Introduction
This article summarizes some of the most important federal coverage provisions and safeguards that promote access to preventive services for individuals with cancer or individuals who are at risk for cancer. It focuses on the perspective of the oncology community on the new policies enacted as part of the recent federal healthcare reform legislation, and it provides observations regarding ways in which the unique expertise of healthcare providers specializing in the prevention, diagnosis, and treatment of cancer—and other stakeholders in the cancer community—might help inform the direction of future policy development and patient safeguards.
Steven K. Stranne, MD, JD
Access to preventive services is a recurrent theme running throughout the healthcare reform legislation. In March of 2010, President Obama signed two pieces of legislation into law—the Patient Protection and Affordable Care Act, and the Health Care and Education Reconciliation Act of 2010; these are often referred to collectively as the Affordable Care Act or the ACA.[1,2] The provisions in the ACA that govern preventive services address both public and private health insurance coverage. As with most major pieces of healthcare legislation, the initial legislative language provides a framework for the US Department of Health and Human Services (in many instances acting through the Centers for Medicare & Medicaid Services [CMS]) to follow during the process of implementation. CMS and other federal agencies are left to exercise discretion to address any gaps, conflicts, or ambiguities arising under the statute through the promulgation of regulations, guidance documents, and coverage determinations.
Coverage of Preventive Services—A Brief History
The evolution in coverage of preventive services in the United States is most clearly demonstrated by reviewing the history of the Medicare program. Medicare is a federal health insurance program that provides healthcare coverage to individuals who satisfy eligibility requirements related to age or disability. When Congress initially created the Medicare program in 1965, there was relatively little emphasis on—or scientific evidence to support—the coverage of preventive screening services. The original law enacted by Congress focused on the coverage of services for the diagnosis and treatment of illness or injury,[3] and the longstanding interpretation of this provision has precluded the coverage of preventive screening tests and many other preventive services under Medicare.
Congress has subsequently enacted narrow legislative provisions in a piecemeal manner over the years that added coverage of specific preventive services under Medicare; the first such provision, enacted in 1980 (effective in 1981), was coverage of the pneumococcal vaccine.[4] Congress retained sole discretion to decide what additional preventive benefits would be added to the Medicare program for nearly three more decades. Congress added coverage of Pap smear screening tests under the Omnibus Budget Reconciliation Act of 1989,[5] screening mammography under the Omnibus Budget Reconciliation Act of 1990,[6] and prostate and colorectal cancer screening tests under the Balanced Budget Act of 1997.[7]
Although Congress still retains the ability to enact targeted provisions that provide coverage for preventive services, Congress began delegating discretion to CMS to make such determinations under the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (commonly referred to as the Medicare Modernization Act, or MMA). Through the MMA, Congress authorized CMS to cover blood screening tests for cholesterol, lipid, and triglyceride levels, explicitly giving CMS the authority to expand coverage to additional cardiovascular screening blood tests as long as the United States Preventive Services Task Force (USPSTF) recommended the test.[8]
Directly relevant to the oncology community, Congress expanded this delegation of authority in 2008, subject to certain constraints, to cover additional preventive services under Medicare without explicit approval from Congress. Specifically, section 101 of the Medicare Improvements for Patients and Providers Act of 2008 granted CMS the authority to add coverage of additional preventive services if the USPSTF either "strongly recommends" (grade A) or "recommends" (grade B) the service. In addition, Congress established a requirement that CMS use its national determination process when considering whether to add such coverage for preventive screening tests.[9] Medicare's national coverage determination process, which often requires at least a year to complete, is designed to promote public input and transparency in the development of coverage policies promulgated at the national level. As a result of these changes, CMS can add coverage of new screening tests for cancer and other diseases to the Medicare program without securing explicit approval from Congress.
Interestingly, Congress also empowered CMS to factor the cost of the screening benefit into the determination of whether or not to establish coverage for a preventive service under this authority. Specifically, section 1861(ddd) of the Social Security Act provides that “the Secretary may conduct an assessment of the relation between predicted outcomes and the expenditures for such service and may take into account the results of such assessment in making such determination.”[10] This is noteworthy in part because issues concerning whether and how the Medicare program can consider cost when making coverage and pricing determinations have been politically charged for many years.
In creating a requirement that the USPSTF recommend a preventive service prior to consideration by CMS for Medicare coverage, Congress placed great importance on the substance and timing of the USPSTF's determinations. The USPSTF is an independent panel that has operated since 1984; it is composed of non-federal primary care providers with expertise in preventive and evidence-based medicine. The Agency for Healthcare Research and Quality (AHRQ) is charged with supporting the panel's activities, and AHRQ also plays a supportive role to CMS in the context of establishing new coverage policies under the national coverage determination process. There is considerable information available on the USPSTF website regarding the composition, process, and activities of the USPSTF, including final recommendations and issues currently under review. Under a relatively new initiative, the USPSTF is providing opportunities for the public to contribute input regarding draft documents and draft recommendations promulgated by the USPSTF.[11]
