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Drug Pricing: Tech Start-Up Provides Solutions for Drug Manufacturers Subject to 340B Duplicate Discounts

solutions for pharmaceutical manufacturers who participate in the Medicaid Drug Rebate Program and pay too much because of 340b duplicate discounts

Kalderos 340B solutions for drug manufacturers.

The extent to which 340B covered entities receive duplicate discounts from pharmaceutical manufacturers who take part in the Medicaid Drug Rebate Program (MDRP) is widely documented.

The Medicaid Exclusion File

The Health Resources and Services Administration (HRSA) established the 340B Medicaid Exclusion File (MEF) as The mechanism to aid 340B covered entities and states to prevent duplicate discounts for drugs subject to Medicaid rebates.

But in terms of efficacy, the MEF is insufficient in mitigating duplicate discounts. An estimated $2 billion in improper rebate payments are paid by pharmaceutical manufacturers — and received by 340B covered entities — on an annual basis.An estimated $2 billion in improper rebate payments are made by pharmaceutical manufacturers — and received by 340B covered entities — on an annual basis. Click To Tweet

A 2016 report published by the Office of Inspector General (OIG) also indicates drug manufacturers pay rebates for drugs sold at 340B discounted prices. This is particularly true in Medicaid managed care (MMC). To be clear, this is illegal. Fortunately, a technology start-up is helping drug manufacturers protect their inventory.

MEDICAID DRUG REBATE PROGRAM 

The Omnibus Reconciliation Act created the Centers for Medicare & Medicaid Services’  (CMS’) MDRP in 1990. In order to get reimbursed by the federal government, and as a prerequisite to enter the Medicaid and Medicare Part B markets, the Act requires drug manufacturers to offer formula based rebates on outpatient drugs.

MEDICAID DRUG REBATE PROGRAM SNAPSHOT

How Medicaid Rebates are Paid

Furthermore, drug manufacturers are required to enter into agreements with two other federal programs to have their drugs covered under Medicaid: (1) a pricing agreement for the 340B Program and (2)  a master agreement with the Secretary of Veterans Affairs for the Federal Supply Schedule.

340B PROGRAM 

To mitigate the unintended consequences of the rebate program — a rise in prescription drug costs for safety-net hospitals and other entities that provide health care services to low-income patients — Congress passed the Veterans Health Care Act of 1992 which created Section 340B of the Public Health Service Act. The Act requires pharmaceutical manufacturers to provide point of sale discounts to covered entities.

340B PROGRAM SNAPSHOT

More about 340B 

The takeaway here is: by law, drug manufacturers are protected from providing covered entities with  both a discounted 340B price and a Medicaid drug rebate for the same product ( a duplicate discount).

DUPLICATE DISCOUNT PROHIBITION, 340B & MEDICAID MANAGED CARE 

Medicaid provides health care coverage to about 70 million beneficiaries nationwide. Medicaid expenditures on outpatient prescription drugs exceeded  $31 billion in 2015. Moreover, in  federal fiscal year (FFY) 2016, total state and federal Medicaid spending exceeded $548 billion, 49 percent of which was directed to MMC programs. Of the $269 billion directed toward MMC programs in FFY 2016, 95 percent of expenditures were paid to comprehensive risk-based MCOs.

Click here for more information on the Duplicate Discount Prohibition.

Medicaid Managed Care

As a strategy to contain rising health care costs, state Medicaid agencies pay MCOs a fixed per-member-per-month fee (e.g., capitation rate) to provide Medicaid benefits to qualifying residents. As of March 2018, 39 states and the District of Columbia had entered into comprehensive risk-based payment arrangements with MCOs to offer Medicaid benefits to eligible population groups.

Revisiting the 340B Drug Pricing Program

As stated before, the policy is not applicable in MMC. This is a concern. At least 42 states pay for prescription drugs through Medicaid MCOs.

States’ use of provider-level data  methods may not accurately identify 340B claims for some covered entities. Provider-level methods generally treat all drug claims from a given covered entity in the same way—that is, as either 340B claims or non-340B claims—and do not allow covered entities to differentiate among specific claims. In practice, however, a covered entity may submit both 340B claims and non-340B claims to Medicaid (OIG).

Finally, the shift from FFS Medicaid to MMC causes challenges with regard to timely and accurate data collection, reporting, and program oversight. This is well documented.

KALDEROS SOLUTIONS 

Jeremy Docken, Founder and GM of  Kalderos  gave a presentation during Mostly Medicaid’s  October 2017, Medicaid Star Search webinar. Kalderos provides technology solutions to mitigate the challenges plaguing the Medicaid Rebate Program and the 340B Drug Pricing Program.

The only party financially harmed due to 340B duplicate discounts are drug manufacturers.  HRSA and CMS continue to struggle to offer real solutions to protect manufacturers from paying duplicate discounts — Jeremy Docken (Kalderos)

The Kalderos Solution in Action

Kalderos identifies suspected duplicate discounts by using proprietary data and works with covered entities to confirm if 340B drugs have been dispensed. Drug manufacturers receive reports guaranteed to be accepted as valid disputes by  states. Kalderos is  piloting a project in Florida to assist drug manufactures subject to duplicate discounts.

More information is on the Kalderos website.

Key Takeaways

Given the role of MCOs in Medicaid, and given the prevalence of  duplicate discounts, it is clear current mechanisms for ensuring program integrity in the 340B program need revision. Fortunately, technology start-up Kalderos is doing what the government and covered 340B entities have failed to do.

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About the Author

Olivia P. Walker is a public affairs strategist, campaign consultant, and writer. Most recently, Olivia served as governance consultant for the International Society for Pharmaceutical Engineering. Prior to this role, Olivia worked as government affairs and public policy analyst for WellCare Health Plans, a Fortune 500 managed care provider/insurer. Olivia holds a master’s degree in public administration from the University of South Florida School of Public Affairs.

In 2016, Olivia was duly initiated into Pi Alpha Alpha, the Global Honor Society for Public Affairs and Administration. She is a member of the American Society for Public Administration and a member of the ASPA Section on Public Law and Administration. Olivia also holds a graduate certificate in globalization Studies. The certificate is a specialized graduate-level credential reflecting knowledge of the most up-to-date research on globalization.

     


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