GAO Draws Attention to Site of Service Payment Disparities and Incentives

The GAO has released a 37 page report on what it views as perverse incentives for hospitals to acquire physician practices and rebrand them as hospital-affiliated outpatient locations.   The report, "Increasing Hospital-Physician Consolidation Highlights the Need for Payment Reform," is online here.  For Medscape's coverage, here.

Pathologist as Movie Star: Concussion (2015)

Rare when a movie stars a pathologist.   

Concussion (2015) tells the story of recent controversies and publications in sports concussion-related encephalopathy through the perspective of Bennet Omalu, a neuropathologist who devoted considerable energies to the definition of chronic traumatic encephalopathy (CTE).

Year End Review: Books of Note & Blog Info

Books of Note

I've posted an annual book review listing, a mix of healthcare policy and books about business disasters and innovation.  Here.  

On a more personal note, I posted an essay about lessons learned in 15 years since finishing an MBA (here) and an essay on the strategy of innovation management (here).

Bloggery

Discoveries in Health Policy hit 59,000 views in December 2015, running about 5000 hits per month. There were about 17,000 hits in year 1 and 42,000 in year 2.  There were 50 blog entries in year 1, and about 150 in year 2.

The vast majority of hits come from Google, but the hits for any given keyword are limited and unpredictable.  (Cologuard seems surprisingly frequent.)  The most popular blogs include the annual CLFS fee schedule releases.  DIHP continues to host the world's longest listing of articles about Theranos (here), which has garnered about 1400 hits in a year.   

Of 20 posts in December, there were 700 hits, with 7 posts having over 40 hits.  The most active post in November, on CMS quality metrics and PSA testing, had 80 hits (here), not counting postings of CMS November fee schedules, which quickly generate over 100 hits.  

My December 23 write-up of favorite and influential books of 2015 had about 60 hits in 48 hours, which I attribute to being kindly cross-listed on my wife's Facebook account.

Quick Links: Out of Network Problems Mount; Special Stains Increasingly Challenged.

Two quick links.

Dark Daily publishes another article in its ongoing series about the weak negotiating position and poor financials for out of network laboratories.  December 21 article here, with multiple links to their previous articles on this topic (when balance billing becomes the entire balance.)

Mick Raich, of Vachette Business Services and Stark Medical Auditing, notes that at Medicare MACs, special stains are increasingly under fire as more MACs adopt a stiffly written LCD originated by the Palmetto MolDX program.  Raich's December 22 essay here.

AMP Responds to the FDA's "20 Case Studies" about Bad LDTs

On November 16, 2015, the House held a hearing on regulation of LDTs, and FDA provided a sometimes poorly written review of 20 inferior or dangerous LDTs as Exhibit 1 (here).

On December 13, 2015, the Association for Molecular Pathology (AMP) released a 15-age response to the FDA's case.  Find it here.  Generally, AMP found that the FDA concerns were overstated (or worse).  In a few cases, such as the Kif6 case study and the OvaSure case study, AMP notes that a modernized CLIA that includes some clinical validity review would have caught any problems and FDA LDT review was not required.

12/21/2015: NYT Discusses New MAAA Diagnostics for Prostate Cancer

Posted online December 21, 2015, the New York Times "Well" (Health) section discusses new diagnostic tools for prostate cancer such as Oncotype DX Prostate.  The full article is here.  The author, Roni Caryn Rabin, discusses pros/cons of the introduction of new tests, with quotations from proponents as well as experts who feel more data is needed.

Update: Wide press in January 2016 on another advanced diagnostic for prostate management, the 4KScore test, see here.

MolDX Updates NGS Coverage; Comes Up With Surprising Definitions

The MolDX program released several coverage and policy updates between December 16 and 18, with some surprises.  The MolDX program uses a distinctive approach to coding, billing, and pricing, which cannot always be predicted by the use of the AMA CPT code book and CMS CLFS price tables alone.

1293 Comments on PAMA reform of the CLFS

On November 24, 2015, the comment period for rulemaking on PAMA Section 216 - new law for new pricing of the Clinical Laboratory Fee schedule.

1293 comments were submitted to CMS and are online.  I culled about 40 of the corporate comments - such as from ACLA, AMA, Advamed, BCBS, American Hospital Assocation, CAP, AMP, NILA, and others - and you can find them bundled in a 17MB zip file in the cloud: here.

WSJ: Employers Include Genetic Tests as a Wellness Benefit

The December 16, 2015 WSJ has a story discussing employers who are adding genetic testing as a Wellness Benefit for employees.   The full story is here.  In a brief extract, they write that:

Employers want workers to know what’s in their genes.  A handful of firms are offering employees free or subsidized tests for genetic markers associated with metabolism, weight gain and overeating, while companies such as Visa Inc., Slack Technologies Inc., Instacart Inc. recently began offering workers subsidized tests for genetic mutations linked to breast and ovarian cancer.  The programs provide employees with potentially life-saving information and offer counseling and coaching to prevent health problems down the road, benefits managers say....

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.