Washington Letter [Hemophilia Centers of Excellence (WSR 12-09-087)]

May 22, 2012


HCA Rules Coordinator
626 8th Avenue
Olympia, WA 98504
E-mail: This email address is being protected from spambots. You need JavaScript enabled to view it.

Subject: Hemophilia Centers of Excellence (WSR 12-09-087)

Dear Ms. Boedigheimer:

The State Patient Access Coalition (SPAC) appreciates this opportunity to provide our comments on the Proposed Rule WSR 12-09-087. The proposed rule would amend Washington Administrative Code (WAC) sections 182-530-7000 and 182-531-0050, and add section 182-531-1625 to the WAC. We are very concerned with the patient access and care issues that will arise if the Health Care Authority (HCA) requires eligible agency clients to receive their blood clotting factors and ancillary supplies exclusively from a qualified hemophilia treatment center of excellence (HTC). We suggest a better way to achieve the goal of improved care oversight is to establish standards that providers of blood clotting factors would have to meet based upon the National Hemophilia Foundation’s Medical And Scientific Advisory Council Recommendation #188 (MASAC 188). The standards should include open access to all specialty pharmacy providers that meet the standards, open access to all blood clotting factors and to require the blood clotting factor providers to ensure that their clients have annual visits to an HTC where they have access to comprehensive care.

SPAC represents the world’s leading manufacturers of clotting factor and the nation’s leading distributors of clotting factor. Clotting factor therapies are vital for individuals with bleeding disorders, including hemophilia and von Willebrand Disease.

We appreciate the HCA sharing the comments they received from stakeholders to the pre-proposed rule statement of inquiry (WSR 11-19-05) on the same topic and the HCA’s responses to the comments. We are pleased to hear that patients will have access to their medically appropriate therapies under the proposed rule.

The HCA’s responses clearly state the purpose of the proposed rule is to “improve care oversight and link hemophilia product management to hemophilia treatment centers designated as Centers of Excellence.” The SPAC shares the goal of improving care oversight and agree that hemophilia treatment centers are an in important link in the care of individuals with bleeding disorders.

The rules indicate that the HCA believes the best way to achieve the stated goal is to require HTCs to provide individuals with bleeding disorders with their blood clotting factor and all necessary ancillary equipment for home-infusion.

The HTCs should be a part of the patient care team because they are Centers of Excellence, but agency clients should have access to specialty pharmacies as well since they are excellent at what they do. Specialty pharmacies are experts at meeting the needs of individuals with bleeding disorders who infuse in the home. The HTCs do not currently provide the types of services that specialty pharmacies perform for patients. One such service is nursing. Nurses are a vital component of care for patients and parents when first learning to self-infuse at home. They are also essential in cases where individuals with severe hemophilia need nurses to support the home infusion.

The HCA mentions in the responses that the HTCs would be required to meet the standards of MASAC 188 under this rule. However, since they currently do not provide all of these services, we believe the HCA would be subjecting agency clients to substandard care as HTCs are attempting to learn their new duties.

The SPAC is greatly concerned that agency clients would be forced to switch specialty pharmacy providers. Continuity of care issues should be thoughtfully considered when imposing new policies on vulnerable patient populations. Hemophilia patients must continue to have the complete range of products available for bleeding disorder treatment.

The proposed policy would also mean less care for agency clients with hemophilia. A 2004 Lewin Study found that specialty pharmacy providers provide a broader, more comprehensive range of services to individuals with hemophilia than HTCs. Among the services found to be provided by specialty pharmacies that aren’t provided by HTCs, are:

  • Emergency telephone support 24 hours a day, 365 days per year;
  • Emergency delivery;
  • Visiting nurse services;
  • Notification of product recalls or withdrawals; and
  • Aggressive Assay Management, reducing units dispensed and spend.

These services are an essential part of hemophilia care and should be available to all agency clients with hemophilia.

We are well aware of the continued financial difficulties facing Washington and other states across the county that are requiring creative cost containment approaches to save on state budgeted health care costs. However, we respectfully do not believe that requiring individuals to obtain clotting factor therapies through a single provider type, even if it is the state recognized hemophilia program, is the best way to accomplish that goal. Unfortunately, this type of arrangement has the potential to restrict patients’ overall access to care which could ultimately lead to higher health care costs rather than the savings the state may be contemplating in this proposal.

The proposed rule adds a definition of a Center of excellence (COE) to WAC 182-531-0500 that could be used to improve care oversight. It states that a COE is, “A hospital, medical center, or other health care provider that meets or exceeds standards set by the agency for specific treatments or specialty care.

The SPAC advocates that the agency should develop standards, based on MASAC 188, that would lead to improved care oversight and link hemophilia product management to hemophilia treatment centers. Specialty pharmacies that meet these standards should be considered COEs and allowed to provide blood clotting factor therapies to agency clients. One way to link product management to the hemophilia treatment centers is to require the specialty pharmacies to ensure that the patients they serve are seen annually by the closest HTC. The state of South Carolina currently does this.

The SPAC suggests that if the HCA would implement our proposal, then Washington residents would receive the best possible care while the HCA would meet their goal of improving care oversight and linking care to the HTCs.

We appreciate your consideration of our concerns and would welcome the opportunity to discuss it with you 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.