Appropriate Use of Advanced Technologies for Radiation Therapy and Surgery in Oncology: Workshop Summary by unknow

Author:unknow
Language: eng
Format: epub
Tags: Health and Medicine: Cancer, Health and Medicine: Medical Technologies and Treatments
Publisher: The National Academies Press
Published: 2016-12-21T00:00:00+00:00

BOX 6

Medicare Reimbursement Decisions

Marc Hartstein, director of the Centers for Medicare & Medicaid Services (CMS) Hospital and Ambulatory Policy Group, and Tamara Syrek Jensen, director of the CMS Coverage and Analysis Group, described the process for determining whether Medicare will provide reimbursement for a new technology and if so, what the reimbursement rate should be. Jensen noted that national coverage decisions generally take 9 months and involve 6 months of in-house discussions and reviews, after which a proposed decision is posted followed by a 30-day public comment period. At the end of that comment period, CMS posts the final decision on their website.

Legally, Medicare is expected to cover medical treatments that are “reasonable and necessary.” The operational definition CMS uses to define reasonable and necessary is that there is adequate evidence to conclude that the item or service improves clinically meaningful health outcomes for the Medicare population. In addition to reviewing the evidence that a treatment offers clinical improvement, CMS also considers whether to narrow the coverage decision for specific patient populations, practitioner specialties, provider volumes, or other factors to ensure positive outcomes. Precedents in other coverage decisions are also factored in, but as Jensen emphasized, “Any decision we make is always based on the evidence and that’s how we defend it.”

For treatments that seem promising but for which there is not yet sufficient evidence for a definitive coverage decision, CMS can use “coverage with evidence development” (CED). Technologies provisionally covered under CED would be reimbursed only if patient outcomes are documented in a registry or a clinical study. Once enough data are collected to answer outstanding questions CMS has on the technology, a final coverage decision is made.

Jensen noted that new devices being studied for Food and Drug Administration (FDA) review under an investigational device exemption may also be covered by Medicare if they meet certain criteria. In addition, Medicare patients being treated in a clinical trial sponsored by the National Institutes of Health (NIH), the FDA, or the Agency for Healthcare Research and Quality (AHRQ) are eligible to have their routine costs in the clinical trial reimbursed by Medicare, and in some cases, the investigative item or service is also covered. She also described a new parallel review process in which manufacturers provide data to both the FDA and CMS so that regulatory and reimbursement decisions can be made simultaneously.

CMS also collaborates with NIH to gather the evidence needed to make coverage decisions, and with AHRQ, which undertakes technology assessments and helps determine the questions that need to be answered with CED.

Hartstein reported that new technologies and the medical procedures in which they are used must have an established benefit category in the Medicare legal statute in order for Medicare to reimburse them. These benefit categories include physician services, services and supplies, hospital services, and X-ray, radium, and radioactive isotope therapy, including materials and services of technicians. There is a subcategory under hospital services for new technologies not yet incorporated into the hospital charges data reported to Medicare.

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