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RX Drug Transaction Record FAQ Sunshine Act

Prescription Drug Transaction Records and Track and Trace – What It Means for You

On November 27, 2013 the Drug Quality and Security Act (DQSA) was signed into law, creating new regulations affecting the sale of prescription drugs in the US. Here at Benco Dental, we want you to understand what the law is, how these requirements affect you, our loyal customers, and what Benco is doing in order to make sure that we are in compliance with the law. Title II of DQSA, the Drug Supply Chain and Security Act (DSCSA) creates tracing, verification, and serialization requirements which started on March 1, 2016 for all prescription drug products throughout the supply chain, from manufacturer through to the dispenser. To meet DSCSA regulations, we will be providing this information electronically through our partnership with TraceLink and their Life Sciences Cloud. In order to ensure that Benco and our customers are in compliance with DSCSA, we would request that you follow TraceLink’s instructions to create your free TraceLink account by clicking here. Once you have created your free account, you will have access to all aspects of your transaction records from Benco.

Below you will find frequently asked questions regarding DSCSA and TraceLink. Please be advised that this information does not constitute legal advice. Please seek legal counsel to determine how the law applies to your specific circumstances.

FREQUENTLY ASKED QUESTIONS (FAQs)

WHAT IS THE DRUG SUPPLY CHAIN AND SECURITY ACT (DSCSA)?
DSCSA, Title II of the Drug Quality and Security Act (DQSA) outlines critical steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States. At this time, DSCSA requires manufacturers, repackagers, and wholesale distributors like Benco to track, trace, and verify prescription drug products down to the dispenser level, including the exchange of compliance documentation.

WHAT COMPLIANCE DOCUMENTATION IS REQUIRED TO BE EXCHANGED?
The documentation that is required to be sent to the new owner of the product includes the Transaction Information, Transaction History, and Transaction Statement. This can also be referred to as a T3 document.

WHAT IS INCLUDED IN THE TRANSACTION INFORMATION (TI)?
The Transaction Information includes the following:

  • Proprietary or established name or names of the product;
  • strength and dosage form of the product;
  • NDC number of the product;
  • container size;
  • number of containers;
  • lot number of the product;
  • date of the transaction;
  • date of the shipment, if more than 24 hours after the date of the transaction;
  • business name and address of the person from whom and to whom ownership is being transferred.

WHAT IS INCLUDED IN THE TRANSACTION HISTORY (TH)?
The Transaction History includes a statement in paper or electronic form, including the transaction information for each prior transaction going back to the manufacturer of the product.

WHAT IS INCLUDED IN THE TRANSACTION STATEMENT (TS)?
The Transaction Statement includes a statement, in paper or electronic form, that the–

  • entity transferring ownership in a transaction is authorized as required under DSCSA;
  • received the product from a person that is authorized as required under DSCSA;
  • received transaction information and a transaction statement from the prior owner of the product, as required under the law;
  • did not knowingly ship a suspect or illegitimate product;
  • had systems and processes in place to comply with verification requirements under the law;
  • did not knowingly provide false transaction information; and
  • did not knowingly alter the transaction history.

You may see companies using the following abbreviated transaction statement: Seller has complied with each applicable subsection of FDCA Sec. 581(27)(A)–(G).

WHAT PRODUCTS ARE EXEMPT?
Over the counter drugs (OTC), blood or blood components intended for transfusion, radioactive drugs or biologics, certain IV products, intercompany distributions, distribution among hospitals under common control, public health emergencies, dispensed pursuant to a prescription, product sample distribution, charitable organization distribution, certain combination products, and certain medical kits.

WHICH IV SOLUTIONS ARE EXEMPT?
Under the DSCSA, the definition of product does not include:

  • Intravenous products that are intended for the replenishment of fluids and electrolytes or calories
  • Intravenous products used to maintain the equilibrium of water and minerals in the body, such as dialysis solutions
  • Products intended for irrigation, or sterile water, whether intended for such purposes or for injection

IS THERE A DEFINITION OF WHAT IS CONSIDERED “COMMON CONTROL” OR AFFILIATED FACILITIES?
Under the DSCSA, transactions do not include:

  • Intracompany distribution of any product between members of an affiliate
  • Distribution of a product among hospitals or other health care entities that are under common control The term “affiliate” means a business entity that has a relationship with a second business entity if, directly or indirectly
  • One business entity controls, or has the power to control, the other business entity; or
  • A third party controls, or has the power to control, both of the business entities

HOW SOON DOES TRANSACTION DATA GET LOADED INTO TRACELINK AND HOW OFTEN IS THE INFORMATION UPDATED?
Transaction data is posted at the end of the day that orders are shipped so that information is available on TraceLink when customers receive their shipment.

