Wednesday, November 18, 2015

CMS Quality Measures and PSA Testing

On an obscure webpage, CMS issued a request for public comment for a physician performance metric that would financially penalize physicians who order PSA testing.  Physicians would be penalized for providing testing allowed to the patient by the Medicare statute, and even for a range of purposes that are recommended by the CMS NCD for diagnostic PSA testing.

From that lead-in, you can guess I view this as a flawed idea for multiple reasons.   These are discussed, and links are also provided to four brand new JAMA articles on PSA testing.

The JAMA articles on PSA testing policy and whither it should be going, were picked up by the New York Times and other major media (here).  The day after this blog appeared, the WSJ (here) ran an article on the new anti-PSA metric that this article discusses.

UPDATE: February 26, 2016:  CMS will not continue work on the proposed measure, according to the AUA (here).

House Hearings on FDA LDT Regulation: Key Quotes, Video, Detailed Notes

The House has posted a two hour, twenty minute video on the November 17, 2015 hearing, "Examining the Regulation of Diagnostic Tests and Laboratory Operations."  Here.

Tuesday, November 17, 2015

CMS Locks Down Final Crosswalks for New CY2016 Codes; Others in Gapfill; Drug Testing Finalized

On November 17, 2015, CMS released final decisions on how it will handle new laboratory codes for January, 2016.  As has been discussed in several public meetings and public comment periods since July, the new codes enter either a crosswalk or gapfill process.  There has been much sturm and drang all year how CMS would handle drug tox coding and pricing.  There was a kerfuffle in September when about ten MAAA tests were priced at about $692.  Increasing attention has been paid to an AMP proposal to price new codes via a "log natural" method.

Generally, simple genetic codes were crosswalked to existing genes, and complex genomic procedures (and new MAAA tests) were sent to the gap fill process for CY2016.  For drug tox results, see below.

CMS Finalizes CY2015 Gapfill Prices

CMS has released final decisions on the CY2015 gapfill process, that is, for codes that were new in January 2015.   There was a stir in September 2015, when the 5-50 tumor gene codes were priced at only around $600 and Oncotype DX was priced somewhat below its historic CMS price.

In the final gapfill pricing, both Oncotype DX and Nanostring Prosigna are priced at $3416 for CY2016.   The codes for 5-50 tumor genes (81445, solid tumor; 81450, hematolymphoid tumor) were still priced at $597 and $647 respectively.

There is *no* CMS price for the 50+ tumor gene code (81445).

At the CMS website, here, see the file for "2015 CLFS Gapfill Final Determinations."

Monday, November 16, 2015

FDA Tells World (And Hill) It Needs to Regulate LDTs

On November 16, 2015, the FDA released a detailed white paper on why LDTs need to be more stringently regulated.

The FDA Blog introduces the topic, authored by Peter Lurie (here).   The FDA's homepage for the report on LDT safety and problems is here.   The FDA's 39 page white paper is here and assesses potential risks and harms associated with twenty different LDT tests.

The report went up the day before FDA will testify at a Hill hearing on the need to regulate LDTs.

30 Slide Deck on PAMA - the New Lab Test Pricing Law

In October, BIO invited me to provide a webinar on PAMA, the law that will eventually create a new pricing system for laboratory tests in 2017 or 2018.

The deck is in the cloud, here.

Yes, Virginia, MolDX is really coming to J15 (OH/KY)

In mid August, Noridian announced that MolDX would expand to Jurisdiction F - the northwestern and mountain states (my blog here).

At that time, I found a Palmetto MolDX webpage remark that MolDX was *also* coming to the CGS MAC (my blog here).   I couldn't find any statement on CGS's own website.

A few days later, on August 17, CGS did post news of the MolDX expansion.  The CGS MolDX webpage (updated as of October 30, 2015) is here.   I've clipped it below as it stood as of November 16, 2015.

Friday, November 13, 2015

My Interview on Mendelspod

I've enjoyed the genomics podcast Mendelspod for a couple years.  It was a special treat to be interviewed by Theral Timpson for a podcast on trends in CMS diagnostics reimbursement.

Via your smartphone podcast app, under the Mendelspod channel, or here.

Wednesday, November 11, 2015



November 12, 2015:

Medicare issued proposed regulations for implementing PAMA's changes to the Clinical Laboratory Fee Schedule on September 23 (Federal Register final version, October 1, here).  The comment period runs til November 24, and comments can be typed up and entered online here.

As of November 12, 75 comments had been submitted.  About 15 are similar letters from employees of Quest Diagnostics.  Otherwise, most of the comments represent a lengthy form letter submitted from dozens of individuals.

My comment, focused only on the definition of ADLT, is here.

Tuesday, November 10, 2015

New Flurry of Letters to LDT Labs: FDA Found You!

November opens with the FDA sending letters to at least three LDT labs, DNA4Life, DNA CardioCheck, and Interleukin Genetics, in Alabama, Illinois, and Massachusetts, respectively.

The three letters are online at the FDA here, here, and here.  For November 16 coverage at Bloomberg, see here.

Sunday, November 8, 2015

Much Interest in CMS Reform of Physician Incentive Metrics ("MIPS" regulations)

Last spring, Congress repealed the longstanding SGR policy for the CMS Part B physician fee schedule.  The legislation also set in motion what could be a big overhaul of the physician performance metrics like "PQRS."   Nearly 200 comments on the topic are already on the website.  Meanwhile, until Tuesday, November 17, CMS is requesting additional deep dive comments through a special MIPS "request for information" process.

Thursday, November 5, 2015

Medicare Releases CY2014 Utilization of Part B Genomic Tests

Data on CMS payments for CY2014 genetic CPT codes have been released.  Total payments were about $650M in Part B; about 10% flowed through "Tier 2" codes.  The top five codes by total dollar volume including the winner - 81401Tier 2, Level 2; followed by two CYP genes and the clotting factor genes Factors 2 and 5.  Just 3 codes captured 55% of the $650M spend.