Setting up a Program

We have received the frequent question: how did you set up your lung screening program? It is not as easy as it sounds. Luckily we had a lot of help from the wonderful folks at Lahey Clinic, who pioneered a clinical lung screening program with free lung screens to eligible patients and who developed Lung-RADS. Many thanks to Drs. Andrea and Brady McKee for that help and for their generous sharing of documents and algorithms.

What every responsible program should have:

  • a physician with expertise and/or interest in lung cancer to oversee the program
  • radiologists with expertise, preferably with body or chest fellowship-training, to read the CTs
  • adherence to low-dose techniques, delivering a CTDIvol of less than 3mGy
  • a database to monitor all high-risk patients, track results, and ensure the performance of followup exams
  • a multidisciplinary team of clinicians (e.g., pulmonology, thoracic surgery) to guide the program and coordinate the management of positive screens
  • personalized navigation of patients – this may mean a nurse navigator or a physician who curates the database, contacts the patients and referring physician with results, and schedules followup exams
  • structured reporting with consistent, evidence-based assessment categories, like ACR Lung-RADS

Institutional Support

Lung cancer screening is difficult to do with a “go-it-alone” approach. It is important to have the support of your group, your hospital, and/or your health system — they need to recognize the importance of lung screening and they have to be willing to offer their resources to help push lung screening into routine clinical practice. In most cases, this means support for having a nurse navigator to coordinate patient communication and database surveillance, IT support for the database and for uploading data to a national registry, financial support to allow creativity in pricing the scans, and legal support for creating the program and defending its particulars.

Pricing

The Lahey Clinic CT lung screening program is free. At Baptist our price is $99 for non-eligible patients and $35 for eligible patients. Many other programs have out of pocket costs in the $150 to $450 range. It is great to have a responsible, well-run lung CT screening program with administration, surgery, oncology, and a myriad group of stakeholders on-board, but what use is that if the quarterly CT volume is in the single digits? In our current environment in 2014, CT lung screening is largely unreimbursed and many patients are facing economic hardship that forces them to make difficult choices about their health care. Luckily, thanks to the USPSTF, in January private insurers will cover lung screening for eligible patients with no copay or deductible, and Medicare has decided to follow suit. Our hope is that in 2015 and beyond, the pricing issue will only apply to a (hopefully) ever-smaller group of uninsured patients. Getting buy-in from stakeholders on a reduced price, however, is an important step to creating a thriving program.

Eligibility

It is not straightforward to decide who is at high-risk and deserving of screening. Remember that nearly 7% of all Americans (and 20% of all smokers) will develop lung cancer, so you can make pretty broad arguments of how many patients should be eligible.The NLST screened smokers 55-74 with 30 pack-years of smoking and who currently smoked or had quit less than 15 years ago. CMS approved lung screening along these exact criteria. The USPSTF smoking history criteria are the same but had previously enshrined a broader age range (55-80) for private insurers, and our program uses this set of criteria. The NCCN eligibility guidelines match those of NLST but also enlarge the age range (50-74) and allow less extensive smoking history (20 pack years; no quit-smoking limitations) AS LONG AS the patient also has an additional, separate risk factor for lung cancer from a relatively large list (occupational exposure excluding second hand smoke, personal or family history of lung cancer, history of chronic lung disease, documented radon exposure, or personal history of non-metastatic non-lung cancer). We follow the USPSTF guidelines but, unless CMS changes its policy, we will have to exclude Medicare patients older than 74. Every patient that is scheduled for LDCT gets a phone call from our navigators to confirm eligibility and also fills out an intake form so that we can document eligibility.

Legal

There are several legal issues in creating a discounted program. The legal department of your group or hospital will have concerns over the perceived sense of obligation a patient might have in getting additional studies at the same institution that provided discounted care. It is important to have clear language in any patient-related materials, as well as on the report, that indicates to the patient that there is no implied obligation to return to your institution for additional services. The legal department may also want consent from patients to be enrolled in a database, even if the only purpose of the database is to ensure that patients do not slip through the cracks.

