National Academy of Medicine and Clinical Utility - Links

 http://www.discoveriesinhealthpolicy.com/2017/03/national-academy-releases-evidence.html

National Academy releases "Evidence Framework for Genetic Testing" - One framework is "QUINN FRUEH."  March 2017

https://nap.nationalacademies.org/catalog/24632/an-evidence-framework-for-genetic-testing

https://nam.edu/perspectives-2015-clinical-utility-informing-treatment-decisions-by-changing-the-paradigm/

Blog?   Clinical Utility: Informing treatment decisions by changing the paradigm.

McCormack and Billings "Discussion Paper" Jan 2015 

The types of evidence needed to support the use of genome sequencing in the clinic varies by stakeholder and circumstance. 

In this IOM series, seven individually authored commentaries explore this important issue, discussing the challenges involved in and opportunities for moving clinical sequencing forward appropriately and effectively.

The Remarkable Growth of 87798 - "Other" Pathogen PCR

87798 is an nonspecific, or "other pathogen" code for amplified PCR.   (87799 is "quantitative" and 87797 is "direct probe.")

Remarkable code growth from 2016 to 2020.

For comparison, data for 81408 for the same periods:

Date of Service vs APC for PATHOLOGY

 Date of Service rules apply to "all tests" meaning (A) Pathology tests and (B) clinical pathology tests.

However, PACKAGING RULES only apply to clinical laboratory tests (those which are not excepted like human genetics).

Pathology APCs have "S" status which means payable under the APC system and not bundled or discounted in multiples.

Note, however, that due to 419.2(b)(18) add on codes are generally packaged and not payable with their own added APC nor is there any way for the add on code to change the weight of the underlying code's APC assignment.

https://www.law.cornell.edu/cfr/text/42/419.2#b_17

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Friday, September 16, 2022

Where Lab Test OPPS Packaging Comes from (CFR)

 The actual rules stem from the definition of bundled hospital services in one regulation, and the complex 14 day rule in another regulation.

Pretty bizarrely, 42 CFR 419.22(l) [el] excludes clinical diagnostic laboratory tests from payment under the APC system or by APCs.    (*)  

Except as provided by 419.2(b)(17), which does the opposite and bundles most lab tests as packaged costs in the APC system (!!!!!).   That's a cause for whiplash.

And - Further details of the bundling and unbundling occur as a result of the date of service rule aka 14 day rule.  42 CFR 414.510.  For example, this sets a separate date of service for "molecular pathology" tests.

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(*) This means CMS will not take CPT lab codes and crosswalk them to payment by linking them to an APC.   CMS does do exactly this, for some other products.

Where Lab Test OPPS Packaging Comes from (CFR)

 The actual rules stem from the definition of bundled hospital services in one regulation, and the complex 14 day rule in another regulation.

Pretty bizarrely, 42 CFR 419.22(l) [el] excludes clinical diagnostic laboratory tests from payment under the APC system or by APCs.    (*)  

Except as provided by 419.2(b)(17), which does the opposite and bundles most lab tests as packaged costs in the APC system (!!!!!).   That's a cause for whiplash.

And - Further details of the bundling and unbundling occur as a result of the date of service rule aka 14 day rule.  42 CFR 414.510.  For example, this sets a separate date of service for "molecular pathology" tests.

___
(*) This means CMS will not take CPT lab codes and crosswalk them to payment by linking them to an APC.   CMS does do exactly this, for some other products.

UCSF Transpers on CED

 

Paying Part B Stuff for Part A Inpatients

MolDx has a policy on infectious disease molecular testing, which includes some rules about inpatient (or hospital outpatients) locations of service.  This may seem odd, since Medicare (Part B) doesn't pay for lab tests for inpatients (or hospital clinical or ER outpatients) (except human gene tests).

There are a few rare situations such as when a patient has exhausted Part A benefits.

See the manual chapter here:

https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/bp102c06.pdf

https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c04.pdf