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Pharmacy Case Law Update 2019: "Painstaking and Undertaken with a Generous and Hospitable Approach..." Col(r) David W. Bobb, RPh, MA, JD Chief, Pharmacy Operations Division Defense Health Agency JOINT FEDERAL PHARMACY SEMINAR FEDERAL PHARMACY: SHARING THE VISION IN PHARMACY

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Page 1: JOINT FEDERAL PHARMACY SEMINAR · A. HIPAA does not prohibit a private right of action for tortious disclosure of healthcare information B. HIPAA declines to create an independent

Pharmacy Case Law Update 2019: "Painstaking and Undertaken with a

Generous and Hospitable Approach..."

Col(r) David W. Bobb, RPh, MA, JD

Chief, Pharmacy Operations Division

Defense Health Agency

JOINT FEDERALPHARMACY SEMINARFEDERAL PHARMACY: SHARING THE VISION IN PHARMACY

Page 2: JOINT FEDERAL PHARMACY SEMINAR · A. HIPAA does not prohibit a private right of action for tortious disclosure of healthcare information B. HIPAA declines to create an independent

Target Audience: Pharmacists and Pharmacy Technicians

ACPE#: 0202-0000-19-199-L03-P/T

Activity Type: Knowledge-based

ACPE Information

Page 3: JOINT FEDERAL PHARMACY SEMINAR · A. HIPAA does not prohibit a private right of action for tortious disclosure of healthcare information B. HIPAA declines to create an independent

The American Pharmacist Association is accredited by the Accreditation Council for Pharmacy

Education as a provider of continuing pharmacy education.

“David W. Bobb declares no conflicts of interest, real or apparent, and no financial interests in any

company, product, or service mentioned in this program, including grants, employment, gifts, stock

holdings, and honoraria.”

Financial Disclosures

Page 4: JOINT FEDERAL PHARMACY SEMINAR · A. HIPAA does not prohibit a private right of action for tortious disclosure of healthcare information B. HIPAA declines to create an independent

This program is not intended to be, and should not be viewed as legal

advice, as it contains only general principles of law and my interpretations

of court decisions. For specific circumstances, you are strongly urged to

contact an attorney familiar with the laws of your state or jurisdiction.

Likewise, it does not represent the official position of the Department of

Defense or any Branches thereof, the Veterans Administration, US Public

Health Service, US Coast Guard, Drug Enforcement Administration, United

States Government, or any Agency or Department thereof. In short, it’s

simply my best professional opinion designed to help you…

Disclaimer

Page 5: JOINT FEDERAL PHARMACY SEMINAR · A. HIPAA does not prohibit a private right of action for tortious disclosure of healthcare information B. HIPAA declines to create an independent

State how a violation of HIPAA standards is now being used in an

unprecedented fashion to support a private cause of action against a pharmacy.

Determine when workplace violence statements support the termination of an

employee.

List the elements necessary to charge someone with criminal conspiracy to

defraud TRICARE.

Despite the differences in state and federal laws, list three ways military

pharmacies can assist civilian patients who may be using medical marijuana.

Learning Objectives

Page 6: JOINT FEDERAL PHARMACY SEMINAR · A. HIPAA does not prohibit a private right of action for tortious disclosure of healthcare information B. HIPAA declines to create an independent

1) Elements the government must prove to find someone guilty of a criminal conspiracy include all of

the following EXCEPT:

A. Two or more people must be involved

B. The planned criminal act needs to be fully completed

C. All parties involved must have the specific intent to complete the objective of the criminal conspiracy

D. Only a step in the completion of the criminal act needs to be completed

2) In the Shepherd v. Costco Wholesale Corporation case, the Arizona court found that:

A. HIPAA does not prohibit a private right of action for tortious disclosure of healthcare information

B. HIPAA declines to create an independent federal statutory private right of action

C. HIPAA does not preempt state law claims for unauthorized disclosure of medical information

D. All of the above are correct

Self-Assessment

Page 7: JOINT FEDERAL PHARMACY SEMINAR · A. HIPAA does not prohibit a private right of action for tortious disclosure of healthcare information B. HIPAA declines to create an independent

3) In the Tenerelli case, Mr. Tenerelli’s employment was terminated due to his comments regarding

workplace violence. When hearing the case, the court determined that:

A. Mr. Tenerelli’s comments were made jokingly, so he should not have been terminated

B. Mr. Tenerelli had a sustainable employment discrimination claim and should be rehired

C. Although there were discrepancies in Mr. Tenerelli’s statement and those of other witnesses, Rite Aid had

sufficient grounds to terminate him based on violations of its Workplace Violence Policy and Standards of

Conduct

D. Both A. and B. are correct

4) According to the New Jersey Compassionate Use Medical Marijuana Act, an employer is required to

provide reasonable accommodations for a medical marijuana user.

