Thoughts on Leadership and Trends in Healthcare in America
From the desk of the CMO
This new communication channel is intended to help busy CMOs and clinical leaders gain access to the information necessary to understand the implications of emerging trends in coverage decisions regarding diagnostics. I will provide resources to help you more efficiently and completely evaluate new opportunities.
--Richard Frank, MD, PhD
The Centers for Medicare & Medicaid Services (CMS) has promoted smoking cessation offerings as part of lung cancer screening programs,1 and the effectiveness of cessation efforts after lung cancer screening has been well demonstrated.2 Recently, the U.S. Preventive Services Task Force issued similar recommendations for behavioral and pharmacotherapy interventions for tobacco smoking cessation in adults, including pregnant women.3 The provision of smoking cessation counselling is both appropriate and effective, however, the provision of cessation counseling services identifies a key role that can be invaluable to the success of your organization’s lung cancer screening program. That role is the Nurse Navigator.
The dilemma: The multi-disciplinary approach to lung cancer detection and treatment is essential to clinical efficiency but requires significant management due to the many participating disciplines and steps in the process. In the recent coverage decision by Medicare, still more steps are required, including shared decision-making meetings between doctors and patients and submission of patient data to registries as a condition of claims payment.1
The complexities in lung cancer screening are not limited to the multi-disciplinary nature of the disease, but arise also from the risk profile of smokers. Their risk of lung cancer does not diminish with negative screenings and, therefore, patients need to be persuaded to return for annual exams despite a “clean bill of health” from prior imaging procedures. Even more difficult for patients to understand is learning that they have a positive scan but may not need biopsy (because the nodule is small, for example). Whether patients are sent home to return in a year, or instead are referred onward for additional investigation, the role for a nurse navigator is crucial to the goal of reducing mortality from lung cancer by early detection leading to accurate diagnosis and staging, followed by early and appropriate intervention.
Patient tracking software and structured reporting can help but not replace the role of Nurse Navigators. Nurse Navigators can perform many valuable functions. For example, they can encourage smoking cessation counseling for active smokers and ensure clinical data are submitted to the required patient registry, while coordinating patient care across the Primary Care Provider, Radiology, Pulmonology, Pathology, Thoracic Surgery, Oncology, et al. Nurse Navigators (and the associated costs) can be shared across these departments but need a home.
Compliance with screening recommendations is crucial to reducing cost and mortality from lung cancer. This begins with screening by primary care providers (PCPs) for risk factors. From screening by PCPs for smoking history to effective treatment, the multi-disciplinary nature of lung cancer should be included in the curriculum and job description of nurse navigators.
Important new developments
On October 30, 2015, CMS issued final rules for the calendar year 2016 Physician Fee Schedule (PFS) and the Hospital Outpatient Prospective Payment System (HOPPS). With the final rulings, CMS has established the codes and rates for lung cancer screening with low dose CT. Still lacking are the instructions for billing for services that occurred in 2015. We will continue to monitor these developments and point you to appropriate guidance when it becomes available. CMS intends to publish the final rules in the Federal Register by November 16, 2015: http://federalregister.gov/a/2015-28005 (PFS) and http://federalregister.gov/a/2015-27943 (HOPPS).
* The use of Siemens CT Scanners for low dose lung cancer screening is pending FDA 510(k) review.
1. Centers for Medicare and Medicaid Services. Decision Memo for Screening for Lung Cancer with Low Dose Computed Tomography (LDCT). CAG-00439N. Online: http://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=274
2. Park ER, Gareen IF, and Japuntich S. Primary Care Provider-Delivered Smoking Cessation Interventions and Smoking Cessation Among Participants in the National Lung Screening Trial. JAMA Intern Med. 2015; 175:1509-1516. Online: http://www.ncbi.nlm.nih.gov/pubmed/26076313
3. U.S. Prenventive Services Task Force. Tobacco Use in Adults and Pregnant Women: Counseling and Interventions. Online: http://www.uspreventiveservicestaskforce.org/Page/Document/UpdateSummaryFinal/tobacco-use-in-adults-and-pregnant-women-counseling-and-interventions
With CMS issuing a final coverage decision on Feb 5, 2015, screening for lung cancer using low-dose CT1 can begin with effect from the date on which the rule was issued. However, submitted claims will most likely be rejected by a provider’s Medicare Administrative Contract (MAC) until CMS establishes the coding and payment rules and communicates them to their MACs. The ACR has suggested that providers perform the procedures, hold claims until guidance is available, and then retroactively bill held claims. Generally, CMS has reimbursed retroactive to a coverage decision.
