An Oncology Perspective on Preventive Services in the Context of US Healthcare Reform

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]

Developments Under the Affordable Care Act

The ACA is very large in scope and is designed to make significant changes to our healthcare system. Among its many other initiatives, the ACA includes provisions designed to reduce the number of uninsured individuals in the United States, create safeguards for access to healthcare services under both public and private insurance programs, and establish new models for the payment of healthcare services. Interspersed throughout are many provisions that address preventive services directly or indirectly. This article does not catalogue every provision in the ACA that references or relates to preventive services; rather, the following discussion attempts to provide a framework for understanding a number of the issues related to the coverage of preventive services that may interest providers specializing in oncology and other stakeholders in the cancer community.

The ACA contains general provisions involving access to care that could have very positive impacts on access to preventive services for individuals who are at risk for cancer or individuals with a history of cancer. For example, the ACA has established a safeguard that prevents many private insurance plans from discriminating against individuals with pre-existing conditions, including cancer. The safeguard on pre-existing conditions became effective for children in September of 2010 and will become effective for adults in 2014.[12] In addition, to the extent that the provisions designed to expand coverage for the uninsured are successful, these changes seem likely to help promote access to preventive services.

Some observers have expressed concern regarding whether the expanded access created under the ACA will improve outcomes for individuals with cancer or at risk for cancer. The ACA relies heavily on expanding Medicaid coverage as a means of extending coverage for the uninsured population. Medicaid is a public health insurance program for low-income individuals and families, and Medicaid programs are operated in each state through collaborations between the state and federal governments. In many states there have been longstanding concerns about the adequacy of benefits available to cancer patients under the Medicaid program, and some of the literature suggests that clinical outcomes in oncology are relatively similar for Medicaid and uninsured populations.[13,14,15] At a minimum, such data highlight the need for the cancer community to remain vigilant in identifying concerns in the future involving Medicaid enrollees and access to preventive screening tests and related follow-up services.

Private sector health plans

Building on its past reliance on the USPSTF, Congress created new requirements under the ACA for coverage of preventive services that apply to private insurers, Medicare, and Medicaid. For example, for the private sector market, the law requires that most group and individual health plans provide coverage of preventive services without cost-sharing for all USPSTF recommendations that have received a grade of A or B. Congress also required private sector group and individual plans to cover the following three additional categories of screening services: 1) immunizations recommended by the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices (CDC ACIP); 2) preventive care and screenings recommended for infants, children, and adolescents by the Health Resources and Services Administration (HRSA); and 3) additional preventive care and screenings for women established by HRSA that are not otherwise addressed by the USPSTF.[16] These safeguards generally became effective for plan years beginning on or after September 23, 2010. Pursuant to this provision under the ACA, HRSA posted new screening guidelines for women on August 1, 2011.[17]

Interestingly, the provision in the legislation on screenings in the private sector market includes a specific exclusion for private group and individual health plans for the recommendations that the USPSTF promulgated in November 2009.[18] The exclusion has the effect of requiring coverage for routine mammography beginning at age 40 even though current USPSTF recommendations encourage screening only in women over the age of 50.

Medicare

In the hope of removing a barrier to utilization under Medicare, the ACA eliminates coinsurance and deductible payments for any preventive service that Medicare covers that also is recommended by the USPSTF with a grade of A or B. In practice, this means that most but not all of the preventive screening tests currently covered by Medicare will no longer require coinsurance or deductible payments from beneficiaries. However, prostate cancer screening through digital rectal exam will continue to require coinsurance and deductible payments because this screening test does not have a USPSTF recommendation of grade A or B. Screening for prostate cancer through prostate specific antigen (PSA) testing and screening for colorectal cancer through barium enema testing would have met the same fate due to the lack of USPSTF recommendations of grade A or B; however, the coinsurance and deductible payments for PSA screening and the deductible for barium enema screening are already waived under separate sections of the Social Security Act.[19] The coinsurance payment requirement for barium enema screening for colorectal cancer remains in place.[20]

The ACA makes additional changes to the coverage of preventive services under Medicare. For example, Congress clarified that certain deductible payment requirements for colorectal screening will be waived regardless of the coding used, the result of the test, or whether tissue is removed.[21] In addition, the ACA gives CMS the authority to remove or modify the coverage of preventive services previously added to Medicare by statute or otherwise if the service lacks a USPSTF grade of A, B, C (no recommendation given for routine use), or I (insufficient evidence). The coverage of PSA screening under Medicare for prostate cancer will likely provide a test for whether and how CMS may exercise this new authority. In a potential change in policy posted on October 7, 2011, the USPSTF proposed to downgrade its statement on PSA screening tests for men under the age of 75 from I (insufficient evidence) to D (not recommended).[22] This change by the USPSTF, if finalized, would trigger the option for CMS to remove Medicare coverage of PSA screening for asymptomatic men.

