On September 21, 2018, CMS posted its proposed prices for public comment.
- Find them here.
About 18 codes under the summer gapfill comment and revision process have not been posted yet.
Sometimes in the past CMS has given pretty telegraphic reasons for its choices. For example, if different stakeholders suggest three codes, CMS might say it has chosen one of the codes "because it is more appropriate." Well, yes. This year, CMS gives an introductory explanation of some of its concerns with the range of pricing suggestions. See the CMS document, but I summarize as:
- Multipliers. Stakeholders can suggest multipliers, and CMS can use them, but CMS says that rationales may be scanty or inconsistent. CMS strongly prefers a crosswalk without any multiplier.
- Stacking CDLT codes. PLA tests may seem to bundle multiple existing codes. Since economies of scale may be uncertain, CMS will tend to recommend gapfill pricing.
- Lots of genes. Since only one large-scale code is available (81455, 51+ genes), CMS prefers to gapfill these codes.
- New BRCA codes. In 2019 we will be facing a mix of new, revised, or deleted BRCA codes. For pricing, Tier 2 MoPath codes were used when possible (81405, 81406).
In last year's exercise, in proposed fall pricing, I believe CMS very rarely recommended gapfill, but switched to gapfill for some codes after fall comments. Here, CMS seems to take the opposite starting position, to recommend gapfill in September more liberally (I believe on 14 codes, agenda numbers 6, 7, 9, 11, 17, 18, 22, 23, 35, 37, 40, 42-44).
CMS used Tier 2 code crosswalks often, such as for BRCA codes and even for codes (Tab 49, 80X00) where almost no one else recommended a Tier 2 code. I tallied the phrase "CMS disagrees" 10 times, but CMS seems to indicate in its preamble that it "disagreed" 15 times. Sometimes it's murky, since panel recommendations were occasionally widely split, so CMS might have agreed with somebody.
CMS accepts comment until October 22 at an email posted in the PDF.
Impact on Future Stakeholder Comments and PAMA Expert Panel
If CMS chooses to follow these rules, it reduces the impact of the PAMA expert panel and stakeholder comments by automating more decisions. High gene count codes or codes that incorporate several codes go to gapfill. Codes for which multipliers are suggested are likely to get "times 1" without too much debate. Finally, remaining codes would get the most obvious Tier 2 crosswalk unless a clear single specific crosswalk is obvious.
Gapfill Process is Better? Why?
In several codes, CMS states that "the gapfill process will yield better information." However, medical directors under the gapfill process are unlikely to have any new information that isn't or can't be provided by stakeholders during the CLFS pricing process. Pretty much anything you would submit to MACs in December you can submit to CMS staff in the same format this summer.
If CMS declines to price small novel gene panels assembled in groups under one new code, because of concerns about (economies of scale), labs will simply bill them individually, in which case they add up individually and there are no economies of scale recognized.
Multipliers Become Small
CMS did allow a multiplier of x2 on a couple codes (e.g. 0061U) but in cases where stakeholders had started by asking for x8 or x12.
Enhanced Analyses - CMS Says Meh?
A few codes with enhanced analysis were proposed to crosswalk to existing prices. For example, 0046U is FLT3, quantitative, and was crosswalked to 81245, FLT3, qualitative. (Most panelists proposed gapfill.) This is a code from Invivoscribe, whose former executive Tim Stenzel MD PhD now heads Diagnostics at FDA. According to CMS, no stakeholder recommendation arrived for this code. MolecularMD requested 81206 x 2.5 for its high sensitivity BCR/ABL test, which is FDA approved, 0040U. CMS proposed 81206, x 1. Its 510(k) refers to a predicate de novo 510(k) product from Asuragen.
Neurologic Expanded Repeat Genes
A lot of the new codes were neurologic expanded repeat genes (see open access review here); crosswalked to 81401, Tier 2 Level 2, $137. These numbered close to 30, being most of the codes tab 67 to tab 99. Exceptionally something else happened (e.g. tab 68, 8X002, AFF2, crosswalked to 81404). A few codes found in this range were different analyses (e.g. tab 80, 8X014, full sequence). The granddaddy of this series is 8X026, Huntington's disease (81401).
