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.

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.

PAMA CLFS COMMENTS: DUE NOV 24; EARLY RETURNS

[UPDATE: SEE THE UPDATED DECEMBER 16 BLOG 

WRITTEN AFTER THE CLOSE OF THE COMMENT PERIOD: HERE.]

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.

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.

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Last spring, Congress repealed the longstanding SGR policy for the CMS Part B physician fee schedule.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 regulations.gov website.  Meanwhile, until Tuesday, November 17, CMS is requesting additional deep dive comments through a special MIPS "request for information" process.

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.

House to Hold Hearing on DTWG in November 2015; Posts Legislative Draft

According to the trade journal Gray Sheet (subscription; here), on November 17, 2015, the House will hold a hearing on a legislative reform that would create a new body of FDA statute for diagnostic tests.  Draft legislation is offered for discussion, and tracks pretty closely to the Spring 2015 DTWG FDA Reform proposal.

Medicare OPPS Rule: Complex Handling of Protein and DNA/RNA MAAA Tests

On October 30, CMS issued its final rule for the hospital outpatient, or "OPPS," fee schedule for CY2016.  (Full listing here).

Regarding molecular pathology, CMS has finalized its plan to treat genetic tests and DNA/RNA MAAA tests differently than it treats protein-based MAAA tests.  For extra confusion, CMS treats some protein-based MAAA tests differently than others.

Medicare Publishes OPPS, PFS Final Rules (October 30, 2015)

On October 30, 2015, Medicare published "final rules with comment" for both the OPPS and PFS payment systems.   OPPS, PFS, Medicaid services adequacy, and ESRD rules after the break.

Sudden Change Can Happen: Legislation on Medicare's Outpatient Location Payments

Often change at Medicare - whether within the agency or from the Hill - appears to come very slowly.  This week was an example of an unexpectedly sudden change.   According to Bloomberg (here),  new budget balancing legislation will call a halt to hospital system acquisitions of physician practices which are then reclassified as hospital outpatient clinics.

The basic issue has been known for a number of years, discussed in newspapers, trade journals, and in CMS rulemaking and MedPAC publications.   For example, from February 6, 2015 in the New York Times:  "When Hospitals Buy Doctors' Offices, Patient Fees Soar."  (Clear; here.)

AMA and Coalition Support Enhanced CLIA

On October 27, 2015, the American College of Medical Genetics issued a press release that it had joined AMA and a broader coalition in supporting an "Enhanced CLIA" approach to LDT regulation.

While there has been some discussion of CAP and AMP producing somewhat different versions of an enhanced CLIA paradigm in recent months, the letter is signed by the AMA (including CAP), and by the AMP.  (Genomeweb, subscription, here.)

The joint letter to both House and Senate, dated October 26, 2015, is online here.  ACMG's news release, which discusses both the two page consensus letter to the Hill and provides a number of helpful ACMG-specific links, is here.

FDA and Theranos: FDA Promised Tougher Enforcement when LDTs are DTC

As is well known in the laboratory and FDA policy communities, the FDA has generally let laboratory developed tests (LDTs) operate under "enforcement discretion."  This means the FDA believes it has the legal authority to regulate LDTs (for example, through 510(k)'s and PMAs) but the FDA declines to routinely require such review - "enforcement discretion."

FDA's Updated October 2015 Documents on 23andMe: Class II Without 510(k)

In February 2015, the FDA announced not only that it would allow 23andMe's DTC carrier screening tests to begin moving forward, but that recessive hereditary genetic tests could be:

• Categorized as Class II devices;
• Not require separate 510(k)s;
• Be offered direct to consumer.

Together, this was a remarkable constellation of decisions.  Links to documents from February to October 2015 are below the break.

Version 2 of the Diagnostic Test Working Group Proposal is Circulating

According to the subscription trade journal Inside Health Policy, the Diagnostic Test Working Group (DTWG) is circulating a revised version of its plan for FDA reform and a new paradigm for diagnostics regulation.   Inside Health Policy also suggests (here) a potential House Energy & Commerce hearing on laboratory tests for October 29, 2015, although this is not publicly calendared at the House website yet.  The hearing was held in November, my blog here.

Inside Health Policy on the revised DTWG plan, subscription, here.   On the Senate side, Inside Health Policy suggests the possibility of standalone diagnostics regulation that would not be part of 21st Century Cures or its Senate equivalent (here).

The DTWG does not maintain a website or provide easily accessible versions of its proposals.   In late September, the trade journal Genomeweb published a long article that assessed the competing approaches to LDT regulation from FDA, CAP, AMP, and DTWG (here).  See also Genetic Engineering News, 10/2015, here.