The Council on Radionuclides and Radiopharmaceuticals, Inc. 

500 North Capitol Street, NWSuite 210  
Michael J. Guastella, MS, MBA Executive Director  Washington, DC 20001-7407(202) 547-6582 michael.guastella@corar.org  
January 29, 2020  
VIA EMAIL  
Ms. Seema Verma  
Administrator  

Centers for Medicare & Medicaid Services Attention: Division of Practitioner Services, Potentially Misvalued Codes7500 Security Boulevard Baltimore, MD 21244–1850 
RE:  Valuation of Myocardial Positron Emission Tomography (PET) Proceduresin MedicarePhysician Fee ScheduleRule for CY 2021 
Dear Ms. Verma: 
The Council on Radionuclides and RadiopharmaceuticalsInc.(CORAR)appreciates theopportunity to submit comments to the Centers for Medicare & Medicaid Services (CMS) in advance of the proposed Medicare Physician Fee Schedule (PFS) rule for calendar year 2021(Proposed 2021 PFSRule), focusing on valuation of myocardial positron emission tomography (PET) procedures. 
CORAR represents the developers, manufacturers, and radiopharmacies that provide RPsto physician offices and imaging centers for the diagnosis and treatment of Medicarebeneficiaries and other patients. Nuclear medicine imaging procedures are a safe and non­invasive way to image the body through the use of specializedcamerasand software applicationsin conjunction with diagnostic RPdrugsthat are introduced into the body. Nuclear medicineimaging with RPs goes a step beyond other imaging tests such as X-rays and MRIs because, in addition to illustrating an organ’s anatomy, it can demonstrate an organ’s function. This iscritical information that otherwise would not be available or available only through the use of more expensive, invasive tests or surgery. Thus, the benefits of nuclear medicine imaging areespecially important for Medicare beneficiaries who may not tolerate more invasive tests or surgery. 
CORAR commends CMS for notadoptingits proposed reductionsto practice expense(PE) and work relative value units (RVUs) for myocardial PET procedures for 2020. CMSinvited comments on payment for these services for consideration in future rulemaking. As discussed below, we urge CMS to ensureit maintainsappropriateRVUs for PET procedures to preserve beneficiary accessto these servicesas it develops the Proposed 2021 PFS Rule. 
I. Background: 2020 PFS Rulemaking 
In the proposed 2020PFS rule,CMSproposed steep reductionsin thework and PE RVUs for myocardial PET procedures, particularly: 
The Council on Radionuclides and Radiopharmaceuticals, Inc. • 500 North Capitol Street, NW • Suite 210 • Washington, DC 20001-7407
(202) 547-6582 • Fax: (202) 547-4658 • michael.guastella@corar.org 
CPT78491 --Myocardial imaging, positron emission tomography (PET), perfusion study (including ventricular wall motion[s] and/or ejection fraction[s], when performed); single study, at rest or stress (exercise or pharmacologic) 
CPT78492 --Myocardial imaging, positronemission tomography (PET), perfusion study (including ventricular wall motion[s] and/or ejection fraction[s], when performed); multiple studies at rest and stress (exercise or pharmacologic) 
The American College of Cardiology (ACC), American College of Nuclear Medicine (ACNM), the American Society of Nuclear Cardiology (ASNC), Cardiology Advocacy Alliance (CAA) and the Society of Nuclear Medicine and Molecular Imaging (SNMMI) estimatedthat theproposed inputs could reduce payment for thetechnical component (TC) for some myocardialPET services by up to 80%. 
Much of the proposed decline in RVUswas attributed to CMS’s proposalto move away from contractor pricing of the TC of nuclear medicine PET servicesand to instead adopt “activepricing”for theseprocedures. For equipment items ER110 (PET Refurbished Imaging CardiacConfiguration) and ER111 (PET/CT Imaging Camera Cardiac Configuration), CMS proposed adopting a 90% --rather than 50% --equipment utilization ratebased only on generalequipmentutilization assumptions for expensive diagnostic imaging equipment. With regard to work values, CMS proposed to disregard theAMA RUC1recommendations and instead adopt sharply lower work RVUs based on a questionable total time ratio methodology. 
In our comment letter on the proposed 2020 rule, CORAR expressed our concerns thatthe proposed rulewould significantly undervalue this equipment, especially relative to contractor pricing. We recommended that CMS restore the 50% utilization assumption for ER110 andER111 and work closely with the specialty societies to develop more accurate inputs. We likewiseurged CMS to defer adoption of the proposed work RVUs for 2020 and to collaboratewith the specialty societies to reevaluate these codes and develop a consensus on accurateRVUs. Finally, to the extent that CMS adoptedsignificant reductions in theRVUs, we requested thatCMS observe the Protecting Access to Medicare Act of 2014 (PAMA) requirementthatreductionsof in total RVUs of 20 percent or moremust be phased in over multiple years to mitigate provider disruptions and preserve patient access to these critical services. 
CORAR was pleased that CMS did not adopt these cuts to myocardial PET procedurevaluations in the final 2020 PFS rule. In particular: 
• 
CMS agreed to delay active pricing of the TC of nuclear medicine PET services in 2020, which would have resulted in deep payment cuts,in “the interest of maintaining payment stability and protecting patient access to these importantservices.” CMS noted that “there is substantial work to be done to assure the new valuations for the TCs of these codes accurately reflect the technical inputs,” and CMSagreed to review inputs submitted by the public. 