FISH Code Enters CLFS Pricing Pathway
Traditionally, CMS has classified FISH and IHC as "physician pathology services" set by RVUs on the Physician Fee Scedule, and absent on the CLFS. Here, AMA code 0053U, oncology, prostate needle biopsy, FISH of 4 genes, is in the CLFS process and being proposed for gapfill into the CLFS fee schedule. CLFS codes do not trigger copays, and molecular CLFS codes are exempt from outpatient hospital bundling. Pathology codes (FISH, IHC) do trigger copays and I believe are sometimes bundled to hospital surgical procedures.
CMS used Tier 2 code crosswalks often, such as for BRCA codes and even for codes (Tab 49, 80X00) where almost no one else recommended a Tier 2 code. I tallied the phrase "CMS disagrees" 10 times, but CMS seems to indicate in its preamble that it "disagreed" 15 times. Sometimes it's murky, since panel recommendations were occasionally widely split, so CMS might have agreed with somebody.
CMS accepts comment until October 22 at an email posted in the PDF.
Impact on Future Stakeholder Comments and PAMA Expert Panel
If CMS chooses to follow these rules, it reduces the impact of the PAMA expert panel and stakeholder comments by automating more decisions. High gene count codes or codes that incorporate several codes go to gapfill. Codes for which multipliers are suggested are likely to get "times 1" without too much debate. Finally, remaining codes would get the most obvious Tier 2 crosswalk unless a clear single specific crosswalk is obvious.
Gapfill Process is Better? Why?
In several codes, CMS states that "the gapfill process will yield better information." However, medical directors under the gapfill process are unlikely to have any new information that isn't or can't be provided by stakeholders during the CLFS pricing process. Pretty much anything you would submit to MACs in December you can submit to CMS staff in the same format this summer.
If CMS declines to price small novel gene panels assembled in groups under one new code, because of concerns about (economies of scale), labs will simply bill them individually, in which case they add up individually and there are no economies of scale recognized.
Multipliers Become Small
CMS did allow a multiplier of x2 on a couple codes (e.g. 0061U) but in cases where stakeholders had started by asking for x8 or x12.
Enhanced Analyses - CMS Says Meh?
A few codes with enhanced analysis were proposed to crosswalk to existing prices. For example, 0046U is FLT3, quantitative, and was crosswalked to 81245, FLT3, qualitative. (Most panelists proposed gapfill.) This is a code from Invivoscribe, whose former executive Tim Stenzel MD PhD now heads Diagnostics at FDA. According to CMS, no stakeholder recommendation arrived for this code. MolecularMD requested 81206 x 2.5 for its high sensitivity BCR/ABL test, which is FDA approved, 0040U. CMS proposed 81206, x 1. Its 510(k) refers to a predicate de novo 510(k) product from Asuragen.
Neurologic Expanded Repeat Genes
A lot of the new codes were neurologic expanded repeat genes (see open access review here); crosswalked to 81401, Tier 2 Level 2, $137. These numbered close to 30, being most of the codes tab 67 to tab 99. Exceptionally something else happened (e.g. tab 68, 8X002, AFF2, crosswalked to 81404). A few codes found in this range were different analyses (e.g. tab 80, 8X014, full sequence). The granddaddy of this series is 8X026, Huntington's disease (81401).
FISH Code Enters CLFS Pricing Pathway
Traditionally, CMS has classified FISH and IHC as "physician pathology services" set by RVUs on the Physician Fee Scedule, and absent on the CLFS. Here, AMA code 0053U, oncology, prostate needle biopsy, FISH of 4 genes, is in the CLFS process and being proposed for gapfill into the CLFS fee schedule. CLFS codes do not trigger copays, and molecular CLFS codes are exempt from outpatient hospital bundling. Pathology codes (FISH, IHC) do trigger copays and I believe are sometimes bundled to hospital surgical procedures.
