The Federal Register home page is here; access the typeset 665 page PDF directly here (83 Fed Reg 35704-36386, published 7/27/2018). CMS fact sheet here. The CMS rule home page with twenty links, attachments, and zip files is here.
- Nerd tip: For me, the 665 page PDF downloads as a frozen or "locked" version. In my PDF editor, I can "extract" all pages and save as "new" 665 page .PDF file which is no longer locked, so I can highlight, annotate, etc.
Coverage at MedPageToday here; MobiHealthNews re telehealth, here; also here. More on telehealth rules from Foley Lardner, here; Drinker Biddle, here.
Coverage focusing on E&M changes here, here, here, here. Here, here. WSJ CFO page, here.
In a press release, CMS framed the rulemaking as "historical changes that increase the amount of time doctors and other clinicians can spend with their patients by reducing the burden of paperwork" (here). The changes are part of the CMS "Patients over Paperwork" initiative. CMS's goals to reduce regulatory burden and paperwork are not limited to physician paperwork: in April, CMS proposed to kill dozens of reporting requirements for hospitals as well.
Overview
CMS proposes to streamline E&M documentation, reduce some physician staff supervision requirements (in radiology), and pay clinicians for telehealth services like short calls that avoid an office visit and review of patient-submitted photos. For the latter, see p. 63ff, especially pp. 66ff, and early coverage at Forbes here.
Regarding telehealth policy, CMS takes a new spin on its statute. CMS has generally only covered "face to face physician services," with a few exceptions like a monthly fee for care management. However, the statute allows coverage of "physician services" per se - without restriction. CMS takes the position that the restriction on limited telehealth for office visits (from rural areas only) is actually a creation of the telehealth section of statute. Where the legacy telehealth statute for office visits doesn't apply, CMS can create more flexible telehealth on its own (!), as it does in this rule. This is most especially true where the "physician services" are new and not inherently face to face. Intriguing viewpoint.
In more detail, I discuss below mass re-indexing of equipment and supply prices, and rulemaking re PAMA lab definitions.
Streamline Measures & E&M Rules
MIPS reporting of quality measures will be pared down by axing what CMS calls low-value measures. 34 topped out process measures will go away.
There will be a mass simplification of rules for E&M visit pricing (details here, here).
Roll Over, RUC: ReIndexing Supply and Capital Equipment Pricing
On page 50ff, there is discussion of better approaches to market-based supply pricing (for RVUs);
PAMA Section 220 gave CMS wide new authorities in this regard (as I discussed in 2015 here).
Interestingly, a large contracted research project found "there was no statistically significant difference between estimated commercial prices and current CMS prices for both equipment and supplies."
But individual prices will change under a proposed shift over 4 years to new input prices. Bringing a smile to my face, they elected to illustrate this four-year phase-in with a hypothetical product that is paid $100 now but will get a new price of $200. See figure at bottom.
See Zip file at CMS here. This includes a 57-page report by consultancy StrategyGen. This includes new prices for 1300 supplies and 740 equipment items (capitalized items).
While total average prices won't changes, shifts will be large. The tables list CMS supply codes, not product types, so they're a bit cryptic by themselves. But for example, the price of ED004 (6MP camera) will drop from $946 down to $152 (16%), and the price of ED017 (brachytherapy workstation) will rise from $105,403 to $281.580 (267%). Supply SA051 (pelvic exam pack) will rise from $1.17 to $20.16 (1720%) while SA046 (laparotomy drapes) drops from $26.12 down to $7.26 (28%). While CMS plans to use these "market prices" rather than GSA product acquisition prices, but where available, GSA prices are listed in a separate table for comparison. For example, Angiography Room EL011 has a CMS price of $1.4M, and new target of $1.1M, and a GSA price of $229,145. (There are some cases where GSA prices are higher than CMS, though).
Article on "rethinking the RUC," here.
As a tidbit of digital health, there is a discussion of the input price for Breast Biopsy Software EQ370 (p 57). (They declined to add software as a line item cost input, but because there is already a global entry for "MR room equipment package EL008"). In current equipment tables, EQ370 is "Breast MRI computer aided detection and biopsy guidance software" but has no dollar value. For very elaborate debates in Fall 2017 on OPPS APC handling of Heartflow software services, see here.
Lab Industry: PAMA Revisited At Length
Minimal rules directly affect the lab industry. CMS proposed to reduce the minimum lab volume for PAMA reporting from $12,500 to $6,250 and requests comment.
Notably, on page 405ff, CMS proposed to consider new definitions of a PAMA reporting laboratory that might include more hospital-based labs. For example, CMS opines whether the law requires them to include Medicare Advantage (Part C) revenues when making certain PAMA determinations for eligible labs. Discussions of how to define laboratories by TIN run from 410ff; CMS recognizes there is a debate (not to mention a lawsuit, and the lawsuit is not mentioned) on this topic. Net-net, CMS lands on "no change" but invites comment at 413ff. Absent the ACLA lawsuit about PAMA, it's unlikely we would have seen 20 pages of discussion of these policies today.
In summary, CMS proposes to exclude Part C revenues from eligible lab definition, but only proposes to consider alternatives to how it handles hospital lab eligibility otherwise.
CAP prepared a table of revisions to PFS pathology prices, here. Big gains for computer assisted tumor IHC.
"No News is Good News?" Department
No use of the words genetic or genomic in the rule.
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| CMS picked cheerful illustrative hypothetical of price change |
