Florida Compounding Pharmacy Pays $3.7 Million in Tricare False Claims Settlement

Posted on September 17, 2015 by thehealthlawfirm

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

In May of 2015, Tricare began screening all compound medication prescriptions to ensure approval of each ingredient with the Food and Drug Administration (FDA). This decision came after a finding of a significant increase in compound drug prescriptions reimbursed by Tricare over the last year.

In April 2015, just four months into the fiscal year, it was already determined that total costs for compound drug prescriptions filled for Tricare recipients were likely to come close to $1 billion. If the trend continues, the Defense Health Agency expects it may need to reallocate funds at the end of this year to cover the prescription drug benefit, which is currently set at $8.25 billion.

For more on this new screening process and its effect on compound medication prescriptions, click here.

With prescription drug costs at an all-time high, the government is cracking down on health care fraud. This includes the implementation of data mining for fraud detection and prevention.

It was during one of these routine mining expeditions of reimbursement data that the United States Attorney’s Office identified MediMix, a compounding pharmacy in Jacksonville, Florida, as the top-biller of compounding pain prescriptions. More importantly, upon further investigation, it was found that Ankit Desai, M.D. was the top referring physician for MediMix.

The significance in the correlation between the two is that, according to reports, Dr. Desai happens to be married to one of the top executives (Senior Vice President) of Medimix.

To read the press release on this story, click here.

Anti-Fraud Laws Prohibit Certain Physician Referrals.

Health care providers are generally prohibited from referring patients to another medical-related business in which they hold a financial interest of some kind, if there are payments made with federal funds.

The prohibition on certain physician referrals is established under Section 1395nn, 42 United States Code (otherwise known as the Stark Law). The Stark Law was specifically enacted to place limitations on physician referrals so as to avoid:

(1) conflicts of interests;

(2) self-referrals;

(3) overutilization of services;

(4) increased health care costs;

(5) a limit on competition by other medical providers;

(6) to prevent ineffective and unsafe treatment; and, ultimately-

(7) fraudulent practices.

Click here for more information on the most common Federal fraud and abuse laws in health care.

The Stakes are High for Non-Compliance.

MediMix reached a settlement agreement with the government which has avoided a determination of liability. However, the Jacksonville-based compounding pharmacy did not get off without a significant penalty. The settlement will cost MediMix an impressive $3,775,458.

Click here to read more about the government cracking down on what they determine to be “a significant threat to the [Department of Defense] DoD healthcare system.”

The FCA has been highly effective in exposing fraudulent practices of pharmaceutical companies. Whistleblower cases brought under the FCA have assisted the government in recovering more than $19 billion in stolen funds due to varying pricing, billing and marketing schemes.

Avoiding False Claims Violations.

Here are the most common pharmaceutical practices that can result in allegations of FCA violations:

(1) Off-label marketing of drugs;

(2) Illegal kickbacks;

(3) Inflating the price of pharmaceuticals;

(4) Best price fraud; and

(5) Pharmaceutical benefits manager fraud.

If you find yourself in a tricky situation with possible allegations of a FCA violation, it’s best to contact an experienced health attorney immediately to properly evaluate your case and inform you of your rights.

For more about your right to consult with a lawyer prior to speaking with an investigator, please read one of our previous blogs here.

Comments?
Are you currently engaged in a questionable financial relationship? Do you agree with the law on prohibiting certain referrals in which there is a financial interest? Why or why not? 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, qui tam and whistleblower cases, 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.

Sources:

Department of Justice, The United States Attorney’s Office, Middle District of Florida. Press release. “United States Settles False Claims Act Allegations Against Jacksonville-Based Compounding Pharmacy.” 1 June 2015. Web. 11 Sept. 2015.

Kime, Patricia. “Tricare to Start Screening Compound Medications Friday.” Military Times. A TEGNA Co., 1 May 2015. Web. 10 Sept. 2015.

“Pharmaceutical Fraud” Web blog post. False Claims Act Resource Center. Pietragallo Gordon Alfano Bosick & Raspanti, LLP, 2015. Web. 11 Sept. 2015.

Rumph, Alan, and Donna Lee Yesner. “When Referrals And Marriage Don’T Mix: MD, Pharmacy Settle Case.” Report on Medicare Compliance. Washington: Atlantic Information Services, Inc., 8 June 2015. Web. 11 Sept. 2015.

