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.

Judge rules against CMS policymaking style - too unclear for informed public comment

September 25, 2015

Several trade press articles have picked up on a judge's ruling this week in Shands Jacksonville Medical Center re Burwell (Advisory Board, here; case online at AHA, here; subscription article at Law360, Sept. 21 here ).

Because the case involves the controversial Two Midnight Rule and a potential (though small) refund to the hospital industry, the broader implications of the case haven't received much attention.   [Addendum: Law360 picked up on this on September 29: here).   I believe that many stakeholders should be interested in this slap against CMS policymaking methods.

Addendum; CMS published a court-ordered explanation of its earlier reasoning, on November 30, 2015: here.

IOM Report: Diagnosis & Misdiagnosis are the Blind Spot in Medicine

Those of us who work intensely in diagnostics will not be surprised by a new September 22, 2015 Institute of Medicine report  on Errors in Diagnosis.  We might be surprised by some of the media response and the degree to which the pivotal role of diagnosis could be considered a "blind spot" in healthcare.

The report, called "Improving Diagnosis in Health Care," is online at the Institute of Medicine, here.  The 450-page PDF is authored by the "Committee on Diagnostic Error in Health Care" - Erin Balogh, Bryan Miller, and John R. Ball.  A four page executive summarize is available, here.

Coverage in US News here - "Countless patients harmed by wrong or delayed diagnosis."
Coverage at Advisory Board here - "IOM says patients are dying because of this 'blind spot' - and providers must fix it."
Coverage at California Healthline here - "IOM report calls for collaborative effort to reduce diagnostic errors."

According to the website on 9/24, 48 hours after release, 1,749 copies of the free PDF had been downloaded.

Craig Venter's Company - Human Longevity Inc - and the $250 Commercial Exome

Craig Venter's company, which has been assembling a suite of top-ranking executives, announced on September 22 it would be able to sell exomes for $250.  See press stories here, here.  According to MIT Technology Review,

Jonathan Broomberg, chief executive of Discovery Health, which insures four million people in South Africa and the United Kingdom, says the genome service will be made available as part of a wellness program and that Discovery will pay half the $250, with individual clients covering the rest. 

Gene data would be returned to doctors or genetic counselors, not directly to individuals. The data collected, called an “exome,” is about 2 percent of the genome, but includes nearly all genes, including major cancer risk factors like the BRCA genes, as well as susceptibility factors for conditions such as colon cancer and heart disease. Typically, the BRCA test on its own costs anywhere from $400 to $4,000.

Technology Review adds, "Deals with other insurers could follow."

At its home base in San Diego, the company will open a genetic and health service with $25,000 self-pay services, including genome, microbiome, and whole body MRI studies.

UnitedHealthcare Provides Limited NGS Panel Coverage in Advanced Lung Cancer

As reported in some trade journals (e.g. Genomeweb, here), United Healthcare has released a new policy, "Molecular Profiling to Guide Cancer Treatment," effective 10/1/2015.  See UHC Policy 2015T0576A, online here.

The eight-page policy states that multiple or NGS sequencing is "proven and medically necessary to guide systemic chemotherapy in patients with stage IV non small cell lung cancer" when two criteria are met.  First, molecular profiling is used ONLY to test for EGFR, HER2, RET, and ALK gene rearrangements (with a citation to current NCCN practice guidance.)   This sounds like they might expect a "don't ask, don't tell" stance on the several hundred other genes found in some commercial panels.  But although profiling is to be used "only" for the four named genes, the policy refers to 5-50 gene CPT codes, which wouldn't technically apply if only 4 genes were tested.

Second, the laboratory must be approved by the New York State Department of Health (which has explicit standards for setting up NGS assays, orthogonal control quality testing, etc).  The policy then states then indications other than the above are explicitly not covered.

The policy may face challenges in staying up to date; for example, in August 2015 a NEJM article found that NSCLC had good responses to BRAF drugs when V600E mutations were present (here, here) - an indication not yet found in the UHC policy.  In a conference report in September 2015, in a Foundation Medicine study of lung cancer patients under 40, 6% had ROS1 rearrangements, another gene not in the UnitedHealthcare list (here).  FMI reported that 76% of 68 patients under 40 had druggable mutations, 44% of the patients having ALK mutations which are vastly less common in unselected populations.  The report is part of the Genomics of Young Lung Cancer Study (GoYLC).

Noted in Passing: Evidence Based Medicine meets Prescription Drug Coupons

Co-pay support programs for expensive drugs have been in the policy news for at least five years (here, here).  Do they simply help patients with $100 copays, or are they a way of boosting sales of overpriced drugs that have a justifiably poor position on the formulary tier?

