between a rock & a hard spot mayhem 2020
TRANSCRIPT
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Between a Rock & a Hard SpotMayhem 2020
Pharmacy Law Update and Case Studies
August 2020
Ronda H. Lacey, J.D., M.S. Pharm
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Thank You AllFor your dedication, sacrifice and service!
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Disclosure
▪ I have no actual or potential conflict of interest in relation to this program or presentation.
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Objectives
1. Recognize legal responsibilities for reporting to HHS in the event of a breach or suspected breach of PHI after a criminal event.
2. Explain and discuss the "off label” use of a prescription drug.
3. Identify professional responsibilities thru an analysis of case studies.
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Legal Responsibilities
▪ August 3, 2020 Data Breach Today reported that Walgreens, CVS and Cub Pharmacies had reported breaches due to looting.▪ https://www.databreachtoday.com/breaches-
tied-to-pharmacy-looting-security-lessons-a-14757.
▪ There are most likely independent pharmacies that will have to report breaches as well.
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Breach
▪ A breach is, generally, an impermissible use or disclosure under the Privacy Rule that compromises the security or privacy of the protected health information.
▪ An impermissible use or disclosure of protected health information is presumed to be a breach unless the covered entity or business associate, as applicable, demonstrates that there is a low probability that the protected health information has been compromised based on a risk assessment of at least the following factors:
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Breach
1.The nature and extent of the protected health information involved, including the types of identifiers and the likelihood of re-identification;
2.The unauthorized person who used the protected health information or to whom the disclosure was made;
3.Whether the protected health information was actually acquired or viewed; and
4.The extent to which the risk to the protected health information has been mitigated.
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The Reality
▪ The pharmacy employees did NOT ▪ Steal PHI
▪ Misappropriate PHI
▪ Leave an unencrypted laptop
▪ Give someone their password
▪ Give PHI to a reporter
▪ But the facilities still DO have an obligation to their patients and to report to HHS.
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Types of Information/Items Taken During the Looting▪ Prescription records (i.e. hard copies)
▪ Including patient name, address, phone number(s), physician name and contact information, prescription numbers, medical records, insurance information, driver’s license numbers and passport numbers.
▪ Vaccination records
▪ Computers
▪ Hard Drives from computers
▪ Vaults/holding drugs & records
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Legal Responsibilities - Breach
▪ Submit a notice to HHS within sixty (60) days of the discovery of the breach (if breach involves 500 or more individuals).▪ Notify the individuals and▪ Publish notice with the press▪ Notice on website for 90 days
▪ May submit the notice on an annual basis if fewer than 500 individuals. (60 days after the end of the calendar year).
▪ Comply with AL Breach Notification Rule, Code of Alabama, § 8-38-1, et. seq.
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Legal Responsibilities
▪ Link for reporting breaches to HHS▪ https://www.hhs.gov/hipaa/for-professionals/breach-
notification/breach-reporting/index.html#:~:text=Submit%20a%20Notice%20for%20a%20Breach%20Affecting%20Fewer,%28OCR%29%20Content%20last%20reviewed%20on%20January%205%2C%202015.
▪ Report a breach to in-house/corporate counsel as soon as possible.
▪ If no in-house/corporate counsel: Get an experienced healthcare attorney to assist you with the breach and notification requirements.
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Legal Responsibilities
▪ Keep in mind that these requirements are in addition to notifying the▪ DEA, Form 106
▪ Board of Pharmacy
▪ Law enforcement
▪ Insurance Company
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Additional Reference
▪ Cases under investigation:▪ https://ocrportal.hhs.gov/ocr/breach/breach_report.jsf.
▪ Vault stolen during riots▪ https://www.foxnews.com/us/fbi-cvs-narcotics-cleveland-
george-floyd-riots.
▪ Walgreens Letter to Customers:▪ https://oag.ca.gov/system/files/BL_DL_L03.pdf.
