My Encounter with RFK Jr; Radical Ideas for HHS Innovation?

Ok, I did not have a "meeting" with RFK Jr, but we did have an "encounter" - said hello to each other on a flight from Washington to LAX on Friday.   Interestingly, this led me to four or five ideas about HHS innovation on the way home in an Uber.   

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The principal here is that change could be sudden and unsettling.   For example, in the last couple days the House voted for what could become large cutbacks in some parts of Medicaid, while HHS issued a policy change (see Fed Reg March 3) rescinding a 1971 position regarding the Administrative Procedures Act (APA).   

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FDA LDT Court Case

The ACLA/AMP challenge to the FDA LDT regulation continues.  I've generally felt they had a strong case, both as to the definition of "device" (not a roomful of people), and because inflicting billions of costs on the lab industry for millions of pages of paperwork was not the best ROI on improving lab quality.

Bump for FDA:  We've got a very active, strongly opinionated Republican administration that has newly thrown its weight behind the FDA LDT regulation.   (There's an alternative universe where they might not have, especially with the tsunami of anti-regulation moves).  

Is a Republican judge more likely to support a Republican agency supported by a Republican Department of Justice?   Maybe.   Hard to weight, but a factor now.

Bump for ACLA/AMP:  HHS and FDA are still being populated with executives, many from the Trump I administration, see an excellent open-access posting from AgencyIQ by Joshua Sztorc and Laura DiAngelo at LinkedIn.  

Under this theory, the support of the FDA LDT rule by DOJ in a recent oral hearing might be viewed as provisional, subject to review especially if FDA-DOJ lose the first round in court.

Pressure on Medicare Finances and Fee Levels

According to the AMA, practice costs have risen 60% since 2001, yet physician fees having risen only 10%.   This grim pressure seems positioned to continue.   Could Medicare fee for service shift into a zone where substantially fewer physicians except it (like Medicaid?)   That's a tough one, since Medicare patients are such a large part of the population needing healthcare.   But let's consider.

Two radical cracks could be balance-billing and concierge fees.  Since changes in the 1990s, balance-billing isn't allowed.  So somebody decides to change that. Such a change may seem radical, but we live in fast-changing times that see unexpected events.  

Similarly, concierge fees (like $500 per year) aren't allowed, but there are already some workarounds like providing non-covered "wellness support" or other extra-Medicare services.   Loosening up enforcement could occur.  If a practice has 500 patients, and adds a $500 fee, it's $250,000 gross.  See a long Chat GPT dialog on these topics here.

MolDx Z Codes as a National Code Set?

Why do we have ICD-10 codes for diagnosis and CPT codes for outpatient procedures?  It's in the Code of Federal Regulations, at 45 CFR 161.1002, called "Medical data code sets."  It dates back to the year 2000 (65 FR 50312).   

MolDx Z-codes are not part of this, as lab tests are today specified to be coded either under HHS HCPCS codes or AMA CPT codes - full stop.  However, in the space of a few months, CMS could issue a regulation and finalize it, that adds a pphrase about Z codes into these lines of regulations.   While this is only a pipedream, let's assume that Z codes could then be the primary codes for their services (making claims processing unexceptional) and let's assume that like the AMA, Palmetto could maintain full copyright control (or even set licenses).  Z codes would not have to be co-billed with 81479 any more, since they'd be primary 5-place codes, and AMA service fees would not apply, nor would AMA be able to make unexpected year-to-year policy changes as it can with PLA codes.   

CMS: Fossilized NCDs and 14 Day Rules

It's widely discussed now that CMS NCD 90.2 (regarding NGS testing in cancer) is badly out-of-whack and out-of-date.   And the bizarrely-worded and cryptic "14-day-rule" continues to be a mess, most severely for cancer inpatients.   (We can credit the first Trump administration for revising the 14-day-rule for outpatients.)   

Yet most stakeholders and experts will predict the timeline for changing any of this is years (or never).   Necessary changes would be only a few sentences long, and could be completed in months. Or maybe even faster under the March 3 decision at HHS pulling many decisions out-of-scope of the APA requirements for notice-and-comment (see opening of this blog.)