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.

Medicare Posts Video of October 19, 2015 Diagnostics Advisory Board

CMS has posted the morning an afternoon sessions of the October 19, 2015 CLFS advisory panel online.  Links at:
Morning (3h30min):  here.
Afternoon (4h):  here.

The panel discussed Medicare's Gapfill recommendations of September 25, 2015, as well as Medicare's proposed implementation of lab fee schedule repricing aka PAMA Section 216.

My Talk at PMC/BIO Solution Summit for Personalized Medicine (October 14, 2015)

On October 14, 2015, I had the privilege of being invited to give the morning keynote address at the 2nd Annual Personalized Medicine Solution Summit, held in Washington.   (The meeting's agenda is here).

The deck is here as PowerPoint, and here as PDF.  Details after the break.

CMS Updates 2015 Gapfill Spreadsheet: Oncotype DX Now $3416 not $2900

On September 25, CMS released a spreadsheet of final CY2015 gapfill prices from its MACs, which listed Oncotype DX Breast at a price (beginning January 1, 2016) of $2900.  This was the median price of a small number of MACs reporting.

On October 7, CMS updated the spreadsheet.  The new spreadsheet lists Oncotype at $3416, and the change was caused by Noridian entries (which were previously blank) now being filled in at $3416.

Keeping Track of CMS Comment Periods for Labs and for MACRA

CMS currently has four comment periods open, one on 2015 gapfill, one on 2016 proposed gapfill/crosswalks, one on PAMA rulemaking, and one on MACRA's physician payment reforms.

More CMS MAC Contractors Publish Next-Gen Sequencing LCDs for Lung Cancer

On Thursday, September 30, two Medicare MAC contractors issued proposed LCDs for the field on next generation sequencing in oncology.  See also a footnote discussing similar coverage at United and Aetna.

Medicare to Hold Extra Clin Lab Advisory Panel: October 19, 2015

Medicare will hold a second meeting of its new Clinical Laboratory advisory panel on October 19, 2015.  Register to attend in person before Tuesday, October 13.

Details via the Federal Register website, here.

Genomeweb posts detailed article on competing LDT regulation proposals

For those with access to the trade journal Genomweb, on September 28, 2015, that site published a detailed discussion of competing proposals and approaches to enhancing regulation of LDTs.

September 28, 2015
Amid Competing LDT Regulatory Proposals, Common Ground but Key Disagreements for Congress to Consider.
By Turna Ray.  Here.

Ray discusses plans proposed by CAP, AMP, and the Diagnostic Test Working Group in the 2,100 word article.

CMS Issues Request for Comment on New Physician Payment Incentives

Last spring, the SGR reform bill ("MACRA") included sections allowing CMS to create new, and considerably larger, penalties and incentives for physician behavior.   The new incentive systems include one system that consolidates and expands existing fragmented incentives (such as e-Prescribing, PQRS, and electronic health records) into a program called MIPS.   The other system is for doctors active in ACOs and is called APM.

Did CMS Miscalculate the 2016 Price of the Oncotype DX Breast Test?

The Genomic Health Oncotype DX Breast test received a CPT code, 81519, that became active on January 1, 2015.   Based on decisioning making in late 2014, CMS placed the pricing of this code in the hands of its MACs under the Gapfill pricing process.   On September 25, 2015, CMS published an excel spreadsheet of the MAC prices.  The spreadsheet shows a "National Limitation Amount" of $2900 for Oncotype DX.   Based on my reading of CMS's own regulations, I believe CMS miscalculated the amount and it should be $3416.

UPDATE:  On October 7, 2015, CMS released a new Excel spreadsheet, now calculating the Oncotype DX price as $3416.  (Here).  CMS did so by adding the dozen Noridian states to the spreadsheet, so now, the median is $3416 whether calculated by "state" or by "MAC."

GAPFILL: CMS Posts September Results of the CY2015 Gapfill for Genomic Procedures and MAAAs

On September 25, 2015, CMS posted the results of MAC gapfill efforts on genomic procedure and other codes under gapfill this year.  By policy, CMS then calculates the median of MAC proposed prices, and sets this as the CY2016 price.  Details after the break.

2016 CLFS PRICING: CMS posts proposed pricing for new CY2016 tests including CY2016 Genome, MAAA, and Drug Tests

Having held the July 2015 summer CLFS comment meeting on new codes, and having held a special PAMA advisory panel on lab test in late August, on September 25, 2015 CMS released its proposed pricing for new lab tests for 1/1/2016.  Details after the break.

Genomeweb's article here. Fierce Diagnostics here.  San Francisco Business Journal here.

PAMA: CMS Posts Proposed PAMA Lab Price Rulemaking - First Thoughts

On September 25, 2015, CMS posting a 131-page document announcing its proposed rulemaking to implement PAMA Section 216.   Through the proposed policy and procedures, CMS will reset the 20-year-old Clinical Laboratory Fee Schedule to new prices based on market price surveys for clinical laboratory tests.  More after the break.

The link to PAMA rulemaking is here.

Genomeweb's article here.  ACLA's press release is here.  Coverage at Gray Sheet is here.

CMS accepts comments until November 24, 2015.  Since that will lead into the holidays, and since comments and complaints will be voluminous, final rulemaking may not appear until January or  February.