September 6, 2005
Via Electronically
Centers for Medicare and Medicaid Services
Department of Health and Human Services
Attention: CMS: 1325-IFC
Post Office Box 8013
Baltimore, MD 21244-9013
Re: Medicare Program; Competitive
Acquisition of Outpatient Drugs
and Biologicals Under Part B [CMS-1325-IFC]
To Whom It May Concern:
The Cancer Leadership Council (CLC), including cancer patients, physicians,
and researchers, submits these comments in response to the interim final
rule with comment period establishing the Competitive Acquisition Program
(CAP) for Medicare Part B drugs and biologicals, published in the Federal
Register on July 6, 2005. We understand that the process for evaluating
and selecting bidders for CAP has been temporarily suspended, but we offer
these recommendations for revision of the program before its implementation
is resumed.
The CLC is concerned about several provisions of CAP which may adversely
affect cancer patients' access to life-saving cancer therapies. These
include:
Patient Coinsurance
The interim rule would permit CAP vendors to stop providing drugs to patients
who have not paid their coinsurance within 45 days. The rule requires
vendors to consider alternatives for collection of coinsurance, including
establishing a payment plan or referring the patient to a charitable organization.
However, the vendor has the right, if these options do not result in payment
of coinsurance, to terminate a patient's access to drugs.
In the current system where the oncologist orders and purchases cancer
drugs, it has been our experience that oncologists absorb the cost of
any coinsurance that cannot be paid by patients. We do not anticipate
or expect that patients will have the same experience with CAP vendors,
and the result will be disruptions in care if patients cannot pay their
coinsurance. This will be an
Centers for Medicare and Medicaid Services
September 6, 2005
Page 2
unacceptable situation, which
patients may be able to avoid only if their oncologists decline to enroll
in CAP. We urge CMS to amend the program to eliminate the ability of CAP
vendors to terminate the provision of drugs to patients who cannot pay
their coinsurance.
Patient Support Initiatives
The regulations require vendors to have procedures to resolve complaints
and inquiries about drug shipments, but there are no clear standards for
systems or procedures that vendors must maintain. Although the establishment
of a call center or other patient support center may not result in the
easy resolution of conflicts related to payment of patient coinsurance,
it may ensure that patients have ready answers to questions about billing,
payment schedules, and other matters.
Prohibition on Movement of Drugs Between Offices
The regulations would prohibit physicians from moving drugs ordered through
CAP from one office to another, even if the offices are part of the same
practice. We understand that these provisions were included at the urging
of prospective CAP vendors as a protection against spoilage or breakage,
but we recommend that they be eliminated.
Cancer patients benefit from the ability to receive chemotherapy in their
physician's office, and those in remote areas have enjoyed the advantages
of receiving treatment in satellite offices, a practice that has minimized
the distance they must travel to receive care. The prohibition against
movement of drugs between offices will either limit the access to care
in satellite offices or will force those physicians who maintain satellite
offices to forego enrollment in CAP.
We urge a revision of this standard to reflect the needs of cancer patients
treated by physicians with satellite offices, including those in rural
areas. Oncologists, nurses, and other staffers in oncologists' offices
have significant experience in transporting and handling cancer drugs,
which suggests that CAP vendors' concerns about breakage and spoilage
are unfounded.
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Centers for Medicare and Medicaid Services
September 6, 2005
Page 3
We appreciate the opportunity to offer these comments that reflect the
special needs of cancer patients under CAP. We urge revisions in the interim
final rule to prevent disruptions of care under CAP.
Sincerely,
Cancer Leadership Council
American Cancer Society
American Psychosocial Oncology Society
American Society of Clinical Oncology
Cancer Care, Inc.
Cancer Research and Prevention Foundation
Coalition of Cancer Cooperative Groups
International Myeloma Foundation
Kidney Cancer Association
Lance Armstrong Foundation
The Leukemia & Lymphoma Society
Lymphoma Research Foundation
Multiple Myeloma Research Foundation
National Coalition for Cancer Survivorship
National Prostate Cancer Coalition
North American Brain Tumor Coalition
Ovarian Cancer National Alliance
Pancreatic Cancer Action Network
Sarcoma Foundation of America
The Susan G. Komen Breast Cancer Foundation
Us TOO International Prostate Cancer
Education and Support Network
Y-ME National Breast Cancer Organization