Screening performed in advance of the coding and payment decisions, and without the benefit of the instruction manuals yet to be issued by CMS, would be at risk of not being reimbursed if each of CMS’ requirements are not met.2 These include:
- Primary care physicians documented the use of “decision aids” in the “shared decision-making” visit resulting in appropriate ordering of LDCT (i.e., the patient meets eligibility criteria).
- Image was acquired within the dose limit of 3 mGy adjusted for body weight.
- Smoking cessation “interventions” were provided.
- Patient data was submitted to a qualified registry.
A summary list of requirements can be found at www.usa.siemens.com/FromtheCMO. Final instructions for implementation will be issued by CMS via transmittals and manuals, which are anticipated in the next few months. As of today, CMS has endorsed one registry; more information can be found at www.CMS.gov.
Payments by private insurance companies are made under an “S” code, issued effective Oct. 1, 2014, by CMS via its Healthcare Common Procedure Coding System (HCPCS). CMS has not assigned a national code, nor has CMS assigned a payment. The S codes are provided for insurance company use in policy development and claims processing.
Payments by private insurance companies vary widely. The ACR recommendation is that Lung Cancer Screening should be paid at a multiple of 1.16 to non-contrast CT, Thorax, due to the additional work required in following up positive scans and reporting to registries, for which there is precedent in mammography. CMS calculated a differential of only 1.02.3
Codes for Medicare and Medicaid patients are provided by CMS via program transmittals to their local contractors (MAC) at regular meetings, the next of which is July 1, 2015. Generally, CMS releases the code (and payment amount) a month in advance in order that its contractors can implement the new payment system. Should CMS persist in its disagreement with ACR’s estimation (that the work in lung cancer screening is 1.16 times the work performed in non-contrast CT of the thorax)3, CMS might instruct claimants to use the existing code to receive the same payment. [Rarely, CMS uses an existing code but instructs claimants to affix a “modifier” for supplemental payment.] CMS may instead use a temporary “G” code in order to pay a different amount—more or less. Either of these decisions could appear in June. Application to the AMA for a novel code would launch an 18-month process.
In anticipation of the establishment of codes and payments within the coming few months, one should consider carefully the requirements specified by CMS for appropriate use, dose, data capture, and reporting.
As you can probably tell by now, this field is changing dynamically and we can only offer educated guesses as to when CMS will issue additional guidance. The best way to keep up-to-date is to visit our website www.usa.siemens.com/FromtheCMO and sign up for the email newsletter.
This table summarizes the CMS coding options described in this communique, when they can be generally anticipated and how they compare to existing reimbursement levels.
|Payment||Lower||Same||Higher||Date of Issue|
|CT, thorax, non-contrast||X||July|
|Novel code (via AMA)||X||X||~2017|
1 The use of Siemens CT Scanners for low dose lung cancer screening is pending FDA 510(k) review.
2 Centers for Medicare and Medicaid Services. Decision Memo for Screening for Lung Cancer with Low Dose Computed Tomography (LDCT).
CAG-00439N. Online: http://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=274.
3 American College of Radiology. ACR Offers Recommendation for Valuation of New S-Code for Lung Cancer Screening. Online:
The Centers for Medicare and Medicaid Services (CMS) issued the final rule regarding coverage for Lung Cancer Screening via Low-dose CT on February 5, 2015. Some of you may be asked to interpret the clinical implications of the final rule for your organizations. Between the draft guidance and the final rule, several key points have changed. CMS has revised the data set requirements for submission to a registry, dropped the requirement for imaging centers to have participated in screening trials, and expanded the upper age limit of eligibility to 77.1 Because the age limit recommended by the U.S. Preventative Services Task Force was 80, there remains a difference between who is covered by Medicare and who the Affordable Care Act requires commercial insurers to cover in their Medicare Advantage plans.
There are several important requirements for coverage that must be satisfied before claims are filed1:
Self-referral for initial scans is prohibited, requiring instead a “lung cancer screening counseling and shared decision making” visit including “decision aids” and a written order by a physician or qualified non-physician (i.e., physician’s assistant, nurse practitioner, or clinical nurse specialist).
