Long Term Care Pharmacy Audit Prevention and Fraud, Waste ... · Medicare Part C and D...

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Long Term Care Pharmacy Audit Prevention and Fraud, Waste, and

Abuse Compliance in 2019

Trenton Thiede PharmD, MBAChief Operating Officer, PAAS National®

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Disclosure

Trenton Thiede is an employee of PAAS National®, a pharmacy audit assistance and FWA/HIPAA regulatory compliance company. The conflict of interest was resolved by peer review of the content.

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Pharmacist and Pharmacy Technician Learning Objectives

At the conclusion of this program, you will be able to:• Discuss consequences of non-compliance with regulations using case examples• Identify and describe the 7 required elements of an FWA compliance program• Explain how the CMS’ final rule change for Contract Year 2019 affects

pharmacies• Discuss unique challenges with LTC pharmacy audits

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THIS SESSION WILL BE UTILIZING AUDIENCE POLLING SOFTWARE

Please go to MEET.PS/LTCAUDIT to answer poll questions

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Fraud, Waste, and Abuse Compliance (FWAC) Laws & Rules• Federal False Claims Act (FCA)

• 31 U.S.C. § 3729-3733• Enacted post-Civil War• Heavily amended in 1986 • Amended multiple times• Criminal felony to submit a false claim for payment from Federal funds

• Medicare, Medicaid, TRICARE, Federal Employee Program (FEP), grants, etc. • Includes making or using a false statement

• Civil Money Penalties (CMPs) • Up to treble (triple) damages plus $11,000 fine per claim filed

• Qui Tam provisions • Incentives of up to 30% of settlement or judgment may be awarded to whistleblowers• Protections in place to protect whistleblowers from retaliation of any kind

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Whistleblower Cases

• Walgreens’ settlements (1/2019)• $209.2 Million for refusing to break insulin boxes, forcing pharmacies to override the days’

supply (and then put patients on auto-refill program)• $60 Million for falsely elevating U&C through Prescription Savings Club• Cases arose from whistleblowers under the FCA that were former employees

• Could get up to 30% of the $269.2 Million in recovery

• Pharmerica (5/2015)• Settled alleged violations of Controlled Substance Act $8 Million

• Consequently, treble damages for violations of FCA $23.5 Million• Whistleblower received $4.3 Million

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FWAC Laws & Rules

• Federal Anti-Kickback Statute (AKS)• 42 U.S.C. § 1320• Effective 1972• Prohibits providing or receiving a “kickback” for referral of any product or service paid by

Medicare or Medicaid • Any remuneration• Safe Harbors (formerly proposed removal of rebates involving prescription pharmaceuticals and

creation of new point-of-sale reductions in price)• 5 years in prison• Fines up to $25,000• CMPs up to $50,000/kickback, plus three times the remuneration• Can lead to exclusion from participation

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FWAC Laws & Rules

• Anti-Kickback Statute (continued) • OIG maintains list of Safe Harbor regulations

• Published 42 CFR §1001.952• Must follow regulations exactly to be “safe”

• OIG will provide advisory opinions in situations that do not meet regulations• Based on facts provided • Only opinion

• Doesn’t mean practice is legal• OIG likely not to prosecute

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Violation of Anti-Kickback

• Johnson & Johnson paid $2.2 Billion to resolve criminal and civil liability (11/2013)• Promoted off-label use of Risperdal®, Invega®, and Natrecor®• Paid kickbacks to physicians (guise of speaker fees) • Paid kickbacks to Omnicare (market share rebates, data purchase agreements, grants, and

educational funding)• Engage Consultants in “active intervention programs”• J&J viewed consultants as extension of its sales force

• CMP resulted in $1.72 Billion• False claims resulted in additional payment of $149 Million

• Omnicare paid $98 Million

• Abbott Labs paid $1.5 Billion for similar conduct with Depakote®(5/2012)• Omnicare paid $28.125 Million

