Tuesday, May 26, 2015

Growing Awareness that Pathology Policy is Crucial for Precision Oncology

Over the past several days I noticed a flurry of interesting, potentially connectable policy articles in precision medicine for oncology.   I'll list them and draw some lines among them in this blog.

If you work on the laboratory side of precision oncology, you've been familiar with challenges created by the outdated CPT/RVU/CLFS payment and pricing system.  You've either never heard of the Medicare "14 day rule" -- or it makes you tear your hair out.

Clinicians are paying attention now, too. And so is biopharma.

Two interesting entry points, from different associations, are ASCO's position on next-generation sequencing reimbursement and a CAP TODAY feature article on pharmas that are paying a lot of attention to the delivery side of combination diagnostics.

Entry Point 1) 
ASCO Senior Leadership: Barriers in the Lab are Holding Back Precision Oncology

I couldn't overlook a headline like this:  "Physicians Struggle with Antiquated Reimbursement for Next-Generation Testing."

Writing for the trade journal OncLive, Tony Berberabe features an extended interview with Richard Schilsky MD, Chief Medical Officer of ASCO, and other clinicians, arguing that "these biomarker tests are increasingly useful" but "payment systems...have fallen behind the times."  For the full interview, here.

Related, see a recent Institute of Medicine webinar on payer viewpoints toward next generation sequencing, here (also here).

Entry Point 2) 
CAP TODAY: Companion Diagnostics: Pharma is in Gear

The May 2015 CAP TODAY features a several page article on companion diagnostics.  But it's most notable for the detailed discussion of how active some big pharmas - like Pfizer and Genentech - have become in trying to ensure that cancer patients get the tests they need, get it rapidly, and with high quality.   Anne Ford's article, "Pharma Strives to Aid Companion Diagnostics," here.

Genentech!  Read this remarkable quote:  "Dr. Hammond reports that her Genentech contacts have been helpful in identifying and remedying the issue of getting surgical suites to record the time of sample removal and gross rooms to record the time of sample receipt....That’s one of the things that these Genentech representatives do. When they go into a practice and they find there’s a specific problem, they try to meet with the person who might have some power over the area.  Sounds simple—even self-explanatory. But in Dr. Hammond’s view, the value of these interventions lies not only in the fact of their doing, but in the fact that Genentech is relieving pathologists of the burden of doing them. "  Oncologist and pharma, for example, seem to be in favor of standing orders for core genetic testing, something that it's unclear payers are ready for or when CMS policy allows standing orders.  (here and here.)

Pfizer! In addition to Genentech's roving help team, the CAP TODAY article discusses Pfizer's "DETECT" program - Diagnostic Evolution: Evaluating Clinical Testing in Non-Small Cell Lung Cancer.

Pfizer has funded grassroots policy research as well.  Pfizer's website had an online funded proposal from Moffitt Cancer Center on "Best Practices in Molecular Testing." although I could find it today only as a Google archive cache (here or here.)

14 Day Rule!  The CAP TODAY article also includes comment on Medicare's 14 day rule.  (By the way, it also comes up in Foundation Medicine's 5/11/2015 investor call, here.)  (For more on the 14 day rule, see my discussion of it here.)

Entry Point 3:
Association of Community Cancer Centers (ACCC) is Beating the Same Drum
Ford's article in CAP TODAY also discussing the problems caused by the 14-day rule and cites an article in Oncology Issues, which is a new internal journal of the Association of Community Cancer Centers (ACCC).  According to Ford's citation, the article is Kim J, 2015, Oncol Issues 1:28-32; I haven't yet been able to access a copy.  (ACCC here.)

The CAP TODAY article, in discussing Pfizer's efforts, added that Pfizer was collaborating with ACCC.  ACCC has had a policy effort, "Molecular Testing in the Community Oncology Setting" (here and here).

I heard several ACCC senior policy staff discuss the 14-day rule at a UCSF-sponsored event last October.  That now makes sense, because if you Google "ACCC" and "14 day rule" and you'll get a page of hits (herehere, here).  Here's an example from the ACCC website: "...Participants agreed that the 14 Day Rule significantly impairs their ability to offer timely care for many lung cancer patients."  That's a finding that both oncologists and biopharma should care about, as well as patient organizations.

Entry Point 4)
Boehringer's Efforts in Molecular Test Lab Access

A late April article in Genomeweb discussed Boehringer Ingelheim's efforts to assess and improve global access to precision genomic tests in lung cancer - here (subscription); see also coverage at MedicalNewsToday (here).

Entry Point 5)
Lab Operations Featured in the ASCO-CAP-AMP Guidelines for Colorectal Cancer

Related is the new ASCO/CAP/AMP draft guideline for genomic analysis in colorectal cancer.  What I found noteworthy here is the multiple references to operational and functional issues like turnaround time, which increase as low payments force labs to centralize, creating delays for shipping and delays to accumulate batch sizes.  (Here, here; comments in response to draft, here).  Note that, like AHRQ, these organizations publish draft documents and responses only temporarily.

Two associations, AMP and ACMG, published articles on the clinical utility dilemma in the last couple months:

AMP on "Clinical Utility" - Liquid Biopsy Review 
CAP Today also has a May 2015 news item, "AMP sees  bright future in liquid biopsy," (here), citing a May 2015 article in AMP's Journal of Molecular Diagnostics, "Do circulating tumor cells, exosomes, and circulating tumor nucleic acids have clinical utility?  Report of the Association for Molecular Pathology" - here.   Authors state, "CTCs and ctDNA are likely to improve cancer diagnosis, treatment, and minimal residual disease monitoring."  [For a podcast with one of the authors, here.]

ACMG on "Clinical Utility" - Their Policy Statement on Genetics and Payers
Earlier this spring, the ACMG Board of Directors published a sharply worded policy statement, "Clinical utility of genetic and genomic services: a position statement of the American College of Medical Genetics and Genomics," Genetic in Medicine, here; press release here.

Note that the AMP and ACMG articles on clinical utility and on payer standards for coverage are not just competent review articles appearing in the relevant society journals; they are presented as position papers of the associations.  The ACMG paper, in particular, is presented as a direct work product of the ACMG executive committee.

What does all this mean?
I was in a discussion with senior policy staff at a global pharma last fall, and there was concern that the 14 day rule, limited tissue, and other barriers to precision oncology were (1) causing substantial problems, and especially (2) not getting nearly enough attention.

The last few months suggest that the role of pathology policy problems is getting the spotlight.  If the policy listings above are a trend, these topics may continue to rise in visibility in 2015/2016.

Closing Figure: 
Today's Tortuous Path from Biopsy to Pathologist to Oncologist 
to Pathologist to Referral Lab to Chart to Patient....
Is this the best we can do?