ACS CAN Comments on Medicare IPI Model

Approximately 1.7 million new cancer cases are expected to be diagnosed in 2018.^[1] Age is one of the most important risk factors for cancer, with one half of cancer cases occurring in people over the age of 65.^[2] Thus, cancer and the therapies used to fight the disease have an enormous impact on the Medicare program, given that almost half of all Part B spending on prescription drugs is related to cancer care.[3] Cancer patients and survivors rely on drug therapies for life-saving treatments. Thus, it is paramount that any new payment model must ensure that beneficiaries have access to medically necessary treatments in the setting that is best for them.

Both cancer patients and survivors rely on drug therapies to treat their disease, prevent recurrence and treat side effects. As more innovative therapies become available, we need to make sure that patients who are likely to benefit from these advances can also afford them so that we can achieve the national goal of eliminating death and suffering from cancer. The inherent challenge will be balancing the need to incentivize continued development of new cancer drugs with greater affordability of these therapies.

We applaud the Administration for further examining new ways to tackle the problem of prescription drug affordability. While we understand the document under discussion is an APRM, we note that many of the concepts provided are broad and open to significant and divergent interpretation. We do not believe that the IPI Model, as described in the APRM, provides sufficient details to ensure that beneficiaries – particularly those in active cancer treatment – will have access to the medications needed for their cancer treatment.

We believe that the Model as written could actually make it harder for cancer patients, especially those living in rural areas, to find the right provider to treat their cancer with the right drug. We cannot sacrifice this patient access for program savings that may or may not materialize, based on price-setting processes that no American citizen can control.

Beyond these major issues we also have other concerns and questions highlighted below including: 

• Beneficiary cost-sharing: We also note the APRM “expects” beneficiary cost-sharing to be the same or lower under the Model, but it is possible that beneficiary cost-sharing could be higher, as discussed in more detail below. We urge CMS to explicitly state that under no circumstances should beneficiary cost-sharing be higher for drugs reimbursed under the Model than under current policy.
• Geographic considerations: CMS intends to implement the Model in certain geographic areas. We also note that a beneficiary could experience different cost-sharing depending on whether they receive a drug within the Model or obtain health care outside the Model’s geographic area. If contiguous geographic areas are randomly assigned to different payment models, it seemingly would be possible for Medicare beneficiaries to be directed to non-Model areas that offers the greater financial incentive to the provider. This diversionary practice could result in higher cost-sharing for the beneficiary depending on the reimbursement model being used. The beneficiary could also face transportation issues accessing the alternate site of care.
• Included drugs: We are concerned that a vast majority of drugs that would be included in the Model are used to treat various types of cancer. Should HHS decide to go forward with this Model, we strongly urge that oncology drugs not be included in the Model, at the very least, until significant guardrails are in place to ensure that beneficiaries maintain timely access to their oncology services. To achieve optimal results, cancer treatments must be provided according to a set schedule. Interruptions to that schedule can lead to negative health outcomes.
• Beneficiary protections: As a theoretical matter, a pharmaceutical manufacturer could choose to no longer sell a product in a foreign country included as one of the countries from which international price data is gathered under the IPI Model. If such an instance were to occur, it is unknown what actions CMS would take with regards to future reimbursement of the product. We urge CMS to ensure that beneficiaries have access to medically-appropriate medications if this hypothetical scenario were to materialize.
• Oncology-specific evaluation: Oncology drugs represent 42 percent of Part B spending.[4] If this Model were implemented, we strongly urge CMS in its evaluation to conduct specific analysis regarding beneficiary access to oncology care. Included in this analysis should be a determination of the extent to which the IPI Model has resulted in disruptions in beneficiary care and beneficiaries having to get care in higher-cost sites.