By Sumeet Singh, Five Rivers RX

The DEA was established in 1973 to prevent drug trafficking and diversion; but within the DEA, it is the Diversion Control Division that is tasked with preventing diversion of controlled pharmaceuticals from legitimate sources to illegitimate markets. As the abuse of opioids by US citizens continued to expand in the 2000s, the DEA established the Distributor Initiative Program in 2005 to educate registrants on maintaining effective controls against diversion, and monitoring for and reporting suspicious orders. Specifically, the Program expanded controlled-substance gatekeeper responsibilities from practitioners to chokeholds higher up the distribution chain--at pharmacy, distributor and manufacturer levels. Although pharmacists have a corresponding responsibility to ensure controlled substance prescriptions they filled were for legitimate medical purposes, DEA has been holding distributors and manufacturers accountable for pharmacies dispensing their drugs downstream.

DEA began enforcing a vague regulation for suspicious order monitoring that had been in place since 1971. Regulation requires manufacturers and distributors to design and operate a system to identify suspicious orders of controlled substances and to report suspicious orders to the local DEA Field Division upon discovery. 21 C.F.R. § 1301.74(b).

The regulation defines suspicious orders as:

Orders deviating substantially from a normal pattern; and

What Does Robust Customer Due Diligence Look Like?

Suspicious Order Monitoring Programs should include:

Verification of DEA registration and state licensure.

Review of all information by trained team member.

Reporting/stop shipment/termination of customer mechanisms.

The CSA authorizes DEA to seek civil penalties for recordkeeping and reporting violations.

Failure to make, keep or furnish a complete and accurate record or report can result in civil penalties now up to $14,700 and in some cases, up to $63,500 per violation. Per fine violation varies on a case-by-case basis and is based on how DEA calculates alleged violations; each record can be counted as a separate violation.

DEA, with US Attorneys offices, has collected millions of dollars in civil penalties from distributors and manufacturers who allegedly distributed to pharmacies that dispensed for non-legitimate medical purposes.

For example, in recent years DEA collected:

$44,000,000 from Cardinal Health/Kinray, 2016

Letters of Admonition: For minor recordkeeping, reporting and security violations, the local DEA office may issue a “Letter of Admonition” that identifies alleged violations requesting a response, usually within 30 days, of how the registrant will remediate.

Informal Administrative Hearings: The local DEA office following cyclic inspection, may issue a notice for the registrant to participate in a voluntary informal hearing to provide an opportunity to discuss alleged violations with DEA; often result in a Memorandum of Agreement.

Orders to Show Cause (“OTSC”): DEA can issue an OTSC to deny or revoke a registration where violations are more serious. The OTSC is served on the applicant/registrant, provides notice of the action and opportunity for a hearing. Applicants/registrants can now submit a corrective action plan prior to hearing. If DEA meets burden of proving sufficient evidence against continued registration, burden shifts to registrant. ALJ recommends decision; DEA Administrator or Deputy Administrator issues a final order, which applicant/registrant can appeal to appropriate U.S. Court of Appeals.

Immediate Suspension Order (“ISO”): DEA can issue an ISO when it believes continued registration creates “an imminent danger to the public health and safety;” i.e., potential ongoing diversion. DEA issues ISO contemporaneously with an OTSC. The purpose is to suspend authority to handle controlled substances while administrative proceedings are pending. ISOs continue in effect until conclusion of formal administrative proceedings. Registrants are entitled to an expedited hearing on the ISO/OTSC before DEA. The process for issuing an ISO was modified by Congress in 2016 (the Ensuring Patient Access and Effective Drug Enforcement Act), making the ISO standard more rigorous for DEA.

Recent high-profile DEA OTSCs and/or ISOs:

Masters, Pharmaceutical , Ohio, June 2017 (U. S Court of Appeals for the District of Columbia Circuit);

Morris & Dickson, Louisiana, 2018 (ISO overturned by U.S. District Court); matter pending before DEA.

The CSA also provides for criminal penalties against DEA registrants and non-registrants for knowing and intentional acts involving the unlawful manufacture, distribution, dispensing or other unlawful activities involving controlled substances. Criminal cases can arise where registrants act with reckless disregard or willful blindness in dispensing or distributing controlled substances.

Over the last decade, there have been a number of cases that the DEA pursued targeting Suspicious Order Monitoring programs for registrants.

The Southwood Pharmaceuticals case is one of the most straightforward cases in which the DEA has revoked a company’s ability to transact business in controlled substances. The company, closed March 2013, was subject to an extensive investigation by the DEA which found it was illegally shipping large quantities of controlled substances to multiple pharmacies that, at least partially, obtained prescriptions from the internet and through tele-medicine activities.

