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NAMSAP Featured Article: CMS Allocations Contrary to Real-Life Practice?

Wednesday, September 30, 2020   (0 Comments)
Posted by: Schuyler Green
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This NAMSAP Corporate Partner featured article is authored by Nahla D. Rizkhalla, PharmD, MSCC, Senior Clinical Pharmacist for ExamWorks Clinical Solutions.

Center for Medicare and Medicaid Services’ (CMS) focus is to protect Medicare’s interest when there is a primary payer on reported claims. The goal of a Workers’ Compensation Medicare Set-Aside Allocation (WCMSA) is to estimate the total cost that is incurred for all medical expenses reimbursable by Medicare for work-related conditions during the course of a claimant’s life, and to set aside sufficient funds. Pricing of medications within MSAs is done per the lowest non-repackaged generic average wholesale price (AWP) in accordance with CMS’ recognized and approved compendium, Micromedex® Red Book®. This amount proposed in the WCMSA is reviewed for adequacy of protecting Medicare’s interests. Discussed below are two CMS determinations for packages which cannot be separated or broken into smaller dispensable packages. Bearing in mind that packaging for medications typically correlates with the FDA approved labeling for use. One determination was returned from CMS as counter-higher and the other as a counter-lower; depicting discrepancies between real-world pricing and that of CMS.

Evzio®, naloxone HCl injection, is an opioid antagonist indicated for emergency treatment for known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression. It is available as a 2mg/0.4mL single use pre-filled auto-injector, for intramuscular or subcutaneous use. As it is an auto-injector, it is designed for use by family, friends or caregivers. The Evzio® package contains two 2mg auto-injectors and a single trainer (to practice), with each auto-injector delivering 0.4mL for a total of 0.8mL per carton. Two doses are provided as repeat doses may be required based on the amount, type, and route of administration of the opioid being antagonized.

The FDA-approved carton states “ATTENTION PHARMACIST: Dispense this entire carton as a unit” to indicate that the carton should not be separated or broken. This ensures that the patient receives two active auto-injectors in case repeat dosing is needed.

As this is a carton which must be dispensed as packaged, 0.8mL, it should be priced in an MSA per package. The package/carton (0.8mL) is $4,920.00, whereas the unit price (1mL) is $6,150.00. Logic would dictate that the package pricing would be utilized for allocation in an MSA; however, a counter-higher determination and reconsideration was rendered based on pricing the medication per unit price, 1mL.

Instead of allocating the package price of 0.8mL, the 1mL unit price was allocated returning a counter-higher of $33,210. In a pharmacy environment, the claim would be processed as per the manufacturer’s package size of 0.8mL instead of 1mL; inconsistent with CMS. Worth noting, Evzio® is now available as a cost-effective generic, naloxone auto-injector, with a package price of $213.60.

Incruse Ellipta® is an inhaler indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease. As it is a maintenance medication, it is expected to be taken at the same time every day as an around-the-clock medication. It is available only as a brand name agent in one strength, 62.5mcg/actuation and two packages sizes, seven inhalations (institutional pack; such as one to be used in a short hospital stay) and thirty inhalations.

The directions for use for Incruse Ellipta are as follow: 62.5mcg/actuation powder for inhalation; inhale one puff every day by inhalation route for 30 days. The CMS determination letter priced the Incruse Ellipta® inhaler utilizing the unit price of the seven inhalations, instead of the commercially available package of 30 inhalations; as any pharmacy would process. Moreover, a pharmacy is unable to adjudicate a claim based on multiples of seven inhalations as this would not provide the required prescribed monthly dosage for the claimant; 28 inhalations instead of 30. To further elucidate the point utilizing the table above, a breakdown of the math is provided below for a claimant over life expectancy (LE) for the two scenarios.

Such examples of CMS allocations protect Medicare’s interest is protected suggest that allocation is overfunded in the Evzio® scenario, and has shifted the burden to other payers. Furthermore, Evzio® is allocated over LE based on opioid therapy for the claimant; however, WCMSAs are based on a snapshot in time. Evidence-based medical guidelines do not recommend opioids as first-line therapy or long-term use due to increased risk of harms that is dose-dependent and limited benefits, and recommend periodic evaluation for weaning.

For the Incruse Ellipta®, manufacturer package products to be dispensed associated with the FDA-approved indication and directions for use. As such, Incruse Ellipta® is packaged in an inhaler with 30 inhalations. A pharmacy would not adjudicate a claim for 30-days’ supply utilizing the seven inhalations package. Does it all come out in the wash? Food for thought! This is a different reality and contrary to real-world practice, but maybe it should be more in line with actual practice?

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