The Northern Virginia Health Policy Forum convenes monthly to provide opportunities for health policy professionals to learn from each other and from guest speakers.

February’s session featured a conversation with Tamara Syrek Jensen, JD, Director of the Coverage and Analysis Group, Centers for Clinical Standards and Quality, Centers for Medicare & Medicaid Services and Jason Bennet, Director, Technology, Coding and Pricing Group, Centers for Medicare & Medicaid Services.

Jim Scott, Applied Policy’s president and CEO, facilitated a discussion focused on: Medicare Coding, Coverage, and Payments: Technical Innovations in Healthcare. The conversation ranged from the process for national and local coverage determinations (NCDs and LCDs) to healthcare apps.

A recording of the hour-long event is available here, but we wanted to share summaries of Mr. Bennet’s and Ms. Jensen’s answers to a few questions that we think could be of special interest to Applied Policy Insight readers.

Question: When is a national coverage determination (NCD) appropriate and how does CMS decide to open the NCD process?

If a stakeholder, and that can be anyone–a patient advocate, patient, caregiver, physician, manufacturer–requests a national coverage determination and meets the criteria outlined in U.S. Federal Register, CMS is obligated to open an NCD.

The challenge is that CMS receives more requests than it has people to process them. So, some requests will be put on a waiting list. Requests are prioritized by their impact on the Medicare population/Medicare patients.

A significant event may occur, or evidence may emerge that requires CMS’s opening of an NCD without an external request. Or CMS may know of an external request that’s coming and want to get the process started and move it along. The best and most current example of that is monoclonal antibody for the treatment of Alzheimer’s disease. CMS opened that decision aware that several external requests were likely coming its way and wanted to get the process started immediately because of what was happening in the community.

Question: Does CMS take costs into account – either to the Medicare program or otherwise – when deciding to open the NCD process?

Once CMS opens a national coverage determination, cost does not come into play in deciding whether something is covered, non-covered, or under what circumstances something might be covered. That is a long-standing policy for CMS, and it has never taken cost into account.

There is an exception to that, because Congress wrote in the statute that CMS can take costs into account for certain preventive or screening services. As a result, CMS has commissioned technology assessments on certain screening services. But other than that, CMS does not take cost into account when writing an NCD. That is also true for local coverage determinations (LCDs) because they follow the same statute as NCDs as to whether something is reasonable and necessary. Cost is not part of that equation.

Question: If a procedure has a CPT or HCPCS level II code, does that mean that Medicare will pay for it?

There are several products and services that do not have a Medicare benefit category but may still be something for which another payer– Medicaid, Veterans Affairs, or private payers– will pay. Without a benefit category, Medicare lacks the statutory authority to pay for these products or services. There are also cases in which the product or service may not have been found to be reasonable and necessary, either through an NCD or an LCD. In all these cases, these products may all still have a code even though Medicare will not pay for them.

Question: What advice would you give to someone submitting an application through CMS’s new Medicare Electronic Application Request Information System (MEARIS)?

Just as in filling out applications for loans, Federal Student Aid, or college admission, don’t wait until the last minute to get started. You’ll need to click through several screens, and you’ll want to pull information together in advance to make certain that you’re presenting a good quality item for CMS to review.

Question: If a device, drug, or diagnostic is cleared or approved by the FDA, does that mean that Medicare will pay for it?

Maybe. CMS pays for most FDA approved or cleared devices, but there are some that are not included. The FDA decides whether something is safe and effective: safe and it does what it says it does. Then CMS takes over, considering specifics such as places of service, defining the appropriate patients, setting guidelines, etc. to establish coverage criteria.

Question: What sort of issues should app developers think about before seeking Medicare coverage, coding, or payment, even if they get cleared by the FDA?

To the degree to which something is bundled into a hospital inpatient stay and a patient is given an app while in the hospital, it is probably covered under the hospital inpatient stay and not identified separately.

However, in the case of an app that’s prescribed for home use, there is not necessarily a benefit category to describe that. The closest benefit that is referenced when people discuss (healthcare) apps with CMS is the durable medical equipment benefit. But if you look at the statute, you’ll see that the DME category was designed for things like iron lungs. Iron lungs are on the opposite end of the spectrum from the devices that the FDA is currently clearing for markets.

App developers should think about the setting of use. In terms of the Medicare fee-for-service environment, they should think about the benefit category in approaching CMS. That does not mean, of course, that other payers have the same restrictions, but that is the framework in fee-for-service Medicare.