MolDX Finalizes Coverage of Nanostring Prosigna Test

On May 14, 2015, the MolDX program published a draft LCD proposing to cover the Nanostring Prosigna test for breast cancer (here).   On August 13, 2015, MolDX published a final coverage LCD which becomes effective on 10/1/2015, coincident with the new ICD-10 diagnosis codes.

The final Prosigna LCD (essentially the same as the draft) is available here - L36125.   MolDX also published a concise response to comments, primarily acknowledging letters of support of the draft policy (A54565, here).

The LCD also exists in draft form in KY/OH under the CGS MAC.  That draft LCD, L36127, does not yet state it is released-to-final (here).

The company's press release is here.

MolDX Updates its Frequently Asked Questions (August 5, 2015: Ver 5)

On August 5, 2015, MolDX updated its "Frequently Asked Questions," which is now in Version 5.
The new version is available on its own MolDX webpage, here.
For those interested in updates between the February 2015 version and the August 2015 version, a redline copied is here.

Noridian Announces Expansion of MOLDX to Jurisdiction F (And J E "Pt A")

On August 4, 2015, Noridian announced expansion of the MolDX program from its current Noridian footprint - Jurisdiction E "Part B" only - to Jurisdiction E "Part A" and Parts A/B in Jurisdiction F.  Their website article provided after the break.

Association for Molecular Pathologists Releases Lab Regulation Plan

As released on its website, on August 4, 2015, the Association for Molecular Pathologists (AMP) met with Senate Finance Committee staff to discuss the AMP's framework for some upgraded controls or regulation of laboratory developed tests.  The project is titled, "Modernization of CLIA Regulations
for Laboratory Developed Testing Procedures (LDPs)."

More after the break.

Federal Court Finds DNA Fingerprint for Specimen I.D. is not a Medicare Benefit

For a couple of years, it's been possible to track the progress of a molecular pathology case through the Medicare appeals system, which works through independent review contractors, a federal administrative law judge, a Medicare board of administrative law judges, and eventual the federal courts.

The lab in question can use DNA fingerprinting to confirm that the tissue in a paraffin block is a perfect match to the patient's DNA (based on blood or saliva).   Some local MAC decisions had found that this was not a Medicare benefit but a lab quality operations procedure.

This summer, a federal judge agreed with the CMS agency that this type of DNA fingerprinting was not, in itself, a payable Medicare benefit as a laboratory service.  The case is online here.

Early parts of the Medicare case, from February 2013, online here, and September 2012, here.  A discussion of the case is also available here (page 4 forward) by Wachler, who represented the lab.

2015 White Paper: Building the Genomics Infrastructure

In late July, the Center for Data Innovation and the Health IT NOW coalition released an insightful ten page white paper, "From Evolution to Revolution: Building the 21st Century Genomic Infrastructure."

In the last few days I've heard a half-dozen different individuals or organizations raise thoughts along these lines, so the white paper must be capturing the Zeitgeist.

Links to the press release, here - and to the actual white paper, here.

Press release quoted after the break.

CMS Announces Members of Lab Advisory Panel; First Meeting 8/26/2015

CMS has announced the experts it has selected for a fifteen-member expert advisory panel on laboratory policy.   The panel will hold its first public meeting on August 26, 2015.

The panel will specifically give CMS an opportunity to reopen and revisit issues about molecular test crosswalking and issues on drugs of abuse testing that were discussed at a prior July 26, 2015 public meeting (here).  Details after the break.  Updated August 20, 2015 with additional information about each panelist.

Theranos Marks 50th Anniversary of Medicare and Medicaid

Press release (online here).
Details after the break.

The Popularity of Palmetto’s Approach to Urine Drug Tox Coding and Payment

Topline:

• Medicare and stakeholders has sparred for years over correct coding and pricing for urine drug tests (UDTs.
• AMA and CMS are using quite different systems in the current year, 2015 – private payers could probably pick either.
• Palmetto GBA has come up with a “tiered” coding and pricing system that was praised by many stakeholders at the July 16, 2015 CMS CLFS meeting.

Details after the break.

Two worthwhile open access articles on Telehealth

Two interesting open access articles on Telehealth appeared in the last few months.

In March, Third Way (here and here), a public policy and communications think tank in Washington, published an excellent white paper on a dozen interesting examples of telehealth being deployed in useful ways nationwide.  The white paper is available here.  It's titled "Local Examples: Innovations in Telehealth."

In July, former Senator Frist, a physician, published a blog at Health Affairs entitled, "Telemedicine: A solution to address the problems of cost, access, and quality."  It's online here.