A. True

B. False

Self-Assessment

Page 8: JOINT FEDERAL PHARMACY SEMINAR · A. HIPAA does not prohibit a private right of action for tortious disclosure of healthcare information B. HIPAA declines to create an independent

TRICARE Fraud

United States of America, Plaintiff-Appellee

v.

Cordera Hill, Defendant-Appellant

No. 17-13545

United States Court of Appeals, Eleventh Circuit

Florida

2018

What behavior constitutes an illegal kickback scheme that violates

the Anti-Kickback Statute?

Page 9: JOINT FEDERAL PHARMACY SEMINAR · A. HIPAA does not prohibit a private right of action for tortious disclosure of healthcare information B. HIPAA declines to create an independent

TRICARE Fraud

The Parties:

➢Plaintiffs, United States of America

➢Defendants Cordera Hill, former Army Staff Sergeant

➢Interested Parties, Erin Berry, “Team Cream” leader

Anthonio Miller, former Navy Petty Officer

Questions:

➢What is the Anti-Kickback Statute (42 U.S.C. §1320a-7b)?

➢Did the conduct of Cordera Hill and Team Cream constitute

an illegal kickback and conspiracy?

Page 10: JOINT FEDERAL PHARMACY SEMINAR · A. HIPAA does not prohibit a private right of action for tortious disclosure of healthcare information B. HIPAA declines to create an independent

TRICARE Fraud

The Anti-Kickback Statute makes it a criminal act if a person:“knowingly and willfully offers or pays any remuneration (including any kickback,

bribe, or rebate) directly or indirectly, overtly or covertly, in cash or in kind to any

person to induce such person — (A) to refer an individual to a person for the furnishing

or arranging for the furnishing of any item or service for which payment may be made

in whole or in part under a Federal health care program, or

(B) to purchase, lease, order, or arrange for or recommend purchasing, leasing, or

ordering any good, facility, service, or item for which payment may be made in whole or

in part under a Federal health care program.”

Page 11: JOINT FEDERAL PHARMACY SEMINAR · A. HIPAA does not prohibit a private right of action for tortious disclosure of healthcare information B. HIPAA declines to create an independent

TRICARE Fraud

Criminal Conspiracy:

A conspiracy occurs when two or more people agree to commit an illegal act and take

some step toward its completion. Conspiracy is an inchoate crime because it does not

require that the illegal act actually have been completed. For instance, a group of

individuals can be convicted of conspiracy to commit burglary even if the actual burglary

never happens. Conspiracy is also unique in that, unlike attempt, a defendant can be

charged with both conspiracy to commit a crime, and the crime itself if the crime is

completed.

Held:

➢ Hill’s conduct clearly violated the Anti-Kickback Statute and placed him in a

criminal conspiracy.

➢ His case was remanded for sentencing

Page 12: JOINT FEDERAL PHARMACY SEMINAR · A. HIPAA does not prohibit a private right of action for tortious disclosure of healthcare information B. HIPAA declines to create an independent

Statements Regarding Workplace Violence

Peter Tenerelli, Plaintiff

v.

Rite Aid Corporation; and Does 1 through 100, inclusive, Defendants

No. 2:17-CV01011-JAM-EFB

United States District Court, E.D. California

California

2019

When can statements by an employee regarding workplace violence

rise to the level of a terminable offense?

Page 13: JOINT FEDERAL PHARMACY SEMINAR · A. HIPAA does not prohibit a private right of action for tortious disclosure of healthcare information B. HIPAA declines to create an independent

Statements Regarding Workplace Violence

The Parties:

➢Plaintiffs, Peter Tenerelli, Pharmacy District Manager

➢Defendants, Rite Aid Corporation and additional Rite Aid

employees (Does 1- 100)

Questions:

➢What are the prima facie elements of an age discrimination case?

➢Was Tenerelli fired because of age discrimination and reporting

drug inventory discrepancies?, or

➢Were Tenerelli’s workplace violence statements sufficient to

justify his firing?

