July 1, 2011

2011 Medicare Part D Compliance & FWA Training

For Blue Shield of California Contracted Network Pharmacies

welcomeWelcome to the Medicare Part D Compliance & FWA Training course! This is Blue Shield of California’s Medicare Part D Compliance & FWA Training for contracted pharmacies.At the end of this training, pharmacies will be asked to complete and submit an attestation for completing the training.

Medicare Part D Compliance Training for contracted pharmacies

Fraud, Waste & Abuse for contracted pharmacies

Attestation

course instructions

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outline

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Click the play button at the bottom of the screen to continue.

To make sure you are comfortable navigating through the course, let’s explore the navigational features:

introduction to the medicare part d program

part d overview

Part D (prescription drugs) is the biggest change in Medicare in 40 years.

The Medicare Modernization Act (MMA) of 2003 provided prescription drug coverage for Medicare beneficiaries.

part d overview, continued

Part D is embodied in statute through the Code of Federal Regulations under Title 42, CFR 423 VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT

Part D is a voluntary benefit offered through health plans, qualified contractors, and some employers

part d playersCMS

PBMs

Plan Sponsors

MEDICs

IREs

Centers for Medicare & Medicaid ServicesGovernment agencies that supervise the administration of Medicare benefits, including Part D

Pharmacy Benefit ManagersCompanies that manage pharmacy benefits, create formularies, process pharmacy claims, and negotiate discounts with drug manufacturers. (Some plan sponsors, like Blue Shield of California may perform some or all of these functions rather than outsourcing to a PBM.)

Plan SponsorsPharmaceutical chains, health insurance companies, and others that contract with CMS to deliver PDP plans (Prescription Drug Plan - Part D benefits only) and MAPD plans (Medicare Advantage Prescription Drug Plan - Part C & Part D benefits) plans

Medicare Drug Integrity ContractorsAgencies contracted by CMS to investigate fraud, waste, and abuse in the Parts C & D programs including compliance and enforcement work.

Independent Review EntitiesAgencies contracted by CMS to review Plan denials of coverage decisions

what’s covered under part dOutpatient prescription drugs

– Approved by the FDA

– Used & sold in the United States

– Used for a medically accepted indication

Vaccines & biologicals not covered by Part B Insulin & medical supplies associated with the injection of insulin

what’s NOT covered under part dDrugs listed under Title XIX of the Social Security ActDrugs currently covered under Part BDrugs for erectile & sexual dysfunctionBeginning January 1, 2011, drugs from pharmaceutical manufacturers that did not sign a manufacturer discount agreement with CMS

– Benzodiazepines

– Barbiturates

– Drugs used for anorexia, weight loss, or weight gain

– Drugs used to promote fertility

– Drugs used for cosmetic purposes or hair growth

– Drugs used for symptomatic relief of cough & colds

– Prescription vitamins & minerals, except prenatal vitamins & fluoride preparation products

– Over-the-counter drugs

– Drugs for which the manufacturer requires that associated tests and monitoring services be purchased exclusively from the manufacturer or its designee

Note: Although benzodiazepines and barbiturates are not covered under Part D, BSC is covering these drugs as a supplemental benefit under Blue Shield of California’s enhanced plans.

2011 Standard Benefit Coverage Design

Coverage Part D Pays Beneficiary Pays

Annual Deductible $0 $0

Initial Coverage Period $2,840 75% of $2,840 25% of $2,840

Coverage Gap (“Donut hole”) Once your total drug cost (what you and your plan pay) exceeds $2,840 you are in the ”donut hole.”

$0 (The 50% discount for brand name drugs comes from drug manufacturers, and the 7% subsidy for generic drugs comes from Medicare.)

50% of covered brand name drugs plus dispensing fee; 93% of covered generic drugs

Catastrophic CoverageThis begins once you have reached your ”out-of-pocket” threshold of $4,550 in 2011.

95% or the drug cost minus the copay

Greater of 5% of the drug costs or $2.50 for a generic drug or $6.30 for a brand name drug

TrOOP = True Out of Pocket

The total amount of money spent by the beneficiaryBecause the catastrophic level of coverage is dependent upon the TrOOP calculation, it is very important for plans to record TrOOP accurately. Plans may offer an “enhanced”benefit to reduce or eliminate the deductible and/or beneficiary costs during the coverage gap.

deductible + initial coverage + money spent in the coverage gap = TrOOP

the Medicare Coverage Gap Discount Program

Starting in January 2011, Medicare Part D members (excluding low income subsidy members) will get a 50% discount under the Medicare Coverage Gap Discount Program on “applicable” brand drugs at point-of-sale and a 7% increase in coverage for all other covered Medicare Part D drugs (i.e. generic drugs, and supplies associated with the delivery of insulin) while in the coverage gap.

