Thursday, March 10, 2022

Digital Medicine & Medicare Law: Bill Introduced for FDA-cleared "Prescription Digital Therapeutics"

In a March 10, 2022, press release, four legislators announced the introduction in House and Senate of a bill that would create a benefit category and payment authority for FDA-cleared Prescription Digital Therapeutics.  The bills are numbered as S. 3791 and H.R. 7051.

See a press release here:

See a PDF of the proposed legislation:

The bill defines a PDT as a software device cleared, approved, or "de-novo'd" by the FDA for prevention, management, or treatment of a medical condition, primarily using software to achieve its effect.  The definition is added to Section 1861(s) of the Social Security Act, where it would become benefit "GG" if enacted.

The bill includes coding and payment rules, modeled in part on the median-market-price surveys implemented for lab tests under PAMA in 2014 (see SSA 1834A).

Like other proposed bills, the proposal will be assigned to House and Senate subcommittees and could be attached to future Medicare updates.

AMCP supports the act,

Coding Updates

AMA.  In September 2021, AMA created a code for cognitive behavior app management as monthly physician's supervisory service (to be active in CY2023).   (For a discussion of codes up to the newest one, see a November 2021 article by Foley Lardner here.)

AMA.   AMA launches a program to help innovators foresee and develop coding for innovative products.  See article on the "CPT Developer Program" at AMA here.

CMS HCPCS.  In early 2022, the CMS HCPCS group approved a HCPCS code A9291, active beginning April 2022, for "Prescription digital behavioral therapy, FDA cleared, per course of treatment."  Announcement here, page 46.