Database

Some kind of method of following patients is required. Per the MQSA, breast imaging already follows mammogram patients and tracks statistics on call-back rates, biopsy yields, etc., and that kind of rigorous approach to screening should and does apply to lung cancer screening with low dose CT. A key to this is some kind of database for keeping track of all the patients — ideally the database “sees” when a lung screening CT is scheduled so that the navigator can call the patient to verify eligibility and discuss the exam, then sees when the study is performed (often with the ability of the radiologist to input the Lung-RADS results directly), then provides tracking options so that the nurse navigator has easy access to patient/MD letters and easy visibility of when the patient needs to return for a followup.

Advanced databases integrate with the Radiology Information System (RIS) and Hospital Information System (HIS) so that pathology results, operative/procedure notes, and other data can be pulled directly into the patient’s database entry. The database can also sort statistics, so that you know how your patients divide into LungRADS 0 through 4, what the true positive and false positive rates were on LungRADS 3 and 4 cases based on biopsy results, etc. For small programs with low volumes, an Excel spreadsheet may serve this purpose, but when volume grows into the 100s of patients, it becomes more cumbersome to follow so many patients using a simple spreadsheet. We use Primordial Design’s lung screening package, which integrates into our PACS system, but there are other good systems out there as well, including LungView made by the MagView folks. These databases are web-based and accessible to the radiologist and the navigator. Medicare will require reporting of results to a national registry, such as the NRDR, and a database streamlines this process.

Multidisciplinary team

Another key element of a lung screening program is a governing body that includes multiple stakeholders from the medical staff and possibly also the administration. At our institution, the lung screening program grew out of the lung tumor team of the Miami Cancer Institute, a large group of physicians and administrators including thoracic surgery, radiology (chest, nuclear ,and interventional), pathology, radiation oncology, pulmonology, medical oncology, as well as key administrators from across the health system. This larger group makes broader decisions over when and where to implement lung screening, the general guidelines lung screening should follow (i.e., the nuts and bolts discussed in this section), and keeps tabs on the progress of the program. This group also created a smaller multidisciplinary panel to watch over the CT Lung Screening Program. Our multidisciplinary panel includes our nurse navigators, pulmonology, thoracic surgery, and radiology and it makes sure that patients receive expedited care when needed (quick turnaround time into pulmonological or surgical appointments, for example) and also reviews all the challenging cases (namely the LungRADS 4 cases) for determination of next steps. How to further image or biopsy or manage a suspicious lesion is not always obvious, and it is great to have a panel of experts from different specialties to discuss each case. The recommendation of the multidisciplinary team is sent by letter to the referring physician. You may also consider issuing an addendum to the original LDCT report.

Case Review

The database monitors all the cases, but there should be a way to review cases on an as-needed basis. Often, this can happen at a regularly scheduled Tumor Board, if that Tumor Board has time to discuss LungRADS cases before they are proven malignancies. Because timely care is important, a monthly Tumor Board probably meets too infrequently to serve this role. Weekly meetings would be difficult to accomplish in person for our distributed health system at Baptist Health South Florida (ranging from Homestead to Coral Springs), and so we have virtual meetings by email. When coming across a LungRADS 4 case, the radiologist captures anonymized key images of the lesion and any relevant findings, summarizes in anonymous fashion the medical history (e.g., 62yo F with emphysema) and sends the images and history by encrypted email to the multidisciplinary panel.The panel can then decide by email consensus or by phone if needed the next best steps — PET/CT and percutaneous biopsy, navigator bronchoscopic biopsy, PET/CT and office visit for surgical excision, etc. The members of the panel need to have support from the hospital/adminstration and from their colleagues to support their ultimate decisions. If there are multiple radiology, surgery or pulmonology groups, a seat that rotates among groups may be considered.

