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December 12, 2013
The 113th Congress, which is ending its first session in a matter of days, has been criticized for being the least productive Congress in recent memory. In the race to adjourn for the year, Congress is seeking to complete action on a budget deal and take initial steps toward reforming Medicare payments for services provided by physicians.
By the first quarter of 2014, the National Coalition for Cancer Survivorship (NCCS) and its colleagues in the cancer advocacy community may see substantial progress toward a Medicare payment system that rewards quality and focuses on care planning and coordination. These core principles have been advanced by NCCS and its colleagues through their emphasis on development of cancer care plans for all Medicare beneficiaries diagnosed with cancer.
As Congress deliberates significant reforms of Medicare payments for physicians, the Centers for Medicare & Medicaid Services (CMS) has released the final fee schedule for calendar year 2014. In the final schedule, CMS abandoned a payment revision that would have significantly reduced rates of pay for certain cancer diagnostic tests and radiation oncology services. At the same time, the agency says that it is still considering the plan to reduce these payments and will seek additional comment on that proposal in the future.
In an opinion piece in the New England Journal of Medicine, Food and Drug Administration officials describe the breakthrough therapy designation authorized by the Food and Drug Administration Safety and Innovation Act (FDASIA) as “the initiation of a new paradigm for investigational drugs undergoing development in a setting of extensive mechanistic understanding of disease pathogenesis.”
The White House announced at the end of the November that the health reform website, healthcare.gov, is functional for most individuals who wish to shop for health insurance online. As many as 10 percent of consumers may need additional assistance beyond the website and are encouraged to seek assistance via phone. The Obama Administration has acknowledged continued problems in the communication of enrollment data to insurance companies and has pledged a solution to that problem.
In late November 2013, FDA sent a warning letter to 23andMe, the company that has provided direct-to-consumer genetic test results with an interpretation of the results. FDA stated in its letter that the “Saliva Collection Kit and Personal Genome Service” was being marketed by the company without marketing clearance or approval, in violation of the Federal Food, Drug and Cosmetic Act (FD&C Act).
August 1, 2013
Congresswoman Lois Capps (D-CA) and Congressman Mike Boustany (R-LA) introduced legislation on June 25, 2013, to establish a cancer care planning service in the Medicare program.
NCCS filed comments in support of proposed cancer care quality measures that will be utilized to assess the cancer care provided by the prospective payment system (PPS)-exempt cancer hospitals.
Shelley Fuld Nasso, NCCS Senior Director of Policy, was a panelist at the June 28, 2013, Food and Drug Administration (FDA) meeting on patient-focused lung cancer drug development. Ms. Fuld Nasso offered advice to FDA about strategies for incorporating patient needs and preferences in lung cancer drug development.
On July 2, 2013, the Department of Treasury posted a blog entry that stated, “The Administration is announcing that it will provide an additional year before the ACA mandatory employer and insurance reporting requirements begin.” A week later, the Internal Review Service published a three-page notice providing a few more details about the employer mandate delay.
An April 3, 2013, article in the Washington Post reported that “cancer clinics are turning away thousands of Medicare patients” because of the budget sequester. The article was published one month after the sequester, or the automatic budget cuts required by the Balanced Budget Act, became effective.
More than 100 experts in chronic myeloid leukemia (CML) signed an editorial in Blood, the journal of the American Society of Hematology, criticizing the price of drugs for treatment of CML. The editorial was published online on April 25, 2013, and has stimulated discussion and editorial comment on the topic of cancer drug pricing.
Shelley Fuld Nasso has joined the National Coalition for Cancer Survivorship (NCCS) as Senior Director of Policy, with responsibility for leading public policy activities, patient education, and other programs. Ms. Fuld Nasso previously served as Director of Public Policy and Director of Public and Medical Affairs at Susan G. Komen for the Cure. She brings to NCCS more than two decades of leadership in the fields of non-profits, philanthropy, and management consulting where she held a variety of roles, including Director of Community Philanthropy with The Dallas Foundation and Director of Strategy for MEplusYOU, a marketing agency in Dallas.
The United States Congress began a two-week spring recess on March 23, 2013, leaving behind a mixed record for addressing the nation’s fiscal challenges. Congress permitted across-the-board federal spending cuts to go into effect on March 1, 2013. Three weeks after that deadline, Congress approved an appropriations bill to fund the government through September 30, 2013. That spending bill slightly mitigated the effects of across-the-board cuts for certain departments and programs and also prevented the government shutdown that had been feared.
It is only six months until the health insurance marketplaces authorized by the ACA are to be operational and nine months before insurance coverage is required. What is happening to ensure that the marketplaces work and uninsured and underinsured Americans can consider purchasing insurance through the marketplaces and receiving premium subsidies if eligible for them?
NCCS hosted a Town Hall in Charlotte, North Carolina on March 14 for discussion about strategies to improve the quality of care for cancer survivors. Local health care leaders and cancer survivors joined NCCS for a stimulating discussion of the experiences of cancer survivors and public policy solutions to improve the cancer care and survivorship experience.
NCCS Offers Advice to FDA on Drug Shortages and Drug Approval Standards- NCCS and other cancer advocates submitted formal comments to the Food and Drug Administration (FDA) regarding strategies to inform consumers of drug shortages and mitigate such shortages. For the last several years, survivors and doctors have confronted serious shortages of drugs that are critical for the treatment of several forms of cancer.