Fraud and Abuse Plagues Medicare Prescription Drug Program

5 Indest-2008-2By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law
Fraud and abuse continue to dog Medicare’s Part D program, despite a surge of initiatives launched to prevent them, according to a new report issued by the Office of Inspector General (OIG), Department of Health and Human Services (HHS). With more than 39 million Americans depending on the program for their prescription drugs costing over $120 billion a year, the OIG is taking aggressive measures to combat fraud.

New Testimony.

On July 14, 2015, Ann Maxwell, Assistant Inspector General of HHS, gave testimony to Congress on the Medicare Part D Program. She presented before the United States House of Representatives Committee on Energy and Commerce and the Subcommittee on Oversight and Investigations. Her testimony focused on fraud, waste and abuse trends in the Medicare Part D Program and recommendations to address the underlying vulnerabilities.

The Medicare Part D Program is Vulnerable to Fraud.

In June of this year, the OIG deployed more than 300 special agents and law enforcement personnel to execute arrest and search warrants for Medicare fraud across the country. To date, it was the largest national health care fraud takedown. It resulted in more than 240 people being charged with defrauding the Medicare and Medicaid programs. Much of the fraud involved prescription drugs and those charged included doctors and pharmacy owners. Additionally, 28 individuals from South Florida were charged with Part D fraud totaling more than $38 million in Medicare overpayments.

According to one of OIG’s reports, more than 1,400 pharmacies had questionable billings for opioid drugs, and a number of cities had higher than average billings for certain medications last year. To read the full report, click here. To read Marshall’s testimony in full, click here.

What Does This Mean for Pharmacists and Pharmacies?

CMS is responsible for improving the program’s effectiveness and protecting its beneficiaries. To do so, CMS should take action on OIG’s recommendations and employ all the tools at its disposal. Expect this to involve more audits, more action by ZPICs and MFCUs, and more health care subpoenas being issued. To learn more about Medicare Part D fraud and how it may affect you, read one of our past blogs here.

For tips on how to handle Medicare subpoenas, click here. For tips on responding to Medicare audits, click here. For tips on how to respond to Medicaid audits, click here.

Contact Health Law Attorneys Experienced in Handling Medicare and Medicaid Audits, Investigations and other Legal Proceedings.

Medicare and Medicaid fraud is a serious crime and is vigorously investigated by the state MFCU, the Agency for Health Care Administration (AHCA), the Zone Program Integrity Contractors (ZPICs), the FBI, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (DHHS). Often other state and federal agencies, including the U.S. Postal Service (USPS), and other law enforcement agencies participate. Don’t wait until it’s too late. If you are concerned of any possible violations and would like a confidential consultation, contact a qualified health attorney familiar with medical billing and audits today. Often Medicare fraud criminal charges arise out of routine Medicaid audits, probe audits, or patient complaints.

The Health Law Firm’s attorneys routinely represent physicians, dentists, orthodontists, medical groups, clinics, pharmacies, assisted living facilities (ALFs), home health care agencies, nursing homes, group homes and other healthcare providers in Medicaid and Medicare investigations, audits and recovery actions.

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

Source:
Ornstein, Charles. “Fraud Still Plagues Medicare’s Prescription Drug Program.” NPR. (June 23, 2015). From:
http://www.npr.org/sections/health-shots/2015/06/23/416546499/fraud-still-plagues-medicares-prescription-drug-program

Comments?

What do you think of these large crackdowns on Medicare Part D fraud? Do you think they work as a deterrent for others committing health care fraud? Please leave any thoughtful comments below.

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

KeyWords: Medicare fraud, Medicaid fraud attorney, Medicare Part D program, Medicare Program, Medicare fraud attorney, fraud attorney, prescriptions, prescription drug program, Medicare audit lawyers, Medicaid audit lawyer, legal counsel, defense attorney, fraudulent claims, Office of Inspector General, OIG, Centers for Medicare & Medicaid Services, CMS, defense attorney, Medicaid fraud defense attorney, Medicaid fraud defense lawyer, health law firm, The Health Law Firm

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

Designation as “Controlled Substance Prescriber” on DOH Provider Profile Not a Bar to Prescribing Controlled Substances, According to Board of Medicine

PS 4 Indest-2009-3By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

According to a posting the Florida Board of Medicine, Department of Health made on its website on July 21, 2015, a physician’s failure to be designated as a “Controlled Substance Provider” in his or her online DOH provider profile, should not prevent pharmacists from filling prescriptions the physician writes for controlled substances.