Over the next 10 years the goal of this program is to increase coverage of all covered drugs in the coverage gap to decrease what Medicare Part D members (excluding low income subsidy members) pay until it reaches 25% in 2020.

how should pharmacies prepare for the Medicare Coverage Gap Discount Program?

1. Manage the Supply Chain: Pharmacies should work with Medicare Part D contractors to review the list of labeler codes on the CMS Web site to determine if their inventories have applicable drugs. This can be done by comparing inventory against CMS’s list of labeler codes that are covered by a signed agreement in 2011. The Medicare Coverage Gap Discount Program labeler code list can be used to identify which manufacturers’applicable drugs will continue to be covered under Medicare Part D in 2011.

2. Educate Staff: Pharmacy staff should be made aware of the Medicare Coverage Gap Discount Program and be prepared to answer patient inquiries about it.

To obtain more information regarding this program and specific claims go to www.Medicare.gov or call the applicable plan sponsor.

member rights to coverageMembers under Part D are entitled to the benefit coverage offered by Blue Shield. As part of the entitlement process, members have specific rights to appeal coverage determinations.

Who can request a coverage determination?

A beneficiary or their authorized representativeA beneficiary’s prescribing physician or other authorized prescriber

If a member disagrees with a plan’s coverage,

the member should contact the health plan.

doing business with the government

exclusion listsCMS prohibits any employee, provider, contractor, or subcontractor that is listed in the General Services Administration (GSA) database of excluded individuals/entities or the Office of Inspector General’s (OIG) database of excluded individuals or entities from performing any activity related to Medicare Part D or other federal programs. Human Resources, Procurement, Pharmacy, Credentialing, Corporate Compliance, Producer Services, and other contractors, and subcontractors must review the exclusion lists for all staff working with Medicare Part D ―upon employment and annually thereafter.

data accuracyNever falsify certifications or attestations or any transmissions to CMS on Medicare enrollment data, disenrollment data, coordination of benefits status, or applicable true out-of-pocket costs. Any outliers in your oversight process should be included as footnotes in your pharmacy’s certifications or attestations. All data used in calculation of your submissions is subject to audit and must be accurate. It must also be retained for ten years. If you become aware of a systems issue that affects the accuracy of any data used in your pricing or submissions to the plan, report it to your pharmacy manager or one of your compliance resources.

lawsHere are important laws you need to be aware of when working with Medicare Part D:

The False Claims Act - Prohibits knowingly presenting (or causing to be presented) to the federal government a false or fraudulent claim for payment or approval.The Anti-Kickback Statute - Section 1128B(b) of the Social Security Act (42 U.S.C. 1320a-7b(b)) provides criminal penalties for individuals or entities that knowingly and willfully offer, pay, solicit, or receive remuneration in order to induce or reward business payable (or reimbursable) under the Medicare or other federal health care programs. The Health Insurance Portability and Accountability Act 75 -All member information under Part D must be done in compliance with HIPAA regulations and internal policies to manage and maintain adequate controls in use and handling of member data.

additional vulnerabilitiesCoordination with State Pharmacy Assistance Programs (SPAPS)National Council for Prescription Drug Programs (NCPDP) and National Association of Drug Diversion Investigators (NADDI)’s lists of susceptible pharmaceuticalsDrugs excluded From Part D coveragePart B and Part D coverage issues Inappropriate duplicate coverage between A, B, and D drugs (Home Infusion, Crossover Drugs, Differential Copays)

– Prevent double billing

– Ensure that the Part D Plans remain the primary payer

– Ensure that benefits are coordinated so that TrOOP tracking of SPAPs is taken into account

– Ensure that expenditures by other plans are excluded for the purposes of reaching the beneficiaries true out-of–pocket (TrOOP) expenditures

Medicare Part D Fraud, Waste, and Abuse Training

Prescription drug fraud, waste, and abuse cost the United States billions of dollars annually.

By learning how to detect, correct and prevent Medicare Part D prescription drug fraud, waste, and abuse, you can save money for your pharmacy, Medicare, and your customers.

The Centers for Medicare and Medicaid Services (CMS) requires that all individuals who work with Medicare Part D in any way receive training on identifying andcontrolling fraud, waste, and abuse.

This training lesson is designed to help you become an active participant in the fight against Medicare Part D prescription drug fraud, waste, and abuse.

what is blue shield doing about it?Special Investigations DepartmentIn 1989, BSC established the Special Investigations Department to centralize the company’s efforts to combat fraud. The department’s investigators work to detect and prevent medical fraud, and now partner with Pharmacy Services to include prescription drug fraud.