HOW LONG DO YOU RETAIN THE TRANSACTION DATA? DO WE NEED TO RETAIN PAPER DOCUMENTS?
We will automatically maintain transaction data for six years for eligible product you buy from Benco. The information is available online where you may access it at your convenience, so you do not need to print and store individual reports. However, you are responsible for maintaining transaction data for six years for any items you receive direct from the manufacturer or from a wholesale distributor other than Benco Dental.

WHAT HAPPENS IF WE TERMINATE OUR BUSINESS WITH BENCO DENTAL? WILL ACCESS TO REPORTS ON TRACELINK BE TERMINATED?
Access to the transaction data will continue to be available on TraceLink for purchases made through Benco Dental once your affiliation to Benco ceased. However, you have the ability to export your transaction data as a PDF or to an Excel or .csv file that you can upload into another database for future access.

PLEASE EXPLAIN WHY LOT NUMBERS DO NOT APPEAR ON THE TRANSACTION RECORDS FOR PARTICULAR PRODUCTS.
Under the DSCSA, when a wholesale distributor purchases “direct,” they receive a primary wholesaler allowance and are not required to include lot number, previous transaction date or previous ship date in the transaction data that they pass to customers. A wholesale distributor that purchases “direct” is buying from a manufacturer, a repackager that purchased direct or an exclusive distributor.

HOW WILL WE RESPOND TO REQUESTS FOR INFORMATION IF WE DO NOT RECEIVE LOT NUMBERS?
As dispensers, when responding to FDA requests, you do not need to provide the lot number as part of transaction history if it was not originally included in your transaction data report.

WHERE WILL OUR TRANSACTION RECORDS BE AVAILABLE?
To meet DSCSA regulations, we will be providing this information electronically through our partnership with TraceLink and their Life Sciences Cloud.

HOW WILL I BE ABLE TO ACCESS MY RECORDS?
In order to ensure that Benco and our customers are in compliance with DSCSA, we would request that you follow TraceLink’s instructions to create your free TraceLink account by clicking here. Once you have created your free account, you will have access to all aspects of your transaction records from Benco.

WHO CAN WE CONTACT IF WE HAVE ADDITIONAL QUESTIONS?
You may refer questions to Benco Dental Supply Co. Customer Service Department at 1-800-GO-BENCO where we will be happy to explain further how Benco Dental is complying with DSCSA.

Sunshine Act Overview

What is the “Sunshine Act” or “Open Payments Law”?

These are terms used to refer to provisions in the 2010 federal health care reform act that require the public reporting of gifts or other “transfers of value” made to physicians by manufacturers or distributors of medical products. The stated intent of these provisions is to give consumers information about what factors may be influencing their doctors’ treatment decisions and recommendations.

What does this means for you?

Any “transfers of value” made to you by Benco or other distributors or manufacturers of dental care products will need to be reported to the Center for Medicare & Medicaid Services (CMS). This information will then be posted by CMS on a public web site.

What is a “Transfer of Value”?

A “Transfer of Value” is anything of value that is given to you or your family members by a pharmaceutical or medical device manufacturer or distributor. For example; meals, gifts, travel, entertainment, education, and charitable donations made on your behalf.

How is Benco Reporting this information?

Before Benco provides you with anything that would need to be reported, we will inform you and give you the opportunity to decline such transfer. If you agree to accept such transfer we may need to collect certain information from you which is required for our report. For example: your NPI number, dental license number, dental specialty, etc.

As one example, the provision of many items in Benco’s BluChip Redemption Catalog will need to be reported. However you will be made aware of this requirement before redeeming such items and will be offered other options (such as merchandise credits) which need not be reported.

Important Dates

The data for the prior year will need to be reported by March 31 of the next year. The final data will be made publicly available on September 30 that same year.

How can I find out what will be reported?

CMS will allow you to access the data that is being reported about you at least 60 days prior to it being posted to the public. Benco will establish a mechanism via which you can correct any errors associated with the information which we reported.

What do I need to do?

Nothing at this time. However, we do recommend that, if you have not already done so, you obtain a National Provider Identifier (NPI) at the NPPES web site. This will help ensure that any transfers made to you by Benco and other manufacturers and distributors are properly reported.

Sunshine Act FAQ

1. Does this affect me?

If you have “Dr.” before your name or are married to someone with a “Dr.” before his or her name, then yes. This includes all medical doctors, dentists, periodontists, oral surgeons, orthodontists, etc. However, this law does not apply to dental hygienists, receptionists, office managers, nurses, lab technicians, etc.

2. Does that mean that these “transfers of value” are illegal?

No, not at all. The government is not prohibiting these “transfers of value,” they are just requiring that they be reported.