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• Omnicare paid $124 Million to settle alleged anti-kickback statue (6/2014)• Offered improper financial incentives to SNFs in return for continued business• Entered into below cost contracts to supply prescription medications• AKS – prohibit offering, paying, soliciting, or receiving remuneration to induce

referrals of items or services• Whistleblower received $17.24 Million

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• Atlanta Nursing Home Chain solicited kickback payments from Omnicare in exchange for 15-year contract (2/2010)• Requested $50 Million as a payment• Omnicare agreed to acquire small business unit with two employees for $50

Million • Nursing Home paid $14 Million in settlement• Omnicare paid $98 Million in settlement

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FWAC Laws & Rules

• Stark Statute• 42 U.S.C § 1395nn• “Stark I” – OBRA 1989• “Stark II” – OBRA 1993• AKA Physician Self-Referral Law• Prevent financial incentives for unnecessary medical services• Prohibits ordering or referring medical services with a financial incentive (ownership)• Provides for CMP and treble damages

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FWAC Laws & Rules

• Public Law 104-191, Health Insurance Portability and Accountability Act (HIPAA) of 1996• Established the Health Care Fraud and Abuse Control (HCFAC) Program

• Public and private health care • Under joint direction of the Department of Health and Human Services (HHS), Office of the

Inspector General (OIG) and the Attorney General • Coordinates Federal, State and local law enforcement

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FWAC Laws & Rules

• Medicare Modernization Act (MMA) of 2003• Created Medicare prescription drug program (Part D)• Requires plan sponsors to have a compliance program

• Covers general compliance and FWAC• Plan sponsors must assure that their employees, contractors

and first-tier, downstream and related entities (FDRs) meet requirements• Pharmacies are FDRs

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FWAC Laws & Rules

• Deficit Reduction Act (DRA) of 2005• Enhanced the Federal False Claims Act

(FCA)• Provides financial incentives to States to

pass their own FCA• Required FWAC requirements for any

entity with $5 million or more in revenue per year from Medicaid

Source: https://www.falseclaimsact.com/states-municipalities-fcas

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FWAC Laws & Rules

• Health Care Fraud Enforcement and Action Teams (HEAT)• Began May 9, 2009• CMS, FBI, DEA, OIG, State and local law enforcement working in conjunction• Medicare Fraud Strike Force, multiple cities

• Baton Rouge and New Orleans, LA; Brooklyn, NY; Chicago, IL; Dallas, TX; Detroit, MI; Houston, TX; Los Angeles, CA; Miami-Dade, FL; Tampa Bay and Orlando, FL; Washington, DC; Newark, NJ and Philadelphia, PA (8/2018); Appalachian Region (10/2018); Rio Grande Valley and San Antonio (8/2019)

• June 2018: National Health Care Fraud Takedown• 600+ defendants in 58 federal districts charged with fraud (65% increase from 2017)• $2 billion in false claims• Exclusion of 2,700 individuals since July 2017

• In FY 2017, government teams recovered $2.6 billion from health care related fraud• In FY 2018 ‘Impact on Investment’ calculated at $100 to $1

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FWAC Laws & Rules

• Patient Protection and Affordable Care Act (ACA) of 2010 (Obamacare)• Expanded the Recovery Audit Contractor (RAC) program to include Medicaid and

Medicare Part C and D• Additional $350 million to fight FWA

• Expected to be budget neutral• FWA Recovery ≥ Enforcement Cost

• FY 2015-2017, recovered $4.20 for every $1 spent on investigation

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FWAC Laws & Rules

• Affordable Care Act (continued) • Increased provider/supplier review

• Site visits, background checks, licensure checks, fingerprinting• False applications may lead to exclusion from all Federal programs• Medicaid termination for unpaid overpayments• Suspension of payments if fraud is suspected!

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Please go to MEET.PS/LTCAUDIT to answer poll questions!

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What is Fraud?

