Comments to Proposed Rule Concerning Covered Outpatient Drugs

April 1, 2012

VIA ELECTRONIC DELIVERY

Marilyn Tavenner
Acting Administrator
Centers for Medicare & Medicaid Services
Department of Health and Human Services
Room 445-G
Hubert H. Humphrey Building
200 Independence Avenue, SW
Washington, DC 20201

RE: CMS-2345-P (Comments to Proposed Rule Concerning Covered Outpatient Drugs)

Dear Ms. Tavenner:

The State Patient Access Coalition (SPAC) appreciates the opportunity to provide comments on the proposed rule published by the Centers for Medicare and Medicaid Services (CMS) regarding reimbursement for Medicaid covered outpatient drugs.1

Although the proposed rule addresses a wide range of issues, this comment letter focuses on the proposed change from estimated acquisition cost (EAC) to actual acquisition cost (AAC). Given the unique requirements of dispensing blood clotting factor, the SPAC would respectfully request that CMS consider using this rulemaking process to promulgate a unique Medicaid reimbursement for blood clotting factor that takes into account the extensive efforts required to provide blood clotting factor to Medicaid recipients. We would also request language in the final AAC rule that would ensure Medicaid reimbursements represent the current market value of blood clotting factors.

SPAC represents the world’s leading manufacturers and the nation’s leading distributors of blood clotting factor. Blood clotting factors are lifesaving therapies for individuals with bleeding disorders, such as hemophilia and von Willebrand Disease. SPAC was created to address issues of patient access to blood clotting factor and to educate policy-makers about the unique process to manufacture and dispense this vital therapy. SPAC works to ensure that once educated, policy-makers will make sound decisions on policies that affect the purchase, dispensing and administration of blood clotting factor therapies.

In the notice of proposed rulemaking, CMS proposes to replace EAC with AAC to improve accuracy in pharmacy reimbursement through the use of a formula that is more reflective of the actual prices paid for Medicaid outpatient drugs. In developing this provision, we commend CMS for recognizing that switching to an AAC-based reimbursement formula in turn requires a dispensing fee that more accurately reflects the actual cost to dispense. This is especially true for the costs associated with the unique services and activities required to dispense blood clotting factor. To this end, we support the proposed requirement that States demonstrate how increased dispensing fees reasonably reflect the actual cost to dispense-prior to CMS’s approval of the State Plan Amendment. This provision will help to ensure continued access to these drugs to Medicaid beneficiaries.

To support CMS in this process, we have highlighted some of the unique services and activities provided by specialty pharmacies in dispensing blood clotting factor. These include, but are not limited to:

  • Increased education by pharmacist regarding mixing, storage and proper use to prevent waste and unnecessary costs
  • Monitoring of bleeds and usage of product to avoid stockpiling
  • Emergency delivery and 24 hour on call support by nurses, pharmacists, and support staff trained in bleeding disorders (which can avoid costly ER visits and hospitalizations.)
  • Case management services to evaluate and promote adherence to variable and at times complex dosing guidelines as well as to facilitate patient access to care for co-morbidity or complications.
  • Monitoring and reporting adverse drug reactions
  • Specialized distribution channels and delivery requirements, including emergency delivery and temperature controlled shipments with proof of delivery
  • Notification of product recalls and withdrawals
  • Inventory management of products with variable assays to minimize waste and cost of excess product usage
  • Warehouse storage and facility costs for stocking product
  • Medically necessary nursing services, including the administration of clotting factor therapies Medically necessary ancillary supplies, including IV start kits, dressings, needles, pumps, tubing, and waste disposal services

As is outlined above, dispensing blood clotting factor requires enhanced services and activities that vary greatly from those performed by a typical retail pharmacy. In many cases, these services are unique even in comparison to other products sold by a specialty pharmacy.

In recognition of these unique services, the SPAC would respectfully request that CMS consider using this rulemaking process to promulgate a unique Medicaid reimbursement for blood clotting factor that takes into account the extensive efforts required to provide blood clotting factor to Medicaid recipients. It is well documented that blood clotting factor therapies provide an increased quality of life for patients with bleeding disorders and result in long-term savings for patients, providers and payers.

Reimbursement proposals that hinder patient access may lead to delays in obtaining proper medical care, resulting in increased hospitalizations, joint damage necessitating surgical intervention, and long term debilitation.

The SPAC would also like to recommend language in the final AAC rule that would ensure Medicaid reimbursements represent the current market value of blood clotting factors. The language should include protections against a substantial time lag between the pharmacies incurring AAC and the calculation of AAC by the Medicaid agency for reimbursement purposes.

It is well understood that a significant lag could result in inadequate reimbursement to providers that would cause patients to have difficulty accessing their medically appropriate blood clotting factor. SPAC appreciates your consideration of our concerns and welcomes the opportunity to discuss them further. Should you have any questions or require additional information please do not hesitate to contact me at: This email address is being protected from spambots. You need JavaScript enabled to view it.or (443) 433-1110.


1 Medicaid Program; Covered Outpatient Drugs, 77 Fed. Reg. 5318 (Feb. 2, 2012).