Advisory Board Gives New Meaning to "One Pager:" Field Guide to CMMI

A typical one pager is supposedly all an executive (or President) has time to read, and a Field Guide is typically a map or atlas of birds, flora, etc.   Advisory Board has produced a 12-topic "field guide' to the CMMI / Center for Medicare & Medicaid Innovation and a couple other CMS payment reform programs.  Screen shot below.   Full PDF available at Advisory Board, here.   Home page for the project, here.

Medicaid Managed Care Final Rule; Implications as we see "Medicaidization" of Health Care

On April 25, 2016, CMS released the massive (1425 page) Medicaid Managed Care final rule.  This is the first update in many years and reflects CMS's acknowledgement that Medicaid is transforming from a classical state-managed system to an outsourced, commercially managed, managed care system with exceptional budget constraints.

The rule is here.  An insightful summary by health policy guru Timothy Jost, online at Health Affairs, here.  More after the break.

MACRA Draft Rulemaking Released; "Reforms" Meaningful Use Mess; Attention for Socioeconomic Status

On April 28, 2016, CMS released 962 pages of rulemaking for MACRA, the physician payment reform passed by Congress last year.   MACRA began by turning off the SGR formula for physician payments ("the doc fix") but gave CMS wide ranging authority to change physician incentives under new schemes that offset much larger upside bonuses with much larger penalty risks.

• The rulemaking is here (81 FR 28162, 5/9/2016)
• A Health Affairs short summary overview is here.  Advisory Board provides "ten key takeaways," here.   For a blog on the patient engagement framework, here.  For a 7-point blog on the HIT framework, by John Halamka, here.  For an article and links see HiTech, here.  For a rundown at Dive Healthcare, here.
• A CMS blog that discusses the need for, and approach to, EHR incentive reform, is here.  The term "meaningful use" is dead.  Long live the term, "Advancing Care Information" or ACI.
• Even more CMS fact sheets and summaries are online at CMS, here.  And don't miss the CMS YouTube animated infomercial, here.

More after the break.

430 Pages of Interviews with CMS Leaders

430 pages of interviews with CMS leaders.

Either this sounds like great summertime beach reading to you, or it doesn't.

Read a blog about the interview series, at Health Affairs, here.   For the National Academy of Social Insurance website about the interview effort, webpage here, press release here.   The 430 page PDF is online here.

For a 12-page, 32-question multiple choice Medicare quiz, here.

CMS Releases "Only Lightly Redacted" Versions of Theranos Audits

Truncated or heavily redacted versions of Theranos inspection reports have circulated in recent weeks, and have been posted at Wall Street Journal and elsewhere.

On April 25, the Wall Street Journal posted newly released, only lightly redacted documents.   A November 2015 inspection report is here.   A March 2016 letter describing potentially very severe sanctions is here.

The second letter carries the headline, "Important Notice - Please Read Carefully."

The WSJ writes in part,

Theranos ran tests on the [Siemens Advia 1800] by diluting small samples of blood pricked from patients’ fingers to increase the samples’ volume to fit Advia’s volume requirements, according to former employees. Ms. Holmes denied in October that Theranos diluted blood samples before running them on traditional machines. Since then, the company has declined to comment on the matter.

For additional links to Theranos journalism online, see www.tinyurl.com/theranoslinks

The Mess That Is MACRA? Two Views in the Same Week

In Spring 2015, Congress passed Medicare Part B payment reform - the SGR fix or Doc Fix - in a bill called MACRA.   In addition to turning off the accounting Tower of Babel that had been the Sustainable Growth Rate formula, the MACRA legislation creating a new...well, Tower of Babel which is a very complex physician reward and penalty system.   The maximum rewards and penalties are much higher than under prior piecemeal reward systems like "PQRS" and "EHR Meaningful Use."  Policymaking to implement these systems is still underway at CMS.

