Oncology and Health Care Policy

Steven Kent Stranne, Allen S. Lichter and Deborah Y. Kamin

• 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 extreme financial pressures, policy makers will continue to make decisions that have tremendous impact on the cancer community.

• Federal policies play a critical role in cancer research. Although the national resources devoted to cancer research remain substantial (exceeding $5 billion in 2012), the nation is losing opportunities and efficiencies because of suboptimal funding. The combination of relatively flat funding for the National Cancer Institute since 2003 and biomedical inflation has eroded the effective level of federal support for cancer research by more than 20% during the past decade. The promise for new highly effective cancer therapies has never been brighter, and as a result, the need to amplify the cancer community’s commitment to ensure that adequate research funding exists has never been greater.

• There are many examples within the federal government of initiatives to create safeguards for patients with cancer through laws, regulations, and agency determinations. For example, genetic testing holds great promise to help prevent significant morbidity and mortality for individuals carrying genetic risk factors for certain types of cancer. Although care must be taken to avoid unnecessary regulation, too few protections are currently provided in this area. Oncologists are uniquely positioned to help agency officials establish more robust safeguards that promote and protect the interests of patients with cancer.

• Drug shortages have also emerged to challenge the oncology community and policy makers. During the past few years, there has been a worsening trend in which critical and often curative anticancer drugs are suddenly becoming unavailable to patients in the United States. In 2012, the U.S. Food and Drug Administration increased its efforts to tackle this issue, and Congress took initial steps to help address drug shortages. The oncology community should continue to work with Congress and federal agencies to address the complex issue of drug shortages.

• Policies adopted by the Medicare program regarding 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 coverage policies, reimbursement levels, and coding used by Medicare as a starting point for establishing their own policies. In the face of extreme 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 the quality of care received by persons with cancer and that reimbursement for cancer care is fair and adequate to permit the ongoing delivery of high-quality, high-value cancer care.

• Oncologists and other cancer care specialists have unique insights involving the care of patients with cancer, and it will continue to 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 a professional responsibility.

Introduction

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—the Affordable Care Act (ACA)¹—has attracted headlines for several 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 funding of research proposals, national coverage determinations for Medicare promulgated by the Centers for Medicare & Medicaid Services (CMS), and policies established by the U.S. 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 extreme 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 intimately 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 can be divided into the following primary functions:

• Research. Through 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.

• Patient Safeguards. The federal government promotes patient safeguards and regulates health care services and products. For example, the federal government has taken steps to establish safeguards for genetic testing and privacy of health records. The FDA determines whether cancer drugs and devices may be provided to patients in the United States. The FDA also regulates other areas that affect the day-to-day practice of oncology, including monitoring and reporting of drug-related adverse events. State law and regulation also have a prominent part in regulating cancer care and establishing patient safeguards. Examples include insurance regulation and cancer-specific initiatives such as oral parity legislation.*

• Health Care Insurance. The federal government operates and funds the Medicare program, which covers approximately 60% of all patients with cancer in the United States.² It also oversees public health programs managed by 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.

Background

Multiple areas of authority and discretion are relevant to cancer policy development within federal and state governments. The three branches of government—the legislature, the executive branch, and the courts—each play distinct roles in a carefully constructed system of checks and balances. Although the Supreme Court’s review of the ACA during 2012 provides a notable example of the interplay between these branches of government, most cancer policies do not involve litigation.

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) and the ACA’s requirements for states to expand their Medicaid programs. 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 did so by defining it as a tax. The court struck down the ACA’s requirement for states to expand their Medicaid programs.³

Medicaid funding and oversight is 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. Although any form of coverage may appear preferable to being uninsured, the coverage for cancer care under most Medicaid programs is grossly inadequate, and some studies indicate that cancer outcomes are not significantly better for Medicaid patients in comparison with the uninsured.6–6

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.7,8 The political debate over the ACA is certain to continue for many years, and these patient safeguards, which have bipartisan support, warrant the cancer community’s ongoing attention.

As with the ACA, cancer-related policies of significance at the federal level often arise from laws enacted by the U.S. Congress (Table 21-1). 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 same dynamics also occur at the state level.

Table 21-1

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 between 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 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 shortages 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