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: False Claims Act defense attorney, FCA, pharmaceutical fraud, compounding pharmacy attorney, fraudulent practices of pharmaceutical companies, whistleblowers lawyer, FCA violations, fraud detection, data mining, financial interest in physician referrals, Stark Law, Department of Defense, DoD, Tricare fraud attorney, health attorney, defense attorney, The Health Law Firm, health law firm, fraud investigations, conflict of interest in physician referrals, compound medication prescriptions, compounding pharmacy lawyer, prescription reimbursement, qui tam attorney, financial relationship with physician

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

Pharmacies May be Liable for Filling Valid Prescriptions

Posted on February 27, 2015 by thehealthlawfirm

By Lance O. Leider, J.D.

Florida pharmacies have had their potential liability significantly expanded by the Fifth District Court of Appeal. In its recent decision, Oleckna v. Daytona Discount Pharmacy, the appellate court held that a pharmacy owes a duty to its patients that go beyond following the prescribing physician’s directions and properly dispensing the medication.

The court defined the pharmacy’s duty to use due care in filling a prescription to mean more than what it called “robotic compliance” with the instructions of the prescribing physician.

From the court’s decision and some others from around the state it would seem that Florida pharmacists are now under an obligation to question the quantity, frequency, dosage, combination, and possibly even the purpose of a valid prescription. Florida pharmacies are no longer simply a conduit for validly prescribed prescription medications. They are now an integral part of the health care system where trained professionals are expected to act as a check and balance on physicians and other prescribers.

This decision is in keeping with recent Florida Board of Pharmacy cases dealing with narcotic pain medications. The Board has interpreted Section 465.003(6), Florida Statutes, and Rule 64B16-27.820, Florida Administrative Code, to place a duty on a pharmacist to use his or her skill and experience to evaluate the propriety of every prescription presented on a global level.

While courts and the Board are more than willing to expand the scope of a pharmacist’s duty to his or her patients, unfortunately, neither have provided any prospective guidance on how to fulfill the duty.

Suggestions for Compliance.

Below are some suggestions for ensuring your pharmacy is fulfilling its obligation to its patients. This list is by no means exhaustive and is only intended to offer some basic guidance.

1. Know the physician and verify the credentials of an unfamiliar one;
2. Check the Prescription Drug Monitoring Program (PDMP);
3. Do not fill prescriptions that are more than 30 days old without verifying them with the prescribing physician;
4. Question higher than normal dosages and more frequent administration instructions;
5. Do not provide early refills without verifiable documentation and contact the physician when the patient is seeking an early refill on a medication with a high potential for abuse (the physician is usually in the best position to recognize drug seeking behaviors);
6. Flag concerning prescriptions for mandatory counseling prior to dispensing to give you an opportunity to discuss the risks with the patient;
7. Check the patient’s profile for interactions and discuss them with the patient and, if necessary, the prescribing physician;
8. Periodically check with the prescribing physician on long term medications;
9. Document everything done to verify the propriety of a prescription in the patient’s record; and
10. Most importantly, don’t be afraid to refuse a fill.

In addition to these steps, you should also be conducting regular staff meetings and routine reviews of your processes to ensure that they remain functional and able to be followed.

Comments?

Do you think a pharmacy or pharmacist should be held liable for filling valid prescriptions? How do you verify you or your employees are in compliance? 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.

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.

DEA Offers New Prescription Drug Return Policy

Posted on September 17, 2014 by thehealthlawfirm

By 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

OIG Issues Advisory Opinion to Specialty Pharmacy for Support Service Payments

Posted on August 28, 2014 by thehealthlawfirm

By Lenis L. Archer, J.D., M.P.H., The Health Law Firm

There is an inherent risk in entering into financial arrangements where payments to a service provider are only made when a referral is generated. On August 15, 2014, the Office of Inspector General (OIG) made this perfectly clear in an unfavorable advisory opinion issued to a specialty pharmacy that wanted to pay local retail pharmacies for providing support services to it.

Background of Request for OIG Advisory Opinion.

According to the OIG, the requestor, a specialty pharmacy, dispenses specialty pharmaceuticals used to treat a variety of chronic and life-threatening illnesses. The specialty pharmacy stated that the drugs offered at its establishment are frequently unavailable to retail pharmacies. In light of this, the specialty pharmacy asked whether it would be permissible to enter into agreements with various local pharmacies in which the specialty pharmacy would provide its specialty drug prescriptions to local pharmacies’ patients. Under the proposed contractual arrangement, the local pharmacies would be required to provide various support services, including:

1. Accepting the prescription from the patient or prescriber;
2. Gathering patient and prescriber demographic information;
3. Recording patient-specific history and use, including drug names, strength and directions;
4. Patient counseling;
5. Informing the patients about access to specialty drugs, including the availability from pharmacies other than the specialty pharmacy;
6. Obtaining patient consent to forward the prescription to the specialty pharmacy;
7. Transferring prescription information to the specialty pharmacy; and
8. Providing ongoing patient assessments for subsequent refills.

