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.