Page 14: JOINT FEDERAL PHARMACY SEMINAR · A. HIPAA does not prohibit a private right of action for tortious disclosure of healthcare information B. HIPAA declines to create an independent

Statements Regarding Workplace Violence

Discussion:

➢Elements of a Prima Facie Age Discrimination Case➢Member of a protected class (40 yrs of age or older)

➢Performing competently in position held

➢Suffer an adverse employment action

➢Some other circumstance suggest a discriminatory motive

➢Workplace violence statements violated Rite Aid policy and

standards of conduct

Held:

➢No discriminatory motive by Rite Aid; the termination is justified

Page 15: JOINT FEDERAL PHARMACY SEMINAR · A. HIPAA does not prohibit a private right of action for tortious disclosure of healthcare information B. HIPAA declines to create an independent

Negligence, HIPAA, and Wrongful Disclosure

Greg Shepherd, Plaintiff/Appellant

v.

Costco Wholesale Corporation, Defendant/Appellee

No. 1 CA-CV 18-0072

Court of Appeals of Arizona, Division One

Arizona

2019

Can HIPAA requirements inform the standard of care in a private

negligence action for wrongful disclosure of healthcare information?

Page 16: JOINT FEDERAL PHARMACY SEMINAR · A. HIPAA does not prohibit a private right of action for tortious disclosure of healthcare information B. HIPAA declines to create an independent

Negligence, HIPAA, and Wrongful Disclosure

The Parties:

➢Plaintiffs, Greg Shepherd

➢Defendants, Costco Wholesale Corporation

Questions:

➢This case is an appeal from the dismissal of a complaint against

Costco

➢Did Costco’s conduct give rise to the intentional infliction of

emotional distress?

➢Can HIPAA standards be used as evidence in a private cause of

action?

Page 17: JOINT FEDERAL PHARMACY SEMINAR · A. HIPAA does not prohibit a private right of action for tortious disclosure of healthcare information B. HIPAA declines to create an independent

Negligence, HIPAA, and Wrongful Disclosure

Discussion:

➢Intentional infliction of emotional distress? No;➢“The liability does not extend to mere insults, indignities, threats,

annoyances, petty oppressions, or other trivialities…There is no occasion

for the law to intervene in every case where someone’s feelings are hurt”.

➢Costco contends that federal authority prevents Shepherd from

using a HIPAA violation as the basis of a lawsuit because HIPAA

does not create a private cause of action.

Held:➢“HIPAA does not prohibit a private right of action for tortuous disclose of

healthcare information, it merely declines to create an independent federal

statutory private right of action.”

Page 18: JOINT FEDERAL PHARMACY SEMINAR · A. HIPAA does not prohibit a private right of action for tortious disclosure of healthcare information B. HIPAA declines to create an independent

Medical Marijuana Use

Justin Wild, Plaintiff/Appellant

v.

Carriage Funeral Holdings, Inc., d/b/a Feeney Funeral Home, LLC,

David B. Feeney, and Ginny Sanzo, Defendant/Appellee

Docket No. A-3072-17T3No. 1 CA-CV 18-0072

Superior Court of New Jersey, Appellate Division

New Jersey

2019

Can HIPAA requirements inform the standard of care in a private

negligence action for wrongful disclosure of healthcare information?

Page 19: JOINT FEDERAL PHARMACY SEMINAR · A. HIPAA does not prohibit a private right of action for tortious disclosure of healthcare information B. HIPAA declines to create an independent

Medical Marijuana Use

The Parties:

➢Plaintiffs, Justin Wild

➢Defendants, Carriage Funeral Holdings, Feeney Funeral

Home, David B. Feeney, and Ginny Sanzo

Questions:

➢Is there a conflict between the New Jersey Law Against

Discrimination and the NJ Compassionate Use Act?

➢When Carriage terminated Wild for failing to disclose his

marijuana use, did it violate the Law Against Discrimination?

Page 20: JOINT FEDERAL PHARMACY SEMINAR · A. HIPAA does not prohibit a private right of action for tortious disclosure of healthcare information B. HIPAA declines to create an independent

Medical Marijuana Use

Discussion:➢NJ LAD – very similar to what we talked about in the Tenerelli case earlier

today (protected class, satisfactory performance, adverse employment

action, some discriminatory motive)

➢NJ CUA – “Nothing in the act shall be construed to require…an employer to

accommodate the medical use of marijuana in any workplace”.

Held:➢No conflict in the two laws

➢The court will allow the case to continue as there may be some set of

circumstances the plaintiff can prove that shows discrimination.

Page 21: JOINT FEDERAL PHARMACY SEMINAR · A. HIPAA does not prohibit a private right of action for tortious disclosure of healthcare information B. HIPAA declines to create an independent

Revocation of Controlled Substance Certificate of Registration

Pharmacy Doctors Enterprises, Inc. d/b/a Zion Clinic Pharmacy

v.