Smoking Cessation Program

A smoking cessation program is another required element of a lung screening program. By definition, all participants in lung screening are either current or former smokers. Current smokers will benefit from smoking cessation therapy, and former smokers may be encouraged to stay non-smokers if there are resources available to help them quit, whether that is counseling, nicotine alternatives to cigarettes, or other medication. Our health system has partnered with Florida AHEC to provide group smoking cessation sessions and we have initiated our own smoking cessation program as well. Many national societies have web-based resources that may be helpful:

Reporting

Structured reporting is at the heart of the ACR Lung-RADS system. In mammography, previously free-text reports often wandered in their language and in the specificity of their findings and recommendations. BI-RADS codified a lexicon for describing breast findings and created a structured system for reporting. Lung-RADS is the ACR answer to lung cancer screening. It has well defined categories for reporting findings, and suggested management approaches for each category.

ACR Lung-RADS

  • Lung-RADS
  • 0
     
  • 1
     
  • 2
     
  • 3
     
  • 4
     
  • Assessment
  •  Incomplete
     
  •  Negative
     
  •  Benign
     
  • Probably benign
     
  •  Suspicious
     
  • Management
  • Await additional images
     
  • Annual screening.
     
  • Annual screening
     
  • 6 month low dose CT
     
  • PET/CT or biopsy
     
  • Example
  • Currently unavailable outside prior CT.
  • Normal study
     
  • 6mm nodule stable for 3 years
  • 7mm nodule found on baseline CT
  • 10mm spiculated nodule
     

Lung-RADS is a useful tool for categorizing low dose chest CTs and providing clear guidance to our nurse navigators and referring physicians as to next steps. We specify the expected date of the next CT exam (e.g., on or around January 2016), as well as the recommended course of action (e.g., Recommend continued annual CT screening). Here is an example of our standard report template. In addition to lung evaluation, we also routinely report: presence/absence of emphysema or interstitial lung disease, absence or presence of calcified coronary plaque, and absence/presence of spinal compression deformity. Please see our guide for the radiologist.

All Lung RADS 4 cases are collected for review by the multidisciplinary panel.

Navigation

Patients are classifed on the report and then in the database according to LungRADS score. That score determines the kind of patient/physician letters that need to be sent out, and it determines the interval for followup. A Lung-RADS 2, for example, would have a one year followup scan as the course of action. The navigator would be prompted to schedule that exam and, once scheduled, the navigator would be prompted a short time before the scheduled exam to remind the patient. It is important for navigators to take patient/referring preferences and the original scan in account when scheduling a followup exam—navigators should be as “facility-neutral” as possible when scheduling a followup test. Of note, for suspicious nodules (Lung-RADS 4), no letter is sent out – the referring physician is contacted first to determine the course of action. If an expected followup CT exam does not occur, the navigator is prompted to send 30 day, 60 day, and 90 day reminders. If after 90 days the patient does not respond, the patient is discharged from the program with a formal letter of notice. All of the actions of the navigator can be assisted by predetermined scripts to guide telephone conversations regarding initial contact, reporting of results, and reminders.

Elements of Navigation

  • Awareness of all patients scheduled for LDCT
  • Contact of patients before the scan – verification of eligibility, counseling about the exam, explanation of the risks and benefits, gathering additional demographic information for the database
  • Awareness of performance of the LDCT
  • Contacting the physician and patient about the results of the exam, both by phone call and by formal patient/physician letters according to Lung-RADS score
  • Scheduling followup exams and office visits as needed
  • Calling to remind patients about upcoming followup exams
  • Adding other results to the database (pathology results, operative notes, pulmonary consults, etc.)
  • Sending out 30/60/90 day reminders for missed appointments
  • Discharging patients from the program
  • Aggregating statistics from the database on the program
  • Sending data to national registry.

One important role of navigation is to connect the patient to needed services. Some physicians very much appreciate our offer to connect the patient to a pulmonologist or a surgeon well versed in lung cancer screening, nodule followup, and lung cancer care. Referring physicians are always, of course, welcome to opt out of using our program and to perform followup studies, procedures, and facilities according to their preferences.

As you can see, navigation is not a small job. It requires dedication and enthusiasm, and is not something to squeeze into the last few minutes of your day. We are very fortunate to have two very dedicated and amazing nurse navigators, and without their advocacy and drive our program would not be as successful as it has been.