Mallinckrodt Pharmaceuticals: Manufacturers Must Analyze Chargeback Data

A truly landmark case for manufacturers - in July 2017, the DOJ demonstrated that manufacturers must maintain due diligence programs, including Suspicious Order Monitoring and Know Your Customer programs. Although manufacturers of opioids were normally targeted for alleged sales and marketing infractions, this is the first case that the DOJ pursued in which a manufacturer of opioids was targeted for allegedly failing to prevent diversion. A key takeaway for manufacturers of controlled substances is to review their current due diligence processes and ensure they have

Masters Pharmaceutical: Must Identify and Report Suspicious Orders

In August 2013, DEA issued Masters a “Show Cause Order” alleging that, between 2009 and 2011, Masters sold Oxycodone to eight of its retail pharmacy customers that it knew or should have known they were engaged in illegal diversion. After a bit of legal battle, on June 30, 2017, the Court of Appeals for the D.C. Circuit issued an order that confirmed the revocation of Masters’ DEA registration, preventing the Company from distributing any controlled substances.

Registrants must adhere to last year’s Masters Pharma-ceutical decision until DEA issues new regulations clarifying requirements. The Court agreed with DEA that suspicious orders are more than orders of unusual size, orders deviating substantially from normal pattern and orders of unusual frequency, and could include:

Pharmacy dispensing high percentage of controlled to non-controlled substances;

High percentage of cash paid for controlled prescriptions; and

Prescriptions for large quantities of controlled substances for individual patients.

Distributors must analyze dispensing data from pharmacy customers to determine whether orders are suspicious and identify potential red flags. Distributors cannot obviate the reporting requirement by limiting order, deleting it or treating it as an attempted order. Once a registrant identifies an order as suspicious, it must report it to DEA (i.e., the “Reporting Requirement”).

If the distributor’s SOPs definition of “Orders of Interest” meets the definition of “suspicious orders,” they must be reported. Then, distributor can only fill and ship the order after conducting sufficient due diligence to dispel suspicion and ensure the drug will not be diverted (i.e., the “Shipping Requirement”).

Future Electronic Reporting of Suspicious Orders

Due to the opioid epidemic, there has been increasing public, industry and political pressure for DEA to revamp enforcement and provide clarity/transparency in their regulation of the supply chain.

The centralized database for the collection of suspicious order reports is required by the SUPPORT Act was to be up and running in October 2019. An RFP for the development of such a database was released on November 22, 2017 (RFP 15DDHQ18R00000001). Registrants will soon be required to access a new Suspicious Order Reporting system (SORS) to submit suspicious order reports. Suspicious Orders Reports will have over 10 components.

Registrants will be required to report the suspicious (i.e. “flagged” order), whether the registrant elected to proceed with the order, what steps the registrant took to determine whether the order was for legitimate purposes and whether the registrant ultimately distributed the controlled substances ordered, and, if so, the date on which the distribution occurred.

Sumeet Singh is founder and president of Five Rivers RX. Based just outside of Philadelphia, Five Rivers RX provides actionable guidance and superior administrative services with a focus on client care across Compliance, Commercial, and Quality solutions.

Articles

DEA’s manufacturer and distributor data-collection requirements are changing

The current state of suspicious- order monitoring

Secondary wholesalers (aka “independent” wholesalers) play a  unique part of the pharmaceutical distribution business. Although, little loved by the largest manufacturers and wholesalers, their existence is entirely legal—and valuable to the overall healthcare system. These wholesalers function by arbitraging pricing among primary wholesalers (who purchase drugs directly from manufacturers) and other sources of drugs, to deliver better pricing to pharmacies and other drug purchasers. Often they are a valued backup to the prime-vendor contracts that pharmacies have with the major wholesalers, in that they can deliver drugs in short supply, or at better prices, than the prime vendors. As represented by organizations like the National Coalition of Pharmaceutical Distributors or the Assn. of Independent Pharmaceutical Wholesalers, Inc. (AIPW), they have engaged regularly with FDA and other regulatory bodies to ensure a level playing field in supplying safe, legal drugs.

In August 2016, OptumRX, a leading PBM, announced a sweeping policy change to their Network Pharmacy Provider Manual: A “pharmacy MUST purchase ALL Covered Prescription Services for claims being dispensed to OptumRx members from a Verified-Accredited Wholesale Distributor (VAWD).” The VAWD accreditation program is offered through the National Association of Boards of Pharmacy (NABP). If pharmacies don't comply, they are at risk of being denied reimbursements, paying chargebacks (100% of the reimbursements) and being dropped from the OptumRX network—all potential death penalties for these small businesses.