• 
Based on information submitted by commenters, CMS did not adopt its proposal to assume a 90% utilization rate for the ER110 and ER111 equipment items; instead CMS maintained the default 50% utilization rate assumption for both items. 

• 
CMS agreed to use the RUC recommendations rather than its proposed lower RVUs, in “consideration of the public comment, and in the interest of payment stability and protecting patient access for these services.” 


1 AmericanMedicalAssociation(AMA)/Specialty Society Relative Value Scale Update Committee (RUC). 
The Council on Radionuclides and Radiopharmaceuticals, Inc. • 500 North Capitol Street, NW • Suite 210 • Washington, DC 20001-7407
(202) 547-6582 • Fax: (202) 547-4658 • michael.guastella@corar.org 
Together these final policies were a significant improvement over the proposed rule, and wecommend CMS for its consideration of the data submitted by stakeholders and its responsiveness to our comments. 

II. Comments in Preparation fortheProposed 2021 PFS Rule 
CORAR appreciates CMS’s solicitation of input on myocardial PET procedure pricing in advance of theProposed 2021 PFSRule. We urge CMS to continuethe 50% utilization assumption for ER110 (PET Refurbished Imaging Cardiac Configuration) and ER111 (PET/CTImaging Camera Cardiac Configuration), which is supported by workflow data submitted to CMS. We agree with CMS that “there is substantial work to be done to assure the new valuations for the TCs of these codes accurately reflect the technical inputs.” CMS should ensure stablevalues for these procedures while this work is ongoing to protect patient access. More broadly, we urge CMS to carefully collaborate with the specialty societies with regard to both the work and PE RVUs for these proceduresso thatthe valuations accurately and fully capture theresources associated with these procedures. 
In the final 2020 rule, CMS indicated that it would not consider itself bound by theprovision of Protecting Access to Medicare Act of 2014 (PAMA) requiring phase-in of significant RVU reductions if the RVU change results from a shift from contractor-priced statusto active pricing status. CMS provided no statutory support for this assertion – only that it“believes”that moving from contractor-priced status to active pricing status“constitutesa ‘revised code’”that is exempt from the PAMA rule, rather than a change to an existing code. 
We respectfully disagree with thisnew interpretation, and believe such a policy is notsupported by the actual statutory language or CMS’s prior final rule for CY 2019, which CMScited in the 2020 final rule preamble. 
Section 1848(c)(7) ofthe Act, as added by section 220(e) of PAMA, providesthat: 
Effective for fee schedules established beginningwith 2017, for services that arenot new
or revised codes,if the total relative value units for a service for a year wouldotherwise
be decreased by an estimated amount equal to or greater than 20 percent as compared to 
the total relative value units for the previous year, the applicable adjustments in work,
practice expense, and malpractice relative value units shallbe phased-in over a 2-year 
period.’’ 
In the 2020 final rule, CMS directed readers to the 2016 PFS final rule for additionalinformation, but that rulemaking fails to justify a blanket exclusion from PAMA phase-in requirements when CMSadopts active pricing for an unchanged code. Specifically, in the 2016 rulemaking, CMSimplemented this policy by applying thephase-in “to all services thataredescribed by the same, unrevisedcode in both the current and updateyear, and to exclude codesthat describedifferent services in the currentandupdate year.” CMS stated that this approach excludes as new or revised: 
•  Codes for which the descriptors were altered substantiallyfor the update year to change the services that are reported using the code.  
•  Codes that describe a different set of services in the update year when compared to the current year by virtue of changes in other, related codes.  
•  Codes that are part of a family with significant coding revisions.  
•  Codes with changes to the global period, since the code in the current year would not describe the same units of service as the code in the update year.  

