Friday, February 2, 2018

Very Brief Blog: Would Costs under Proposed NGS NCD Be Paid by Medicare Advantage Plans or by CMS FFS?

This blog provides an entry point to some CMS policy information that can be hard to nail down in its obscure resting places.

Medicare Advantage plans are generally obligated to pay for all services covered under Fee for Service Medicare, including the provision of immediate coverage for new NCDs.   This means a lot of new costs could occur under the proposed umbrella NCD for all next-generation sequencing services for cancer patients.   Medicare Advantage plans are not, however, responsible for costs that CMS has deemed exceed a regulatory "significant cost threshold."  These costs would be billable directly to the local Medicare FFS MAC even though the patient, otherwise, is in a Medicare Advantage plan.
  • An explanation of the rules is provided in Section E, page 23, of a February 1, 2018, CMS Medicare Advantage document (here).   
    • That's page 23 of a 231-page policy document. 
Rule 1:  CMS states that costs for "routine costs of clinical trials" under NCD 310.1 are billable to FFS Medicare, even for Medicare Advantage beneficiaries (the relevant regulation is 42 CFR 422.109).

Rule 2:  However, CMS states that costs for all other NCDs, including "coverage with evidence development" NCDs, are generally the responsibility of the Medicare Advantage plan from its capitated budget. 

Rule 3.  If and when CMS determines that there are special billing rules under the significant cost law for a particular NCD, instructions will be released by CMS as part of the billing instructions for that NCD.  So there's another Easter egg hunt for you.  For example, this document on page 182 states that "supervised exercise therapy NCD for symptomatic peripheral artery disease" is a MAC FFS benefit during CY2018 but not in CY2019.[*][**]

CMS will have to determine whether the NGS NCD, whatever its final form, meets the significant cost threshold that "holds harmless" the Medicare Advantage plans for unanticipated costs.   That accounting activity may be especially difficult if the prices of the tests are based on PLA codes or G codes and don't have fee schedule prices yet.   Additionally, CMS would have to estimate whether maximal costs are likely (many hundreds of thousands of patients at $3000? per test is many hundreds of millions of dollars), or whether clinical uptake of actual testing might be smaller than the NCD allows and only reach a fraction of the eligible patients, thus becoming a much smaller cost burden on Medicare Advantage plans.

For real nerds, Section E of the cited document also gives some complicated rules that Medicare Advantage plans must follow for tracking of patient copays for services that are shifted to FFS MAC payment.

[*] And they indicated this was conveyed in a MA program email on 8/12/2017.  See the NCD here and some trade press here.  CMS wrote, ""Trials showed that SET (supervised exercise therapy) decreases mortality, reduces cardiovascular risk factors, increases exercise capacity, and increases quality of life in older adults.  While the increase in general exercise capacity alone, which was an endpoint in a number of studies, would not be an appropriate outcome, it is a meaningful outcome for IC (intermittent claudication) due to symptomatic PAD since there is a well-established evidence link to all-cause mortality."
[**]  While the MA documentation in this blog (its page 182) says the exercise therapy NCD leads to MAC-covered benefits, not MA-benefits, that's not obvious to me from CR10295, which provides instructions to MACs.  Note also that while the NCD was released in May 2017, the CR to implement it was not released until February 2018 with an implementation date at MACs of April 2018 (effective date retroactive to May 2017).

The rule also contains some interesting text but the agency voluntarily broadening the definition of "health benefits" that may be supplemental benefits (rather than being rejected as outside the possible scope of supplemental benefits.).   However, MA plans must still go through arduous paperwork for each "supplemental benefit," which is becoming increasingly arcane as the whole fabric of the health system and modern delivery system evolve.  See page 182ff.