Medicare Compliance ProgramWith the introduction of the Medicare Prescription Drug Benefit (Part D) in 2006, Blue Shield updated it’s existing Medicare Compliance Program to include Fraud, Waste, and Abuse (FWA) for Part D.

Elements of the updated Medicare Compliance Program include:

FWA Training

Procedures for reporting non-compliance with Medicare Program requirements & FWA

Reviewing OIG and GSA exclusions lists

Internal Monitoring/ Auditing

Pharmacy Network Monitoring/Auditing

what can you do?You can help to detect prescription drug fraud, waste, and abuse related to Medicare Part D plans by reporting suspicious incidents to Blue Shield. To do so, you need to be able to recognize activities that may constitute Medicare Part D fraud, waste, or abuse committed by a pharmacy, provider, customer, subcontractor, or plan employees, and then report incidents as quickly as possible. It’s the right thing to do!

what is prescription drug fraud?DefinitionFraud means that someone is trying to obtain something of value by intentionally deceiving, misrepresenting, or concealing. Proof of fraud involves the following components:

Examples

Fraud

A person uses someone else’s insurance card to receive Medicare Part D benefits. This person intentionally posed as someone else and received Medicare Part D benefits they were not entitled to.

A provider intentionally prescribes drugs that are not medically necessary.

Not Fraud

A pharmacy bills for a full 30-day supply, fills only 15 days, but later revises the claim to 15 days. The intent to misrepresent is not present.

An intentional misrepresentation, a lie, a false statement, an omission, or a concealment of the truth, related to a pharmacy prescription or claim, orAn individual or company receiving money or pharmacy prescription drug benefits.

who commits fraud?

ProvidersMembersPharmaciesWholesalersPharmaceutical manufacturersMedicare Part D sponsor plan employees

On the next few slides you’ll see examples of fraud committed by each of the groups above.

Just about anybody could potentially commit prescription drug fraud:

provider fraud examplesProviders could participate in Medicare Part D fraud that involve:

Prescribing drugs without reviewing a patient’s condition.Prescribing drugs in exchange for payment, usually involving narcotics and physicians with “marks” on their licenses.Writing a prescription for a higher quantity than appropriate to assist member with minimizing their copay.

member fraud examplesMedicare Part D members may participate in fraud that involves:

Stealing a prescription pad and writing their own prescriptions.

Using someone else’s ID card to get Medicare Part D benefits.

Modifying a prescription to add more refills, increase quantities, etc.

pharmacy fraud examplesPharmacies could participate in fraud that involves:

Billing for the full amount prescribed but filling only a portion, and not crediting the difference back to the plan sponsor.

Billing for brand but dispensing generic, or for the wrong NDC code.

Manipulating calculations to keep beneficiaries in the coverage gap or to push beneficiaries into catastrophic coverage.

wholesaler fraud examplesWholesalers may participate in fraud that involves:

Selling counterfeit and adulterated drugs through black and gray market purchases, including fake, diluted, expired, and illegally imported drugs.

Illegally gaining control of discounted medicines intended for nursing homes, hospices, and AIDS clinics, marking up the prices, and selling to small wholesalers who sell to consumers (people who do this are referred to as “diverters”).

pharmaceutical manufacturer fraud examplesPharmaceutical manufacturers may participate in fraud that involves:

Offering inducements if the purchased products are reimbursable by any of the federal healthcare programs.

Promoting off-label drug usage illegally through marketing, financial incentives, or other promotion campaigns.

Using free samples illegally by knowingly providing them to physicians who will bill the federal health care programs for the samples.

part D sponsor fraud examplesMedicare Part D Sponsor employees could participate in fraud that involves:

Violating the Medicare marketing guidelines, such as offering beneficiaries a cash payment as an inducement to enroll in Part D.

Bait and switch pricing.

Payment for prescriptions written by dead or sanctioned physicians.

Misrepresenting or falsifying information furnished to CMS or to an individual under the Part D drug benefit program.

Altering or manipulating Part D claims data to avoid paying interest.

red flags of Part D fraudNow you know the two main components of prescription drug fraud and some examples, but how would you actually identify prescription drug fraud in your daily work in the pharmacy? Let’s take a look at some “red flags” that would lead you to suspect prescription drug fraud may have occurred:

Multiple Pharmacies

Repetition and Excessive Billing

Large Pharmacy Claims/Excessive Billing

High-Prescribing Physicians

Medical Conditions Don’t Match or Don’t Exist

We’ll explain each of these on the next few slides.

