The New Health Care Legislation: A Look Ahead

Congress and the Obama administration took a historic step toward expanding access and improving health care for all Americans in passing health reform legislation last month. The most comprehensive health reform in decades, “The Patient Protection and Affordable Care Act (HR 3590),” was built upon through subsequent legislation “The Reconciliation Act of 2010 (HR 4872),” also passed by Congress and signed into law by President Obama last month.

Strong interdisciplinary teams form the backbone of care for chronic kidney disease See our special section, beginning on p. 7


The health reform legislation focuses primarily on expanding insurance coverage and increasing its affordability, reducing health care costs, and transforming care delivery. Eventually, the legislation aims to ensure coverage for 32 million people—meaning more than 94 percent of all legal U.S. residents will be covered. However, reforms laid out in the bills will not be implemented immediately, and some of the most important provisions will not go into effect for years. Significant responsibility for carrying out health reform goes to the Department of Health and Human Services (HHS); H.R. 4872 appropriates $1 billion to HHS for enactment. Table 1 shows when provisions of the health care legislation become effective and highlights components pertinent to the kidney care community, and can also be downloaded as a pdf from ASN’s Kidney News website at

Table 1


Many aspects of these broad reforms—greater access to coverage, emphasis on prevention, closure of the donut hole, expansion of comparative effectiveness research—will almost certainly influence patients at every level in the coming years, including those with kidney disease. Health reform does not address kidney disease at length, but there are a number of key sections of interest for the nephrology community in the 2400-plus pages of legislation.

Models of care delivery

Transforming the delivery system is a primary focus in the health care bill. The legislation paves the way for a host of pilot programs and enables physicians to begin sharing in savings derived from improved care delivery as early as 2010.

The Patient Protection and Affordable Care Act establishes a “shared savings program” through which groups of providers coordinate care for Medicare beneficiaries in accountable care organizations (ACOs). ACOs—which are groups of providers and suppliers with shared governance that meet quality performance standards determined by the HHS secretary—will be eligible to receive payments for shared savings beginning January 1, 2012. Intended to promote efficient service and accountability for a patient population, the ACO program encourages investment in infrastructure and redesigned care processes. Among other things, qualified ACOs must promote evidence-based medicine and patient engagement, and meet patient-centeredness criteria specified by the secretary, such as through the use of individualized care plans.

Although the Act grants the HHS secretary discretion in further defining ACOs, it suggests that ACOs may be formed of an array of providers and organizations, including professionals in group practice arrangements, networks of individual practices, and hospitals employing ACO providers. This inclusive model would afford nephrologists numerous avenues to participate in an ACO—and potentially to improve the delivery and quality of care for patients with kidney disease at any stage of progression from stage I through dialysis.

In addition to the ACO program, the Act creates a Center for Medicare and Medicaid Innovation (CMI) within CMS, tasked with testing innovative payment and service delivery models beginning no later than January 2011. The HHS Secretary will select for testing models that address a specific population for which a care deficit exists, or a population with potentially avoidable expenditures. The patient-centered medical home (PCMH) model and Healthcare Innovation Zones (HIZ) are among possible opportunities for funding and investigation in the legislation.

The PCMH concept has received increasing attention within the nephrology community as a possible opportunity to better harmonize care (1). Potentially, nephrologists could provide care and receive payment as a “neighbor” to the medical home, or serve as the “home,” for some patients. HIZs—groups of providers including a teaching hospital, physicians, and other clinical entities—would receive a comprehensive payment for delivering a full spectrum of coordinated health care services. Given the well-recognized challenges of managing chronic kidney disease and its common co-morbidities, nephrologists are likely contenders to be included in at least some test service and delivery models in the CMI.

GAO study on access under bundled payments

Although CMS has yet to release a Final Rule on the bundled rate payment system for end stage renal disease (ESRD) care, health reform legislation includes a provision requiring the Government Accountability Office (GAO) to conduct a study on the impact on Medicare beneficiary access to dialysis drugs, including drugs or biologicals for which there is no injectable equivalent or other non-oral form of administration. The report will examine providers’ ability to furnish oral drugs or arrange for their provision, and their ability to comply with state pharmacy licensure requirements. Furthermore, GAO will assess whether appropriate quality measures exist to safeguard care for patients being furnished specified oral drugs by providers and renal dialysis facilities and will make recommendations to Congress.