The retail pharmacies would be paid a “per-fill fee” by the specialty pharmacy at the time that the initial prescription was transmitted and upon each subsequent refill.

OIG Issued Negative Opinion Due to Anti-Kickback Statute.

The OIG issued an unfavorable opinion for this proposed agreement, concluding that the federal Anti-Kickback Statute was implicated because the specialty pharmacy would pay a per-fill fee for support services each time a local pharmacy referred a specialty drug prescription. After evaluating the arrangement, the OIG concluded that the per-fill fees were inherently subject to abuse because they were paid only when the support services provided by the retail pharmacy resulted in a referral to the specialty pharmacy. Thus, the OIG found that such a per-fill fee is directly linked to business generated by the local pharmacy for the specialty pharmacy, and could influence the local pharmacy’s referral decisions. OIG noted that the Anti-Kickback Statute is implicated if one purpose of the remuneration is to generate referrals.

Click here to read OIG Advisory Opinion No. 14-06.

Exceptions to Anti-Kickback Laws.

Like many other regulatory frameworks, the Anti-Kickback Statute has exceptions. The law provides a number of safe harbors to the rule 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 Anti-Referral and Anti-Kickback Laws.

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

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. Call now or visit our website www.TheHealthLawFirm.com.

Sources:

Department of Health and Human Services Office of Inspector General. “OIG Advisory Opinion No. 14-06” (August 15, 2014). From: https://oig.hhs.gov/fraud/docs/advisoryopinions/2014/AdvOpn14-06.pdf

Ciesla, Frank, Christian, Beth, and Burd, Ari. “Office of Inspector General (OIG) Issues Unfavorable Advisory Opinion to Specialty Pharmacy for Support Service Payments.” The National Law Review. (August 18, 2014). From: http://www.natlawreview.com/article/office-inspector-general-oig-issues-unfavorable-advisory-opinion-to-specialty-pharma

About the Author: Lenis L. Archer is as attorney with The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, Florida 32714, Phone: (407) 331-6620.

Florida Legislature Reforms Pharmacy Benefit Manager Audit Practices

Posted on July 7, 2014 by thehealthlawfirm

According 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.

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

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

Posted on March 25, 2014 by thehealthlawfirm

By 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.

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

Florida Board of Pharmacy Updates Record Retention Rules for Pharmacies

Posted on February 25, 2014 by thehealthlawfirm

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

At its meeting held on February 12, 2014, the Florida Board of Pharmacy voted to approve language changes to a number of rules. Specifically, those changes were put into effect to establish a uniform four-year retention policy for pharmacy records.

Previously the Board’s rules were not consistent with respect to how long pharmacies were required to retain different types of records.

When approving new rules or changes to existing rules, administrative bodies are required to evaluate the regulatory costs of the changes. In examining these costs the Board found that any financial costs imposed upon small businesses would be balanced by the efficiencies created by a uniform retention period.

Board of Pharmacy Voted to Change the Wording in These Rules.

Below is a list of the administrative rules that were changed:

– Standards for the Approval of Registered Pharmacy Technician Training Programs
Rule 64B16-26.351, Florida Administrative Code

– Standards for Approval of Courses and Providers
Rule 64B16-26.601, Florida Administrative Code

– Continuing Education Records Requirements
Rule 64B16-26.603, Florida Administrative Code

– General Terms and Conditions to be Followed by a Pharmacist When Ordering and Dispensing Approved Medicinal Drug Products
Rule 64B16-27.210, Florida Administrative Code

– Standards of Practice – Continuous Quality Improvement Program
Rule 64B16-27.300, Florida Administrative Code

– Requirement for Patient Records
Rule 64B16-27.800, Florida Administrative Code

– Change of Ownership
Rule 64B16-28.2021, Florida Administrative Code

– Centralized Prescription Filling, Delivering and Returning
Rule 64B16-28.450, Florida Administrative Code

– Transmission of Starter Dose Prescriptions for Patients in Class I Institutional or Modified II B Facilities
Rule 64B16-28.503, Florida Administrative Code

– Class II Institutional Pharmacies
Rule 64B16-28.605, Florida Administrative Code

– Remote Medication Order Processing for Class II Institutional Pharmacies
Rule 64B16-28.606, Florida Administrative Code

– Automated Pharmacy System – Long-Term Care, hospice, and Prison
Rule 64B16-28.607, Florida Administrative Code

– Modified Class II Institutional Pharmacies
Rule 64B16-28.702, Florida Administrative Code

– Record Maintenance for Animal Shelter Permits
Rule 64B16-29.0041, Florida Administrative Code

Make Sure Your Facility is Prepared.