Here's an ad for Outcomes and adherence in patient assistance support programs.

Company here.

In Medicare, Can You Appeal a Pricing Decision made by a MAC?

Periodically I am asked, "Can an ALJ making a pricing decision and enforce it on a MAC?"   The answer is a little cryptic and I always have to dig up a Federal Register publication from 2009.  Here is the short answer.

Tom Norton's Insightful Futurism: Pharma Price Escalation, Key Events, and Public Policy

Pharm Exec is an open source trade journal for the biopharma industry.  One regular author, Tom Norton of a communications consultancy, has written a set of three excellent blogs/articles on pharma pricing trends and political forces.

See the following -
September, 2015 - The Pathway to Public Price Controls (here)
May, 2015 - "Take a Breath" on the Specialty Drug Pricing Issues...? (here)
November, 2014 - How Gilead Blew Out the Lights with Sovaldi (here)

See also:
August, 2015 - 2015 Medicaid Drug Price Controls - The Past is Prologue? (here)

Anyone interested in the future of health policy - whether in drugs or other areas - would benefit from seeing how Norton writes, thinks, and assembles a forward-moving story line.

The September, 2015 article contains links to the California Drug Price Relief Act, which will be on November ballots (here).

Trade journal: Hill will not "tinker with" FDA LDT Guidance before it is Final

On September 10, 2015, GRAY SHEET (a subscription trade journal, here) reported that across both political parties and in both House and Senate, the FDA probably will be left to develop a final LDT guidance without interference.  On background, staff indicated the Hill might act after the FDA has acted, but not before.

At a Next Generation Sequencing conference in Washington in mid-August 2015, FDA speakers remarked that public comment on the FDA LDT draft guidance had been considered thoroughly, the draft guidance had been revised, and it was working its way through approval and release channels at the FDA and/or executive branch.

Genomics and RBC Transfusion; Note on Palmetto's LCD.

This week's JAMA has an online-first article on the growth of genomic medicine in the century-old field of RBC transfusion.   The article, "Red Blood Cell Transfusion: Precision vs Imprecision Medicine," by Klein, Flegel, and Natanson, is here.

News Watch: "Medical Testing is So Hot Right Now!"

Two articles within a few days on the theme that medical testing, venture investment, and direct to consumer topics are riding a wave.

From Wired.com, here, September 4, 2015, the article "Medical Testing is So Hot Right Now. This Startup Wants In."  The journalist interviews the founders of CoFactor Genomics and writes,

Why don’t the two of you tell me how you plan to diagnose disease from little rings of RNA that most biologists considered junk three years ago? Let’s talk about your $1.5 million National Institutes of Health grant. While we’re at it, why did you decide to temporarily uproot your company—which is nearly a decade old and already pulling in millions of dollars—to join Y Combinator, the startup boot camp known more for putting nestling consumer tech companies like Instacart, Airbnb, and Dropbox into high orbit?

From Bloomberg Business, here, September 10, 2015, "Consumer Blood Test to Detect Cancer Hits Market Amid Skepticism."  The journalist writes,

Biotechnology startup Pathway Genomics Corp. is introducing the first “liquid biopsy” tests designed to detect cancer-associated mutations in the blood of healthy people who are at high risk of developing tumors....Pathway, a closely held firm backed by investors including International Business Machines Corp. and venture capital firm Founders Fund, is offering its CancerIntercept Detect test for $699, according to Chief Executive Officer Jim Plante. The price tag drops to $299 if the consumer signs up to be tested once a quarter.
“The cost is a big advantage because a liquid biopsy could be one-10th or one-20th the cost of an invasive biopsy,” Plante said. “There’s a lot of value here for the patient and consumer.”

The FDA shared the market's skepticism, asserting that the test was improper for marketing.  For trade press, here.   For the FDA's September 21, 2015 letter, here.  Pathway Genomics has received warning letters from the FDA in prior years (here, here).

The FDA seems polite enough in writing:

 [We] believe you are offering a high risk test that has not received adequate clinical validation and may harm the public health. We would like to discuss with you your offer of the CancerInterceptTM Detect and the associated blood specimen collection device, and any validation strategies you have undertaken beyond those reported in the publications cited in your white paper, including your determination of the test’s clinical sensitivity and specificity and the corresponding positive and negative predictive values for its claimed intended use. Given the importance of your claims, we request an acknowledgement of receipt of this letter and a proposed timeline for meeting with the FDA within 15 business days. 

