New Jersey Vaccine Preventable Disease Program Vaccine for Children Program Christopher Ryan, MICP, CPM

Learning Objectives At the end of this session, attendees will:  Understand what issues constitute fraud and abuse  Understand best practices to prevent fraud and abuse  Know how to track and prevent waste  Know how to report fraud and abuse  Comprehend the fraud & abuse investigation process

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Fraud and Abuse

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The Vaccine for Children Program (VFC) is entitlement program that is funded by the federal government and operated by the NJ Department of Health for all providers geographically located in New Jersey.

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New Jersey’s VFC and 317 spends over $70 million a year in vaccines

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One of the jobs of the New Jersey Vaccine Preventable Disease Program (VPDP) is to act as stewards for federally-funded vaccines. Part of that job is to monitor providers to ensure no one is mishandling or misappropriating vaccine.

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What is Fraud and Abuse?

Fraud is defined as: “an intentional deception or misrepresentation made by a person with the knowledge that the deception could result in some unauthorized benefit to himself or some other person.”

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Abuse is defined as: “provider practices that are inconsistent with sound fiscal, business, or medical practices, and result in an unnecessary cost to the Medicaid program, or in reimbursement for services that are not medically necessary or that fail to meet professionally recognized standards for health care…”

Examples • Providing

federally-funded vaccine to non-eligible patient • Selling or otherwise misdirecting federally-funded vaccine • Billing a patient or third party for federally-funded vaccine • Charging more than the established maximum regional charge as an administration fee • Denying eligible patients federally-funded vaccine because of inability to pay for the administration fee • Failing to screen for and document eligibility status at every visit • Failing to maintain records and comply with other requirements of the VFC Program • Failing to fully account for federally-funded vaccine • Failing to properly store and handle federally-funded vaccine • Ordering federally-funded vaccine in quantities or patterns that do not match the provider’s profile • Negligent waste of federally-funded vaccine

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DID YOU KNOW WASTE IS A FORM OF FRAUD AND ABUSE?

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Waste 

Not all waste is considered negligent.

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Waste up to 5% of your inventory is allowable.

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Waste as a result of expired vaccines MAY or MAY NOT be acceptable  If you don’t think your going to use a vaccines by time it expires, give

the New Jersey VFC Program a call about three to six months in advance and we can help find a provider to take your vaccines.  We are not always able to find another provider that can take vaccines, therefore it is very important that you try to order only what you need.

Waste costs the $2 billion-a-year federal Vaccines for Children Program about $20 million a year, and the biggest single problem is improper refrigeration http://www.msnbc.msn.com/id/22100133/

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Waste Prevention with Vaccine Rotations 

All providers are REQUIRED to rotate vaccine stock weekly  Always place vaccines with shorter expiration dates

in front of those with longer expiration dates  Notify New Jersey VFC at least three months in advance if you have vaccines that you will not use before it expires

When you have vaccine that has expired or spoiled, you are required to complete a wasted/expired report (IMM-39)to ensure complete accountability

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What can be returned? o

Only unopened vials or pre-filled syringes can be returned.

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Opened vials or non-prefilled syringes must be disposed of using your normal office medical waste practice

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Regardless of whether or not the vaccine is physically shipped back to the manufacturer, all vaccine waste must be reported to the NJ VFC Program for both VFC and 317 funded vaccines

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Accountability Using Transactions 

There are three categories for transactions:  EXPIRED ○ When vaccine expire, use this to transact from your

inventory. This will not give you return labels. You will still need to complete IMM-39 on-line (Waste Return Label)  WASTED ○ Vaccine drew up but patient refused, Vial broke, Vial

contaminated or out of temperature range ○ Report on IMM-39 form  DOSES GIVEN TO PATIENTS NOT IN NJIIS ○ Should only be used for those patients who have opted

out of NJIIS.

Log on to your Inventory

Click the name hyperlink for the lot you want For example C4454AA is the lot you need to transact a dose from, so you would click the hyperlink DTaP.

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CLICK HYPERLINK “ TRANSACTIONS >> ”

CLICK ADD A TRANSACTION

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Transact one (1) dose at a time, except for expired. • Expired: • Date medication expired • Wasted: • Reason for Waste – the explanation should be consistent with the IMM-39 • Dose given to Patient NOT in NJIIS: • Should be used very rarely • Indicate patient’s last name and first initial or medical record number. This is to allows staff the ability to cross reference the data entered.

