The Next Step, August 2012

3rd Annual Childhood Cancer Summit Scheduled for September 20

The Congressional Childhood Cancer Caucus will host this year’s Childhood Cancer Summit on Thursday, September 20 at the U.S. Capitol, from 9:00-11:00 a.m.

This year’s Summit will feature FDA Deputy Commissioner Stephen Spielberg, MD, PhD. Dr. Spielberg has extensive academic and industry experience in pediatric medicine. The focus this year will be on what the federal government is doing on behalf of kids with cancer, according to Congressman Michael McCaul’s office. Congressman McCaul co-chairs the Childhood Cancer Caucus with Congressman Chris Van Hollen. Additional speakers and topics will be announced through the Caucus website at http://childhoodcancer-mccaul.house.gov/ as the event draws closer.

Congressional Leaders Reach Tentative Budget Deal

With the November elections looming, House and Senate leaders announced this week that a tentative budget agreement has been reached, in an effort to avoid the damaging political implications of a budget showdown this fall.  The deal is a six-month continuing resolution to fund the federal government through March 2013.

Last year's budget negotiations nearly led to a government shutdown, something both parties want to avoid in an election year. The deadline for passing fiscal year (FY) 2013 spending bills is October 1st. 

The compromise budget would provide a slight funding increase for FY2013, despite Republicans' desire to cut spending further. The House Appropriations Committee recently passed a FY2013 budget that would have sliced funding for the Department of Health and Human Services (HHS), defunded the Affordable Care Act, and cut funding for Medicare and Medicaid. It would have eliminated all funding for the Agency for Healthcare Research and Quality (AHRQ). Much of the debate over funding those issues, and many others, will now be postponed until after the election.

Congress begins a five-week recess on Friday and will tackle the spending bill when they return in September.

State Directors of Medicaid Seek Clarity after Supreme Court Ruling on Healthcare Reform

Following the Supreme Court’s ruling upholding the Affordable Care Act (ACA), the National Association of Medicaid Directors is seeking answers from the federal Center for Medicare and Medicaid Services (CMS) to complex policy questions left unanswered by the nation’s highest court.

The June 28th Supreme Court ruling enables a state to opt out of the ACA’s Medicaid expansion without losing all of its Medicaid funding. The ACA provision calls for an expansion of Medicaid eligibility to 133 percent of the federal poverty level. Medicaid directors are now trying to understand their options surrounding a more limited expansion of Medicaid in their states. State directors are also asking CMS to clarify the benefits for eligible individuals who opt to purchase coverage through healthcare exchanges instead of through Medicaid.

Several Republican governors have spoken out since the Supreme Court’s ruling, declaring that their states will not expand Medicaid. According to one analysis, 2.1 million fewer people will be eligible for Medicaid if Texas and six other states follow through with their threats to decline the expansion called for under ACA. Medicaid covers crucial treatment and services for low income children with cancer, whereas at this point it is unclear what health care benefits will be provided under state-based exchanges. CCCA will be keeping close watch on this issue for children as health care reform evolves.

Advocates Continue to Seek Solutions to Drug Shortages after Passage of FDA Law

Companies are now required to notify the Food and Drug Administration (FDA) early when they anticipate drug shortages, according to a provision in the recently signed FDA Safety and Innovation Act. While early notification to the FDA has already proven to be fairly effective at helping to prevent shortages, many experts worry that the new law will not be strong enough. Stakeholders are discussing what more needs to be done to ensure a long-term solution to the root problems causing the shortages.

Industry experts note that it could take many years for manufacturing companies to upgrade their facilities to increase capacity to meet demand. Some say the federal reimbursement policies may also cause shortages, while others say that FDA’s manufacturing monitoring procedures may be too strict.

The American Society of Clinical Oncology (ASCO) has spoken out in support of comprehensive legislation to supplement the provision in the new FDA law. The law does not impose monetary penalties on companies that do not comply with the early notification mandate. ASCO and other stakeholders note that penalties are necessary for the system to be effective. Dr. Michael Link, Stanford pediatric oncologist, championed the drug shortages issue during his recent tenure as president of ASCO. He has stated that the data are insufficient about economic factors at play and is calling for more studies to determine the underlying causes of the shortages in order to draft effective and targeted legislation.

Industry and Congressional sources agree that any new legislation on drug shortages is unlikely to gain traction between now and the November election.

New Survey: Primary Care Providers Lack Awareness about Late Effects

Primary care providers (PCPs) lack education and awareness about the long-term effects of chemotherapy treatment for cancer survivors, according to a large physician survey presented in June at the annual meeting of the American Society of Clinical Oncology (ASCO).

Survey data showed that many PCPs could not correctly identify specific late effects associated with chemotherapy agents. The survey revealed that even oncologists were lacking in awareness – although to a much lesser extent – about some of the damaging late effects from treatment. The physicians were surveyed on four drugs commonly used to treat breast and colorectal cancers. Just 6% of the PCPs were aware of late effects associated with all four drugs, compared with 65% of oncologists.

Survey respondents included over 1,000 PCPs and 1,100 oncologists. Although this survey focused on common drugs given to treat adult cancers, many of the same drugs are used to treat pediatric malignancies. The transition to adult PCP care from pediatric specialty care is particularly challenging for survivors because pediatric cancers are rare and PCPs may not have experience treating the long term and late effects associated with childhood cancer treatments.

Save the Date: Pro-Am Charity Doubles Invitational, Long Island

On Sunday, August 12, CCCA will be one of the charities to benefit from the Pro-Am Charity Doubles Invitational, a tennis tournament to be held at the Old Westbury Golf and Country Club on the North Shore of Long Island. Amateur players of all abilities will be paired with professionals for a fun day on the courts. The event begins with a cookout in the beautifully landscaped Old Westbury Country Club. Tickets are $350/player and can be purchased from CCCA. Spectators are welcome to attend the lunch and watch the matches with a suggested donation of $50. For more information, please contact Adam Rosen at arosen@silvermanacampora.com.