On September 24, 2015, Pathway Genomics issued a public blog posting commenting on the most recent FDA letter (here):

Pathway Genomics greatly respects and shares the FDA’s concerns about patient safety. We have received a letter from FDA, dated September 21, 2015, requesting certain information regarding the Pathway Genomics CancerIntercept™ Detect testing service.  We are carefully considering the concerns of the FDA as stated in their letter, and we will be responding to that letter.  We assure that there is physician involvement in the ordering, review and follow-up of CancerIntercept™ testing.  We believe that CancerIntercept™ Detect is a  laboratory developed test and, as a CLIA and CAP certified clinical laboratory, we are offering it as such.  While Pathway Genomics is involved in educating and marketing the tests to physicians and consumers, we do not believe this is a direct-to-consumer model. We believe we have performed appropriate validation of the test as a laboratory developed test, and we are in the process of performing additional studies.

WSJ coverage on September 28, 2015, here.

Patient Engagement is a Wellspring of New Trends...from Venture Capital to FDA to CMS.

This blog often starts off with trends in the lab industry but includes a wide range of healthcare topics as well, reflecting the range of health policy consulting work I do.

On the laboratory side, there are many efforts to seek "closer engagement with patients," ranging from Theranos to Labcorp (from here to here).

However, the concept of patient engagement is high in other areas as well.  For background, see Marc Boutin's excellent open access article on Patient Engagement at American Journal of Managed Care earlier in 2015 (here).  Boutin is CEO of the National Health Council.  The Food and Drug Law Institute is offering a webinar on Patient Engagement and the FDA, on September 30, 2015, here.  (The webinar features Pat Furlong of the Parent Project Muscular Dystrophy, Janet Woodcock of the FDA, and is moderated by my colleague Debra Lappin of FaegreBD Consulting).

PMC and BIO host second Personalized Medicine Solutions Summit, October 14, 2015, in DC

The Personalized Medicine Coalition and BIO are holding the second annual Personalized Medicine Solution Summit on October 14, 2015 in Washington, DC.

The home page for the meeting is here.  Topics, following an opening keynote speaker, will be:

• Evidence and integration of personalized medicine into health practice: Issues faced by CMS.
• Education regarding the use of personalized medicine through the health care continuum.
• Integrating a Total Health Solutions Approach.
• Demonstrating the value of personalized medicine in clinical practice.
• Health systems: Infrastructure and information challenges related to personalized medicine.

The first annual summit was attended by several hundred participants.  I have the privilege of being a lead speaker for this year's summit.

Registration site is here and the PDF agenda is here.  Registration is $500; $250 for PMC or BIO members.

FDA Announces NGS Public Policy Workshops on November 12,13, 2015

The FDA has announced public policy workshops on two aspects of next generation sequencing, to be held Thursday November 12 and Friday November 13.  (This was the only Friday the 13th available this year).

The November 12 session is: Standards-Based Approach to Analytical Performance Evaluation of Next Generation Sequencing In Vitro Diagnostic Tests.

The November 13 session is: Use of Databases for Establishing the Clinical Relevance of Human Genetic Variants.

UPDATE (October 22, 2015): FDA has updated the conference webpage with a Discussion Document on the use of databases for variants.  Here.

What is the AMP comment on the MolDX Next Gen Sequencing Analytic Performance Guidance?

The Medicare Palmetto MolDX program has finalized an LCD that provides next generation sequencing panels in patients with lung cancer who have met certain preconditions (here).

Along with this LCD, MolDX published guidance as to its analytical standards for comprehensive gene panel testing, typically by NGS.  The Association of Molecular Pathologists has released a public comment.  Details after the break.

What has AMP recommended for genomic sequencing pricing?

In summer CLFS public meetings of July 2014 and July 2015, the Association for Molecular Pathologists recommended interesting methods by which CMS could price new CPT codes for genomic sequencing procedures, such as 5-50 tumor genes.  AMP also held a webinar on this topic at early 2015 (archived here).

I believe I understand what they've recommended, and helpfully, AMP publicly posted its detailed 12-page public comments to the agency (dated August 6, 2015 (here)).

My sense is that in just a few key places, the AMP document is a bit confusingly worded so the transition from one AMP pricing method to another is not obvious to the reader.   AMP re-presented its methodology to the new CLFS public advisory board which held its first meeting on August 26, 2015 (here).  I haven't yet seen that presentation, the Gray Sheet report on the meeting was a little confusing based on what I already knew about AMP's proposals (Gray Sheet here, subscription).

What follows is, in my own words, my grasp of AMP's proposals.  For the final word, readers should work through AMP's original documentation (here).