While these rule changes are not final, it is important to recognize if they will be affecting your facility. You should also be making arrangements in your facility to ensure that there is enough computer disk space or physical space to retain these records. Keep in mind that these records retention rules are in addition to any others imposed by other Florida or federal statutes or rules relating to controlled substances or other pharmacy practices.

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?

How do you feel about the requirement of pharmacy records to be retained for four years? 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 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.

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

Posted on February 18, 2014 by thehealthlawfirm

By 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.

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.

“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.

Generic Drug Labeling Change Proposed by FDA is Significant and Will Likely Negate Preemption of State Failure-to-Warn Claims in Generic Drug Cases

Posted on February 5, 2014 by thehealthlawfirm

Guest Post: Alina Denis Jarjour, Esquire, Jarjour | Legal

Under current law, an individual can bring a product liability action for failure to warn against a brand name drug company, i.e., the NDA (New Drug Application) holder, but generally not against a generic manufacturer, the holder of an ANDA (Abbreviated New Drug Application).

Federal preemption stems from FDA regulations that do not permit the holder of an approved ANDA to change labeling to add new safety information the generic company becomes aware of until and unless the brand name company that holds the NDA for the reference listed drug (RLD) modifies the labeling. This interpretation was affirmed by the U.S. Supreme Court in 2011 in the Pliva, Inc. v. Mensing case. The Court, however, left the door open when it added “Congress and the FDA retain the authority to change the law and regulations if they so desire.”

In November 2013, the US Food and Drug Administration (FDA) began the process to do just that when it published a proposed rule that will require generic drug companies to update the labeling of their drugs in light of new safety risks even though the RLD labeling for those products has different information on warnings, precautions, contraindications, adverse reactions and the like.

Under the proposed regulation, when the ANDA holder has “newly acquired information” that presents “sufficient evidence of a causal association” between the unlabeled warning and the approved generic drug, the generic manufacturer must submit a Changes Being Effected (CBE-0) supplement to its ANDA and immediately change its label. Also, the ANDA holder will be required to send the NDA holder both the labeling change and a copy of the information supporting the change. Any changes ultimately approved by FDA would affect both the generic label and the RLD holder’s labeling.

The FDA has noted that “if this proposed regulatory change is adopted, it may eliminate the preemption of certain failure-to-warn claims with respect to generic drugs.”

Interested parties wishing to provide input on the proposed rule must submit comments by January 13, 2014. The full text of the proposed rule is available at this link.

The Pliva v. Mensing, 131 S.Ct. 2567 (2011) decision is available at this link: http://www.supremecourt.gov/opinions/10pdf/09-993.pdf.

About the Author: Alina Denis Jarjour is a business attorney, corporate governance / compliance professional and mediator. In addition to being a private practitioner, Alina has served in executive level legal, operational and governance/compliance roles within life sciences, telecommunications and technology companies. Her firm, Jarjour | Legal, works closely with clients engaged in the life sciences, tech / telecom, media, healthcare, consumer products and non-profit activities in and outside of the United States. Alina is an alumna of the University of Pennsylvania Law School, is bilingual (English/Spanish) and speaks frequently on business development, regulatory, compliance, conflict resolution and legal topics.

This article was originally published in the Florida Bar December 2013 Health Law Monthly Updates.

Drug Quality and Security Act Boosts FDA Regulations Over Compounding Pharmacies

Posted on December 13, 2013 by thehealthlawfirm

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

On November 18, 2013, the United States Senate voted to increase federal oversight of compounding pharmacies that produce large volumes of mixed drugs. This bill comes in the wake of last year’s meningitis outbreak stemming from unsanitary conditions at the New England Compounding Center (NECC). Click here to read a previous blog on the meningitis outbreak.

This bill does not give the U.S. Food and Drug Administration (FDA) absolute authority over compounders, but creates significant safeguards.

This particular piece of legislation passed the House of Representatives in September of 2013, passed in the Senate in November 2013, and President Obama signed it into law on November 28, 2013. To read a summary of the Drug Quality and Security Act, click here.

