Tuesday, July 13, 2021

CMS Issues Physician Policy Rule Proposals for 2022 (PFS), Sets Dr. Meena Seshamani as Center for Medicare Director

Dr. Meena Seshamani

First, let me catch up on a CMS press release from a few days ago.  CMS is the Centers for Medicare and Medicaid; thus, it has internal directors for Medicare and for Medicaid.  CMS has announced the new Director of the Center for Medicare is Dr. Meena Seshamani.   Press release here.   She has an MD/PhD, the PhD being in Health Economics from Oxford.  She's an otolaryngologist trained at Hopkins.

PFS Rule for CY2022

With a triplet of press releases, CMS releases proposed Physician Fee Schedule and other outpatient proposals for CY2022.  This kicks off a 60 day comment period.   

  • Press release here.
  • Fact sheet here.
    • The fact sheet weighs in at 6500 words, which may be a record.
    • For me it prints as 17pp.
  • Special fact sheet about Diabetes Prevention Model (MDPP) here.
  • There's also a separate 21-page PDF fact sheet for quality measurement program changes, here.
  • Rulemaking permalink here.
  • Published version July 23, 2021, 86 FR 39104, 804pp.
    • Link here.  It's an awesome 60mb this year.  And locked (no highlighting)
    • I've made a version which is 30mb and unlocked (allows notes and highlighting), in the cloud here.
  • Inspection copy aka typescript version here.
    • It's an imposing 1747 pages long.

Telemed Liberalization

See early coverage of telemed liberalization proposals, here.   See the Center for Connected Health Policy (CCHP) 7-page fact sheet here and 13-page slide deck here and 19-minute YouTube here.

See a full review of virtual medicine provisions by McDermott Will & Emery, here. See an update on finicky RPM rules through 12/2021, by Foley Lardner, here.  

Extensive Discussion of AI Pricing, e.g. AI-retina or Heartflow

Extensive discussion of RVU pricing for software and AI/ML, such as for AI-retinal diagnostics or for the Heartflow fractional flow reserve Category III code.  P. 39123-6. version.  References RAND studies of how to update the RVU/PE system.  Note that CMS held a workshop on this topic earlier this summer

In contrast, there's no proposed national price for iRhythm. Discussion at 39178. (However at 39169ff they do tweak RVUs for similar remote cardio codes code 93228/29).  

See new codes for "remote therapeutic monitoring" RTM page 30183ff (989X1 ff).  This is a new code set different than, but echoing, "remote physiological monitoring" RPM.

Quite interesting, they propose new regulations for IDTFs that perform computer analysis primarily, rather than patient facing services like x-rays.   IDTF regulations require patient friendly signage, perhaps even bathrooms, things irrelevant to companies like Heartflow or iRhythm.  CMS proposes to update IDTF rules for for computer-modeling-focused IDTFs.   39313.

Ejection from Program

CMS has regulations allowing it to revoke participation from abusive-billing providers.  They want to revise the rules that even a short period of severe abuse could result in revocation.  (For example, a lab submits $1000 of normal claims January-June and submits $10M of fraudulent claims in July).  P. 39311ff.

Regulations for Documentation During Review - MACs, RACs, Etc.

CMS has authority to collect medical records for payment review at 1833(e) but proposed a set of regulations to implement this historical authority.  Page 39314ff.  Revising 42 CFR 424.535ff.  They don't say very much; they just say MACs and others can do this, can use certain dates, can allow certain exceptions.

Lab Note

CMS has varied lab blood specimen collection fees between $3 and $25 (COVID), and asks what long-term policy should be.  Submit your comments.

AMA has replaced longstanding codes for pathology consultations (80500, 80502) with four codes.  CMS carefully reviews pricing issues to set RVU units.  39167ff.  Also, the RUC included microscope time, but CMS doubtful that is part of clinical pathology consultations.  (See, in contrast, a different code range for consultation on slides prepared elsewhere, 88321, 88323).  

In quality measures, CMS will delete C.7, Myelodysplastic syndrome & leukemia, cytogenetic testing performed on bone marrow.  39786.   It's listed as "no longer maintained" by the measure steward, American Society of Hematology.  I haven't looked up the affiliated CPT codes, but would just note this has been a huge area of technological innovation, from conventional cytogenetics (light microscope) in the 1970s/80s, to FISH, to microarrays, to low-coverage NGS (new CPT code created), to optical genome mapping (see Genomeweb this week here and Mendelspod this week here.)