The ACA also establishes coverage (with no coinsurance or deductible requirement) for annual exams under Medicare that will facilitate the development of personalized prevention plans. Through this new Medicare annual exam benefit, the treating physician is to establish a screening schedule for the upcoming 5 to 10 years based on the recommendations of the USPSTF. The annual visit is also to include a comprehensive health risk assessment with personalized advice to address risk factors, as well as a number of other elements to be identified by CMS.[23]

Medicaid

With respect to the Medicaid program, the ACA establishes new safeguards that also rely in part on the recommendations of the USPSTF and the CDC ACIP. Preventive services that receive a grade of A or B from the USPSTF and immunizations recommended for adults by the CDC ACIP must be covered by state Medicaid programs that provide other diagnostic screening, prevention, and rehabilitative services, effective January 1, 2013. The legislation provides for the level of federal financial assistance-the federal medical assistance percentage (FMAP)-to increase by 1% for such preventive services and for tobacco cessation counseling for those states that cover additional services and vaccines without cost sharing.[24]

The ACA also created new preventive services coverage for pregnant women under Medicaid. As of October 1, 2010, Medicaid programs must cover counseling and drug therapy for tobacco cessation for pregnant women without imposing cost-sharing requirements on enrollees. There are to be no limitations or restrictions on the coverage of such drugs, as long as the drugs are approved by the US Food and Drug Administration for this purpose and they are recommended in a publication entitled Treating Tobacco Use and Dependence: 2008 Update: A Clinical Practice Guideline.[25]

More generally, the ACA creates incentive grants for Medicaid projects to test the use of evidence-based incentives for preventing chronic diseases for Medicaid enrollees. As envisioned under the ACA, $100 million will be provided over 5 years to this program, which began with the award of grants in September of 2011. The grant program's five specific goals emphasize smoking cessation, weight reduction or control, lowering blood pressure, lowering cholesterol levels, and avoiding the onset or improving the management of diabetes.[26]

Other measures designed to promote access to preventive services

In addition to the provisions that establish coverage requirements and safeguards for preventive services, there are a number of provisions throughout the ACA that are designed to promote access to preventive services. For example, the legislation establishes a council called the National Prevention, Health Promotion, and Public Health Council (the Council) that is to coordinate federal prevention, wellness, and public health activities. The Council is composed of public officials, and they are charged with developing a national health strategy in collaboration with an advisory group, the members of which are not federal officials. Council duties include coordinating federal activities; obtaining input from stakeholders; and providing recommendations on the most pressing health issues, including reduction of tobacco use, sedentary behavior, and poor nutrition. The Council is also to consider and propose evidence-based models, policies, and innovations for prevention, integrative health, and public health on individual and community levels.

The Council developed a national prevention strategy and published the document on June 16, 2011.[27] This document focuses on issues such as active lifestyles, tobacco-free living, and healthy eating. There are to be subsequent annual reports that list national priorities that address lifestyle behavior modification (including smoking cessation, proper nutrition, and appropriate exercise) and prevention measures for the top five disease killers in the United States. The subsequent annual reports, the first of which was published on June 30, 2011, are also required to include science-based initiatives to achieve measureable goals based on the Department of Health and Human Services' "Healthy People 2020" objectives with regard to nutrition, exercise, and smoking cessation.[28]

One aspect of the ACA that has been a source of ongoing confusion is a provision that appears to create two new task forces with important responsibilities involving preventive services. However, this provision in fact refers to entities that have existed for many years-the USPSTF (United States Preventive Services Task Force) and the CPSTF (Community Preventive Services Task Force).[29] There do not appear to be any significant changes in policy arising from this particular provision.