Under Law, Registration with the FDA is Voluntary.

The goal of the Drug Quality and Security Act is to enact greater controls, tracking, and oversight of the compounding pharmacy industry. Presently, the U.S. Food and Drug Administration (FDA) only regulates manufacturers of medications, leaving compounding pharmacies to be regulated by state boards of pharmacy.

However, this two-part regulation left large compounding operations like the NECC in somewhat of a gray area. Large compounding labs like NECC that mass produce products to ship across state lines have come under fire from state boards of pharmacy.

At a recent meeting of the Florida Board of Pharmacy’s Compounding Committee, the panel members expressed concerns over the lack of inspections and oversight of pharmacies shipping drugs into Florida. In general, the Committee supported the efforts to strengthen regulations, whether by the FDA or state boards.

Overview of the Law.

Under the final legislation, compounders that mix sterile drugs without a prescription and ship across state lines can choose to register as outsourcing facilities. The pharmacies that register would then be regulated by the FDA rather than by state boards of pharmacy. The hope is that compounding pharmacists will want to register with the FDA because physicians will prefer using compounding pharmacies that are federally regulated, and therefore considered safer.

The law also creates a national system for tracking prescription drugs from the manufacturer to retail pharmacies, first this is done through serial numbers on bottles and later through electronic codes. Drug makers will be required to add serial numbers to all drug packages within four years, and within 10 years drug makers must implement electronic codes that can be used to track medicine from the factory to the pharmacy.

Issues with Previous Inspections.

As mentioned above, the issue of large-scale compounding and nonresident pharmacies was recently discussed by the Florida Board of Pharmacy.

Florida has more than 700 nonresident pharmacy permits outstanding. According to the Board of Pharmacy, approximately half of those are shipping compounded sterile products into Florida.

Prior to the events at NECC, state boards of pharmacy were under the mistaken assumption that their sister boards were appropriately regulating and inspecting these pharmacies. However, it turns out that many of the inspections were conducted by inadequately trained staff, or the staff was misled as to exactly what was going on at the pharmacy.

Many of the pharmacies wrongly informed the state inspectors that they were registered with the FDA as a manufacturer and did not have to provide prescriptions during inspections. This led to largely unregulated production of compounded sterile medications and eventually the meningitis outbreak of 2012.

Florida Board of Pharmacy to Have More Oversight.

Frustrated with the general lack of oversight and the potential harm to Floridians, the Board is preparing to take additional steps to ensure that compounders are appropriately regulated.

Among the possible steps to be taken are:

1. Outsourcing nonresident pharmacy inspections to organizations like the National Association of Boards of Pharmacy (NABP);

2. Require personal inspection by a Florida Board-approved inspector prior to issuing or renewing a license (costs of the inspection would be paid by the permittee);

3. Training specialized compounding pharmacy inspectors; and

4. Creating a Verified Pharmacy Program in conjunction with the NABP and other state boards.

Ultimately, the result of the additional regulations will mean more rigorous compliance standards on both in and out-of-state compounding pharmacies.

New Permit Law for Florida Pharmacies that Compound Sterile Products.

The Florida Board of Pharmacy also recently announced a new law which will be required for pharmacies that compound sterile products. 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. Pharmacies compounding sterile products under their current pharmacy permit may continue to do so, but must obtain the new Special Sterile Compounding Permit on or before March 21, 2014. To read more, click here.

These new standards will make it easier for authorities to quickly spot where tainted batches of medications were produced. It is important to regularly review the Board of Pharmacy rules and USP guidelines to ensure your facility is compliant.

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.

Comments?

Have you heard of these new possible pharmacy regulations? How will this affect you or your pharmacy? Please leave any thoughtful comments below.

Sources:

Lee, Jaimy. “Bill Boosting FDA Authority Over Compounding Pharmacies Heads to Obama.” Modern Healthcare. (November 18, 2013). From: http://www.modernhealthcare.com/article/20131118/NEWS/311189973/bill-boosting-fda-authority-over-compounding-pharmacies-heads-to?utm_source=frontpage&utm_medium=newsitem309&utm_campaign=carousel-traffic

Perrone, Matthew. “Pharmacy Bill Set for Test Vote in Senate.” Washington Post. (November 11, 2013). From: http://www.washingtonpost.com/politics/pharmacy-bill-set-for-test-vote-in-senate/2013/11/11/a961c958-4b25-11e3-9890-a1e0997fb0c0_story.html

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Drug Quality and Security Act Boosts FDA Regulations Over Compounding Pharmacies