• Knowingly and willfully executing, or attempting to execute, a scheme or artifice to defraud any health care benefit program or to obtain (by means of false or fraudulent pretenses, representations, or promises) any of the money or property owned by, or under the custody or control of, a health care benefit program.• 18 U.S.C. Section 1347

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Examples of Possible Fraud

• Intentionally submitting false information in order to get money or a benefit• Billing for items that were not purchased or delivered• Prescription forging, altering or shorting• Switching to a more expensive dosage form to increase the amount of

reimbursement• Submitting claims for entire amount on partial fills were the balance is

not picked up• Reusing medications that were already paid for by Medicare

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Prison & Fines for Fake Claims

• Pharmacist at A to Z Pharmacy, FL• Sentenced to 10 years in prison• $3.2 million in restitution• $1.4 million in forfeiture• Paid kickbacks to Medicare, TRICARE, & Medicaid patients • Compounded pain and scar creams• Not medically necessary• Never provided• Or both

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What is Waste?

• Waste is the overutilization of services, or other practices that, directly or indirectly, result in unnecessary costs to the Medicare program. Waste is generally not considered to be caused by criminally negligent actions but rather the misuse of resources. (CMS, Prescription Drug Benefit Manual Chapter 9 – Compliance Program Guidelines, Section 20)

• Waste is a misuse of resources or to spend carelessly

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Examples of Possible Waste

• Overbilled quantities – submitting for a quantity larger than what is allowed by the plan or ordered by the prescriber• Dispensing a 90-day supply that is discontinued after 30 days• Billing an incorrect day supply resulting in the patient receiving a larger

quantity than allowed• Dispensing a 60-gram tube of ointment when a 15-gram tube would be

sufficient• Auto-refills when the previous supplies not exhausted

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What is Abuse?

• Abuse includes actions that may, directly or indirectly result in: unnecessary costs to the Medicare program, improper payment, payment for services that fail to meet professionally recognized standards of care, or services that are medically unnecessary. Abuse involves payment for items or services when there is no legal entitlement to that payment for the provider.• Abuse may involve obtaining an improper payment, but does not require

the same intent and knowledge as fraud.

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Examples of Possible Abuse

• Using an override code to force a claim to go through early

• Filling a prescription after expiration

• Splitting prescriptions to obtain additional dispensing fees or to avoid prior authorization requirements

• Changing to an incorrect diagnosis code in order to receive payment

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Fraud vs. Abuse

• Did you do it intentionally?

• Can you prove that you didn’t?

• Repeated abuses are often considered to be intentional frauds in the eyes of the auditors• Once or twice = oops• More = Fraud

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Basics of FWAC

• Prevent! Detect! Correct!

• Required to adopt and implement an effective compliance program

• CMS requires 7 core elements • 33 sub-elements

• Much more than just training!

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The 7 Core Elements are:

1. Written Policies, Procedures and Standards of Conduct;2. Compliance Officer, Compliance Committee and High-Level

Oversight;3. Effective Training and Education;4. Effective Lines of Communication; 5. Well Publicized Disciplinary Standards; 6. Effective System for Routine Monitoring and Identification of

Compliance Risks; and7. Procedures and System for Prompt Response to Compliance

Issues

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Policies & Procedures

• Detailed and Specific• Describe operations of Compliance Program• Reporting structure• Training requirements• Investigation and remediation

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Standards of Conduct

• AKA “Code of Conduct” (CoC)• State the principles and values by which you operate• Expectation that ALL employees will act in an ethical manner• Noncompliance and potential FWA is reported• Reported issues are addressed and corrected• Compliance is everyone’s responsibility!

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Distribution of P&P and Code of Conduct

• Compliance program not effective unless distributed to employees• Within 90 days of hire• Updates • Annually

• Can distribute manually or electronic• Need proof of distribution• Signed acknowledgement

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Compliance Officer

• Should be full-time employee • Experience with compliance• Recommend manager or direct report • Duties:• Aware of daily activities• Develop and Implement compliance program• Coordinate internal reviews and investigations• Maintain reporting mechanisms• Exclusion list checking

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Effective Training and Education

• General Compliance Training• ALL Employees (includes temps and volunteers)• Within 90 days of hire and annually • Classroom, online or attestation that have read and received CoC

and P&P• Must have proof of training (sign-in, attestation or certificates)

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Effective Training and Education

• Fraud, Waste and Abuse Training• Only requirement deemed to have been met thru Part B accreditation• Only employees that are involved in the administration or delivery of Medicare

benefits• Within 90 days of hire and annually• May be required as corrective action for noncompliant employees• Sponsors required to provide training to FDRs

• Have more latitude on how they meet and oversee FWA training. May require additional training.

