleviate some of the stress that comes with dealing with an audit. We’re hoping with the implementation of this law pharmacists will be able to spend more time focusing on patient care.

Comments?

What do you think of this new law? Will it affect your pharmacy? Please leave any thoughtful comments below.

Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.

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

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.

Recall Alert: FDA Warns Steroid Injections Compounded by Tennessee Pharmacy May Be Contaminated

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

The U.S. Food and Drug Administration (FDA) sent out a warning to health care professionals that steroid injections compounded by Main Street Family Pharmacy, LLC, in Tennessee, may be contaminated. The announcement came on May 24, 2013. So far, seven patients have allegedly suffered adverse reactions from the medications. The FDA says it is working with the Centers for Disease Control and Prevention (CDC) and the Tennessee Board of Pharmacy to investigate. The steroid injections were allegedly sent to 13 states, including Florida.

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

Steroid Injections Recalled.

According to an article in the Associated Press, officials have not yet confirmed the products are contaminated. The FDA is treating all sterile products from Main Street Family Pharmacy as if they were contaminated as a precaution. The pharmacy has agreed to recall all of its sterile products. Click here to read the Associated Press article.

The injections in question allegedly contain the same drug at the center of the October 2012, deadly fungal meningitis outbreak. More than 55 people, including five in Florida were killed and 740 others were sickened after receiving contaminated injections from a Massachusetts compounding pharmacy. I previously blogged about that outbreak. To read more, click here.

Patients in North Carolina and Illinois Allegedly Reacted to Injections.

Federal authorities have allegedly identified seven cases of patients who have suffered complications after being injected with the potentially contaminated medications. There are five cases in Illinois and two cases in North Carolina. The Illinois patients supposedly have skin infections and one patient in North Carolina allegedly suffered from a fungal infection.

Florida Department of Health Working to Contain Allegedly Tainted Injections Statewide.

According to the Florida Department of Health (DOH), at least three Florida facilities received the drugs under investigation. Two of the facilities are in Melbourne, Florida, and one is in Chipley, Florida. The Florida DOH says it is not aware of any local cases of infections from these drugs.

To read the press release from the Florida DOH, click here.

Previous Florida Case of Contaminated Medication.

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

Congress Debating on Giving Authority Over Compounding Pharmacies to FDA.

Currently, compounding pharmacies are regulated by state pharmacy boards. There is currently legislation moving through Congress that would give the FDA direct authority over the compounding manufacturers. The goal is to prevent any national outbreaks tied to compounded medications.

Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.

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

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

Sound Off.

Do you think each state should be responsible for regulating compounding pharmacies, or do you think the FDA should be responsible? Please leave any thoughtful comments below.

Sources:

Gentry, Carol. “FL Got Drugs Linked to New Outbreak.” Health News Florida. (May 24, 2013). From: http://health.wusf.usf.edu/post/fl-got-drugs-linked-new-outbreak

Kelly, Christopher. “FDA Alerts Health Care Providers of Adverse Reactions Associated with Steroid Injections from Main Street Family Pharmacy in Tennessee.” Food and Drug Administration (May 24, 2013). From: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm353941.htm

Stobbe, Mike and Loller, Travis. “FDA Warns of Infections Tied to Tennessee Pharmacy.” The Associated Press. (May 24, 2013). From: http://www.npr.org/templates/story/story.php?storyId=186473297

Florida Department of Health. “The Florida Department of Health Partners with Federal and State Health Organizations to Ward of Adverse Reactions Associated with Steroid Injections.” Florida Department of Health. (May 24, 2013). From: http://newsroom.doh.state.fl.us/wp-content/uploads/newsroom/2013/05/052413CDCinfection.pdf

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.
“The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999. 

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

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