Friday, April 24, 2015

PMC 2015 White Paper: How ACOs Impact Personalized Medicine

In April 2015, the Personalized Medicine Coalition released a new 40-page white paper entitled, "Paying for Personalized Medicine: How Alternative Payment Models Could Help or Hinder the Field."  The white paper discusses the impact of ACOs, bundling, and other payment systems on precision medicine.    Download here.

The white paper is authored by Andrew Shin (here), of ML Strategies, the consulting arm of Mintz Levin LLP.

Wednesday, April 22, 2015

Congress Gives CMS a Free Hand to Reset RVUs

Sound bite:
The rules for establishing RVUs are greatly changed, and the power balance tipped far in favor of the Medicare agency, by § 220 of the Protecting Access to Medicare Act of April 2014.  Medicare has not yet begun to implement its new value-setting powers, but it will probably begin to do so by mid 2015.   
More after the break.

The Wall Street Journal won the 2015 Pulitzer Prize for investigative reporting for its series, "Medicare Unmasked."

See also:  The GAO's negative report on the RVU system, published May 21, 2015 (here), and a blog on the GAO report, 5/22/2015, here.  See a May 31, 2015, New York Times article on the GAO report, here.  

For further recent RUC critiques, both cited within the GAO report, see Urban Institute, June 2014, "Development of a model for the valuation of work relative value units: Objective service time task status report," Auckerman et al., 139 pp, here.   RAND, 2015, "Development of a model for the validation of work relative value units for the Medicare Physician Fee Schedule," Wynn et al., 263 pp, here.

Thursday, April 16, 2015

Coalition Announces FDA Diagnostics Reform Plan; FDA-CMS Announce Dx Quality Collaboration

Out of the Hat - The Diagnostic Test Working Group (DTWG)

As noted today on the Hyman Phelps FDA Law Blog (here), an emerging coalition called the Diagnostic Test Working Group has released a broad plan to up-end the way FDA regulates diagnostics.   If enacted by Congress, the FDA, CMS, and states would undertake a very substantial revamping (including changes in law) of FDA's governance of diagnostics.

Details are on the Personalized Medicine Coalition website (here); see also my cloud archive - executive summary, here;  full white paper, here;  one pager, here.

The proposal would leave diagnostic test design and validation in the hands of the FDA, but would extend this authority for both IVD (kit-distributed) and LDT diagnostics.   Once the test is designed and validated, operations to run the test would be in the hands of CLIA (or its designated examining agencies).   Unusually, the proposal leaves much of the claims and sign-out authority in the hands of the states.

For those with subscription access, see Genomeweb, "Small Group of Labs, Dx Manufacturers Float Alternative to FDA LDT Guidance" - here, which comments the Hyman Phelps blog.  See also "Coalition of Manufacturers, Labs Floats Alternative to LDT Approach" at Inside Health Policy, here.

FDA and CMS announce "Task Force" on LDT Quality 

Webpage announcement here, at  Co-authored by Jeff Shuren (FDA) and Patrick Conway (CMS), the agencies describe some stakeholder confusion in the wake of the FDA's plan to regulate LDTs under FDA law but in a phased-in fashion.   The two-agency "task force" will

...Establish an interagency task force that will continue and expand on our collaboration related to the oversight of LDTs, which are tests intended for clinical use and designed, manufactured, and used within a single lab. The task force, comprised of leaders and subject matter experts from each agency, will work to address a range of issues, including those involving quality requirements for LDTs.

Of course, this is a poke in the eye to those stakeholders who felt that CLIA already enforced the quality of laboratory developed tests.

More analysis and insight on these topics, to follow....