Are Pharmacogenetics a "Culture Shock" Zone for Payers, FDA, and Labs?

This entry discusses why pharmacogenetic information (like recommendations for CYP gene testing) proliferate on FDA labeling but are rarely covered by payers.   At the FDA pharmacokinetics, dosing, pharmacogenetics, are fundamentals of every drug approval.  On the other hand, for doctors who are medical directors (including active physicians) pharmacokinetic data and equations may be at most a rare or incidental part of their thinking and practice.  

WSJ 12/11/2015: Are LDTs the Wild West of Medical Care?

On December 11, 2015, the Wall Street Journal ran a lengthy article on laboratory developed tests, the contrast with FDA approval procedures, the FDA's efforts to regulate LDTs, and included a range of interviews on "both sides of the issue."   See the WSJ article here.

Next Gen Reimbursement in Germany Crazy in its Own Way

Two years ago, Genomeweb reported briefly on kerfuffles in the German health care system over whether next gen sequencing methods were reimburseable or not under their policies and procedures.

In December, 2015, Genomeweb provides its readers with a deep dive update showing there is still a tempest raging over this issue in Europe's largest economy, and it's gotten bigger, not smaller.   Julie Karow's article here (subscription).

AMA CPT: 1Q2016 Will Be Very Active!

The AMA CPT editorial process has become much more public and open over the last several years.  One key improvement is that the AMA CPT meeting agendas are now posted publicly well in advance on the AMA website.

New hot topics will include (1) quarterly special AMA CPT lab codes; (2) AMA CPT responses to CMS changes regarding drugs of abuse lab test panels; (3) several new MAAA codes, including one for "comprehensive pharmacogenetic data," and (4) potential changes to the 88361 IHC code.  And (5) AMA initiatives for telemedicine coding are also reviewed below.

Expanding Medicare Telehealth: S.2343, "Telehealth Innovation and Improvement Act of 2015."

Sen Gardner of Colorado has introduced the Telehealth Innovation and Improvement Act of 2015, with press releases on December 2 and, after a delay, the actual legislative text is posted at Congress.gov.

The Top Ten Health Issues of 2016: From Price Waterhouse Cooper

PWC Health Research Institute:

HRI’s top 10 health industry issues for 2016

#1-#5: Mergers, drug prices, apps, cyberscurity, deductibles.

#6-#10: Behavior, community care, big data, biosimilars, and value-based costing (not purchasing).

Details and links after the break.

The Other LDT Regulatory Battle: Genetic Testing in Europe

While news about U.S. LDT regulation pops up almost weekly - there's an FDA hearing, or a legislative proposal - lab test regulation is also on the charts in Europe.

Below, the European Society for Human Genetics (ESHG) and "a range of organisations" raise concerns about in likely changes in European diagnostic test regulation.

Larry Kricka's 20 Page Review of the History and Future of Laboratory Medicine

Approach the end of 2015, we can turn to 2016 by taking a look at a fascinating article that appeared a few months ago.

Larry Kricka, professor of pathology and laboratory medicine at Penn (here), is first author of four on the review and opinion article, "The Future of Laboratory Medicine: A 2014 Perspective," which appeared as an Invited Critical Review in Clinical Chimica Acta 438:284-303.   It is online (subscription or article purchase) here.

Kricka opens by citing a 1920 prediction that someday, there might be "as many as two lab workers" at major hospitals (here).

CMS Publishes Correct Coding Manual of Pathology Rules for 2016

For a number of years, CMS has published giant Excel spreadsheets of "correct coding edits" and "medically unlikely edits" which give allowable units of thousands of CPT code services or show which codes cannot be used together (e.g. "appendectomy" cannot be supplemented by a code for "wound closure.")  

There is also a text document in paragraph style with hundreds of concepts and rules that govern correct coding for Medicare.  This "provider's manual" has now been updated for 2016, and as usually, new revisions are shown in festive holiday red.   The whole kit and caboodle can be downloaded at this CMS web page, here.   Look for "NCCI Policy Manual...2016 [ZIP]."   For the chemistry and pathology section, see inside that ten document ZIP file or see just the pathology chapter in the cloud, here.

Bringing Genomics into the Clinic: Explaining Complex Issues

Genomeweb's Turna Ray has written a detailed article on the pathway from genomics discovery and genomics laboratory to the clinic.  It's mixed news, in that things seem to be getting better, but there's still much to be done.  The article is online here (subscription).

Just a couple years ago, Boehringer Ingelheim conducted a survey suggested that only 50% of lung cancer patients were getting basic genomic testing, like EGFR.  In a new survey, that number had risen to 81%.  However, due to delays in genomic test results, a significant proportion of patients are already started on non-precision chemotherapy even before their tests are back.

December 3, 2015: CMS Posts the Full CY2016 Lab Fee Schedule

On December 3, 2015, CMS published the full CY2016 clinical laboratory fee schedule.  The CMS CLFS fee schedule website (including 2016 and back years) is here.  At the CMS CLFS website, download the "16LAB" zip file for the fee schedule plus some explanatory files.

I've loaded the fee schedule itself, a 1300-line Excel spreadsheet, in the cloud here.

Medicare Grapples with Ashkenazi Heritage in BRCA Policies

Medicare has very few national policies for coverage that are predicated on racial background.  One is the glaucoma screening benefit, which is specialized for individuals who are African American and 50 or older, or Hispanic American and 65 and older (here).  Medicare is silent on questions like how this is defined or how mixed-background individuals are coverd.  And for example, individuals from Egypt or Dutch background South Africa are from the continent of "Africa" and now live in "America" but the coverage is silent on how their benefits would be handled.

There is no national policy that is specialized for individuals of Ashkenazi descent, but there are draft local coverage policies that would guide BRCA testing for individuals with different backgrounds.  While these have statistical bases, they also raise challenging implementation questions.

CAP TODAY on (1) Novel Cardiac Biomarkers and (2) CAP's NGS Proficiency Programs

CAP Today frequently runs excellent reviews on timely topics.  The November issue includes a detailed article on CAP's rapidly evolving efforts to ensure high consistent standards for clinical NGS testing, here.  Interesting in light of New York State and FDA efforts to do the same.

CAP Today also offers a detailed article on sorting out new waves of novel cardiac biomarkers, focused on heart failure biomarkers.  Here.

The Senate's Bipartisan Report on Sovaldi Pricing

The week of December 1, there were numerous news reports on a lengthy Senate report on the pricing of Sovaldi.   Many of the press reports don't include links to the original documents.

The Senate's own detailed press release is here.  Note that on this Senate webpage, there are links to 13 separate PDF files running down the right-hand margin.

A two page executive summary is here.   The 144-page main report (excluding numerous online appendices) is here.

MEDPAC Touches Telehealth

Federal government policy on telehealth has advanced slowly, even as we all read about the rapid growth of a multi billion dollar industry.   For example, in 2012, the Institute of Medicine published a workshop on telehealth (here).

On November 5, 2015, the MEDPAC held a one hour session to update on the Medicare program and telemedicine.  Its concise "issue brief" is here, the PowerPoint deck here, and the 50 page transcript of the MEDPAC discussion is here.