This week, two interesting and contrasting reviews of MACRA appear. The first one, at Health Affairs and written by staff at Urban Institute and supported by Robert Wood Johnson - here.  It has the generic title, "Medicare's New Physician Payment System."  Available as a long blog or a well-illustrated 7p PDF.

The second is penned by attorney and CMS expert Kip Sullivan and appears at THCB, The Health Care Blog.  It has the more provocative title, "The Mess That Is MACRA."   Find it here.  Sullivan writes,  "MACRA is so devoid of details about each compartment that it is impossible to predict anything" and has a section titled, "Sandcastles on top of sand castles."

For a September 2015 post by Medicare's senior management on MACRA rulemaking, see here.  

In March 2016, the House held a hearing on MACRA implementation, here for a news post at American College of Radiology (ACR) and here for archived documents and video at House E&C.

News Tidbit: FDA Backs Off A Sole-Source LDT Enforcement Effort

News tidbit.  In November 2015, the FDA sent Interleukin Genetics (Waltham, MA) a formal letter finding that the FDA had no records of FDA review, clearance, or approval of its LDT test "PerioPredict."  FDA letter to the comapny here; Genomeweb here.

This was about 24 months after Interleukin issues a policy statement comparing its LDT tests to the LDTs tests offered direct to consumer by 23andMe (here.)

On April 5, 2016, Interleukin issued a press release that via discussions with FDA, PerioPredict had been confirmed as the type of genomic LDT that was currently under enforcement discretion (here).  Interleukin's press release is fairly detailed and worth reading for those with an interest in this field.

Interleukin Genetics is a small independent company which trades over the counter and has a current market cap of $19M (ILIU; here).  It had total revenue of $1.4M in CY2015 and an operating loss of $7.9M.  

Dueling Publicity: FDA LDT regulation, Congressional LDT regulation

In the last couple days, the P.R. battle on FDA regulation of LDTs continues.

PRO FDA LDT
In an Op Ed for THE HILL (here), the President of the American Cancer Society Cancer Action Network insists that "the FDA is the most appropriate agency to evaluate the validity of these diagnostic tests."  ACS/ACN urges that attempts to derail the FDA on the hill should be avoided.  Specifically, a rider to an unrelated bill would have blocked the FDA from using its funding to regulate LDTs.  See text at bottom.

AGAINST FDA LDT
At the same time, according to the subscription journal Gray Sheet, "house appropriators"  told the FDA to "suspend further efforts to finalize LDT guidance" and "work with Congress on a new regulatory pathway."   Here.   Week by week currently, the House E&C commmitee is working on draft legislation modeled on the Diagnostic Test Working Group Proposal (DTWG).  For an open access review at Genomeweb, here.

PRO FDA LDT
According to Gray Sheet, Rep. DeLauro (D-CT) and Beutler (R-WA) protested the amendment, and support a rollout of FDA regulation, just as ACS/ACN does.  Similarly, American Association of Cancer Research (AACR) supports FDA regulation of LDTs (here) and cosponsors a public workshop on approaches to FDA regulation of liquid biopsy cancer tests in July 2016 (here).

Some further details after the break.

CMS releases annual spring inpatient rulemaking

On April 19, 2016, CMS issued its annual spring festival of proposed inpatient rulemaking.  This year the PDF weighs in at 378 pages, here.  See 81 Fed Reg 24946, April 27, 2016.

Centers for Medicare & Medicaid Services 42 CFR Parts 405, 412, 413, and 485 [CMS-1655-P] RIN 0938-AS77 Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Proposed Policy Changes and Fiscal Year 2017 Rates; Quality Reporting Requirements for Specific Providers; Graduate Medical Education; Hospital Notification Procedures Applicable to Beneficiaries Receiving Observation Services; and Technical Changes Relating to Costs to Organizations and Medicare Cost Reports. 

