New Orleans, LA—The Patient Protection and Affordable Care Act, ie, “health care reform,” was recently passed, but oncologists and those who pay for their services are still wondering what’s in store for them. In a keynote address delivered at the annual conference of the Hematology/Oncology Pharmacy Association (HOPA), Joseph S. Bailes, MD, chairman of the Government Re la tions Council and past-president of the American Society of Clinical Oncology (ASCO), enlightened attendees.
“This horse has left the barn and they tied an awful lot to it,” Dr Bailes said of the bill. “We will all be engaged in this, whether we like it or not.”
The main principles of reform—fairness and stability—were never in dispute, he said. “This is what the American people and physicians alike want.”
Nor are the general components of the legislation arguable: access to high-quality cancer care regardless of gender, race, ethnicity, or income; coverage, consistent with evidence-based medicine and reflective of the important role of clinical trials in cancer care; and reimbursement that reflects both the full scope of medically necessary services and fair payments that are stable from year to year.
But there have been disagreements as to how to achieve these principles, and now, how to implement change.
By way of background on Medicare policy development, Dr Bailes noted that “Congress is in charge” and many members want to “micromanage” Medicare. The Centers for Medicare & Medicaid Services (CMS) interprets Congress’ directions, he said, “and going forward this is going to be incredibly important to us and the patients we care for.”
A number of other entities will also be involved in interpreting the bill and making coverage decisions, including state legislations. “These will be more important than they have been previously,” he predicted.
Payers may see the emergence of a new entity that will help design Medicare payment policy, sort of a “MedPAC on steroids,” Dr Bailes commented.
MedPAC was established in 1997 as an independent advisory committee to advise Congress, based on concerns that Congress lacks the political will to make controversial payment decisions. Some have proposed an Independent Payment Advisory Board that will have additional authority to cut payment rates, he said. Supported by the Obama adminis tration, this board would provide recommendations outside of Medicare.
The concept of the healthcare reform bill is to cover the 35 million uninsured Americans and stabilize coverage for the currently insured, to make changes in the healthcare delivery system that will promote efficiencies and quality, and to slow the increasing costs of healthcare.
“If fully implemented, this bill contains $140 billion in savings the first 10 years and over $1 trillion the second 10 years,” Dr Bailes noted.
The components of reform will be paid for through individual and employer mandates; taxes on high incomes, employer health insurance benefits that exceed certain levels, and the pharmaceutical industry; US Food and Drug Administration–approved biosimilar pathways; productivity adjustments; Medicare provider cuts; a medical device tax; and multiple other provisions.
He emphasized that one-third of the cost of the healthcare reform act will be funded through reductions in the growth of Medicare spending.
Several “trends” in improving access and quality will be debated and refined as the reform movement evolves. There are movements to promote access to quality care and “value,” address disparities in care, develop and use performance measures, obtain and use data to promote best practices, promote the use of evidence-based medicine, and address the lack of coordination among providers.
Specific to cost-control, he also named these trends:
Registries will be promoted because they provide “a real-world view of the effectiveness of various drugs and devices,” he said. They are viewed as an important means of determining effects on smaller subpopulations and addressing disparities in care.
CMS is naming specific registries as useful tools for reporting performance measures to the federal government, and using registry data for some newly covered items and services, ie, coverage with evidence development, or “CED,” he said.
“This is incredibly important. I urge you to pay attention to how this is formulated and who is included in these registries,” he said, “and to be vigilant against unintended consequences [of the use of the data].”
“Cancer is viewed in Washington as an area that needs greater efficiency,” said Dr Bailes, who described what the oncology community can expect to face with regard to coverage issues.
Coordination of care will be promoted, but Medicare does not adequately recognize and cover the labor-intensive services required to coordinate cancer patients’ care with other providers and social services, he pointed out.
Medicare also does not adequately cover treatment planning and educational services, but demonstration projects are targeting this area. Other innovative pilots include the medical home, accountable care organizations, bundled hospital and postacute care plans, and programs to reduce hospital readmissions. These pilot projects will be combined under a new CMS Center on Payment Innovation.
Medicare no longer covers consultation codes, although the codes exist for potential use by other payers. Regarding compendia, Medicare contractors are using documentation requirements as a barrier to coverage for off-label drugs, he observed.
Clinical trials for patients with serious or life-threatening diseases—cancer being one—will be covered in terms of routine costs; however, Medicare does not cover the labor-intensive services associated with identifying and enrolling patients, he added.
The “framework” of reimbursement contains 4 key pieces: physician services, chemotherapy administration, drug costs, and the potential movement away from fee-for-service to bundled payment models.
A number of factors will affect reimbursement, Dr Bailes said. He foresees practice expense reductions, especially for chemotherapy administration codes, due in large part to CMS’ use of flawed Physician Practice Information Survey data. Additionally, the costs of doing business are rising faster than annual updates (sustained growth rates, Medicare economic index, etc).
The Competitive Acquisition Program (CAP) for Medicare Part B drugs and biologics, as an alternative to buy-and-bill, was refined in 2009 and can be implemented by Congress without further action. It was established under the Medicare Modernization Act of 2003, but its initial implementation was plagued by low interest from vendors and low enrollment by physicians, and it was eventually terminated.
“But some members of Congress feel wedded to this program,” he said. “CAP is not dead. There is much interest in revitalizing this. You will see this return as an innovative, efficient way to handle injectable drugs.”
Other issues to be tangled with are average sales price + 6%, prompt pay discounts, reductions in the malpractice component of payment, shift in clinical practice toward oral agents, the impact of Medicare’s decision to discontinue payment under consultation codes, the potential costs inflicted by Medicare audits, and the potential for payment to be tied to performance measures and to the use of electronic medical records.
In closing, Dr Bailes assured the assembled oncology pharmacists that there will be many opportunities to be part of positive changes. “There are opportunities here in oncology,” he emphasized. “As we move forward, it is important for us to be at these tables for discussion, so that our patients are represented and cared for by professionals who understand them.”