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Effective Lines of Communication

• Ways to communicate information from the Compliance Officer to others• Officer’s name, location, and contact information• Changes to P&P, CoC, laws and regulations• Methods of communication

• Written, email, website, or meetings

• Communication and Reporting Mechanisms• Must have P&P and CoC that requires reporting of suspected or detected noncompliance

or FWA• Must maintain confidentiality • Allow anonymous reporting• Prohibit retaliation or retribution (no-tolerance policy)• User friendly, easy to access

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Disciplinary Standards

• Clear and specific disciplinary standards• Contents:• Expectation to report noncompliant, unethical or illegal behavior• Participate in required training• Timely, consistent and effective enforcement• Disciplinary action must be appropriate to seriousness of the

violation• Retraining, suspension, termination

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Enforcing Disciplinary Standards

• Maintain records for 10 years• Date reported• Description of violation• Date of investigation• Summary of findings• Disciplinary action taken and date

• CMS encourages that de-identified disciplinary actions be reported to employees• Demonstrate importance of Disciplinary Standards

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Whistleblower Protections

• P&P must include protection from intimidation or retaliation• Encourage reporting without fear of repercussions• Required by False Claims Act• Disciplinary Standards should be enforced against anyone

that violates whistleblower protections• Can involve law enforcement if necessary

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Routine Monitoring & Auditing

• Compliance Officer must conduct• Monitoring = regular review of operations to ensure compliance• Auditing = formal review based on a set of standards (P&P, laws

and regulations) • Address areas at risk• What audits will be performed?• When will audits be conducted?• Who will conduct audits?• How will audits be conducted?

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Procedures for Prompt Response to Compliance Issues

• Need to investigate suspected or detected FWA• Policy should cover process (who, how, etc)• What happens if there’s an external investigation• Employee cooperation considerations• Remediation needs to be taken as soon as possible• Consider procedural changes for prevention• Discipline standards for bad actors• Disciplinary standards need to be well publicized and consistently

enforced

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Exclusions

• OIG/GSA Exclusion• OIG LEIE: Office of the Inspector General List of

Excluded Individuals and Entities• http://exclusions.oig.hhs.gov

• GSA EPLS: General Services Administration Excluded Parties Lists System • Moved to SAM (System for Award Management) website• http://www.sam.gov

• Be mindful if your state has an exclusion list

Source: https://www.exclusionscreening.com/oig-exclusion-list-2/

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https://www.exclusionscreening.com/oig-exclusion-list-2/

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OIG Exclusion

• Search up to 5 individuals at a time• Allows SSN/EIN

verification • Provider records

also contain NPI/UPIN if available

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GSA Exclusion

• Search only 1 individual at a time• Need to contact the

excluding agency to confirm• Exclusions often not

related to health care

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Exclusions

• OIG/GSA Exclusion (continued)• “Federal funds may not be used to pay for services, equipment or drugs

prescribed or provided by a provider, supplier, employee or FDR excluded by OIG or GSA.”

• Must screen PRIOR to hire and at least Monthly• Any employee, temporary employee, volunteer, consultant, governing body member or

FDR• Ensure that not excluded or become excluded

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Exclusions

• OIG/GSA Exclusion (continued)• Mandatory Exclusions: Previous fraud, patient neglect or abuse, felony

convictions relating to unlawful manufacture, distribution, prescribing or dispensing of controlled substances

• Permissive Exclusions: Misdemeanor convictions for above, Pharmacy License suspension for reasons bearing on professional competence, financial integrity – providing unnecessary or substandard services, engaging in unlawful kickback arrangements, defaulting on a health education loan or scholarship obligations