We looked at waste, now lets look at others….

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High Inventory Discrepancy 

Failure to account for federally-funded vaccines shipped to your office is considered abuse.

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Dose-for-dose accountability is required for all VFC and 317 providers

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Using transactions inappropriately to deal with high inventory is fraud and will get you removed from the program.

Altering Lot Numbers and Expiration Dates 

It is against federal law to tamper with or alter any vaccines lot numbers or expiration dates

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Altering lot numbers will result in removal from the New Jersey VFC Program.

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Administering Federal Vaccines to Private patients 

Federal vaccines should only be used to support those patients who would normally not have access to vaccinations.

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Failure to screen for eligibility and giving non-eligible patients VFC/317 vaccines is a form of abuse as federal funds are being misallocated.

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Borrowing 

Borrowing is prohibited.

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Borrowing falls under the same category of giving non-eligible patients federally-funded vaccines.

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OIG found that in the majority of cases where borrowing was found, it was done to keep the provider solvent and not necessarily in the best interest of patients.

Patient Administered Wrong Dose We are all medical professionals, and it is our duty to know the vaccine schedule and appropriate dosages. Under dosing will cause the patient not to be fully immunized.

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Patient Administered Compromised Vaccines

If cold chain storage is not maintained, vaccines will become compromised and will not provided the necessary immunization protection

“By CDC estimates, hundreds of thousands of doses of vaccines…are thrown out each year because of poor refrigeration at clinics, hospitals and doctors' offices.”

http://www.msnbc.msn.com/id/22100133/

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Cases of Compromised Vaccine in New Jersey

Let’s Stay Out of the NEWS!!!!

Stay out of news, with proper techniques

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6 Rights of Vaccine Administration* 

Right patient  VFC eligibility screening

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Right medication  Check your vials

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Right time  Check the schedules

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Right dose  Pediatric vs. adult vaccine

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Right route  IM, subcutaneous, intranasal, oral

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Right site  Based on age, muscle development *adapted from Indiana Department of Health

Education Your best resources to preventing fraud and abuse is to be educated.  Understand your roles and responsibilities by: 

 Reviewing the CDC Storage and Handling

Toolkit  Attend Annual Provider Education  Use the VFC Program as a resource - Have a question? ASK!

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Report Suspected Fraud/Abuse A provider has four ways to report: 1. Call 609-826-4862 2. Fax 609-826-4868 3. Email [email protected] 4. Mail: NJDOH, VFC Program PO Box 369 Trenton, NJ 08625 REPORTS CAN BE ANONYMOUS

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Fraud and Abuse Investigation Process Intake  Vaccine Controls  Investigation  Corrective Action/Termination 

Intake 

The Fraud and Abuse Unit will open an investigation based on your information or findings of VFC staff during their normal course of work.

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The Fraud and Abuse Unit will look at every piece of information and determine if a possible violation occurred

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Vaccine Controls 

If preliminary information shows possible mishandling or misuse of vaccines, you will be placed on vaccine hold.

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If the information shows that vaccines are being mishandled or have become compromised, staff will remove the vaccine immediately.

Investigation  The

Fraud and Abuse Unit will review all available documents and obtain statements from all involved.

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Fraud and Abuse Unit will work quickly to validate the findings and remove hold if no fraud or abuse is found.

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Corrective Action Reimbursement to the VFC Program 

Provider may be required to reimburse for mismanaged vaccine on a dose-for-dose basis.

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Providers will have 30-90 days to reimburse the VFC/317 Program by privately purchasing vaccines for use on VFC/317 eligible patients. ○ If vaccines were compromised for both your VFC and

317 vaccines, two separate restitutions will be issued and these stocks must be kept separate.

Other Types of Corrective Action 

Re-training of staff by way of re-taking: ○ NJIIS Fundamentals ○ NJIMODS

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If your office is found to have violated VFC/317 Policy all staff involved in handling vaccines from point of screening eligibility to administration and quality assurance will be mandated to take Understanding VFC/317 Webinar prior to any new vaccines being shipped.

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Termination REFERRALS

Referral to Outside Agencies Failure to comply with program requirements may result in referral to appropriate agency for further action and suspension from the VFC Program.  Office of the Inspector General (OIG)  Centers for Medicaid and Medicare Services

(CMS)  Board of Medical Examiners (BME)  Board of Nursing (BN)  New Jersey Department of Health- Criminal Investigation Unit or Acute Care Licensing

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Thank You!

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