3. What does the government do with these reports about me and my business?

The government is going to compile all of the reports from all of the companies about all of the doctors and post it on the Centers for Medicaid and Medicare Services (CMS) website every year on September 30.

4. Wait, so things about me are being posted on the internet without my consent?

No. It is Benco policy to explain to our customers beforehand that something they are about to receive will be reported, giving them the opportunity to decline the item. If the customer accepts the item, before Benco sends the report to the government, there will be opportunity to review the transaction to ensure it is correct.

5. Are these reports being provided to the IRS?

No, the reports are being provided to the Centers for Medicaid and Medicare Services (CMS) not the IRS. However, the reports will be made available on a public website. Benco recommends that you contact your own financial advisor if you have tax related questions.

6. Will items that I redeem with my BluChips be reported?

Certain BluChip redemptions will be subject to reporting under the Sunshine Act. For example, personal items fall under the definition of “transfer of value” and will be recorded. Conversely, discounts associated with purchases from Benco such as account credits and free shipping will not be reported.

When you seek to redeem BluChips, non-reportable items will be so indicated. If you wish to redeem for a reportable item, you will need to supply certain information including the dentist who will be receiving the item, his or her address and his or her National Provider Identifier (NPI) number.

7. What is an NPI number?

NPI stands for National Provider Identifier. This number is given by the federal government to any physician requesting federal reimbursement for services or filing electronic claims. Benco is required by law to submit this number when reporting a transfer of value. For more information on NPI numbers please visit https://NPPES.cms.hhs.gov .

8. Can I redeem BluChips in the name of my office staff or family member in order to avoid reporting?

No. All BluChips must be redeemed in the name of a dentist practicing on behalf of the account earning the BluChips.

9. Why can’t I redeem for (gifts cards, bikes, clothes, gifts, etc.)? 

There are three reasons why you might not be able to redeem BluChips for personal items:


1. If you are located in California, Minnesota, Nevada or Vermont, state law prohibits Benco from providing such items. 

2. If you accept Tri-Care, Medicaid, CHIPS or Medicare, federal law prohibits us from providing such items.

3. We received a notice from you that you are opting-out and don’t want anything reported under the Sunshine Act.
10. I accept Tri-Care, Medicaid, Medicare or CHIPs why are my BluChip redemptions being limited?

Benco has recently revised its policy to allow customers that accept federal reimbursement (through programs like Tri-Care, Medicaid, Medicare, or CHIPs) to receive BluChips. However in order to ensure that Benco is not in violation of federal regulations such as the federal anti-kickback statute, Benco is restricting these customers from using BluChip redemptions for personal items and gift cards. Instead, BluChip redemptions for customers accepting federal reimbursement will be limited to rebates and discounts associated with the purchase of dental supplies and services. In order to monitor compliance with this policy, Benco is requesting that customers indicate whether they accept Tri-Care, Medicaid, Medicare, or CHIPs as part of the BluChip redemption process.

11. If I redeem BluChips for a service call, does that need to be reported?

No. The Sunshine Act provides an exemption for Discounts and Rebates and BluChips redeemed by an office for service calls and discounts on equipment or merchandise purchases would fall within such exemption. On the other hand, it is Benco’s policy to report Blu-Chip redemptions for personal items which are not related to the practice of dentistry.

12. In a Buy 4, Get 1 Free situation, is the free item reported?

No. The Sunshine Act provides an exemption for Discounts and getting five items for the price of four would simply be considered a discount and thus not reportable under the Sunshine Act.

13. How will I know what is being reported to the CMS?

As part of Benco’s Sunshine Act Policy we will tell you prior to giving you anything that it may have to be reported to the CMS in accordance with the Sunshine Act.

You can also obtain a report of all past payments and transfer of values that may had been/have to be reported to the CMS. You can access the reports from Painless Web at shop.benco.com/Reports/SunshineAct you will be required to enter your Painless username & password to access the report. If you don’t have a Painless user id & password, please contact your Benco sales representative.

Once a year, for a period of 45 days, the CMS will also allow Doctors to review all reports submitted under their name from the previous year. We recommended that you review the reports on the CMS website as they will contain reports from all manufacturers and distributes.

We realize that mistakes can happen. If a report was filed incorrectly under your name, please contact your Benco Sales Representative ASAP. After CMS’s review & dispute period is over, there will be no way to change the report and it will become public record.

14. I still have a question. Who should I contact?

• Call us at Benco’s Sunshine Act Hotline: (570) 602-7027
• Or email us at SunshineAct@benco.com 

Related Links:

Center for Medicare & Medicaid Services (CMS)

California Compliance Policy