This independent analysis of patient access under the bundled payment system will be vital to ensure quality and accessibility of care. Yet the provision is also of interest because of its relationship to the forthcoming Final Rule on the bundled payment system. One possible interpretation of this language is that Congress intended the study to be prospective—and that CMS should therefore delay implementation of bundling until it is completed. Conversely, it could be interpreted that Congress intends for all drugs without injectable equivalents—including calcimimetics and phosphate binders—in the bundle as of January 2011.


As the nephrology community prepares for implementation of the bundled rate payment system for ESRD care, the health reform bill lays groundwork for further shifts toward payment bundling. Specifically, the Act requires the HHS secretary to develop a pilot program for integrated care during an episode of hospitalization. Most important, the pilot bundle would include physicians’ services. Also included in the bundle would be payments for acute inpatient care, outpatient and emergency department, and post-acute care services. No date is set for initiation of the pilot program. However, if the secretary determines that expansion of the program would improve—or not reduce the quality of—patient care and reduces costs, he or she must develop a plan for implementation no later than January 16, 2016.

This landmark pilot program marks the first attempt to unite physician fees with other payments since the inception of the Medicare program. Theoretically, the pilot could in the long term prove to be the first step in major changes to the physician payment system.

Industry payments to physicians have long been of interest to Congress, and the Patient Protection and Affordable Care Act will begin bringing these transactions into the public eye as of March 31, 2013. All manufacturers of drugs, devices, biologicals, or medical supplies will submit to the HHS secretary detailed documentation of payments made to physicians or teaching hospitals every 90 days. The name and address of recipients, as well as the amount, date, and description of payments are among the information required for all payments or “transfers of value,” including consulting fees, honoraria, gifts, education, research, and travel. The secretary will make payment information publicly available via an Internet database, plus “background information on industry-physician relationships” and “any other information the Secretary determines would be useful for the average consumer.”

The Act contains a limited number of exceptions, including delayed publication of payments made related to research on a potential new medical technology or application, and of those made in connection with a clinical investigation regarding a new drug or device. Notably, nephrologists, like other physicians, will not share any reporting burden; the Act places this responsibility solely on industry.


The number of U.S. medical students pursuing careers in nephrology has been declining for years, and many consider the lack of student interest in internal medicine residencies to be part of the problem. Seeking to address this shortfall of general interest and other primary care physicians, Congress included numerous approaches to encourage more students to go into primary care.

In addition to multiple incentive payment programs and loan repayment options for students entering primary care, the bill also redistributes 65 percent of currently unused residency training slots and directs those slots to hospitals in certain states in July 2011. “The nation’s medical schools and teaching hospitals have expressed their full support for this bill to President Obama,” said Association of American Medical Colleges (AAMC) President and Chief Executive Officer Darrell G. Kirch, MD (2).

Comparative effectiveness research

“The most significant thing [in the health care bill] is comparative effectiveness research,” said National Institutes of Health (NIH) Director Francis Collins, MD (3). Indeed, the legislation establishes a “Patient-Centered Outcomes Research Institute,” an independent, nonprofit corporation to increase the quality and relevance of medical services and treatment through comparative effectiveness research. The institute is tasked with identifying national priorities for comparative effectiveness research, taking into account factors of disease incidence, prevalence, and burden—and emphasizing chronic conditions and gaps in evidence in terms of clinical outcomes, among other factors. In carrying out its research agenda, the institute will enter into contracts to manage funds and conduct research with federal government agencies as well as the academic and private sectors.

ASN will be actively engaged in collaborating with members of Congress, HHS (particularly the Centers for Medicare and Medicaid Services), and the rest of the nephrology community to implement these reforms and address other important aspects of the U.S. health care system not included in this historic legislation.



DuBose T, et al. The Nephrology–Primary Care Interface: Providing Coordinated Care for Chronic Kidney Disease. NephSAP 2010; 9:1–4.


Kirch D. “AAMC Hails Final Passage of Reform Legislation.” March 21, 2010. Press Release. Available:


Saslow R. “Conversations: Francis S. Collins. NIH Director Sees Hits and Misses in Health Care.” March 24, 2010. The Washington Post.