1 st Tier & Downstream Training Focus

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Colorado Access Advantage (HMO)

Medicare Advantage Part D

Fraud, Waste and Abuse

Compliance Training

2010

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Introduction

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y The Centers for Medicare & Medicaid Services (CMS) requires The Centers for Medicare & Medicaid Services (CMS) requires annual fraud, waste and abuse (FWA) training for organizations providing health, prescription drug or administrative services to Medicare Advantage (MA) or Prescription Drug Plan (PDP)

beneficiaries on behalf of a health plan. beneficiaries on behalf of a health plan.

y As MA and PDP Sponsors, Colorado Access Advantage (HMO) is

committed to following all applicable laws, regulations and guidance that govern these programs.

Th f i i t d b f d l l ti

y The foregoing requirements are governed by federal regulations: 42 CFR § 422.504(b)(4)(vi)(c) and 42 CFR § 423.504(b)(4)(vi)(c)

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1 ^st Tier & Downstream Training Focus

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y

Catalyst: New federal regulations

y

Purpose: To detect, prevent and resolve fraud, waste

and abuse and to raise awareness about the issue

y Responsible Party: MA and PDP plan sponsors must

implement an effective compliance plan that include

measures to detect prevent and resolve fraud waste

measures to detect, prevent and resolve fraud, waste

and abuse

y Training Schedule: Upon rollout of new training g p g

program and annually thereafter

y Target Audience: 1

^st

Tier and Downstream Entities

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Definitions

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y

_Abuse:

excessive or improper use of services or actions that are p p inconsistent with acceptable business or medical practice. Refers to

incidents that, although not fraudulent, may directly or indirectly cause financial loss. Examples include:

¾ charging in excess for services or supplies

¾ providing medically unnecessary services

¾ billing for items or services that should not be paid for by Medicare

y

_Fraud:

i t ti l t f d ti i t ti y

_Fraud:

an intentional act of deception, misrepresentation or

concealment in order to gain something of value. Examples include:

¾ billing for services that were never rendered

¾ billing for services at a higher rate than is actually justified

¾ deliberately misrepresenting services, resulting in unnecessary cost to the Medicare program, improper payments to providers or overpayments

Sources: 42 C.F.R. §455.2 (2005); Prescription Drug Benefit Manual, Chapter 9 – Part D Program to Control Fraud, Waste and Abuse (Rev. 2, 04-25-2006)

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Definitions - Continued

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y First Tier Entity: A party that enters into a written arrangement, acceptable to CMS, with a Plan Sponsor to provide administrative

services or health care services for a Medicare eligible individual under the MA or Part D programs. Examples include Pharmacy Benefits

Manager (PBM), contracted hospitals, clinics and allied providers.

y Downstream Entity: A party that enters into a written arrangement, acceptable to CMS, with persons or entities involved in the MA or Part D benefit, below the level of the arrangement between a Plan Sponsor and a first tier entity. These written arrangements continue down to the level of the ultimate provider of both health and administrative p

services. Examples include pharmacies, marketing firms, quality assurance companies, claims processing firms and billing agencies.

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Definitions - Continued

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y Plan Sponsor: _p

An entity that has a contract with CMS to offer y one or more Medicare Products (i.e., MA Plans, Prescription Drug Plans (PDP), 1876 Cost Plans, MA PDPs).

R l t d E tit

y Related Entity:

An entity that is related to the Plan Sponsor by common ownership or control and performs some of the Plan

Sponsor’s management functions under contract or delegation; p g g ; furnishes services to Medicare enrollees under an oral or written agreement; or leases real property or sells materials to the Plan Sponsor at a cost of more than $2 500 during a contract period Sponsor at a cost of more than $2,500 during a contract period.

y Waste:

The over-utilization of services (not caused by criminally negligent actions) and the misuse of resources.g g

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First Tier and Downstream Example

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Source: Prescription Drug Benefit Manual, Chapter 9 – Part D Program to Control Fraud, Waste and Abuse (Rev. 2, 04-25-2006)

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Federal Requirements

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y

Federal law requires MA and PDP Sponsors to have a Federal law requires MA and PDP Sponsors to have a

Compliance Plan

y

An MA or PDP Sponsor must create a Compliance Plan

that:

¾ Incorporates measures to detect, prevent, and correct FWA

¾ Consists of training, education and effective lines of communication

A li i i d i d i i i ll

¾ Applies training, education and communication requirements to all entities which provide benefits or services under MA or PDP

programs

¾ Produces proof in the form of attestations or copies of training logs

¾ Produces proof in the form of attestations or copies of training logs from first-tier, downstream and related entities to show compliance with these requirements

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What is a Compliance Plan?