Discharge from the program

Patients can be discharged from the lung screening program for multiple reasons. They no longer fit the age criteria (e.g., they “age out” by exceeding age 74 or 80 according to insurance), they no longer fit the smoking criteria (e.g., they have quit smoking by more than 15 years by the time of the next planned LDCT), they choose to have their care elsewhere, or they fail to respond to multiple reminder letters after a missed appointment.

Patients are also discharged from the program temporarily if they are proven to have lung cancer. They undergo care and surveillance for that cancer as per the usual lung cancer protocol, and 5 years later when they are presumed in remission, they can continue annual LDCT screening assuming their eligibility criteria are still fulfilled.

You may consider using certified mail or other “formal” means to issue a letter of discharge.

Certification

The ACR offers Center of Excellence designation for each CT scanner used for lung cancer screening. Cost is $400 every 3 years per scanner. It should go without saying that CT scanners should also have baseline CT certification from the ACR.

The Lung Cancer Alliance has guidelines for designating responsible lung cancer screening centers Inclusion is free. To be included, please contact Amy Copeland, acopeland@lungcanceralliance.org.

Special cases

Our program requires a doctor’s prescription, but some programs in the country do not require a prescription for eligible patients for lung screening. According to the institution, the physician of record may end up being one of the pulmonologists, one of the fellows, or a radiologist. This creates more difficulty in ensuring appropriate followup. In these scenarios, a likely requirement is a “physician of record” for the patient, so that the program has a primary care physician or specialist on record as the person who will receive results, even if that physician did not write the prescription for lung screening.

Uninsured patients deserve health care, too. It is important to have the health system’s support for uninsured patients who may be able to afford the lung screening CT fee, but who are unable to afford downstream tests or surgeries. This scenario is one that should be accounted for.

Consider the workflow also for “walk-in” patients who arrive at a center with prescription in hand. There should be some method for determining eligibility, either by tech interview, phone call to the navigators, or intake form. We use an a href=”http://thelungspot.com/wp-content/themes/ypo-theme/pdfs/intakeform.pdf” rel=”nofollow” target=”_blank”>intake form. When the patient’s study shows up in PACS, the a href=”http://thelungspot.com/wp-content/themes/ypo-theme/pdfs/intakeform.pdf” rel=”nofollow” target=”_blank”>intake form is available and the radiologist can verify eligibility. If the patient is eligible, the navigators are notified of the patient’s eligibility for the database. This can be cumbersome but is important to ensure followup. One downside we have noticed is that the navigators often elicit a better history than is written on the a href=”http://thelungspot.com/wp-content/themes/ypo-theme/pdfs/intakeform.pdf” rel=”nofollow” target=”_blank”>intake form. For example, the a href=”http://thelungspot.com/wp-content/themes/ypo-theme/pdfs/intakeform.pdf” rel=”nofollow” target=”_blank”>intake form filled out by the patient says “1/2 pack per day”, but on careful history, it turns out that while the patient currently smokes 1/2 pack per day in fact that is a recent development and the patient has for most of his life smoked 2 packs per day.

What you need to prepare

LDCT technical protocol for the scanner, a reporting template for the radiologist to report the CT, scripts for contacting patient/physician, patient and physician letters according to Lung-RADS 1/2 or 3, a FAQ/explanatory material to send or give to the patient that explains the exam and risks/benefits.

Who you need on board

Administration, a chest/body supervisory radiologist, a small core of reading radiologists, clinical navigator, interventional radiology, pulmonology, oncology, and thoracic surgery. A smoking cessation therapy team is also vital. Clerical assistance for receiving phone calls/mail database entry, paperwork and printing/sending letters. Marketing to let your region know about your program.

What you should acquire

Database software for following patients. Lung Cancer Screening certifications.

Lung Cancer Screening Center - Radiology Associates of South Florida - Lung Cancer
RASF is the proud provider of radiological services for Baptist Health South Florida in Miami Dade and Broward. We are the leading provider of radiological services in Miami / South Florida.
Screening Center of Excellence - Radiology Associates of South Florida - Lung Cancer