News sources reported circa September 24, 2018, that a US district court judge had dismissed ACLA's case on the grounds that the court lacked jurisdiction.
- For the 33 page, December 11, 2017 complaint, see here.
- For an open access 13 page PDF of the judge's dismissal, see here.
- For open access reporting on the September 2018 dismissal, see MedTechDive here. Fierce Healthcare here. HealthLeaders here. Seeking Alpha here ("Labcorp down 2%"). Becker's here. Reuters here.
- For coverage and quotes at 360DX, here.
- For ACLA's statement on the dismissal, here.
- For CAP's statement lamenting the dismissal, here.
- Follow up: On October 19, ACLA issued a press release that it filed "notice of appeal" with the court. here.
Separately: for ACLA's comment on Summer 2018 Part B rulemaking, which includes extensive comments on PAMA, see here. AMP's 5-page letter on Part B rulemaking is here. CAP's website for CMS letters appears to list its September 2016 and September 2017 PFS comment letters but not its September 2018 letter. CAP does have webinar slides on the PFS 2019 proposals (here).
As a non-attorney working full time on federal policy, I've always been puzzled by laws written by Congress which include a clause stating the implementation of the law is "shielded from judicial review." Checks and balances?
According to news reports, the judge's dismissal hinges on lack of jurisdiction. Even if the judge had jurisdiction, the section of law regarding which labs can report (with a 50% rule regarding Medicare Part B billings) is (or was or remains) problematic to craft around the issue of hospital labs. ACLA offers a mathematical solution on pages 9-11 of its comment letter.
CMS proposed to use 1450 claims forms in regard to its definition of hospital reference lab reporting. AMP and ACLA seem to take diametrically opposed positions on the wisdom of this CMS suggestion.
From summer proposed rulemaking, 1799 documents to the 2019 rule (CMS 1693 P) cited "PAMA" (here).
* As quoted by judge: ACLA wrote, "It would raise constitutional concerns of the highest order if Congress were to require the Secretary to promulgate substantive legislative regulations that directly regulate primary conduct on threat of civil penalties but then [also] attempt to insulate those regulations and the Secretary's enforcement of them, from any form of judicial review." [Decision, page 12].