Council on Radionuclides and Radiopharmaceuticals, Inc.

CORAR advocates for public policies that impact health care, transportationsafety, homeland security, and manufacturing in an effort to expandaccess to safe and affordable health care treatments for all.

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CORAR Comments Submitted to The NNSA’s Office of Global Threat Reduction (GTRI) “Call for Input Form”

The Council on Radionuclides and Radiopharmaceuticals (CORAR) provides the following 
comments and recommendations to the Department of Energy in support of the implementation 
of the American Medical Isotopes Production Act of 2012 (AMIPA). 
CORAR members are committed to working with all U.S. and international stakeholders to 
ensure a reliable, sufficient and sustainable supply of medical radioisotopes from non-HEU 
production sources, in particular due to nonproliferation and nuclear security risks arising from 
potential theft or diversion of highly enriched uranium (HEU) targets to unauthorized uses. At 
the same time, CORAR believes that efforts to promote the use of non-HEU produced 
molybdenum-99 (Mo-99) must be closely monitored to ensure that U.S. patients are not 
adversely impacted either by (1) supply shortages due to inadequate or unreliable supply sources, 
or (2) insufficient reimbursement for higher cost non-HEU Mo-99 including low enriched 
uranium (LEU).

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CORAR submitts comments to CMS on 2014 proposed rule for the Medicare Hospital Patient Prospective Payment System (OPPS)

CORAR recently submitted comments to CMS on the 2014 proposed rule for the Medicare Hospital Patient Prospective Payment System (OPPS).   The CORAR comments focused on a number of provisions of particular importance to the radiopharmaceutical/nuclear medicine industry, including the following:

  • CORAR continues to believe that CMS should unpackage diagnostic radiopharmaceutical drugs from the nuclear medicine procedure if they meet the applicable cost threshold for other “specified covered outpatient drugs” that are paid separately.

  • To the extent that CMS' packaging policy is applied, CORAR believes that the costs of packaged diagnostic radiopharmaceuticals must be fully reflected in the associated hospital ambulatory payment classification (APC) procedure payments.  Therefore, CORAR suggests that CMS continue to apply radiopharmaceutical edits for nuclear medicine procedures.

  • CORAR requests that CMS present detailed information on how it attempts to capture the full cost of radiopharmaceuticals in associated APC procedural payments.  Likewise, CORAR recommends that CMS reconfigure the nuclear medicine APCs to better account for the range of packaged radiopharmaceutical costs, or develop a separate outlier or add-on policy for high-cost packaged diagnostic radiopharmaceuticals.

  • CORAR has concerns about CMS’s proposal to package seven new categories of supporting items and services into the APC payment, since it could result in items and services that are economically and clinically dissimilar being included in the same APC in violation of the Social Security Act.  Likewise, CORAR requests clarification on CMS’s regulatory authority to classify drugs, biologicals, and radiopharmaceuticals as “supplies.”

  • CORAR supports the Administration’s efforts to ensure a reliable, sufficient and sustainable supply of medical radioisotopes from non-highly enriched uranium (HEU) production sources.  We agree with CMS that OPPS payment policy should recognize full cost recovery of the additional costs, which are not accounted for in historical claims data, and which are not likely to be passed on to hospitals uniformly as the industry converts.  However, CORAR believes that CMS must take additional measures to more effectively gather the cost data necessary to fully recognize the cost disparities between HEU and non-HEU sources.

  • CORAR supports radiopharmaceutical eligibility for pass-through status and suggests that CMS consider a higher pass-through payment amount for radiopharmaceuticals.  CORAR strongly recommends that CMS make radiopharmaceutical pass-through payments available for the full three-year period authorized by law.  To that end, CORAR objects to CMS’s proposal to expire the pass-through status of Ioflupane I123 Injection (C9506/A9584) after only 2.5 years.

  • CORAR opposes CMS’s proposed $10 increase in the threshold for separate payment for outpatient drugs.  CORAR instead recommends that CMS limit increases in the threshold amount to the hospital update for the year (reflective of all statutory adjustments).

  • CORAR supports CMS continuing its policy to reimburse separately-payable, non-pass-through OPPS drugs, including therapeutic radiopharmaceuticals, at the “statutory default” rate of average sales price (ASP) plus 6%.  CORAR suggests that CMS evaluate ways to compensate hospitals for higher overhead and handling costs associated with radiopharmaceuticals.

  • CORAR recommends that CMS continue the current requirement that hospitals report the “FB” modifier for nuclear medicine scans in which a no cost/full credit diagnostic radiopharmaceutical is used to promote accurate cost reporting.

  • CORAR expresses cautious support for CMS’s proposal to use data from new cost centers for CT, MRI and Cardiac Catheterization to calculate cost-to-charge ratios (CCR) that will be used to set 2014 rates because it appears to more accurately account for hospital costs associated with nuclear medicine procedures.  However, we share the concerns of other stakeholders about the potential impact of the change on other imaging procedures.

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