The legislation also provides for significant investment in prevention and public health initiatives. The law establishes a Prevention and Public Health Fund to provide a dedicated and stable stream of funding for these activities at the federal level. The fund is to support programs authorized under the Public Health Service Act that facilitate prevention, wellness, health screening, and immunization. After an initial phase-in, the legislation envisions annually allocating $2 billion to this fund in fiscal year 2015 and thereafter. This fund has been targeted for elimination by opponents of the healthcare reform legislation. For example, the US House of Representatives passed legislation on April 13, 2011 that would completely repeal the section that established the Prevention and Public Health Fund and rescind all unobligated amounts allocated by the ACA to the fund.[30]

One of the few explicit references to "secondary prevention" in the healthcare reform bill occurs in the context of an education campaign. There is a provision that envisions an extensive national campaign for disease prevention and health promotion across the lifespan using science-based social research. The objectives of this campaign are to include the promotion of wellness, the reduction of disparities in care, and the mitigation of chronic disease. The initiative is to promote the use of the preventive services recommended by the USPSTF and the CPSTF, and the media campaign is to include secondary prevention through promotion of disease screening, along with other required elements, such as smoking cessation.[31]

Issues and Concerns

Many of the safeguards and requirements arising from the ACA that focus on preventive services are welcome improvements that show great promise to improve clinical outcomes for individuals with cancer or at risk for cancer. However, there remain a number of issues of potential importance to the oncology community that will require building on the ACA framework.Broadly, the emphasis on preventive screening services throughout the ACA provides a platform that the cancer community can use to educate policymakers and others on the importance of ensuring that, in addition to traditional primary screening to detect cancer, there is also meaningful access to services that address the unique needs of individuals with cancer, cancer survivors, and other groups of individuals who require types and frequencies of preventive services that may not be protected under general guidelines. For example, depending on the nature and intensity of cancer treatment received in the past, a cancer survivor may have a need for certain screening tests for cardiovascular disease, secondary cancers, and other chronic conditions at an earlier age or with greater frequency than the rest of the population. Also, depending on an individual's family history, race, or ethnicity, access to specific types or frequencies of preventive oncology services may be necessary. Even though many of the individuals involved in enacting the ACA probably conceptualized preventive screening and services in a more general sense, the ACA provisions provide an opportunity to promote the more nuanced clinical needs of some at-risk individuals.

Another broad consideration arising from the ACA involves the growing importance of the USPSTF in defining the coverage of preventive services. Although no oncologists serve on the USPSTF, the USPSTF has addressed many issues involving oncology (including politically charged issues such as mammography screening and PSA screening.) The oncology community should continue and intensify its efforts to work with the USPSTF by developing clinical evidence and providing unique perspectives that can help protect individuals at risk for cancer.

Despite the reliance on evidence-based recommendations for the ACA's prevention safeguards, inadequate protections exist for racially and ethnically diverse populations. Moy et al, describing concerns related to disparities in access to cancer screening services, noted that certain subpopulations of patients may require more frequent screening tests or screenings starting at a younger age than the broader population.[32] Additional resources need to be targeted to addressing gaps in the scientific literature concerning these issues. In the interim, the oncology community should work with the USPSTF, CMS, and private insurers to ensure that adequate flexibility exists in coverage policies to address the needs of special populations.

There is also a need to make explicit the requirement that covered screening services be linked with coverage of any necessary follow-up care. For example, while specificity exists under the healthcare reform legislation for recommendations graded as an A or B by the USPSTF, it is much less clear whether public and private health insurance programs will cover further testing for abnormalities found during an initial screening. Especially during this time of transition, the oncology community must remain vigilant to ensure that the potential gaps in coverage for critical follow-up testing or care do not undermine the intent of this legislation.

References:

h3 class="onc_header">REFERENCES

1. Pub. L No. 111-148.

2. Pub. L No. 111-152.

3. Social Security Act, 42 USC §1395y(a).

4. Social Security Act, 42 USC §1395x(s) as amended by Parental Kidnapping Prevention Act of 1980, Pub. L No. 96-611 §1(a)(1).

5. Social Security Act, 42 USC §1395x(s) as amended by Omnibus Budget Reconciliation Act of 1989, Pub. L No. 101-239 §6115(a)(1).

6. Social Security Act, 42 USC §1395x(s) as amended by Omnibus Budget Reconciliation Act of 1990, Pub. L No. 101-508 §4163(a)(1).

