Oncology and Health Care Policy

Summary of Key Points

Policies promulgated by government at the federal, state, and local levels have profound effects on virtually every aspect of the day-to-day practice of oncology. In the face of growing financial pressures, policy makers will continue to make decisions that may have tremendous impacts on the cancer community.
Federal policies play a critical role in cancer research. Although the national resources devoted to cancer research remain substantial ($5.6 billion in 2017), federal funding has not kept pace with inflation or increased scientific opportunities, and the nation is not making all of the progress it should. Legislation enacted in 2015 and 2016 increased the federal commitment to cancer research but does not overcome the impact of the combination of relatively flat funding for the National Cancer Institute since 2003 and biomedical inflation. The promise offered by new, highly effective cancer therapies has never been brighter, and as a result the benefits we are likely to realize from adequate and consistent research funding have never been greater.
Policies adopted by the Medicare program regarding the prevention, diagnosis, and treatment of cancer have greatly influenced both the practice of oncology and the services available to both Medicare and non-Medicare patients throughout the United States. Both public and private insurers often rely on the coverage policies, reimbursement levels, and coding used by Medicare as a starting point for establishing their own policies. In the face of growing economic pressure, oncologists and other cancer care professionals must remain engaged in helping to inform policy makers and to shape these changes. This effort includes working to ensure that policies designed to reduce health care expenditures do not undermine access to care or the quality of care received by persons with cancer and that reimbursement for cancer care is fair and adequate.
Oncologists and other cancer care specialists have unique insights involving the care of patients with cancer, and it will be increasingly important to communicate these insights effectively. Policy can have a profound impact on practice, making engagement in the process not only important but also a professional responsibility.

Federal and state governments play critical roles in establishing policies that shape and fund virtually every aspect of cancer care and research throughout the United States. Although federal health care reform legislation—including the Affordable Care Act (ACA) and subsequent legislative efforts—has attracted headlines for many years, such high-profile legislation is just one aspect of cancer policy. Many important policies arise with much less fanfare. Examples include policies adopted by the National Cancer Institute (NCI) to guide the funding of research proposals, national coverage determinations for Medicare promulgated by the Centers for Medicare and Medicaid Services (CMS), and policies established by the US Food and Drug Administration (FDA) regarding products used for the prevention, diagnosis, and treatment of cancer.

For the foreseeable future, cancer policy initiatives must be forged in a political environment beset by growing financial pressure. Potential cuts in reimbursement and funding will remain an ongoing threat, raising the stakes for efforts to advocate for policies that protect and promote the needs of persons with cancer, the cancer research enterprise, and oncology professionals.

As the modalities and therapies available to diagnose and treat cancer have become more successful and more complex, the administrative burdens and financial constraints placed on all cancer care specialists have become more extreme. Perhaps more than at any other time, policy issues confronting the cancer community are most properly viewed as affecting the oncology community as a whole rather than any individual segment. The fates of community-based, hospital-based, and university-based cancer care providers and researchers are increasingly linked in ways that may not be transparent to the casual observer.

This chapter does not catalogue every policy initiative that affects the cancer community. Rather, the following discussion provides a framework for understanding the important roles that federal and state governments play in regulating, shaping, and funding the oncology care delivery system and research enterprise.

The roles played by federal and state policy makers in cancer include:

Research. Through the NCI and other federal agencies, the federal government serves a leadership role in and provides significant funding for cancer research performed throughout the United States, including basic science research, translational research, and clinical trials.
Health care insurance. Through the ACA and subsequent legislative initiatives, the US Congress is engaged in reforming the health care system, addressing concerns regarding access to health care insurance and the affordability of health care insurance. In addition, the federal government operates and funds the Medicare program, which covers approximately 60% of all patients with cancer in the United States. The federal government also oversees public health programs managed by the CMS, the Department of Defense, the Veterans Health Administration, and other federal agencies. Coverage, reimbursement, and coding policies established by Medicare have significant influence on the policies adopted by most other public and private health care insurers. Federal and state laws may also create patient safeguards that private insurers must follow, such as the protections established under the ACA to promote patient access to cancer care through clinical research trials.
Cost of care. Through its payment policies for providers and services, the federal government has a major impact on the care of patients with cancer. Policy makers have placed increasing emphasis on promoting quality, cost-effectiveness, and value in the health care system over the past decade. With strong bipartisan support, Congress enacted the Medicare Access and CHIP Reauthorization Act (MACRA) in 2015 to create a new framework for promoting quality and value. The CMS articulated an aggressive timeline for reforming its long-standing fee-for-service payment framework in favor of a system driven by value. These are some of the most significant changes in health care organization and delivery since the Medicare program was established in 1965. They will also motivate significant transformation on the part of oncology practices in the coming years.
Health information technology. Oncology care often involves complex diagnostic and treatment regimens delivered by multiple health care providers, and health information technology holds tremendous promise to promote quality, communication, efficiencies, and research. Despite a federal investment of over $30 billion to promote the adoption of health information technology infrastructure, health care providers continue to face significant challenges in obtaining health care information stored by other health information technology systems. Congress enacted provisions to promote interoperability as part of the 21st Century CURES Act in 2016.