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Exclusions

• OIG/GSA Exclusion (continued)• Costs of Employing Excluded Individual

• CMPs of up to $10,000 for each item or service • Recovery up to three times the amount claimed• Exclusion

• Self-Disclosure Protocol• Reduce recovery to 1.5 times amount paid• Can prevent exclusion• Limited to $10,000 minimum

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Examples of Exclusion

• 2012: Hy-Vee Pharmacies, Iowa• Agreed to pay $831,871.61 for allegedly violating CMP Law• Employed an individual that they knew or should have known was

excluded• 2018: Healthways Pharmacy and Surgical, New York • Employing an excluded individual• Agreed to pay $204,426.64

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FWAC Attestations

• Initially focused on:• Training

• 2011 Office of Inspector General (OIG) Report• 87% of pharmacies completed training • 30% of plan sponsors did not require documentation • 41% of plan sponsors did not measure effectiveness

• CMS guidance has changed over time• 2006 – pharmacies can develop own training• 2008 – sponsors must provide training• 2009 – sponsor provided or equivalent training

• Avoid duplicate trainings• 2012 – optional CMS developed training• 2016 – CMS developed training mandatory• 2019 – CMS discontinued support of training

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Training Changes

• April 2018 CMS final rule• What changed:

• The rule change gives Plan Sponsors (e.g. Humana) more latitude on how they meet and oversee FWA training and compliance for their contracted pharmacies

• What didn’t change:• Pharmacies (FDRs) still must have a compliance program that meets all 7 elements required

by CMS. • Pharmacies are expected to retain records to support FWA training and compliance for at

least 10 years.

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FWAC Attestations

• Increased focus on other FWA compliance requirements• Code of Conduct• Conflict of Interest Statement• OIG/GSA Exclusion Lists

• Originally - Upon hire and annually• Current - Prior to hire and at least monthly

• Contractor compliance (downstream entities)

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Penalties for being noncompliant

• Network TERMINATION!• Exclusion from Federal health programs.• CMPs, fines and jail time.

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Being Compliant

• FWA Training alone is not a compliance strategy• Appoint experienced, trusted employees to be your

Compliance Officer• Can be the owner, Pharmacist in Charge (PIC), technician

• Evaluate and revise your policies and procedures regularly• Know your State and Local laws• Seek professional and peer advice/assistance• Compliance is everyone’s responsibility, not just the

Compliance Officer

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Summary

• Consequences of Non-Compliance with FWA regulations• False Claims Act

• Pharmerica billing C-IIs without valid orders• Anti-kickback Statutes

• Drug Manufacturers rebating based on performance• Omnicare pricing Med A drugs below cost

• CMS final rule for Contract Year 2019• Plan Sponsors have more latitude about how they meet and

oversee FWA compliance

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Summary

• Elements of a Compliance Program1. Written Policies, Procedures and Standards of Conduct;2. Compliance Officer, Compliance Committee and High-Level Oversight;3. Effective Training and Education;4. Effective Lines of Communication; 5. Well Publicized Disciplinary Standards; 6. Effective System for Routine Monitoring and Identification of Compliance Risks;

and7. Procedures and System for Prompt Response to Compliance Issues

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LTC Pharmacy Audits

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Why so many audits?

Escalating Healthcare costs

Opioid Epidemic

Contractual Requirement

Fraud, Waste & Abuse

Common Billing Errors

Data Analytics/Outliers

PBM Revenue Source = $$$

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Audit Penalties

Financial Recovery

Network Termination

Reputation

License

OIG Exclusion

Fines

Prison

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Desk % Onsite % Invoice* %2014 72 27 12015 73 26 12016 78 20 22017 82 16 22018 86 12 1

Audit Trends from 2014 - 2018

• *Many invoice audits are in addition to desk/onsite audit• 5-year trend is a 60.3% increase in audits overall• 2018 started tracking ‘72-hour prescription validation’

requests• Extrapolated to 10.7% of annual total

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Big Picture

Do you have a prescription?