The posting on its online website sates the following:

“The Department has received numerous calls in recent weeks from physicians expressing concerns that some pharmacists are not filling controlled substance prescriptions if the physician is not listed as a controlled substance prescriber on the practitioner profile on the Department of Health’s website. While there may be many reasons a pharmacist may decide in his or her professional judgment not to fill a prescription, the Department wants to ensure that any confusion concerning the physician registration requirements is addressed.”

The posting on the website goes on to state:

“The lack of a designation on the physician profile concerning controlled substances does not necessarily mean that the physician cannot prescribe controlled substances. Section 456.44, Florida Statutes, requires a physician licensed under chapter 458, chapter 459, chapter 461 or chapter 466 who prescribes controlled substances listed in Schedule II, Schedule III, or Schedule IV for the treatment of chronic nonmalignant pain, to designate himself or herself as a controlled substance prescribing practitioner on the physician’s practitioner profile. This requirement is applicable only to those physicians that are treating patients for chronic nonmalignant pain. Therefore, physicians that are not treating patients for chronic nonmalignant pain are not required to register and may continue prescribing controlled substances for other diagnoses.”

This type of confusing bureaucratic “guidance” seems as though it will do nothing but cause further confusion, especially to pharmacists. To read the statement from the DOH, click here.

Comments?

Do you agree with the Department of Health’s statement on their website? Do you think physicians should have a profile on the DOH provider profile in order to prescribe a controlled substance? 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.

Source:

Florida Board of Medicine.”Controlled substance prescriber not required on profile”. Department of Health. (July 21, 2015). From:
http://flboardofmedicine.gov/latest-news/controlled-substance-prescriber-not-required-on-profile/

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: Florida Board of Medicine, Department of Health, DOH, controlled substance, controlled substance provider, controlled substance prescribing practitioner, physician registration requirements, health care professional, health law, health care law, health law attorney, health care lawyer, health law, The Health Law Firm

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

FDA Approves New Cholesterol-Reducing Drug

5 Indest-2008-2By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

The first of a new class of cholesterol-lowering drug was approved by U.S. regulators on Friday. The new medicine is a highly anticipated medical advance that, unfortunately, will have the effect of escalating already growing drug costs. This will also offer new options for the millions of Americans who suffer from cardiovascular disease, the nation’s leading killer.

The new drug, Praluent, was developed by Regeneron Pharmaceuticals Inc and Sanofi SA.

It’s Available, but It’ll Cost You.

Praluent provides a desperately-needed option for the millions of high-risk heart patients who can’t get their cholesterol down with medicines known as statins. The problem however, is that drug companies are pricing this new drug much higher than other Cholesterol medications. In contrast, statins, which are the mainstay drug option for cholesterol reduction, can be purchased for just a few dollars a month.

Regeneron and Sanofi Defend the Product.

Regeneron and Sanofi defended the price of Praluent, saying the price is justified by the potential benefits to patients and savings to the health care system.

Praluent is an antibody that patients inject themselves with. It would prevent heart attacks and strokes, but the ability to do so has not been proved. However, in clinical trials, Praluent reduced levels of LDL cholesterol, the so-called bad cholesterol, by 40 percent or more. This was even among patients already taking statins, pills like Lipitor for controlling blood lipids.

To read the press release issued by the U.S. Food and Drug Administration (FDA), click here.

Comments?

Are you a health care professional who agrees with the distribution of this costly drug? Would you write prescriptions for it? Please leave any thoughtful comments below.