Background

Multiple areas of authority and discretion are relevant to cancer policy development within federal and state governments. Each of the three branches of government—the legislature, the executive branch, and the courts—plays a distinct role in a carefully constructed system of checks and balances. Although the Supreme Court's reviews of the ACA during both 2012 and 2015 provide notable examples of the interplay among these branches of government, most cancer policies do not involve litigation.

In 2012 the Supreme Court considered the constitutionality of two major provisions of the ACA—the individual mandate (a requirement that individuals maintain a minimum level of health care insurance for themselves and their tax dependents or pay a tax penalty) and the ACA's requirements for states to expand their Medicaid programs. The architects of the ACA relied heavily on Medicaid as a vehicle for expanding coverage to the uninsured. In June 2012 the Supreme Court upheld the individual mandate but struck down the ACA's requirement for states to expand their Medicaid programs.

In 2015, the Supreme Court again considered the constitutionality of a major provision in the ACA, this time focusing on the validity of federal tax credits, which provide financial subsidies for health insurance, in states without state-operated health insurance exchanges. With annual federal subsidies to 6.4 million Americans at stake in the 34 states with insurance marketplaces operated by the federal government, the Supreme Court upheld the ACA subsidies. In 2017, Congress eliminated the financial penalty for individuals who fail to maintain health insurance (effective January 1, 2019). Although Congress did not repeal the requirement for individuals to maintain health insurance, the legislation eliminated the ACA’s enforcement mechanism used to encourage individuals to obtain health insurance coverage.

Medicaid funding and oversight are a shared responsibility between states and the federal government, and political leaders in many states have indicated an initial unwillingness to engage in any significant expansion of their Medicaid programs. From the perspective of oncology patients and providers, the issue of Medicaid expansion remains complicated. The coverage requirements for the expanded population created under the ACA differ from traditional Medicaid. Although we do not have much evidence regarding the adequacy of coverage for cancer care under the ACA expansion population, concerns remain regarding Medicaid-covered cancer patients because some studies have indicated that, historically, cancer outcomes are not significantly better for Medicaid patients in comparison with the uninsured. The Trump Administration has refocused federal administration of the Medicaid program by enhancing opportunities for states to apply for and receive waivers to redesign the rules for Medicaid program benefits and eligibility, creating the potential that protections could erode for cancer patients on a state-by-state basis.

Although some provisions of the ACA will remain highly controversial, a number of relatively noncontroversial provisions are particularly important for the cancer community. These provisions include protections for patient access to preventive screening for cancer; protections to help vulnerable individuals with cancer secure and retain access to health insurance; safeguards for individuals with cancer and other preexisting conditions; and protections for patient access to clinical trials. These patient safeguards, which have bipartisan support, warrant the cancer community's ongoing attention and support.

As with the ACA, cancer-related policies of significance at the federal level often arise from laws enacted by the US Congress ( Table 20.1 ). However, in virtually every law enacted by Congress, there are substantial gaps, conflicts, and ambiguities within the legislation that must be resolved as part of the implementation process. As a result, the work to influence the final version of a national policy involving cancer rarely ends with the enactment of legislation. Advocates for the cancer community must typically devote substantial attention to educate agency officials and influence policies adopted by agency officials under both new and preexisting legislative authority. These dynamics also occur at the state level.