NCD Death Watch

CMS has a process for deleting outdated and obsolete NCDs.  Circa 10 were on the list last year, although a number of those weren't actually deleted due to public comment.   

This year 2 are proposed for deleted, a DME NCD for parenteral nutrition and an NCD that controls use of PET scans outside of oncology.  39255ff.  Oncologic PET scans would continue under fairly broad NCDs, but a historical ban on local LCDs for non-oncologic indications will be lifted.  Some miscellaneous one-off specified non-oncology PET NCDs will remain, if they've already been written, like one that blocks brain amyloid PET scans except in approved clinical trials, and one that blocks sodium fluoride PET scans.


CMS established a Medicare benefit for diabetes prevention programs several years ago, based on a demo project by the YMCA that was cost-saving in the Medicare population.  The program has never really taken off and was probably really torpedoed by the COVID epidemic.  CMS proposed some changes to make it more friendly to those who would fund and provide the programs.

Remote Therapeutic Monitoring

I understand the Remote Physiological Monitoring codes well enough, but there are new codes for "Remote Therapeutic Monitoring" and CMS explains these are intended, in part, to allow billing by non-physicians, e.g. physical therapists.  See code text here.   

However, CMS is concerned this is a contradiction in terms, because the practice expenses for RTM involve "incident to" expenses which is a concept used only for physician services.  

An expert explained the difference between "remote physiological monitoring" (several years old) and "remote therapeutic monitoring" of respiratory or musculoskeletal function.  The RTM codes are intended for things like monitoring inhaled drug usage or musculoskeletal range of motion. 

Colon Cancer Screening Copays

Screening services generally don't have copays, like screening colonoscopy, but CMS has long converted this to a "copay" medical service if there is a biopsy event during the colonoscopy.  Legislation recently aimed to remedy this (Consolidated Appropriations Act, 2021, section 122); CMS has a section on implementing the legislation.  39218ff.   (In a true nerdy twist, they mention that the ACA dealt with this regarding deductibles but not regarding copays.)  There is a footnote to the CY2022 OPPS rule - not released as early as the PFS rule - that there will be changes stemming from CAA-122 there, also.
The financial changes will dribble in; status quo CMS pays 80% in 2022.   CMS pays 85% in 2023-2026 (thanks!).  CMS pays 90% in 2027-2029, then 100% from 2030 forward.   

This change in Medicare payment (from 80% now to 100% per CAA 122) is described over 3 pages.

Colon cancer copays have been bouncing around since 2014; see Howard et al. here



AMA has created different code sets for "remote physiological monitoring" (e.g. blood pressure), "remote therapeutic monitoring" (e.g. range of motion), and (remote) "cognitive behavioral therapy" by devices per 30 days.   (The latter will be January 2022 Cat III codes).   So these are RPM, RTM, and CBT.   Note that you also see the abbreviation RPM = Remote Patient Monitoring, rather than "p=physiological" monitoring.

Historical Note: Incident-To Evolves (I Think)

The code for remote physiological monitoring was created by AMA some years ago, but not accepted by CMS until about 3 years ago.  (As of 2019, it still had quite limited utilization).  I believe this is because CMS felt that the physician providing (for example) a home blood pressure monitoring device, exceeded the concept of "incident to" which historically covered things purchased and used in the office suite. (This including disposable surgical supplies, even expensive ones, and chemotherapy, things that were used "in the office" or literally "furnished in the office.")   

Validation of this comes from the fact there is a special section of statute for allergists to compound and supply the patient with take-home allergy shot antigens (at 1861(s)(2)(G), so take-home antigens were not considered included in the prior definition of incident-to services (furnished IN the office per statute) at 1861(s)(2)(A)).  SSA here.  See 2002 OIG report and 2006 OIG report.

With the RPM (and now RTM and we expect CBT) codes, CMS has opened up its view of what is "furnished in the office" and "incident to" (it now includes the take-home monitors), but this is still contingent on the physician "incident to" benefit which doesn't apply to psychologists or physical therapists.

For a vender's listing of the RPM CPT codes, here.  99454, 30 days RPM service, is priced for a $1000 "heart failure patient physiol monitoring equipment (EQ392)" (table 16 here; see also here) with a 5 year life, prorated at $49 value per month in the AMA RVU tables (subscription).  After various obscure calculations for practice expense, the CMS payment for 99454 is circa $63.