Sources:

Pollack, Andrew. “New Drug Sharply Lowers Cholesterol, but It’s Costly.” (July 24, 2015). The New York Times. From: http://nyti.ms/1LCiSPn

Winslow, Ron. “FDA Approves Cholesterol Drug from Regenron, Sanofi.” (July 24, 2015). The Wall Street Journal. From: http://on.wsj.com/1CVaO9n

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: Food and Drug Administration, FDA, defense attorney, defense lawyer, defense counsel, Praluent, cholesterol medication, cholesterol-reducing drug, pharmacy, pharmacists, physician, doctor, health care professional, health care provider, health care practitioner, prescriber, new medicine, Regeneron, Sanofi, medicine advances, cardiovascular disease, products liability attorney, products liability lawyer, health care attorney, health care lawyer, health law, health law firm, The Health Law Firm

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

Why Physicians Should Not Prescribe for Family or Self

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

Physicians are frequently asked by their family and friends to refill prescriptions. However, there are legal and ethical issues associated with prescribing to self, family or friends. A physician may prescribe to family and friends but the medical standards and regulations for prescribing still apply. A physician must perform a physical examination, and maintain adequate and complete medical records and obtain a history from any patient before prescribing. Although there is no law prohibiting physicians from prescribing uncontrolled substances to themselves, this is not recommended due to ethical reasons. State laws governing physicians vary significantly from state to state. In Florida there are disciplinary actions taken if a physician does not prescribe within the physicians professional practice.

Disciplinary Action under Section 458.331, Florida Statutes.

Under the grounds for disciplinary action, Section 458.331(q), Florida Statutes, has listed; “Prescribing a legend drug, including any controlled substance, inappropriately or in excessive or in inappropriate quantities is not in the best interest of the patient and is not in the course of the physician’s professional practice, without regard to his or her intent.” Based on this statute, self-prescribing or prescribing to an individual who is not actually a legitimate patient, which is determined by a valid patient record or chart, will not be considered part of a physician’s professional practice. To view the entire statute, click here.

Pharmacist are Liable for Physicians Self-Prescribing and Prescribing to Family.

Section 465.016(s), Florida Statute, which applies to all pharmacists, states: “Dispensing any medicinal drug . . . when the pharmacist knows or has reason to believe that the purported prescription is not based upon a valid practitioner-patient relationship,” this is grounds for denial of a license or taking disciplinary action against a license. Therefore, based on this statute a pharmacist within Florida is also at risk when he/she dispenses medication to a physician who has prescribed to themselves or family. To view the entire statute, click here.

Arguments For and Against Self-Prescribing and Prescribing to Family.

Supporters of self-prescribing and prescribing to family argue that much of the information and literature on the subject is focused primarily on controlled substances, while non-controlled substances, such as antibiotics and contraceptives, are in the gray area. The counter argument is that due to a lack of objectivity and professional distance that is usually found in a practitioner-patient relationship non-controlled medications should not be prescribed.

From a legal standpoint, self-prescribing and prescribing to family who are outside of the valid physician-patient relationship is against Florida law. From an ethical standpoint, the risks related to a lack of objectivity resulting in poor health should inevitably be a deterrent. To view an article on the guidelines for prescribing in Florida, click here.

American Medical Association’s Opinion on Self-Treatment and Treatment of Family.

Opinion 8.19 of the Code of Medical Ethics of the American Medical (AMA) states: “It is not appropriate for physicians to write prescriptions for controlled substances for themselves or immediate family members.” The AMA is a supporter of educating professionals on the pitfalls of self-prescribing and prescribing to family and friends. The AMA is working to deter physicians from this practice unless it is an emergency situation.

The AMA recommends that physicians do not treat themselves or members of their immediate family. Professionalism may be compromised when a family member of the physician is the patient. A physician’s relationship with the patient may unduly influence his/her professional medical judgement. Therefore, the physician may fail to ask sensitive questions when taking medical history or may fail to perform intimate parts of the physical exam. The patient may be in the same position, they may feel uncomfortable disclosing sensitive information or undergoing an intimate exam when the physician is a family member. To view Opinion 8.19 in its entirety, click here.

Comments?

What are your thoughts on self-prescribing and prescribing to family and friends? Please leave any thoughtful comments below.

Contact a Health Law Attorney Experienced in the Representation of Health Care Professionals.

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

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

Sources:

American Medical Association. “Opinion 8.19 – Self-Treatment or Treatment of Immediate Family Members. (June 1993). From
http://www.ama-assn.org/ama/pub/physician-resources/medical-ethics/code-medical-ethics/opinion819.page?

