Through the procedures of CMS under the statute governing regarding Medicare, there is news that Medicare is highly likely to start paying for low dose CT scans seeking to find early stage lung cancers before they become malignant. The news of the screenings arrives in the form of notice of proposed decision from CMS. The full announcement is online, and is extensive. The CMS web site includes large amounts of prior information about the evidence supporting the conclusion, such as this prior meeting. The news and implications should be relevant to and not surprising to persons involved in asbestos litigation, such as lawyers, risk managers, futures representatives, and trustees of bankruptcy trusts, to name but some of the persons involved. The outcome has been inevitable for years due to the advance of science, and other events, including a 2007 study focused on CT scans and mesotheliomas, and various guidelines followed by oncology professionals. The evidence for CT scans also was at issue and discussed in a well known 2009 decision in which the Massachusetts Supreme Court enthusiastically endorsed a medical monitoring class action for persons with extensive smoking histories. The proposed medical monitoring program included low dose CT scans. The opinion was much discussed, including an October 19, 2009 article here on GlobalTort. Note also that CT scans of course can find early stage mesothelioma tumors. The uses of low dose CT scans are well known to asbestos plaintiff lawyers, as shown by articles on web sites for plaintiff firms. For example, see this page from the web site of Terry Johnson.
Set out below is CMS’ basic summary of its proposed decision: Proposed Decision Memo for Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) (CAG-00439N) COMMENT The Centers for Medicare & Medicaid Services (CMS) proposes that the evidence is sufficient to add a lung cancer screening counseling and shared decision making visit, and for appropriate beneficiaries, screening for lung cancer with low dose computed tomography (LDCT), once per year, as an additional preventive service benefit under the Medicare program only if all of the following criteria are met: Beneficiary eligibility criteria: Age 55-74 years; Asymptomatic (no signs or symptoms of lung disease); Tobacco smoking history of at least 30 pack-years (one pack-year = smoking one pack per day for one year; 1 pack = 20 cigarettes); Current smoker or one who has quit smoking within the last 15 years; and A written order for LDCT lung cancer screening that meets the following criteria: For the initial LDCT lung cancer screening service: the beneficiary must receive a written order for LDCT lung cancer screening during a lung cancer screening counseling and shared decision making visit, furnished by a physician [as defined in Section 1861(r)(1) of the Social Security Act (the Act)] or qualified non-physician practitioner (physician assistant, nurse practitioner, or clinical nurse specialist as defined in §1861(aa)(5) of the Act). For subsequent LDCT lung cancer screenings: the beneficiary must receive a written order, which may be furnished during any appropriate visit (for example: during the Medicare annual wellness visit, tobacco cessation counseling services, or evaluation and management visit) with a physician (as defined in Section 1861(r)(1) of the Act) or qualified non-physician practitioner (physician assistant, nurse practitioner, or clinical nurse specialist as defined in Section 1861(aa)(5) of the Act).
A lung cancer screening counseling and shared decision making visit includes the following elements (and is appropriately documented in the beneficiary’s medical records): Determination of beneficiary eligibility including age, absence of signs or symptoms of lung disease, a specific calculation of cigarette smoking pack-years; and if a former smoker, the number of years since quitting; Shared decision making, including the use of one or more decision aids, to include benefits, harms, follow-up diagnostic testing, over-diagnosis, false positive rate, and total radiation exposure; Counseling on the importance of adherence to annual LDCT lung cancer screening, impact of comorbidities and ability or willingness to undergo diagnosis and treatment; Counseling on the importance of maintaining cigarette smoking abstinence if former smoker, or smoking cessation if current smoker and, if appropriate, offering additional Medicare-covered tobacco cessation counseling services; and If appropriate, the furnishing of a written order for lung cancer screening with LDCT. Written orders for both initial and subsequent LDCT lung cancer screenings must contain the following information, which must also be documented in the beneficiaries’ medical records: Beneficiary date of birth, Actual pack-year smoking history (number); Current smoking status, and for former smokers, the number of years since quitting smoking; Statement that the beneficiary is asymptomatic; and NPI of the ordering practitioner. Radiologist eligibility criteria: Current certification with the American Board of Radiology or equivalent organization; Documented training in diagnostic radiology and radiation safety; Involvement in the supervision and interpretation of at least 300 chest computed tomography acquisitions in the past 3 years; and Documented participation in continuing medical education in accordance with current American College of Radiology standards. Radiology imaging center eligibility criteria: For purposes of Medicare coverage of lung cancer LDCT screening, an eligible LDCT screening facility is one that: Has participated in past lung cancer screening trials, such as the National Lung Screening Trial, or an accredited advanced diagnostic imaging center with training and experience in LDCT lung cancer screening; Must use LDCTs with an effective radiation dose less than 1.5 mSv; and Must collect and submit data to a CMS-approved national registry for each LDCT lung cancer screening performed. The data collected and submitted to a CMS-approved national registry must include, at minimum, all of the following elements: Data Type Minimum Required Data Elements Facility Identifier Radiologist (reading) National Provider Identifier (NPI) Patient Identifier Ordering Practitioner National Provider Identifier (NPI) Demographics Date of birth, gender, race/ethnicity. Indication Lung cancer LDCT screening – absence of signs or symptoms (y/n) Smoking history Current status (current, former, never), If former smoker, years since quitting, Pack-years as reported by the ordering practitioner. CT scanner Manufacturer, Model. Effective radiation dose CT dose index, tube current-time, tube voltage, scanning time, scanning volume, pitch, slice thickness (collimation). Screening exam results Baseline or repeat screen; Screen date; Clinically significant non-lung cancer findings (y/n), if yes, list; Nodule (y/n), if yes: number, type (calcified or non-calcified; solid or semi-solid), size and location of each nodule. Diagnostic follow-up of abnormal findings within 1 year Low dose chest CT, Diagnostic chest CT, Bronchoscopy, Non-surgical biopsy, Resection (with dates), Other (please specify). Lung cancer incidence within 1 year Incident cancers, Date of diagnosis, Stage, Histology, Period of follow-up for incidence. Health outcomes All cause mortality, Lung cancer mortality, Death within 60 days after most invasive diagnostic procedure.
For purposes of Medicare coverage of LDCT lung cancer screening, national registries interested in seeking CMS approval must send a request either electronically or hard copy to CMS (Note: It is not necessary to submit both electronic and hard copies of requests). Please send electronic requests via email to caginquiries@cms.hhs.gov. Hard copy requests may be sent to the following address: Centers for Medicare & Medicaid Services Center for Clinical Standards and Quality Director, Coverage and Analysis Group ATTN: Lung Cancer LDCT Screening Mail Stop: S3-02-01 7500 Security Blvd. Baltimore, MD 21244 CMS is seeking comments on the proposed decision. We will respond to public comments in a final decision memorandum, as required by §1862(l)(3) of the Social Security Act.