CANCER RESEARCH, PREVENTION & EARLY DETECTION
Short-Term Funding Bill Increases Cancer Research Funding, Protects Access to Health Care Services
On Feb. 9, Congress passed and the President signed a short-term extension to the FY18 spending bill which includes several ACS CAN priorities. The bipartisan deal increases investment in medical research funding over the next two years and lifts budget caps for FY18 and FY19 budgets, enabling appropriators to work to finalize FY18 spending bills. The bill also allows for an increase of at least $1 billion for the National Institutes of Health (NIH) for FY18 and FY19 each recognizing NIH as a critical national priority and acknowledging the importance of reliable funding growth for medical research at NIH.
The bill also protects access to care for millions of low-income Americans. It also includes two years of funding for Federally Qualified Health Centers (FQHCs) and an additional four years of funding for the Children's Health Insurance Program (CHIP) beyond the six-year extension that Congress approved in January. Extending funding for FQHCs and CHIP will make it possible for millions of low-income adults and children, including many cancer patients, to receive critical health care services.
While the legislation addresses a number of critical federal programs that are instrumental in making progress against cancer, ACS CAN is disappointed that it cuts the Prevention and Public Health Fund by $1.35 billion as an offset. Funding for effective prevention programs is essential to reducing death and suffering from cancer.
Administration Budget Threatens to Undo Advances in Cancer Fight
Yesterday, the administration released its FY19 budget proposal which includes a minimum $1 billion cut for medical research at NIH, significantly less than the amount House and Senate committees have approved for FY 18 funding levels. The administration's budget also reduces funding and eliminates important cancer screening and prevention programs at CDC, eliminates subsidies for purchasing health insurance through the exchanges, and transforms Medicaid funding into a per capita cap or block grant structure. In our press release, ACS CAN detailed the considerable risks to cancer research, prevention, early detection and treatment if the administration's budget is implemented.
Through advocacy, we will urge Congress to reject these proposed cuts and to build on the broad bipartisan consensus around support for medical research including cancer research at the NIH by appropriating at least $2 billion per year for FY18 and FY19.
ACS CAN will also press lawmakers to maintain funding for cancer prevention and screening programs at the Centers for Disease Control (CDC) and for important tobacco cessation programs through the Office of Smoking and Health (OSH).
ACCESS TO CARE
ACS CAN Joins Many Patient Advocates to Oppose Proposed Right to Try Legislation
On Feb. 6, ACS CAN, together with nearly 40 other patient organizations sent a letter to U.S. House Leadership today opposing proposed Right to Try legislation being considered in the House. The letter notes, "The Right to Try bills currently under consideration in the House do not effectuate policy changes that would afford our patients greater access to promising investigational therapies. Instead, these bills would likely do more harm than good."
The groups note that when access to a therapy is denied to a patient, it is generally the company that denies the request, rather than the Food and Drug Administration (FDA), for reasons such as a determination that the benefits do not outweigh the risks or lack of sufficient product to offer outside of clinical trials.
The letter urges leadership to instead consider legislation that, "would improve the ability of patients to genuinely and safely access unapproved therapies."
ACS CAN Submits Comments to the Centers for Medicare and Medicaid Services
On Jan. 16, ACS CAN filed comments in response to the Centers for Medicare and Medicaid Services' (CMS) proposed rule implementing changes to the Medicare Part C and Part D programs. ACS CAN commented on a number of proposed issues, including:
- Implementation of the Comprehensive Addiction and Recovery Act (CARA): CMS proposed to implement a number of policies as required under the CARA, which requires Medicare Part D plans to limit access to opioids for beneficiaries deemed at-risk for misuse or abuse. ACS CAN raises a number of questions related to how this policy will be implemented for cancer patients and asks CMS to issue clarifications.
- Medicare Advantage (MA) Plan Flexibility: CMS proposed to allow MA plans additional flexibility to reduce cost-sharing for certain benefits for its enrollees. ACS CAN is generally supportive of the proposal, but cautioned that CMS should engage in careful monitoring to ensure that plans are not using the flexibility to increase costs to beneficiaries.
- Limitations on the Special Enrollment Period (SEP) for Low-income Subsidy (LIS) Beneficiaries: CMS proposed to limit the ability for LIS beneficiaries to switch Part D plans mid-year. ACS CAN urged CMS not to adopt the policy at this time because these beneficiaries may need to switch plans if their current plan undergoes a mid-year formulary change.
- MA Quality Rating System: CMS proposed to require that quality reporting be done at the plan rather than organizational level. ACS CAN supported this provision because it would more accurately reflect the quality of care provided to beneficiaries. CMS also proposed new policies regarding the adoption of new quality measures. ACS CAN is concerned that the proposed policy would result in a lag time between when the quality measures are first proposed and when they are actually implemented by CMS.
- Request for Information on Manufacturer Rebates and Pharmacy Price Concessions: Included in the proposed rule is a request for information (RFI) on requiring Part D plans to include a minimum percentage of manufacturer rebates and pharmacy price concessions be included in the negotiated price at the point of sale. CMS does not propose specific regulations, but rather is using the proposed rule as an opportunity to solicit comment that will be used for future rulemaking. ACS CAN is generally supportive of the policies outlined in the RFI.
Activities in the States
ACS CAN Comments Help Proposed Rule Avoid Negative Impact on Medical Research
In the latter stages of his administration, New Jersey's governor, Chris Christie, prioritized policies addressing the opioid epidemic in a variety of ways, including a proposed rule intended to provide additional oversight of the financial relationship between prescribers and pharmaceutical manufacturers. Of specific concern to ACS CAN was a proposed cap on payments to physicians for their services which would have had an unintended effect on cancer drug development. The cap would have limited the ability of physicians to enroll patients in clinical trials and stall commercial drug development in the state.
ACS CAN submitted comments on the rule to the Division of Consumer Affairs, explaining that while the aim of the proposed rule was laudable, it could inadvertently result in the limitation of appropriate payments and ultimately cause a significant negative impact on cancer research and clinical trials in the state. The final rule was adopted on Jan. 16, and due in part to ACS CAN's engagement on the issue, included amendments ensuring that the compensation cap specifically excludes research and clinical trials.