Is prescription legal/valid per state and federal laws?Prescription

Did you fill and bill accurately (including calculable directions?

Data Entry & Filling

Do you have proof of dispensing?

Do you have proof of copay collection?Dispensing

Did you purchase enough inventory from an appropriate source?

Other

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Common Audit Discrepancies

Prescription• Missing/Invalid Rx• Altered Rx

Data Entry• Overbilled Quantity• Refill Too Soon• Incorrect DAW Code

Dispensing• Missing/Invalid Signature Log• Dispensed > 14 Days• Copay Collection

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Audit Algorithms ≠ Random

Historical Billing/Documentation Errors

1. Days’ Supply2. DAW

Historical Fraud Targets 1. Controlled Substances – “Pill Mills”2. Compounds

Telemedicine & Delivery –Zip code analysis

1. Patient2. Prescriber3. Pharmacy

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Data Entry Filling Verification Delivery Billing

Workflow Prevention Strategies

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• Match NDC on stock bottle against billing label (including package size) using barcode technology if possible

• Be careful not to short cycle or break open “Dispense in Original Container” medications• e.g. Linzess, many HIV/Oncology medications, etc…

Filling

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• Produce delivery Manifests with sufficient detail • Obtain signature from agent of the Nursing Home, with hand-written

date• If mailing, you must establish a clear link between the tracking number

and the prescription• Ensure timely reversal of prescriptions that are refused/returned

Delivery

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• When changing pay types, verify days’ supply on Refill On Demand prescriptions• Charge accounts must have good accounting practices with Policies and

Procedures• When are statements produced• Describes follow-up on deficient accounts• When are patients cut-off from services• Cash application process

Billing

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1. Day Supply – Insulin2. Day Supply – Topicals3. Day Supply – Inhalers4. Day Supply – Eye drops5. DAW6. Controlled Substance Prescriptions7. E-Prescriptions8. Transfer Prescriptions9. Compound Prescriptions10. Proof of Dispensing/Copay Collection11. Non-FDA approved products or FDA approved devices

“Top Eleven” Audit Discrepancies

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• 1 box of pens (15 mL)• Obtain Max Daily Dose and add a

Clinical Note• Submit accurate DS

•Must break boxes if plan limits exceeded!!

1. Day Supply – Insulin

Rx #1Insulin Lispro U-100 Pen15 mLUAD per sliding scale

7/29/18 per Kate, RN max daily dose = 30 units EEH

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1. Days Supply - InsulinDOJ Settlement with WAGs

• January 22, 2019 - $209.2 million settlement • Regarding billing and dispensing of insulin pens (WAGs had Rx system set up to prevent breaking

boxes)• Forced pharmacies to alter Days’ Supply to plan limits• Then put patients on auto-refill program leading to early refills

• DOJ cited examples of patients selling insulin on Craigslist• For Single Patient Use Only

• FDA safety announcement from 2015: guidance regarding HCP utilizing the same pen on multiple patients and just swapping the pen needles

• Remember to provide Patient Information Handouts• Seeing PBMs enforce (Humana, EnvisionRx, ESI, OptumRx, and Prime)!

Sources: DOJ https://www.justice.gov/usao-sdny/pr/manhattan-us-attorney-announces-2692-million-recovery-walgreens-two-civil-healthcare

FDA https://www.fda.gov/Drugs/DrugSafety/ucm435271.htm

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https://www.justice.gov/usao-sdny/pr/manhattan-us-attorney-announces-2692-million-recovery-walgreens-two-civil-healthcare

https://www.fda.gov/Drugs/DrugSafety/ucm435271.htm

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• Submit accurate DS if possible•Mathematical instructions for use• Grams per application (if one area

only)• Max Daily Dose per MD or expected

day supply• List of affected areas + Finger Tip Unit

(FTU) Method

2. Day Supply – Topicals

Rx #2 Calcipotriene 0.005% cream360 GMAAA BID

7/29/18 per Josie, RN affected area = both hands and feet EEH

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• 1 FTU » 0.5 gram (adult)• 1 FTU covers one hand (front/back)