Drug Enforcement Administration

No. 18-11168

United States Court of Appels, Eleventh Circuit

Florida

2019

What is the appropriate standard of evidence an ALJ must use when

hearing a COR revocation case and what can constitute appropriate

evidence?

Page 22: JOINT FEDERAL PHARMACY SEMINAR · A. HIPAA does not prohibit a private right of action for tortious disclosure of healthcare information B. HIPAA declines to create an independent

Revocation of Controlled Substance Certificate of Registration

The Parties:

➢Plaintiffs, Pharmacy Doctors Enterprises

➢Defendants, Drug Enforcement Administration

➢Interested Party, Veronica Taran, owner & operator of pharmacy

Questions:

➢What is the appropriate standard of evidence in this case?

➢Did the factual findings lack substantial evidence?

➢Was the decision to revoke the COR arbitrary and capricious?

Page 23: JOINT FEDERAL PHARMACY SEMINAR · A. HIPAA does not prohibit a private right of action for tortious disclosure of healthcare information B. HIPAA declines to create an independent

Revocation of Controlled Substance Certificate of Registration

Discussion:

➢Substantial Evidence➢Lower standard than preponderance of the evidence

➢“Such relevant evidence as a reasonable person would accept as

adequate to support a conclusion”

➢Arbitrary and capricious➢“…the agency relied on factors Congress did not intend it to consider, the

agency entirely failed to consider an important aspect of the problem, or

the agency offered an explanation for its decision that runs counter to the

evidence before the agency”

Held:

➢ The ALJ acted properly in revoking the pharmacy’s COR

Page 24: JOINT FEDERAL PHARMACY SEMINAR · A. HIPAA does not prohibit a private right of action for tortious disclosure of healthcare information B. HIPAA declines to create an independent

1. Be vigilant for signs of TRICARE fraud, even by members of the military.

2. Any suggestions of workplace violence need to be reported to appropriate

entities.

3. More and more courts are allowing patients to use HIPAA standards as a basis

for private causes of action. Ensure you pharmacy meets compliance standards.

4. As the number of states permitting medical marijuana use increases, be

prepared to answer patient’s questions regarding drug interactions, etc.

5. Ensure your pharmacy is in compliance with all DEA regulations and

standards.

Take-aways

Page 25: JOINT FEDERAL PHARMACY SEMINAR · A. HIPAA does not prohibit a private right of action for tortious disclosure of healthcare information B. HIPAA declines to create an independent

1) Elements the government must prove to find someone guilty of a criminal conspiracy include all of

the following EXCEPT:

A. Two or more people must be involved

B. The planned criminal act needs to be fully completed

C. All parties involved must have the specific intent to complete the objective of the criminal conspiracy

D. Only a step in the completion of the criminal act needs to be completed

2) In the Shepherd v. Costco Wholesale Corporation case, the Arizona court found that:

A. HIPAA does not prohibit a private right of action for tortious disclosure of healthcare information

B. HIPAA declines to create an independent federal statutory private right of action

C. HIPAA does not preempt state law claims for unauthorized disclosure of medical information

D. All of the above are correct

Self-Assessment

Page 26: JOINT FEDERAL PHARMACY SEMINAR · A. HIPAA does not prohibit a private right of action for tortious disclosure of healthcare information B. HIPAA declines to create an independent

3) In the Tenerelli case, Mr. Tenerelli’s employment was terminated due to his comments regarding

workplace violence. When hearing the case, the court determined that:

A. Mr. Tenerelli’s comments were made jokingly, so he should not have been terminated

B. Mr. Tenerelli had a sustainable employment discrimination claim and should be rehired

C. Although there were discrepancies in Mr. Tenerelli’s statement and those of other witnesses, Rite Aid had

sufficient grounds to terminate him based on violations of its Workplace Violence Policy and Standards of

Conduct

D. Both A. and B. are correct

4) According to the New Jersey Compassionate Use Medical Marijuana Act, an employer is required to

provide reasonable accommodations for a medical marijuana user.

A. True

B. False

Self-Assessment

Page 27: JOINT FEDERAL PHARMACY SEMINAR · A. HIPAA does not prohibit a private right of action for tortious disclosure of healthcare information B. HIPAA declines to create an independent

Thank you for your time and attention!

Col(r) David W. Bobb, RPh, MA, JD

Chief, Pharmacy Operations Division

Defense Health Agency

[email protected], 703-681-8920

JOINT FEDERAL

PHARMACY SEMINARFEDERAL PHARMACY: SHARING THE VISION IN PHARMACY