So why has OptumRX implemented the VAWD requirement? In my opinion, there are several reasons why OptumRX has established such a policy:

1. OptumRX wants to drive independent pharmacies out of business to win market share for its mail-order pharmacy business and its preferred pharmacy partners, CVS and Walgreens.

This isn't the first time a PBM has been the center of controversy. Over the last few years, numerous lawsuits across the country have popped up from pharmacies, claiming unfair practices that cause irreparable harm to pharmacies. Three such lawsuits in the past two years include Trone Health Services Inc., Linden Care Pharmacy and Irmat Pharmacy suing a PBM. They were initiated by the pharmacies on the grounds that the PBM was going to terminate their network contract with the pharmacy or that the PBM was using sensitive data to try to steal pharmacy patients.

On the retail pharmacy side, OptumRX struck deals with Walgreens and CVS during 2016 for each of the retail pharmacies to be “preferred” pharmacies. These deals stand to provide a cut of profits to OptumRX,  to the detriment of the retail pharmacies as prescription volume is pulled away  from them.

With this requirement, in addition to the ever-controversial MAC pricing and declining reimbursements, PBMs are collectively putting the viability of the independent pharmacy business model  at risk.

2. OptumRX is aligned with major manufacturers, wholesalers and other PBMs to destroy the secondary distribution market

AIPW, a non-profit trade association representing the interests of pharmaceutical distributors across the country, filed a legal complaint against OptumRx in late 2016. The lawsuit argues that because OptumRX manages prescription drug benefit plans not only for private insurance companies and large insurers, but also the state and federal government through the Medicare and Medicaid program, it is acting as an agent of the government. [1] Given the power and reach of OptumRX (66 million covered lives or about 25% of insured Americans), its VAWD requirement effectively creates an industry regulation.

Specifically, AIPW is concerned about one specific requirement of VAWD accreditation: Pharmacies are not allowed to sell prescription drugs. Much of the secondary market relies on pricing inconsistencies for their business model where pharmacies sell prescription drugs to wholesalers because they have access to special pricing. VAWD Accreditation specifically outlines that products cannot be “previously distributed to pharmacies, healthcare entities or under special restricted pricing contracts.” [2] However, repurchasing is a fully legal (federal and state) business activity performed by fully licensed entities.

Further, in private correspondence with a wholesaler applying to the VAWD program, a NABP investigator claimed that the practice of repurchasing “violates VAWD criteria and allows purchasing of suspect product.” This disingenuously adds an additional classification to the definition of suspect product that is not contained within the DSCSA. The DSCSA defines suspect product as product that is potentially counterfeit, diverted, stolen, adulterated or will potentially result in serious adverse health consequences to the patient.

We trust pharmacies to dispense drugs to patients every day as fully trained, licensed and educated healthcare providers. However, with this additional requirement, VAWD is alleging that these same healthcare providers cannot be trusted to distribute drugs, even if they are fully licensed by state and federal authorities.

In my opinion, for a third-party organization like a PBM to disallow such an activity represents a conflict of interest with the payers and consumers who ultimately bear the cost of purchasing drugs. PBMs are increasing their profit at the expense of small businesses and the American public.

3. OptumRX is using VAWD to give the appearance of protecting consumer health.

VAWD accreditation is beneficial to the supply chain because it contains 250 requirements that encompass the operational activities of a pharmaceutical distributor. However, most of these requirements have been superseded by the Drug Supply Chain Security Act (DSCSA), which was passed in 2013 and is currently being implemented. DSCSA has increased the transparency, integrity and safety of the supply chain. Regulation is backed by the power of the federal government with full cooperation from the State Boards of Pharmacy. Counterfeiting and drug diversion will be a thing of the past as the DSCSA aims to track every drug product on a unit level, starting from the manufacturer until it reaches a patient.

Currently, there is considerable debate over how much of the cost of drugs (which are high and getting higher) is attributable to manufacturers, and how much is attributable to PBMs and other intermediaries in the supply chain who tack their own fees or obtain their own rebates from manufacturers for the drugs that they provide. The OptumRx action seems to lead in a direction of PBMs protecting their revenue streams by excluding other sources of drugs, which might be obtainable at lower prices. Ultimately, it should be the decision of those purchasers as to how their drugs are obtained, and not the arbitrary imposition of out-of-date industry standards.

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Sumeet Singh is the president and founder of Five Rivers RX, a compliance firm focused on the pharmaceutical distribution industry. Five Rivers RX’s clientele ranges from Fortune 500 manufacturers to family-run independent pharmacies. Our team specializes in achieving VAWD accreditation and maintaining federal and state compliance.

Is the industry’s VAWD accreditation being used for unfair advantage?