Radiologists are held to quality standards including Board eligibility and “involvement in the supervision and interpretation of at least 300 chest CT acquisitions in the past three years.” Notably, CMS requires that a radiology imaging facility “makes available smoking cessation interventions for current smokers.” Forthcoming CMS instruction manuals will define “make available.”
Screening centers also must achieve dose standards (CTDIvol <3.0 mGy, adjusted up or down for body size) and report a minimum set of data elements to a CMS-approved registry. Registries must be capable of electronic submission to CMS and linkage of registry data to CMS claims data sets. As of today, CMS have endorsed one registry. Find out more at www.CMS.gov. Many of these topics will be addressed in CMS manuals, which I will bring to your attention as soon as they are available. Future communiques will also cover coding and payment, which will require additional consideration as CMS moves to implement payment for lung cancer screening services, and may appear a month in advance of one of their next two meetings in April and July. For more timely updates, please consider subscribing to the email version of this communique, via the website above.
1Centers for Medicare and Medicaid Services. Decision Memo for Screening for Lung Cancer with Low Dose Computed Tomography (LDCT). CAG-00439N Online: http://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=274
Coverage decisions from The Centers for Medicare and Medicaid Services (CMS) play a critical role in your hospital’s daily operations. As a clinical leader in your organization, you often help decode these complex decisions for administration. With this ”CMO to CMO Communique,” I hope to establish a communication channel to help busy CMOs gain access to the information necessary to understand the implications of emerging trends in coverage decisions regarding diagnostics. I will provide resources to help you more efficiently and completely evaluate new opportunities.
One of the most buzzed about topics today is lung cancer screening with low-dose computed tomography (LDCT)—an approach that can enable your organization to provide new population health services that result in early detection and intervention. Whether you have just begun to evaluate your organization’s readiness, or you are already providing screening services, the information below should provide greater insight into what to expect from CMS.
Many retail insurers have begun to provide coverage (without co-pay) for LDCT of lung cancer as required by the Affordable Care Act due to the United States Preventive Services Task Force “B” recommendation.1 However, Medicare coverage is being determined under CMS’ own authority by a complex process, which takes longer and may require significant changes in your multidisciplinary detection and treatment of lung cancer.
CMS is reviewing comments on its draft National Coverage Decision (NCD or “rule”) and will issue a final rule by February 8, 2015, followed by a set of instructions for implementation. The rule will include three categories: appropriateness criteria, requirements for acquisition sites, and qualifications for interpreting physicians. Next will come transmittals with instruction manuals entitled “National Coverage Determination,” “Claims Processing,” “Program Integrity,” and “Benefits Policy.” These are typically issued two to three months after a rule, but may appear sooner.
Self-referral will likely be prohibited, requiring instead a “lung cancer screening counseling and shared decision-making” session with a healthcare professional prior to the screening exam. Radiologists will be held to quality standards including training, certification, and experience. Screening centers must achieve dose standards, report to a CMS-approved national registry and be accredited as an “advanced diagnostic imaging center with training and experience in LDCT lung cancer screening.” Reporting to a registry may require input from well beyond the radiology department.
My next two communiques will follow the issuance of the final rule, and then the manuals, to summarize and provide links to source documents by means of a Web resource to help you quickly locate relevant collateral materials such as clinical evidence from peer-reviewed journals. You will also be able to opt-in to receive more timely email updates on these and other topics; or you can correspond with me directly at firstname.lastname@example.org.
Richard Frank, MD, PhD
CMO, Siemens Healthcare
1Available online: http://www.acr.org/Advocacy/Legislative-Issues/CT-Lung-Cancer-Screening
National Comprehensive Cancer Network Guidelines for Patients® Lung Cancer Screening. Version 1.2015
American College of Radiology (ACR) Lung Cancer Screening Center.
Institutions may apply for designation status as an ACR Lung Cancer Screening Center.
CMS Proposed Decision Memo for Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) (CAG-00439N). November 10, 2014.
United States Preventive Services Task Force (USPSTF) Lung Cancer Screening Summary and Recommendation. December 2013.
Offering Lung Cancer Screening to High-Risk Medicare Beneficiaries Saves Lives and Is Cost-Effective: An Actuarial Analysis. Published in American Health and Drug Benefits. Accessed on January 27, 2015.