Finger Tip Unit (FTU) Method

Body Surface # of FTUs

Hand 1

Foot 1

Arm + Hand 4 (3+1)

Leg + Foot 8 (7+1)

Buttocks 4

Trunk (front or back) 8 each

Face & Neck 2.5

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Federal Law3 elements as per 21 CFR 1306.05(a)

• Patient Address• MD Address• DEA number

State Law(s)• Where applicable• Part D Opioid Restrictions

Buprenorphine/naloxone – DATA 2000 Waiver ID aka “X DEA number” in addition, not in place of

6. Controlled Substances

Rx #57/11/2018

Homer Simpson742 Evergreen Terrace, Springfield

Buprenorphine/naloxone 8/2 mg film#601 film SL BID + 0 refills

Dr. Nick123 Main St, SpringfieldAB1234567 XB1234567

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• Rx must match compound log AND Claim• NDCs• Quantities

• Ingredient strengths assumed to be “final” unless specified• E.g. in lidocaine 5% ointment

• Base QS amount – make sure software does not overbill• LOE codes 11-15• Be careful with defaults

9. Compounds

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Proof of Dispensing - Signature LogsElements

1. Patient Name2. Date of Service3. Rx Number4. Facility Name5. Date of Delivery6. Signature of person accepting delivery, with hand-written date

• “Mail” or “Delivery” will NOT be sufficient• Do not deliver before billing

10. Proof of Dispensing & Copay Collection

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10. Proof of Dispensing &Copay Collection

Copay Collection• Contracts require collection WITH PROOF (limited exceptions)• Documented proof of collection

• Front/Back copies of canceled checks, bank deposits, and even Credit Card Merchant Account Reporting, including evidence of settlement and payment through bank records

• How could you prove copay collection on a transaction from last year on a specific prescription?

• House Charge Accounts• Documented Policy and Procedures• Timely invoice and documented attempts at collection• How are payments applied

• Bad Debt/Hardships• Documented Policy and Procedures• Tax return documentation, etc

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Humana offers the most specific guidance on LTC documentation:• Prescription hard-copy requirements• Signature Log Requirements• Cycle Fill

Long Term Care Challenges

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Humana Prescription hard-copy requirements: 1. Patient Name2. Date of Issuance3. Name of Drug4. Strength of Drug5. Dosage Form of Drug6. Directions for use7. Duration of Therapy (e.g. number of refills, clear start/stop dates or duration written

by prescriber)8. DEA # (for controls)9. Prescriber’s signature on the original PO/hard copy


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Humana acceptable prescription hard-copy documentation: • Original signed PO/Hard copy and refill sticker for the Date of

Service• Original signed PO/Hard copy and signed PO for month requested• A prescription drug order, a chart order, progress notes, or a MAR

that clearly contains all 9 elements outline • Specific prescription discharge orders with a clear duration of

therapy


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Humana Signature Log Requirements1. Patient name2. Date of service3. Rx number4. Facility name5. Date of delivery (hand-written by person signing)6. Signature of person who accepted

• Do not utilize a summary/generic signature page for proof of delivery• Billing date must be before, or concurrent with, delivery date• Suggest never providing fill dates or start dates to avoid confusion


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•Humana Cycle Fill Requirements• May be done at the beginning or end of the month, must be

consistent• Cannot interfere with normal days’ supply and quantity-limit edits

• If submitting SCC for short-cycle dispensing, must be able to produce appropriate delivery documents for each dispensing• 2/2/3 cycle – 12 delivery documents in 28 days


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• Problems with Physician Orders• Ideal to have refills or valid time frame on form (e.g. All non-

controlled prescriptions are good for 31 days’ supply with 11 refills from written date)• Controlled substances (DEA requirements)

• Quantity, Pt Address, Prescriber Address, Signature, and DEA • Prescriber signature on page 4 of PO, prescription on page 2 –

only provide page 2 to auditor • Happens with delivery logs as well


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• Valid Fax Prescriptions• LTC nurse takes non-controlled drug order via telephone from prescriber• Reduces it to writing and sends to pharmacy as new order• What origin code are you utilizing?