Table 20.1

Selected Federal Laws Relevant to Cancer Policy

Federal Law	Summary of Selected Effects on the Cancer Community
National Cancer Institute Act of 1937	Established the National Cancer Institute and charged it with conducting, fostering, and coordinating research and training related to the cause, prevention, diagnosis, and treatment of cancer
National Cancer Act of 1971	Began “War on Cancer,” initiated the National Cancer Program and its various boards, authorized creation of new cancer centers and training programs, expanded existing research facilities, enhanced collaboration in cancer research among federal, state, and other entities, and appropriated significant funds for a variety of research-related purposes
Biomedical Research Training Amendments (1978)	Expanded research on preventing cancer caused by workplace and environmental carcinogens and emphasized cancer education programs initiated within local communities and hospitals
Veterans Health Care Act of 1992	Amended the Public Health Service Act by adding section 340B, which limits the amount certain safety net providers must pay to manufacturers for covered outpatient drugs
Omnibus Budget Reconciliation Act of 1993	Required Medicare to cover off-label uses of anticancer drugs recognized in certain medical compendia and required Medicare to cover orally administered anticancer drugs that have the same indications and active ingredients as covered infused anticancer drugs
Health Insurance Portability and Accountability Act (1996)	Limited the restrictions that group health plans can place on the coverage of preexisting conditions and created security and privacy protections
Balanced Budget Act of 1997	Expanded Medicare coverage for several cancer screening tests, implemented the Sustainable Growth Rate reimbursement methodology, and provided coverage for antiemetic drugs used as part of anticancer chemotherapeutic regimens
Medicare Prescription Drug, Improvement, and Modernization Act (2003)	Created Medicare Part D (prescription drug benefit), changed methodology for calculating relative value of drug administration services, and instituted new average sales price payment methodology for many drugs and biological products covered under Medicare Part B
Genetic Information Nondiscrimination Act (2008)	Prohibited employment decisions made on the basis of genetic information and prohibited group health plans and health insurers from making coverage and premium decisions for healthy persons on the basis of genetic predispositions for future illnesses
Affordable Care Act (2010)	Established safeguards under private health insurance plans to ensure coverage of individuals with preexisting conditions and for individuals participating in clinical trials, established protections for patient access to preventive screenings for cancer under Medicare, Medicaid, and private insurance, and established the Innovation Center within the CMS for evaluating new payment methodologies, including but not limited to accountable care organizations
Food and Drug Administration Safety and Innovation Act (2012)	Established provisions to address shortages of cancer drugs and other medications, included a notification requirement for manufacturers 6 months in advance of an anticipated drug shortage, directed the Food and Drug Administration to include biologicals on drug shortage listings, and included fees for generic drug applications to support agency resources for more rapid reviews of generic drugs, which also may help avoid or alleviate drug shortages
Medicare Access and CHIP Reauthorization Act (2015)	Created a new framework for promoting quality and value within the context of Medicare's traditional fee-for-service benefits, replacing the previous formula for physician reimbursement
21st Century Cures Act (2016)	Authorized additional federal funding for cancer research and created mandates to promote interoperability among health information technology systems.
Bipartisan Budget Act of 2018	Repealed the Affordable Care Act's “individual mandate” tax penalty for failure to maintain health insurance and made unrelated changes to the Medicare program in a number of ways that benefit the cancer community, including a correction to avoid reductions to Medicare Part B drug reimbursement.

For policies relevant to the cancer community at the federal level, the discretion to identify and address the gaps, conflicts, and ambiguities in the statutory language rests with the executive branch, including the Office of the President and the US Department of Health and Human Services. In practice, all but the most politically sensitive issues are typically determined by one of the sister agencies within the Department of Health and Human Services, including the NCI, National Institutes of Health (NIH), CMS, FDA, Centers for Disease Control and Prevention, Health Resources and Services Administration, and Agency for Healthcare Research and Quality.

These agencies are charged with providing the expertise to make effective policies in areas involving complex scientific and clinical issues. As a result, there often are a substantial number of agency employees who have scientific and clinical backgrounds, although other agency officials may have limited experience in these areas. In many instances, agency employees are left with lean staffing to contend with some of the most challenging issues facing the US health care system. This situation heightens the importance of efforts by oncologists to share detailed, practical solutions with federal and state policy makers regarding the complex issues facing the cancer community and the health care system.

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