Fla. Stat. § 458.331.
http://www.leg.state.fl.us/statutes/index.cfm?App_mode=Display_Statute&URL=0400-0499/0458/Sections/0458.331.html

Fla. Stat. § 465.016.
http://www.leg.state.fl.us/Statutes/index.cfm?App_mode=Display_Statute&Search_String=&URL=0400-0499/0465/Sections/0465.016.html

“Ohio Physicians Stop Prescribing to Self and Family Members!” Ohio Physicians Advocate. (May 18, 2015). From:
https://ohiophysiciansadvocate.wordpress.com/2015/05/18/ohio-physicians-stop-prescribing-to-self-and-family-members/

Shands at the University of Florida. “The Legality and Ethics of Self-Prescribing.” Drugs & Therapy Bulletin. (July/Aug. 2006). From:
http://professionals.ufhealth.org/files/2011/11/0706-drugs-therapy-bulletin.pdf

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

Shelby Root is a summer associate at The Health Law Firm. She is a student at Barry University College of Law in Orlando.

KeyWords: Florida, Florida Statutes 458.331, Florida Statutes 465.016, prescribing, self-prescribing, American Medical Association, AMA, Code of Medical Ethics, Opinion 8.19, physician, pharmacist, disciplinary action, controlled substances, defense lawyer, defense attorney, health law attorney, The Health Law Firm

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

Purpose of Florida E-FORCSE Prescription Database Not for Disciplinary or Criminal Prosecution Purposes Against Physicians, Pharmacists or Other Health Professionals

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

8 Indest-2008-5As you are no doubt aware now, Florida has an active prescription drug monitoring program (PDMP). It is called the “Electronic-Florida Online Reporting of Controlled Substances Evaluation” or “E-FORCSE.” More often it is referred to simply as the “prescription drug database” by Florida physicians.

The Florida Legislature adopted the E-FORCSE system in Florida by Section 893.055, Florida Statutes.

Section 893.055(7)(b), Florida Statutes, States Access to Program’s Database is Limited to Program Manager.

A pharmacy, prescriber, or dispenser shall have access to information in the prescription drug monitoring program’s database which relates to a patient of that pharmacy, prescriber, or dispenser in a manner established by the department as needed for the purpose of reviewing the patient’s controlled substance prescription history. Other access to the program’s database shall be limited to the program’s manager and to the designated program and support staff, who may act only at the direction of the program manager or, in the absence of the program manager, as authorized. Access by the program manager or such designated staff is for prescription drug program management only or for management of the program’s database and its system in support of the requirements of this section and in furtherance of the prescription drug monitoring program. Confidential and exempt information in the database shall be released only as provided in paragraph (c) and s. 893.0551. . . .

Data from E-FORCSE Not Intended to be Used to Bring Disciplinary Action Against Health Care Practitioners.

Most notably, it was not the intent of the Legislature for any state or federal agency to use the data from the E-FORCSE system primarily as evidence for the purpose of taking licensure or disciplinary action against physicians, dentists, pharmacists or other licensed health professionals.

Unfortunately, we have seen cases where, contrary to the Legislature’s intent, data from E-FORCSE has been recited in a case against a licensed health professional as an example of “substandard performance,” “falling below the standard of care,” or professional “negligence.” Additionally, we have been informed of the alleged use of the E-FORCSE system by state and federal law enforcement authorities in criminal investigations and prosecutions of licensed health professionals. However, the exact wording of Sections 893.055 and 893.0551, Florida Statutes, should be carefully analyzed in determining under what conditions access and use of the information are authorized.

Defending Against E-FORCSE Data’s Being Used Against a Health Care Practitioner.

If you are a physician, dentist or pharmacist, and data from E-FORCSE is used in or discussed in any complaint investigation, license investigation, Drug Enforcement Administration (DEA) investigation, criminal investigation, administrative complaint, charge sheet or indictment, you should ask your attorney to research the advisability of filing a motion to strike it. In addition, your attorney should also consider filing a motion in limine, before any major hearing or trial, to exclude all use or mention of the data and E-FORCSE system.

