This inaugural issue of The ASCO Post follows an intense year of debate about the American health-care system. The themes of the health-care debate on both sides were distilled down to two issues: (1) concerns about access to quality health care, and (2) the personal, private sector, and public costs of health care. Driving these two issues were the appropriateness-and the costs-of current medical practice patterns.

A year ago, the evaluation of current medical practice by comparative effectiveness research (CER) was codified in the American Recovery and Reinvestment Act (ARRA). The ARRA created an interagency infrastructure, the Federal Coordinating Council for CER, within the Department of Health and Human Services. To accelerate CER, this infrastructure received $1.1 billion in appropriations. The passage of the Patient Protection and Affordable Care Act (PPACA) 2010, in title VI, part III, subtitle D, section 6302, subsequently ordered the indefinite insertion and funding of the Federal Coordinating Council for CER within title XI of the Social Security Act, in addition to the creation of multiple other agencies for the evaluation of medical practice.

Targeted Areas of Research

Quickly fulfilling its charge to prioritize topics for CER of medical practice, the Institute of Medicine under ARRA targeted high-volume and high-cost areas in oncology for the first quartile of the program. Among the topics in oncology targeted for the first quartile of CER were the "effectiveness of management strategies," including watchful waiting for ductal breast carcinoma in situ and localized prostate cancer, the use of imaging technologies in every aspect of cancer diagnosis and care, and the use of genetic and biomarker testing. These oncology topics have also been recently addressed by the U.S. Preventive Services Task Force, the Medicare Coverage Advisory Committee, the Medicare Payment Advisory Commission (MedPAC), and the Institute of Clinical and Economic Review.

Reducing Medicare Spending

The Congressional Budget Office estimated that the impact of a Federal Center for Comparative Effectiveness Research on total health-care spending would be five times the cost of funding the center. It was estimated that CER could reduce Medicare and Medicaid spending by $1.3 billion between the years 2008 and 2017. This is particularly important given the approximate $500 billion cuts in Medicare reimbursement budgeted within the PPACA. With a $75 billion appropriation, the PPACA mandates that the Administrator of the Centers for Medicare & Medicaid Services develop quality measures for medical practice between 2010 and 2014, with an additional $20 billion dollars appropriated for periodic review. These measures will be used to report performance information to the public, and for all public and private health-care programs.

The Social Security Act will be amended by the PPACA to include an Authorization of Adjustment for Cancer Hospitals. In this authorization, the Secretary will conduct a study to determine if the costs incurred by cancer hospitals "exceed...costs incurred by other hospitals furnishing services under this subsection with respect to ambulatory payment classification groups," taking into account the cost of drugs and biologicals. However, this provision allows the Secretary to "provide for an appropriate adjustment...to reflect those higher costs effective for services furnished on or after January 1, 2011." Both children's and free-standing cancer hospitals remain excluded from the Medicare prospective payment system (PPS). Quality reporting by PPS-exempt cancer hospitals is required in section 3005 of the PPACA and must be published by October 2012.

Programs of Importance to Oncology

Oncology is included within the PPACA's provision for tax credits and grants for therapeutic discovery projects. Qualifying therapeutic discovery projects must show reasonable potential to (1) produce new therapies that treat areas of unmet medical need, by preventing, detecting, or treating chronic or acute diseases; (2) reduce long-term health-care costs; or (3) "significantly advance the goal of curing cancer within the 30-year period." Moreover, consideration will be given to projects with the greatest potential to (directly or indirectly) create and sustain high-quality, high-paying jobs in the United States, and to advance U.S. competitiveness in the fields of life, biologic, and medical sciences. In addition, the PPACA addresses initiatives for the diagnosis of oral cancer and colorectal cancer.

Also important to oncology is the Community-Based Care Transitions Program in section 3026 of the PPACA, which "provides funding to eligible entities that furnish improved care transition services to high-risk Medicare beneficiaries." A high-risk Medicare beneficiary is defined by a "hierarchical condition category score, as determined by the Secretary, based on a diagnosis of multiple chronic conditions or other risk factors associated with hospital readmission," which may include cognitive impairment, depression, a history of multiple readmissions, or "any other chronic disease or risk factor as determined by the Secretary."
Additionally, the Secretary "may expand the duration and the scope of the program...if the Secretary determines...that such expansion would reduce spending under this title without reducing quality." This Community-Based Care Transitions Program will be funded by $500 billion from Medicare.

Hospice Reform

In concert with the Community-Based Care Transitions Program, section 3132 (entitled Hospice Reform) mandates that "the Secretary shall collect additional data and information...appropriate to revise payments for hospice care" by no later than January 1, 2011. The data may include but are not limited to (1) charges and payments, (2) the number of days of hospice care attributable to individuals enrolled for benefits, (3) the number of days of hospice care attributable to each type of service, (4) charitable contributions and other revenue, (5) the number of hospice visits, (6) the type of practitioner providing the visit, and (7) the length of the visit and "other basic information with respect to the visit" that can include but is not limited to the cost of the type of service and the amount of payment for the type of service. Adjustments in per diem payments "will reflect changes in resource intensity in providing...care and services during the course of the entire episode of hospice care." The legislation also adopts MedPAC hospice program recertification recommendations.

In Conclusion

The sweeping health-care legislation passed over the past year will impact oncology practice through increased regulatory intervention and justification of therapeutic measures via comparative effectiveness research that incorporates patient-centered outcomes. Watchful waiting is now an accepted strategy in oncology. It is unknown whether the current strategies for locally advanced, metastatic, or other poor prognosis cancers will be influenced by CER, especially given the focus on hospice care within the PPACA. Time will tell how these legislative measures will influence the care of the cancer patient.

Dr. Janjan is a consultant in health policy after retiring in 2008 as Professor of Radiation Oncology and Symptom Research at The University of Texas M. D. Anderson Cancer Center in Houston, Texas.