Centers for Medicare and Medicaid Services (CMS)

Conditions of Participation

On February 4, 2013, the Centers for Medicare and Medicaid Services (CMS) released the Proposed Rule for Part II Regulatory Provisions to Promote Program Efficiency, Transparency, and Burden Reduction.  This long-awaited proposed rule is important to nuclear medicine and addresses the issue of direct supervision in the preparation of radiopharmaceuticals.

The current requirement at § 482.53(b)(1) requires that the in-house preparation of radiopharmaceuticals be performed by, or under the direct supervision of, an appropriately trained registered pharmacist or a doctor of medicine or osteopathy. Direct supervision means that one of these professionals must be physically present in the hospital and immediately available during the preparation of all radiopharmaceuticals.

Following SNMMI’s suggestions, CMS has proposed removing the word “direct.”

We propose to revise the current requirement at § 482.53(b)(1) by removing the term “direct.” The revised requirement would then require that in-house preparation of radiopharmaceuticals be performed by, or under the supervision of, an appropriately trained registered pharmacist or doctor of medicine or osteopathy. The revision to “supervision” from “direct supervision” would allow for other appropriately trained hospital staff to prepare in-house radiopharmaceuticals under the oversight of a registered pharmacist or doctor of medicine or osteopathy, but it would not require that such oversight be exercised by the physical presence in the hospital at all times of one of these professionals, particularly during off-hours when such a professional would not be routinely present.

In the past, hospitals have reported to CMS that the direct supervision requirement is extremely burdensome when the presence of a pharmacist or physician is required for the provision of off-hour nuclear medicine tests that require only minimal in-house preparation of radiopharmaceuticals.

We currently await the Final Rule for Part II Regulatory Provisions to Promote Program Efficiency, Transparency, and Burden Reduction.

Coverage with Evidence Development

On September 27, 2013 CMS released their final decision memo for beta-amyloid positron emission tomography (PET) in dementia and neurodegenerative disease (CAG-00431N).  SNMMI was disappointed that the final decision requires coverage with evidence development (CED). Under the decision, CMS will cover one PET scan to exclude Alzheimer's disease, but only for patients participating in specific clinical studies under a CED program, which grants conditional reimbursement upon collection of specific data.

Appropriate use criteria jointly developed by the Alzheimer’s Association and SNMMI demonstrated that more than adequate evidence exists for Medicare to cover beta-amyloid PET. CMS coverage for this imaging test would give physicians an additional tool that could change patient management, leading to better health outcomes for patients and assisting families making care decisions.

SNMMI appreciates that in its final decision, CMS included CED with short-term outcomes related to changes in management. A test that can rule out Alzheimer’s disease can result in patients being taken off powerful medications that can be costly and are not indicated for their condition. That is a positive outcome. Although Alzheimer’s disease is the leading cause of memory loss, several other factors—such as other neurodegenerative diseases, strokes, thyroid problems or medications—can cause similar symptoms. Ruling out Alzheimer’s disease also has significant outcomes for a patient’s family and caregivers. SNMMI looks forward to working with all stakeholders to establish an appropriate method to meet the required CED process so that we can offer this valuable test to our patients.

SNMMI will soon be launching a comprehensive education program for physicians who will be referring patients and those who will be reading the scans. Additionally, SNMMI is developing technical procedure guidelines for ensuring quality in the performance of the scans.

Medicare Reimbusement Rates

Hospital Outpatient Prospective Payment System

More than 4,000 hospitals, including general acute care hospitals, inpatient rehabilitation facilities, inpatient psychiatric facilities, long-term acute care hospitals, children’s hospitals, and cancer hospitals are paid under the HOPPS.  There are approximately 5,000 Medicare-participating ASCs paid under the ASC payment system.

The HOPPS is currently a hybrid of a prospective payment system and a fee-for-service system, with some payments representing costs packaged into a primary service and other payments representing the cost of a particular item, service, or procedure.  Payment amounts vary according to the Ambulatory Payment Classification (APC) group to which a service is assigned.  The HOPPS includes payment for most hospital outpatient department services, and covers partial hospitalization services furnished by hospital outpatient departments and community mental health centers.

Medicare Physician Fee Schedule

The Medicare Physician Fee Schedule (MPFS) sets reimbursement rates which affects physicians and office payment for services paid under the resource-based relative value scale (RBRVS). Prior to the use of this schedule, which began in 1992, charges for services were based on customary, prevailing and reasonable charges. With the implementation of MPFS, charges were intended to be based on resource costs required to provide the services. The MPFS pricing amounts are adjusted to reflect the variation in practice costs from area to area. A geographic practice cost index (GPCI) has been established for every Medicare payment locality for each of the three components of a procedure's relative value unit (RVU). The GPCIs are applied in the calculation of a fee schedule payment amount by multiplying the RVU for each component times the GPCI for that component.

More information on the HOPPS and MPFS can be found at SNMMI's Coding Corner.