CMS recently released a new National Coverage Determination (NCD), which was implemented on January 4. NCD 210.14 titled “Lung Cancer Screening with Low Dose Computed Tomography” is good news and expands the preventive services CMS offers its beneficiaries.
CMS prefers that none of its beneficiaries smoke, but it recognizes the reduced treatment complexity and cost of identifying lung tumors in their earliest stages using low dose CT. In order for a patient to be eligible, two separate criteria must be met: beneficiary eligibility and performance of a shared decision making E&M type service that includes smoking cessation counseling in addition to discussion of the benefits of screening and possible follow up testing.
I was impressed by the documentation requirements – which immediately raised a red flag for me. When CMS is being this specific about required documentation to support a service, it is likely they will also audit records to make certain providers are meeting medical necessity requirements.
Documentation regulations of this type can create a challenge for providers. What to do with a patient who wants to be screened, but refuses in advance any treatment should a tumor be discovered? Or how to manage the patient who assumes that now that they are being screened for lung cancer their continued smoking is somehow a safer habit because should they have a tumor, it will be detected earlier. In addition to auditing the patient screening requirements, CMS will also be interested in how these challenges are managed from a medical decision making standpoint.
I believe requirements such as those in 210.14 foreshadow what the industry can expect from CMS regarding documentation of specific data required to support medical necessity. Another example along these lines is the new preauthorization required for access to certain durable medical equipment (DME) services (more about that in a future blog).
So, what exactly is CMS looking for? First, let’s look at the documentation required for the beneficiary eligibility criteria for the initial screening – all must be met:
- Age 55 – 77 years
- Asymptomatic (no signs or symptoms of lung cancer)
- 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
- Receive a written order for lung cancer screening with LDCT. Written orders for lung cancer LDCT screenings must be appropriately documented in the beneficiary’s medical records, and must contain the following information:
- 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 (no signs or symptoms of lung cancer); and
- National Provider Identifier (NPI) of the ordering practitioner.
In addition to the beneficiary criteria, the documentation of the counseling and shared decision making visit performed by an MD, PA, Nurse Practitioner or Clinical Nurse specialist must include all of the following:
- Determination of beneficiary eligibility including age, absence of signs or symptoms of lung cancer, 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 and harms of screening, follow-up diagnostic testing, over-diagnosis, false positive rate and total radiation exposure;
- Counseling on the importance of adherence to annual lung cancer LDCT 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 the importance of smoking cessation if current smoker and, if appropriate, furnishing of information about tobacco cessation interventions; and
- If appropriate, the furnishing of a written order for lung cancer screening with LDCT
CMS also expects that for beneficiaries who require repeat yearly screening, the entire event must be documented again – with all criteria mentioned above.
I’ve often been asked “What documentation is CMS looking for? I don’t have time to write a book on each patient – I barely have time to write a note on each patient!”
NCD 210.14 is a perfect example of what CMS is looking for with regard to documenting the medical necessity for lung cancer screening. You can extrapolate this to more general documentation requirements as well.
Will CMS audit this service? I believe they will due to volume and cost. An article titled “Lung cancer screening with low-dose computed tomography: costs, national expenditures and cost-effectiveness” by Goulart, PH, Bensink, ME Mummy DG and Ramsey SD published in February 2012 by the US National Library of Medicine National Institutes of Health predicted that LDCT screening will add $1.3 to $2.0 billion in annual national health care expenditures for screening uptake rates of 50% to 75% – in 2011 dollars.
Document as though you will be audited – this time you know exactly what CMS is looking for.
Barbara Aubry is a regulatory analyst for 3M Health Information Systems.
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