Red flag: multiple pharmacies

You see that a Medicare Part D recipient has used three or four pharmacies long distances from each other within a six-month period for the same prescription.

This can be indicative of substance abuse or narcotics trafficking.

red flag: repetition and excessive billing

Pharmacy bills a high volume of only one type or limited type of medication.

This may be a case where pharmacy is billing for medication not being dispensed.

You start to notice a pattern of the same claims for prescriptions being submitted on a weekly, monthly, or yearly basis, and you know that is inconsistent with how the drug is typically administered.

red flag: large pharmacy claimsHigh-dollar claims are worth inspecting further.

The bill is three or more times the usual and customary price contracted rate for a drug.

Excessive numbers of refills for one patient or same family members, which may indicate pharmacy employee collusion.

red flag: high-prescribing physicians

You notice that a physician is one of the highest prescribers, but he has relatively few patients. This may be a case where medications are used for illegal sale, especially with medications that have a high likelihood of being abused.

red flag: medical conditions don’t match or exist

The prescribed medications are out of line with the medical history/claim history of the patient.

For example, a pharmacy bills for a large number of antipsychotic medications, with no patient history of psychiatric illness.

difference between fraud and abuseThere is a fine line between fraud and abuse, based on whether there was intent to deceive.

Fraud involves intentional deception or misrepresentation intended to result in an unauthorized pharmacy benefit.

Abuse may be similar to fraud except that it may not be possible to establish that the abusive acts were done with an intent to deceive the insurer.

abuse examples

Charging for Medicare Part D benefits when it should be Part B

Using multiple NDCs for a compounded drug and billing separately when only the highest NDC should be charged

Incorrectly billing for secondary payers that resulted in an increased reimbursement

Can you prove that the person knewthey were committing a crime? If so, it’s fraud. If not, it’s probably abuse. In either case, you should report it.

what is waste?A portion of Medicare Part D dollars are spent on waste. Waste and inefficiencies continue to increase, costing taxpayers more while providing beneficiaries with less.Waste is described as:“The extravagant, careless, or needless expenditure of funds, or the consumption of property that results from deficient practices, systems, controls, or decisions.”Think about how you can help reduce waste in the administration of Part D benefits.

waste examples

Submitting a claim with an inflated ingredient cost for extra payment rather than the actual price of the drug

Consistently filling prescriptions for a 30-day supply (when a 15-day supply will suffice)

Drugs prescribed that are not medically necessary

Making payment and other errors in the administration of Part D benefits

why should I report?

The Centers for Medicare and Medicaid Services (CMS) requires you to report fraud.

By detecting and reporting fraud, waste, and abuse, you are doing the right thing.

what if I’m not sure?In some cases you may want to do a little research to find an explanation for the unusual claim. But if you suspect that something is not right, report it.

If you are concerned that you could be wrong about suspecting Part D fraud, waste, or abuse, don’t be. Rest assured that Blue Shield of California’s Medicare Compliance, Pharmacy Services, and Special Investigations Department appreciate all tips and will work to screen the case and collect the evidence to determine if there is a reason to suspect fraud.

If you suspect, report

All tips are welcome

how to reportThere are several ways to report Blue Shield of California Medicare Part D fraud, waste & abuse:

Form Form Access the Fraud Report Form Pharmacists and other people outside of Blue Shield of California:https://www.blueshieldca.com/bsc/aboutbsc/fraud-prevention/fraud_report.jhtml

PhonePhoneCall Blue Shield of California Anti-Fraud Hotline

at 800-221-2367.

EmailEmailSend an email to stopfraud@blueshieldca.com

Contact the Blue Shield of California Medicare Compliance OfficeContact the Blue Shield of California Medicare Compliance Officer, r, Mark Andes.Mark Andes. Telephone: 818-228-2655 or via email at mark.andes@blueshieldca.com

When you report a suspicious incident, you can identify yourself or you may remain anonymous.

Part D-related calls and emails related to all

suspected fraud, waste & abuse will be routed to

the appropriate area for screening, then submitted to our Pharmacy Services

and/or Special Investigations

departments for further assessment.

what happens after I report?1. Routing of Forms, Calls, and Emails

Prescription drug fraud forms and Medicare Part D fraud, waste, and abuse calls/emails are routed to Pharmacy Services and/or Special Investigations.

Compliance issues are routed to Medicare Compliance.

2. Assessment, Investigation, and Coordination with CMSWhen Pharmacy Services and Special Investigations determine that an issue is a potential prescription drug fraud, Special Investigations follows their investigation process to follow up on fraud issues reported.