▪ Rite Aid Breach:▪ https://www.beckershospitalreview.com/cybersecurity/rit
e-aid-pharmacy-thefts-expose-information-of-9-200-patients.html?origin=PharmacyE&utm_source=PharmacyE&utm_medium=email&oly_enc_id=0895H1308567F5O.
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Question
▪ You must report a breach to HHS within sixty days of the breach if the breach involved the information of _____ individuals or more?
A. 100
B. 250
C. 500
D. 1,000
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Off-Label Use of Prescription Drugs
Healing or Harm
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Off Label Use of a Prescription Drug
▪ FDA information: https://www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/understanding-unapproved-use-approved-drugs-label.
▪ Quote from FDA:▪ “From the FDA perspective, once the FDA
approves a drug, healthcare providers generally may prescribe the drug for an unapproved use when they judge that it is medically appropriate for their patient.”
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Off Label Use of Prescription Drug
▪ You are required to use your professional judgment when filling the prescription.
▪ Consider asking the following questions:▪ What is the drug approved for?
▪ Are there other drugs approved to treat the condition?
▪ Are there scientific studies available?
▪ Is it likely that it will work better than an approved treatment?
▪ Benefits vs. risks
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Off Label Use of Prescription Drugs
▪ Will the patient’s health insurance cover the cost of the medication?
▪ Are there any clinical trials the patient could enroll in?
▪ Have you talked with the patient’s healthcare provider?
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Questions
▪ Would you fill a prescription for propranolol for essential tremor?
a) Yesb) No
▪ Would you fill a prescription for Seroquel® for insomnia?
a) Yesb) No
▪ Would you fill a prescription for hydroxychloroquine for COVID-19?
a) Yesb) No
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How to encourage your staff to wear a mask
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Case Studies
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Presumption of Innocence
▪ When we discuss cases that are pending, please keep in mind:
▪ The charges contained in the Complaint are merely accusations, and the defendant is presumed innocent unless and until proven guilty.
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United States of America vs. Richard Schirripa, “The Mask Man”
Schirripa, a licensed pharmacist (New York) has been charged with participation in 3 different criminal schemes:
1. Hoarding and price gouging involving N-95 masks in March and April 2020;
2. Lying to the DEA; and
3. False billing to Medicare and Medicaid from 2014 to 2019 (including using patient information without authorization during the health fraud)
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United States of America vs. Richard Schirripa, “The Mask Man”
▪ Hoarding and price gouging violate the Defense Production Act (DPA) which was in effect when Schirripa obtained and sold the N-95 masks.
▪ Allegations state that he spent over $200K obtaining masks and charged inflated prices*.
▪ DEA states that there was a markup (in some cases) of fifty (50) percent.
▪ Bought for $10/Sold for $15
▪ Bought for $20/sold for $25
▪ Repeatedly sold masks out of his car.
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United States of America vs. Richard Schirripa, “The Mask Man”
▪ Schirripa had also recently sold his pharmacy and told the DEA that he had transferred or destroyed all of the controlled substances from his store.
▪ The products were in a safe in Schirripa’s home.▪ Fentanyl
▪ Oxycodone
▪ Oxymorphone
▪ Approximately 4,000 pills/patches
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United States of America vs. Richard Schirripa, “The Mask Man”
▪ Schirripa sold product to an undercover agent and also sent text messages to an undercover agent.
▪ Reported to have said “when you have something no one else has, its not a high price”.
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United States of America vs. Richard Schirripa, “The Mask Man”
▪ Alleged to have billed Medicaid and Medicare for CS prescriptions.
▪ Prescriptions were filled and the CS in Schirripa’s home
▪ It should go without saying that, if the allegations are true, he used the personal information of patients without their authorization.