• Fax – Rx has fax header• PBMs will mark invalid prescription (not valid fax without prescriber

signature), must call to verify


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•Medicare A days’ supply• Do not ‘fudge’ days supply on Med A “refill on demand”

medications (e.g. Insulin with 1 days’ supply)• Increased likelihood of billing to Med D incorrectly if changing pay

types

• Short cycle• Short cycle based on NDA/ANDA (versus Brand/Generic)• Use caution with medications that need to be dispensed in

original container (e.g. Linzess)


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• Current gap in Medicare Part B Competitive Bid (since 12/31/2018)• LTC pharmacies can now resume delivery of diabetic testing supplies –

Hooray!!!???• Must deliver same day as billed (careful with overnight runs)• DMEPOS Accreditation still applies for those that aren’t exempt• Be prepared for intense documentation requirements, and AUDITS• Safety Lancets in ALF – Medicare Part B will not reimburse; facility’s

responsibility to meet OSHA requirements – cannot upcharge patient directly


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• Beyond Use Dating• Recommend dispensing in smallest package size when/where appropriate• Nursing Home practices do not invalidate FDA/manufacturer sterility

testing• PBMs will not pay for early refills, or will recoup on audits despite nursing home

policies (e.g. throw away all ‘opened’ insulin or eye drops after 28 days)


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•Medicare D audits/reversals due to patient being on a Medicare Part A stay• Often 6-12 months in arrears • Consider contractual language with SNF to correct billing discrepancies• Engage facility early in relationship and work on communication with

census changes before problems arise• Think about post-relationship recoupments


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• Transitions in Care• Do not bill discharge medications prior to day of discharge for Med A

residents• Careful with SNF to ALF transitions, make sure the date of the move is

accurate • Facilities are tempted to request medications in advance of patient

transitioning, not understanding the repercussions


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• Agent of the Prescriber• LTC nurses are not agents of the prescriber and cannot communicate CS

prescriptions to the pharmacy• Physician may assent manifest to nurse for communicating controlled substances

(pharmacy must have on file)• PBMs have been known to ask for proof of relationship

• Residence Codes• Use appropriate codes based on patients’ residence

• 03 – SNF• 04 – ALF


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• Submission Clarification Codes (CVS/CRK policies)Long Term Care Challenges

Override Code Definition Documentation Required Typical Allowance

04 – Drug Missing, Dropped

Medication cannot be located or has been dropped

- Copy of MAR, nursing notes, or med pass report that has reason for override,

Up to a 5-day supply

14 – Leave of Absence or Vacation Supply

Separate dispensing of small quantities for take home use

- Copy of prescription order allowing patient to leave, chart notes with vacation supply requested, or POS indicating vacation supply requested


15 –Contaminated, ‘Spit Out’

Medication has been spit out or contaminated

- Copy of MAR, nursing notes, or med pass report that has reason for override,


18 –Admission / Level of Care Change

Newly admitted - Copy of Admission Sheet that includes date and copy of the discharge orders (if applicable)

Multiple fills up to a 31-day supply

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Summary

• LTC Audit Challenges• Valid Prescription Orders/POS• Delivery Sheets• Beyond Use Dating • Medicare A/D• Submission Clarification Codes

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LTC Pharmacy Audit Prevention/FWA Compliance in 2019 - Handout• The False Claims Act and Anti-Kickback Statutes are

two laws the federal government will use to prosecute violators of FWA regulations.• FWA Compliance Training is only one of seven

elements required for a Compliance Program.• The most challenging aspects for LTC pharmacies when it

comes to audits are valid hard copies and signature logs .

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Trenton Thiede PharmD, MBAChief Operating Officer – PAAS National®

[email protected]

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Long Term Care Pharmacy Audit Prevention and Fraud, Waste ... · Medicare Part C and D...

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Transcript of Long Term Care Pharmacy Audit Prevention and Fraud, Waste ... · Medicare Part C and D...