Saturday, October 31, 2015

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.

Wednesday, October 28, 2015

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.)

Tuesday, October 27, 2015

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.

Tuesday, October 20, 2015

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.

Wednesday, October 14, 2015

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.

Wednesday, October 7, 2015

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.

Saturday, October 3, 2015

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.

Friday, October 2, 2015

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.