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An effective Compliance Plan includes the following core elements: p g

y Written Standards of Conduct. Colorado Access has established Standards of Business Conduct and Policies & Procedures that promote its

commitment to compliance and that address specific areas of potential fraud, waste and abuse. These documents are available for review at: www.coaccess.com

y Designation of a Compliance Officer. Colorado Access has both a

Corporate Compliance Officer and a dedicated Medicare Compliance Officer who is responsible for the development, implementation and monitoring of Colorado

responsible for the development, implementation and monitoring of Colorado Access’ Medicare compliance program.

y Effective Compliance Training. The development and implementation of regular, effective education and training, such as this training.

I t l M it i d A diti U i i k l ti t h i d y Internal Monitoring and Auditing. Using risk evaluation techniques and

auditing to monitor compliance and assist in the reduction of problem areas. y Disciplinary Mechanisms. The consistent enforcement of policies to

address issues arising from individuals or entities that are excluded from g participating in CMS programs.

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Compliance Plan - Continued

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y Effective Lines of Communication. The Medicare Compliance Officer relies on open lines of communication between Colorado Access’ officers,

directors, managers, employees and members of the Compliance Committee, as well as first tier, downstream and related entities. Such communication:

{ Includes a system to receive, record and respond to compliance questions, or y , p p q , reports of potential or actual non-compliance, while maintaining confidentiality

{ Includes reporting of identified concerns by first tier, downstream, and related entities relating to compliance concerns and/or suspected or actual misconduct involving Colorado Access’ Medicare Advantage program or Part D programsg g p g p g y Procedures for Responding to Detected Offenses and

Corrective Action. Colorado Access’ policies and procedures are designed to detect compliance issues, respond to and investigate such issues, and initiate corrective action to resolve and/or prevent similar issues

corrective action to resolve and/or prevent similar issues.

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Why is FWA Detection and Prevention

Important? p

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d h h l h d h

y

Fraud costs the health care industry more than $100

billion annually

y

Fraud, waste and abuse programs save Medicare dollars

d h b fi h l h l d

and that benefits taxpayers, government, health plans and

beneficiaries

y

Detecting, correcting and preventing FWA requires

ll b i b

collaboration between _:

¾ Employees and vendors

¾ Providers of services such as physicians, nurses and pharmacies

S d f d l i

¾ State and federal agencies

¾ Beneficiaries

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Examples of FWA

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Provider:

y Illegal Payment Schemes

¾ Provider is offered, paid, solicits or receives unlawful payment to induce or reward the prescriber to write prescriptions for drugs or products.

y Script Mills

¾ Providers write prescriptions for drugs that are not medically necessary, often in mass quantities, and often for patients that are not theirs. These scripts are usually written but not always for controlled drugs for sale scripts are usually written, but not always, for controlled drugs for sale on the black market, and might include improper payments to the

provider.

y Theft of Provider’s Drug Enforcement Agency (DEA) Number or Theft of Provider s Drug Enforcement Agency (DEA) Number or Prescription Pad

¾ Prescription pads and/or DEA numbers stolen from providers. This information could illegally be used to write prescriptions for controlled substances or other medications

substances or other medications.

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Examples of FWA ^(cont’d)

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Wholesaler:

y

Counterfeit, Impure Drugs through Black Market

¾ Black Market includes fake, diluted, expired, illegally imported

d t

drugs, etc. y

_Diverters

¾ Individuals who illegally gain control of discounted medicines and g y g mark up the prices and move them to small wholesalers.

y

Inappropriate Documentation of Pricing

I f ti

Information

¾ Submitting false or inaccurate pricing or rebate information.

Source: Prescription Drug Benefit Manual, Chapter 9 – Part D Program to Control Fraud, Waste and Abuse (Rev.2, 04-25-2006), Section 70.1.5

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Examples of FWA ^(cont’d)

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Member/Beneficiary:

y

Identify Theft

¾ Using a member’s I.D. card that does not belong to that person to obtain prescriptions services equipment supplies doctor visits obtain prescriptions, services, equipment, supplies, doctor visits, and/or hospital stays.

y

Doctor Shopping

¾ Visiting a number of doctors to obtain multiple prescriptions for painkillers or other drugs. Might point to an underlying scheme (stockpiling or black market resale).

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Examples of FWA ^(cont’d)

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Pharmaceutical Company: p y

y

Illegal Off-label Promotion

¾ Promotion of off-label drug use

y

Illegal Usage of Free Samples

¾ Providing free samples to prescribers knowing and expecting prescriber to bill Medicare for the sample

y

Kickbacks, Inducements, Other Illegal Payments

¾ Inappropriate marketing or promotion of products reimbursable by federal health care programs

by federal health care programs

¾ Inappropriate discounts or educational grants

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Examples of FWA ^(cont’d)

Examples of FWA ^{(cont d)}

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Plan Sponsor (i.e., Colorado Access):

y Payments for Excluded Drugs

¾ Receiving payment for drugs not covered by the Plan Sponsor’s formulary y Marketing Schemes

¾ Offering beneficiaries a cash payment as an encouragement to enroll in a Medicare Plan