This process involves Special Investigations coordinating with Blue Shield of California’s Medicare Compliance, CMS, MEDIC, and other law enforcement (as needed) for resolution.

MEDIC (Medicare Drug Integrity Contractor) is an organization that CMS has contracted with to manage CMS’ audit, oversight, and anti-fraud and abuse efforts related to the Part D benefit.

module summaryWe’ve covered a lot of information about Medicare Part D in this training module.So what are the key points to remember?

It’s important for you to understand the basics of Medicare Part D, the standard benefit, and Blue Shield of California's requirements for offering Medicare Part D plans.

To do business with CMS we all have to follow the rules they’ve set regarding exclusion lists and data accuracy, as well as all applicable laws. As an entity processing and accepting payment for Medicare part D claims, your pharmacy and all staff are responsible to abide by all Federal and State requirements of this program.

Identifying and reporting prescription drug fraud, waste, and abuse is the right thing to do because it may reduce the money spent by the government, plans, and ultimately taxpayers due to fraudulent, wasteful, and abusive practices.

If you suspect any possible fraudulent, wasteful or abusive activity, please let us know right away!Call Blue Shield of California AntiCall Blue Shield of California Anti--Fraud Hotline:Fraud Hotline:800-221-2367Submit form:Submit form:https://www.blueshieldca.com/bsc/aboutbsc/fraud-protection/fraud_report.jhtml

Email:Email:

StopFraud@blueshieldca.com

Contact the Medicare Contact the Medicare Compliance Officer:Compliance Officer:

Mark Andes

818-228-2645

Mark.Andes@blueshieldca.com

modules complete!Congratulations! You’ve completed the Medicare Part D Compliance & FWA Training for Pharmacies! What should you do next?Complete the attestation on the next page and submit it to Blue Shield of California.

MEDICARE PART D PRESCRIPTION DRUG PLAN PROVIDER COMPLIANCE ATTESTATION Rev.2/15/2011

MEDICARE PART D PRESCRIPTION DRUG PLAN PROVIDER COMPLIANCE ATTESTATION

California Physicians’ Service dba Blue Shield of California requires its contracted pharmacies to formally attest that they are in full compliance with the following CMS-mandated requirements: (1) The contracted pharmacy must ensure that all pharmacy personnel, employees and contracted staff involved in the administration or delivery of Medicare Part D benefits (pharmacists, pharmacy technicians, etc.) complete Blue Shield’s required training entitled, “2011 Annual Medicare Part D Compliance and Fraud, Waste & Abuse training”, an alternative Blue Shield approved Medicare Part D training or through enrollment into the Medicare program accreditation as a durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) supplier. This requirement applies to all personnel, employees and contracted staff upon initial hire and annually thereafter. Any alternative Medicare Part D training must be approved by Blue Shield in writing by Blue Shield’s Pharmacy Medicare Compliance Coordinator. (2) The contracted pharmacy must either distribute to Medicare Part D enrollees, or have posted in the pharmacy, the CMS-mandated notice entitled, “Medicare Prescription Drug Coverage & Your Rights pharmacy notice OMB #0938-0975”. The purpose of this notice is to provide Medicare Part D enrollees with information on how to contact their Part D plan to obtain a written coverage determination or to request an exception to the Part D plan’s formulary. This notice reminds Medicare Part D enrollees about certain rights and protections related to their Medicare prescription drug benefits. The undersigned attests that all pharmacy personnel, employees and contracted staff involved in the administration or delivery of Medicare Part D benefits have completed Blue Shield’s training entitled, “2011 Annual Medicare Part D Compliance and Fraud, Waste & Abuse Training program”, an alternative Blue Shield approved Medicare Part D training or through enrollment into the Medicare program accreditation as a durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) supplier and that the contracted pharmacy is distributing the CMS-mandated notice entitled ,“Medicare Prescription Drug Coverage & Your Rights pharmacy notice OMB #0938-0975”, to Medicare Part D enrollees, or posting this notice in a conspicuous location at the pharmacy.

Indicate the name of training taken\ or if a DMEPOs supplier: _______________________________________________________________ Date completed/ effective date: __________________________________________________________________________________________

(Print Name) on behalf of (Pharmacy Name/ Pharmacy Chain NCPDP# or NPI#)

(Signature) Date Signed Contact Person for questions:

Name:

Phone:

E-mail:

Please Sign and Return by FAX (888) 221-1585, Or Mail To: Blue Shield of California Pharmacy Services Attn: Pharmacy Network Coordinator P.O. Box 7168 San Francisco, CA 94120-7168

For questions or concerns, please contact Pharmacy Services at (800)535-9481, Option 1