Bruce Quinn Joins FaegreBD Consulting as Senior Director

Health Markets & Reimbursement Policy Expert Bruce Quinn, M.D., Ph.D. Joins FaegreBD Consulting

Washington, D.C. (20-July-2015) - Bruce Quinn, M.D., Ph.D., has joined FaegreBD Consulting as a senior director with the firm’s health and biosciences team in Washington, D.C., where he leads the firm’s health markets and reimbursement strategy consulting practice. He has offices in Washington, D.C. and Palo Alto, California.

Quinn is a national leader on Medicare policy, the impact of health reform on innovation and the crafting of successful business strategies within the U.S. health care reimbursement system. In addition to his work in the health and biosciences sector, Quinn also provides significant synergies with the firm’s intellectual property, compliance, and corporate transactions groups.

Prior to joining FaegreBD Consulting, Quinn was a senior health policy advisor with Foley Hoag after serving as the medical director for the Medicare Administrative Contractor in California.  Earlier in his career, Quinn was a physician executive in the health and life sciences division of Accenture, working with the pharma, biotech and genomics industries.

“Bruce has unparalleled experience advising companies of all sizes through the enormous change occuring across the health policy landscape, particularly in bringing new technologies into a reimbursed market,” said Dave Zook, FaegreBDC chair. “We are pleased to add Bruce’s deep expertise to our regulatory and legislative capabilities as the shift from volume to value unfolds in our public and private health plans.”

“Bruce brings invaluable expertise to our expanding health and biosciences practice,” said group leader and principal Debra Lappin. “Bruce joins shortly after we’ve welcomed former CMS senior offical Mike Adelberg. Bruce brings yet another new perspective that we’re thrilled to offer our clients.”

Quinn is a board-certified pathologist with a subspecialty in neuropathology. As a physician-scientist on the faculty of Northwestern University School of Medicine, he led pathology research for Northwestern’s NIH-funded Alzheimer Research Center. Quinn has also held academic positions at New York University School of Medicine and the UCLA Center for Health Sciences — and is the author or co-author on over 30 scientific publications.

Quinn holds an M.D. and Ph.D. from Stanford University School of Medicine and an M.B.A. in health, finance and strategy from Northwestern University’s Kellogg School of Management.

LInks:

http://www.faegrebdc.com/

http://www.faegrebdc.com/bruce-quinn

Press release:

http://www.faegrebdc.com/19454

Media Contact: Meg McCormick, +1 612 766 8127, megan.mccormick@FaegreBD.com

CMS Holds July 16 Public CLFS Meeting - Drugs of Abuse Codes and Genomic Procedure Codes

On July 16, 2015, CMS held its annual public meeting to discuss new codes for the Clinical Laboratory Fee Schedule.  This summer's meeting was attended by one of the largest audiences ever.

Topics included:

• Implementing the PAMA authority to reprice the CLFS based on market prices of commercial insurers; 
• How to price the Exact Sciences Cologuard test; 
• How to price new genomic procedures such as exome sequencing; and 
• How to code and price drug screening tests.

CMS has posted the entire workshop online at Youtube, and I have detailed speaker by speaker meeting notes on this blog.

Note that the most important topics discussed at the July 16 public meeting will be revisited by CMS's new expert advisory panel on lab test crosswalking and policy, on August 26 (here).

More after the break.

Medicare and End of Life Planning – What Actually Happened?

In early July, within a couple days of a very dry and deeply buried CMS policy change, the media produced hundreds of stories about Medicare newly offering an “Advance Planning Option” – which means "paying for doctors to talk to patients about end-of-life decisions."

What happened?  What does it mean?  See a full history and discussion after the break.

Links to the CY2016 Proposed Rules (IPPS, OPPS, PFS, ESRD)!

Each year from April to July, CMS  issues annual rulemaking and policymaking proposals for inpatient, outpatient, physician office, renal, and other policy domains.

Links to all are found here, after the break.

April's Diagnostics Reform Plan Moves to Draft Legislation in June

In April, a coalition of stakeholders called the Diagnostic Test Working Group released a substantial plan for FDA reform (my short mid-April note here, including several key links to more information).

In June, the House Energy & Commerce workgroup, 21st Century Cures, worked to convert the essay-style proposal into draft legislation.  For example, actual legislation includes many conforming amendments that reconcile new parts of the FDA statue (if enacted) with older parts.  

Turna Ray at Genomeweb has published the second of two very detailed articles on the plan, the newer article dated June 17, 2015.  Available here (subscription only.)

Since the legislative draft language exists now, it is likely getting comments from some stakeholders but to my knowledge it has not been publicly posted yet.