¾ Unsolicited door-to-door marketingg

¾ Use of unlicensed agents

¾ Enrollment of individual in a Medicare Plan without such individual’s knowledge or consent

individual s knowledge or consent

¾ Stating that a marketing agent/broker works for or is contracted with the Social Security Administration or CMS

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Examples of FWA ^(cont’d)

Examples of FWA ^{(cont d)}

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Pharmacy Benefit Manager (PBM):

y

Prescription Drug Switching

¾ PBM receives a payment to switch a beneficiary from one drug to another or influence prescriber to switch patient to a different drug another or influence prescriber to switch patient to a different drug

y

Prescription Drug Splitting or Shorting

¾ PBM mail order pharmacy intentionally provides less than the

¾ PBM mail order pharmacy intentionally provides less than the prescribed quantity, does not inform the patient or make

arrangements to provide the balance and bills for the fully- prescribed amount

p

¾ Splits prescription to receive additional dispensing fees

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Examples of FWA p ^(cont’d)

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Billing Department: g p

y

Inappropriate Billing Practices

¾ Billing for services not provided

i i h i h id d

¾ Misrepresenting the service that was provided

¾ Billing for a higher level than the service actually delivered

¾ Billing for non-covered services or prescriptions as covered items

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Federal FWA Laws

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y

False Claims Act:

P hibit f k i l y

False Claims Act:

Prohibits any person from knowingly

presenting or causing a fraudulent claim for payment.

y

Anti-Kickback Statute:

Makes it a crime to knowingly and willfully offer, pay, solicit, or receive, directly or indirectly, anything of value to induce or reward referrals of items or services

reimbursable by a Federal health care program.

y

Self-Referral Prohibition Statute (Stark Law):

Prohibits physicians from referring Medicare patients to an entity with which the physician or a physician’s immediate family member has a financial relationship — unless an exception applies.

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Penalties: Imposition of Intermediate Sanctions

y Civil Money Penalties (CMPs). The penalties range

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y ( ) p g

from $10,000 to $100,000 depending on the

violation;

y Suspension of enrollment of Medicare beneficiaries;

y Suspension of payment of the MA organization; and

y Suspension of marketing activities to Medicare

beneficiaries.

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Reporting Potential FWA

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Everyone has the right and responsibility to report possible

fraud waste or abuse Report issues or concerns to:

fraud, waste or abuse. Report issues or concerns to:

y Your organization's compliance officer or compliance hotline; and/or

y Colorado Access’ Medicare Compliance Officer (Cindy Allen 720

y Colorado Access Medicare Compliance Officer (Cindy Allen, 720- 744-5468 or cindy.allen@coaccess.com);

y Colorado Access’ Compliance Hotline (1-877-363-3065); and/or

y 1 800 MEDICARE

y 1-800-MEDICARE

IMPORTANT:

You may report anonymously and retaliation is

prohibited when you report a concern in good

faith.

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FWA Resources

Federal government websites are sources of information

di d i i d i f FWA

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regarding detection, correction and prevention of FWA:

y

Department of Health and Human Services Office of p

Inspector General: http://oig.hhs.gov/fraud.asp

y

Centers for Medicare & Medicaid Services (CMS):

y

Centers for Medicare & Medicaid Services (CMS):

http://www.cms.hhs.gov/MDFraudAbuseGenInfo/

y

CMS Information about the Physician Self Referral Law:

www.cms.hhs.gov/PhysicianSelfReferral

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Training Completed

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y

Congratulations! You’ve completed the Colorado Access

FWA compliance training.

y

Please report back to your organization that you have

completed this training This step is important Your

completed this training. This step is important. Your

organization is required to keep a log of who completed the

training.

y

Complete the Attestation form (provided) and mail, fax or

e-mail it to:

Colorado Access Advantage (HMO) Colorado Access Advantage (HMO) ATTN: Medicare Compliance Officer 10065 E. Harvard Avenue, Suite 600 Denver CO 80231

Denver, CO 80231

Fax: 720-744-5115; E-mail: cindy.allen@coaccess.com

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Attestation

As a first tier, downstream or related entity, ______________________ [name of entity] attests that it has conducted appropriate education and training to identify, correct and prevent potential fraud,

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it has conducted appropriate education and training to identify, correct and prevent potential fraud, waste and abuse as required by 42 CFR Parts 422 and 423.

I further attest that the following method of education and training was utilized: ____ Reviewed Colorado Access’ training materials

Reviewed training materials provided by another Medicare Advantage organization, Part D ____ Reviewed training materials provided by another Medicare Advantage organization, Part D

sponsor or another source. Name of source: ___________________________ ____ Conducted internal training and education at our company

By signing below, I also attest that my organization will furnish training logs upon Colorado Access’ and/or CMS’ request to validate that training was completed.

and/or CMS request to validate that training was completed.

__________________________ ___________________________

Printed Name Organization Name

__________________________ ___________________________

Title Tax ID No.

__________________________ ___________________________

Signature Street Address

__________________________ ___________________________

Date City, State and Zip Code

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