In addition, the attorney for the licensed health professional may explore the possibility of moving to exclude any and all information and evidence derived from the unauthorized use of the E-FORCSE databank under the “fruit of the poisonous tree” doctrine. To date, we have not seen any cases where this has been done.

Again the exact language of Sections 893.055 and 893.0551, Florida Statutes, should be consulted to determine whether access and use have been properly authorized.

Information on Florida’s Prescription Drug Monitoring Program from the Florida Department of Health.

The information below is taken from an informational pamphlet distributed by the Florida Department of Health (DOH) called “E-FORCSE; Florida’s Prescription Drug Monitoring Program.” It is available online, at http://www.e-forcse.com.

Florida’s Prescription Drug Monitoring Program Facts.

E-FORCSE will take in controlled substance dispensing data from pharmacies and health care practitioners, and will make the information available to all health care practitioners who can then use the database to guide their decisions when prescribing and dispensing certain highly-abused prescription drugs. With this information, health care practitioners may be able to identify patients who are “doctor shopping”—obtaining multiple prescriptions for the same controlled substance from multiple health care practitioners. Doctor shopping is a felony in Florida.

Who is Required to Report Controlled Substance Dispensing Information to E-FORCSE?

Any health care practitioner who has dispensed a controlled substance in schedule II, III and IV, as defined in section 893.03, Florida Statutes-like OxyContin, Percocet, Vicodine, etc., will be required to report to the database. This includes pharmacies licensed under chapter 465, Florida Statutes, (including mail order and Internet pharmacies that dispense controlled substances into Florida) and health care practitioners licensed under chapters 458, 459, 461, 462, 465, or 466, Florida Statutes.

Who is Not Required to Report Controlled Substance Dispensing Information to E-FORCSE?

A health care practitioner who:

– Administers a controlled substance directly to a patient if the amount is adequate to treat the patient during that particular treatment session;
– Administers a controlled substance to a patient or resident receiving care as a patient, at a hospital, nursing home, ambulatory surgical center, hospice or intermediate care facility for the developmentally disabled;
– Administers or dispenses a controlled substance in the health care system of the Florida Department of Corrections;
– Administers a controlled substance in the emergency room of a licensed hospital;
– Administers or dispenses a controlled substance to a patient under the age of 16; and
– Dispenses a one-time, 72-hour re-supply of a controlled substance.

How Can E-FORCSE Help Improve a Patient’s Standard of Care?

– It allows the health care practitioners to choose and prescribe controlled substances that will not negatively interact with medicines prescribed by other health care practitioners.
– Pharmacists can determine for their patients if their health care practitioners have prescribed controlled substances that might negatively interact when used together.
– Health care practitioners can determine if their patient has had multiple prescriptions for the same drugs from multiple health care practitioners. This identifies those patients potentially engaged in the crime of doctor shopping. When health care practitioners intervene, they can help their patients find treatment.

How Can E-FORCSE Help Improve the Public Health of Florida?

Health care practitioners can identify a potentially illegal diversion pattern for drugs when they request and receive a Patient Activity Report (PAR). A PAR can alert health care practitioners to doctor shopping. In addition, this information can assist law enforcement, medical regulatory boards and the Attorney General’s Medicaid Fraud Control Unit (MFCU) with active investigations into criminal activity regarding controlled prescription drugs.

Who Has Access to the Information Stored in E-FORCSE?

A health care practitioner who is subject to licensure or regulation by the DOH under chapter 458, chapter 459, chapter 461, chapter 462, chapter 464, chapter 465, or chapter 466, Florida Statutes, will have direct access to their specific patient’s information. Other direct access to information will be limited to the E-FORCSE program manager and designated staff for the purpose of program management.

Indirect access may be requested by the following organizations upon being verified and authenticated by E-FORCSE staff.

– DOH or appropriate health care regulatory boards who are involved in a specific investigation involving a designated individual for one or more prescribed controlled substances;
– The Attorney General (AG) for Medicaid fraud cases involving prescribed controlled substances; and
– A law enforcement agency during active investigations regarding potential criminal activity, fraud or theft of prescribed controlled substances.