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United States of America vs. Richard Schirripa, “The Mask Man”
▪ Potential sentences▪ 1 year for violation of DPA
▪ 5 years for false statements
▪ 20 years for healthcare fraud
▪ 2 years for aggravated identity theft
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Obligations
▪ Obligation to follow the law
▪ Copy of charges:▪ https://www.justice.gov/usao-sdny/press-
release/file/1278736/download
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Refusal to Fill Prescriptions
▪ CVS, Walgreens and Costco have been sued for refusing to fill opioid prescriptions.
▪ Press release August 10, 2020.
▪ https://www.beckershospitalreview.com/pharmacy/cvs-walgreens-costco-sued-for-not-filling-opioid-prescriptions.html.
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Refusal to Fill Prescriptions
▪ Plaintiff alleges ▪ That she has used opioids to treat chronic
conditions for years
▪ That the prescriptions are legitimate
▪ That the defendants are violating the Americans with Disabilities Act.
▪ The defendants have not commented on the lawsuit.
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Americans with Disabilities Act of 1990
▪ Also referred to as the ADA
▪ To be protected by the ADA, one must have a disability, which is defined by the ADA as a physical or mental impairment that substantially limits one or more major life activities, a person who has a history or record of such an impairment, or a person who is perceived by others as having such an impairment.
▪ The ADA does not specifically name all of the impairments that are covered.
▪ https://www.ada.gov/ada_intro.htm
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Americans with Disabilities Act of 1990
▪ This claim says that the plaintiff was discriminated against because of their disability versus a typical negligence claim, such as filling a prescription incorrectly.
▪ Negligence claims are composed of the following:▪ Duty of care
▪ Breach of duty
▪ Causation
▪ Damages
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Challenges for the Pharmacist
▪ The laws and your store policies may not take into consideration unique cases.
▪ Policy is more like a one size fits all scenario.
▪ Violations of law can result in fines and/or loss of your professional license.
▪ Violations of policy can result in loss of your job.
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U.S. vs. Ryan Patrick
▪ Pharmacist Ryan Patrick has entered a guilty plea:▪ Obtaining drugs by fraud
▪ Using the registration number of another in the course of acquiring controlled substances.
▪ Sentencing is scheduled for August 28, 2020.
▪ Max 4 years in prison and/or
▪ Fine up to $250,000
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U.S. vs. Ryan Patrick
▪ Pharmacist at Rite Aid in Saltville, Virginia.
▪ Girlfriend operated a vet clinic in Bluff City, Tennessee.
▪ Patrick was filling prescriptions in the names of their five (5) dogs and using for his own use.
▪ Prescriptions written by another vet in the clinic, not Patrick’s girlfriend.
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U.S. vs. Ryan Patrick
▪ Total of 47 prescriptions
▪ DEA not able to trace the origins of the prescriptions listed in the PMP.
▪ When the veterinarian was questioned, the vet confirmed that the prescriptions had been altered and/or photocopied from previous prescriptions.
▪ Seven (7) of the prescriptions filled were for a dog that has previously been euthanized in August 2019.
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Don’t Involve the Dog!
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ALBOP Wellness Program
▪ Dr. Michael C. Garver, D.M.D. DirectorAlabama Board of Pharmacy Wellness ProgramBOP WELLNESS: 251-605-2883Fax: [email protected]
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Case Info from This Week
▪Greg Neal told the Bristol Herald Courierhe was asked to resign as CEO of Bristol (Tenn.) Regional Medical Center after participating in a surgical procedure without a medical license.
▪Mr. Neal stepped down from the role Aug. 20. He had served as CEO of Bristol Regional since 2013 and as president of Johnson City, Tenn.-based Ballad Health's northeast market since 2018.
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Case to Watch:BCBS vs CVS
▪ BCBS in six (6) states has sued CVS – case set for trial later this year.▪ Including Alabama
▪ Claiming that CVS submitted inflated prices to BCBS.▪ Prices were lower for cash patients
▪ Allegations of fraud
▪ CVS has denied the charges
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Before we closeAdjusting to the challenges we have faced so far
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Who Packed Your Parachute?https://www.youtube.com/watch?v=Bhx_anC8Q7I