The Council on Radionuclides and Radiopharmaceuticals, Inc. • 500 North Capitol Street, NW • Suite 210 • Washington, DC 20001-7407
(202) 547-6582 • Fax: (202) 547-4658 • michael.guastella@corar.org 
These exclusions were intended to address situations in which “there is no practical way to phase-in changes to RVUs that occur as a result of a coding change for a particular service over 2 years because there is no relevant reference code or value on which to base the transition.” 
We have reviewed CMS’s policy adopted in the 2016 final rule, and observe that none of CMS’s examples of a revised code apply to a situation in which CMSmovesan establishedprocedurefrom contractor-pricedstatus to active pricing status.  That is, there is no altered codedescription, no different set of services, no significant coding revisions within the family, nor changes to the global period. Furthermore, CMS has reference values (e.g., carrier prices, paid claims data) for theseestablished proceduresthat could be used as a reference for purposes of determining the maximum one year adjustment under PAMA. 
Thus,to theextentthat CMS adoptsmyocardial PET code RVUsthat represent asignificant reduction as a result of adoption of active pricing, we reiterate our request that CMSobserve the statutory PAMA standard. Specifically, in such a case, any reduction of 20% or morein total RVUs must be phased in over multiple years to mitigate provider disruptions and preserve patient access to these critical services. 
** * 
CORAR appreciatesCMS’scarefulconsideration of our comments. I would be happy to answer any questions you may have and can be reached at (202) 547-6582 or michael.guastella@corar.org. 
Sincerely, 

Michael J. Guastella, MS, MBA Executive Director 
cc: Council on Radionuclides and Radiopharmaceuticals, Inc.Kathy Flood, Executive Director, American Society of Nuclear CardiologyGeorgiaLawrence, Director, American Society of Nuclear CardiologyVirginia Pappas, CEO, Society for Nuclear Medicine and Molecular ImagingSukhjeet Ahuja, Senior Director, Society for Nuclear Medicine and Molecular ImagingPamela Kassing, Sr Director, Economics&Health Policy, American College of RadiologySue Bunning, Industry Director, PET, Medical Imaging and Technology AlliancePatrick Hope, Executive Director, Medical Imaging & Technology AllianceCassandra McCullough, CEO, Association of Black Cardiologists, Inc.Rhonda Taller, Team Leader-PVS -American College of Cardiology 
The Council on Radionuclides and Radiopharmaceuticals, Inc. • 500 North Capitol Street, NW • Suite 210 • Washington, DC 20001-7407
(202) 547-6582 • Fax: (202) 547-4658 • michael.guastella@corar.org 