Are Health Care Practitioners Required to Access E-FORCSE Before Prescribing a Controlled Substance?

Health care practitioners will not be required to access E-FORCSE before prescribing a controlled substance. It will be voluntary; however, physicians are encouraged to use it as a tool to improve patient care.

Is E-FORCSE Compliant with the Federal Health Insurance Portability and Accountability Act (HIPAA)?

Yes, in addition to meeting the federal HIPAA requirements, E-FORCSE will meet all required DOH security requirements.

What is the Penalty for Disclosure of Confidential Information in the E-FORCSE Database?

A health care practitioner or other individual who has access to the information in the E-FORCSE database who discloses confidential information will be committing a third-degree felony.

Contact Health Law Attorneys Experienced with Investigations of Health Professionals and Providers.

The attorneys of The Health Law Firm provide legal representation to physicians, nurses, nurse practitioners, CRNAs, pain management doctors, dentists, pharmacists, psychologists 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 and visit our website at www.TheHealthLawFirm.com.

Comments?

As a health care practitioner, do you use E-FORCSE? Why or why not? Please leave any thoughtful comments below.

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

KeyWords: prescription drug monitoring program, PDMP, Florida prescription drug monitoring program, Electronic-Florida Online Reporting Controlled Substance Evaluation, E-FORCSE, E-FORCSE data, prescription database, physician, doctor, pharmacist, dentist, health care professional, health care provider, health care practitioner, Florida Legislature, prescriber, cases against licensed health care professionals, substandard performance, falling below the standard of care, professional negligence, criminal investigation, criminal investigation of a physician, prosecution of health care professional, prosecution of physician, compliant investigation, license investigation, Drug Enforcement Administration, DEA, DEA investigation, administrative complain, charge sheet or indictment, defense attorney, defense lawyer, Florida defense attorney, Florida defense lawyer, Florida Department of Health, DOH, doctor shopping, controlled substance, Attorney General, AG, Medicaid Fraud Control Unit (MFCU), dispensing controlled substances, reporting to E-FORCSE, who can access E-FORCSE, Health Insurance Portability and Accountability Act, HIPAA, E-FORCSE HIPAA compliant, health law firm, The Health Law Firm

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

FDA Issues New Warning for Popular Type 2 Diabetes Drug

2 Indest-2009-1By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law
The Food and Drug Administration (FDA) recently warned that a new class of type 2 diabetes drugs may cause a serious condition and can lead to hospitalization. Included in that warning is Invokana, the first in a new class of frontline treatment for type 2 diabetes. It was approved in 2013 and quickly gained popularity among health care providers and patients. Other drugs in the class include Invokament, Jardiance, Xigduo XR, Farxinga and Glyxambi. These drugs, known as SGLT2 inhibitors, are intended to improve glycemic control in patients with type 2 diabetes by blocking the absorption of glucose in the kidneys.

The Problem.

According to the FDA’s warning, SGLT2 inhibitors can lead to the development of diabetic ketoacidosis, a serious condition that can result in cerebral edema, pulmonary edema, heart attacks, strokes, cardiac dysrhythmia, nonspecific myocardial injury, diabetic retinopathy, severe dehydration, coma and death. The FDA recently took notice of these significant health risks and issued a safety announcement that warned of the serious side effects potentially resulting from treatment with SGLT2 inhibitors. To read the FDA’s warning, click here. To read one of our blogs on a similar case, click here. Click here to find out how The Health Law Firm can help you with a situation such as this.

Comments?

Did you develop ketoacidosis after taking a SGLT2 drug such as Inkovana? If you or a loved one took Invokana or another type 2 diabetes drug that resulted in ketoacidosis, you may have legal options. Please leave any thoughtful comments below.

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

KeyWords: Food and Drug Administration, FDA, defense attoryney, defense lawyer, defense counsil, Inkovana, Type 2 Diabetes Drug, SGLT2 inhibitors, products liability attorney, products liability lawyer, ketoacidosis, safety announcement, recall, safety warning, drug side effects, plaintiff products liability attorney, health care attorney, health care lawyer, health law, The Health Law Firm

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

Pharmacies May be Liable for Filling Valid Prescriptions

Lance Leider headshotBy 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.

“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.