7. Social Security Act, 42 USC §1395x(s) as amended by Balanced Budget Act of 1997, Pub. L No. 105-33 §4103(a)(1) and §4104(a)(1).

8. Social Security Act, 42 USC §1395x(xx) as amended by Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Pub. L No. 108-173 §612(b).

9. Social Security Act, 42 USC §1395x(s) as amended by Medicare Improvements for Patients and Providers Act of 2008, Pub. L No. 110-275 §101(a)(1).

10. Social Security Act, 42 USC §1395x(s) as amended by Medicare Improvements for Patients and Providers Act of 2008, Pub. L No. 110-275 §101(a)(1)(B).

11. Opportunities for public comment. US Preventive Services Task Force Web site. Available from: http://www.uspreventiveservicestaskforce.org/tfcomment.htm. Updated September 2011. Accessed October 11, 2011.

12. Public Health Service Act, 42 USC §300gg-3(a) as amended by Patient Protection and Affordable Care Act, Pub. L No. 111-148 §1201(2)(A) and §1255.

13. Roetzheim RG, Gonzalez EC, Ferrante JM, et al. Effects of health insurance and race on breast carcinoma treatments and outcomes. Cancer. 2000;
89:2202-13.

14. Kelz RR, Gimotty PA, Polsky D, et al. Morbidity and mortality of colorectal carcinoma surgery differs by insurance status. Cancer. 2004;101:2187-94.

15. Roetzheim RG, Pal N, Gonzalez EC, et al. Effects of health insurance and race on colorectal cancer treatments and outcomes. Am J Public Health. 2000;
90:1746-54.

16. Public Health Service Act, 42 USC §300gg-13(a) as amended by Patient Protection and Affordable Care Act, Pub. L No. 111-148 §1001(5).

17. Women's preventive services: required health plan coverage guidelines. Health Resources and Services Administration Web site. Available from: http://www.hrsa.gov/womensguidelines/. Accessed October 11, 2011.

18. Public Health Service Act, 42 USC §300gg-13(a)(5) as amended by Patient Protection and Affordable Care Act, Pub. L No. 111-148 §1001(5).

19. 75 Fed Reg 226 (November 24, 2010) 72014-72015.

20. 75 Fed Reg 226 (November 24, 2010) 72015.

21. Social Security Act, 42 USC §1395l(b) as amended by Patient Protection and Affordable Care Act, Pub. L No. 111-148 §4105(c).

22. Draft recommendation statement: Screening for prostate cancer. US Preventive Services Task Force Web site. Available from: http://www.uspreventiveservicestaskforce.org/draftrec3.htm. Published October 7, 2011. Updated October 11, 2011. Accessed October 11, 2011.

23. Social Security Act, 42 USC §1395x(s) and 42 USC §1395x(hhh) as amended by Patient Protection and Affordable Care Act, Pub. L No. 111-148 §4103.

24. Social Security Act, 42 USC §1396d(a) and 42 USC §1396d(b) as amended by Patient Protection and Affordable Care Act, Pub. L No. 111-148 §4106.

25. Social Security Act, 42 USC §1396d as amended by Patient Protection and Affordable Care Act, Pub. L No. 111-148 §4107.

26. Patient Protection and Affordable Care Act, Pub. L No. 111-148 §4108.

27. National Prevention Council. National prevention strategy. Available from: http://www.healthcare.gov/prevention/nphpphc/strategy/report.pdf. Published June 16, 2011. Accessed October 11, 2011.

28. National Prevention Council. 2011 Annual status report. Available from: http://www.healthcare.gov/prevention/nphpphc/2011-annual-status-report-nphpphc.pdf. Published June 30, 2011. Accessed October 11, 2011.

29. Public Health Service Act, 42 USC §299b-4 and 42 USC §280g-10 as amended by Patient Protection and Affordable Care Act, Pub. L No. 111-148 §4003.

30. To repeal the Prevention and Public Health Fund, HR 1217, 112th Cong, 1st Sess.

31. Patient Protection and Affordable Care Act, Pub. L No. 111-148 §4004.

32. Moy B, Polite BN, Halpern MT, et al. American Society of Clinical Oncology Policy Statement: Opportunities in the Patient Protection and Affordable Care Act to reduce cancer care disparities. J Clin Oncol. 2011;29:3816-24.