The new technology add on payments section is a bit longer than usual, and discusses 9 products (including those continuing from last year).  These are the MAGEC spine bracing system, MIRODERM wound matrix, Idarucizumab [Praxbind, anticoagulation reversal], Titan Spine Interbody Device, Andexanet Alfa [factor 10 inhibitor/antidote], Defitelio [Defibrotide], Edwards INTUITY value system, GORE EXCLUDER Iliac Branch Endoprosthesis, and Vistogard (uridine triacetate; for fluorouracil overdose).  Section H, New Technology, begins at page 25031.

CMS reopens 340B policy discussion; defines "Knowing and Intentional"

340B pricing policy remains under debate and CMS continues to look for ways to make the 340B program more rational.   On April 19, 2016, CMS reopened a comment period for 2015 rulemaking that is not yet finalized (here).  Three topics are in play.  (A) How CMS will handle situations where current pricing rules and discounts result in negative, $0.00, or $0.01 pricing.  (B) How CMS will handle pricing o the launch of a drug (e.g. before ASP reporting has kicked in).   (C) How CMS will apply penalties to entities that charge a 340B covered entity a price that is "knowingly and intentionally" hire than the bona fide 340B price.

CMS is reopening comment on the latter issue because it had not previously defined "knowing and intentionally."  CMS is considering the definition below.  If you don't like it, you can write them and let them known until May 19.  CMS text after the break.

Surprise Press Release: MolDX Prices BRCA Panel Code at $622.

In November 2015, the final CMS Clin Lab Fee Schedule for CY2016 was released and locked in some surprisingly low prices for gene panel tests.  Receiving the most attention, the code for 5-50 genes, solid tumors, was priced at $597, and the code for 5-50 genes, hematopoetic tumors, was priced at $648.   Getting a little less attention, the gene panel for Lynch syndrome was priced at $796 (sequencing) and $796 for a sister code for large indels.  (The 2016 CLFS is here).

On April 19, 2016, the San Francisco genetics company Invitae announced that it was being covered for the hereditary breast and colon cancer code 81432 at $622.   This payment comes from the Jurisdiction E contractor, Noridian, but presumably reflects pricing that will apply through the 24-state MolDX policy system (here).   Code 81432 is defined as BRCA1 and BRCA2, full sequencing, plus 12 or more additional hereditary breast cancer related genes.  More details after the break.

CMS gives up on two midnight rule financial cut; But there's a bigger lesson

CMS undertakes annual hospital rulemaking.  It proposes a budget cut, with a bit of handwaving and a few sketchy numbers.  The AHA sues: on the grounds that federal rulemaking must be rationale and explicit.  A court ordered CMS to cough up its rationale in terms a CPA could understand.  CMS threw in the towel and gave up on the cut.  Full article online at Modern Healthcare, here.

NGS concordance with single gene tests... Perfect? Does perfect work for you?

Penn has just published a large scale study by Hiemenz et al. on the concordance of gene calls in tumor tissue made by NGS versus calls made by single gene methods.

In an open-access article at PLoS One, the authors summarize:

For samples that passed our validated tumor percentage and DNA quality and quantity thresholds, there was perfect concordance between NGS and targeted single-gene tests {with the exception of two FLT3 internal tandem duplications that fell below the stringent pre-established reporting threshold but were readily detected by manual inspection.}

But wait, there's more:

NGS identified clinically significant mutations not covered by single-gene tests. These findings confirm NGS as a reliable platform for routine clinical use when appropriate quality control metrics, such as tumor percentage and DNA quality cutoffs, are in place. Based on our findings, we suggest a simple workflow that should facilitate adoption of clinical oncologic NGS services at other institutions.

Article online here.  Subscription coverage at Genomeweb, here.

Modern Views of Diagnostic Testing and Barr's "TTP" Model of the 1980s

Sometimes you hear that today, there is a sudden new interest in outcomes of diagnostic test use, and not just the test result as an analytic variable. That's how it was with payers, you know, five years ago.

This always strikes me as nonsensical, like when someone asserts, "evidence based medicine first became the goal in the 1990s."

Take for example Judith Barr's model of "Total Test Process" which begins with a clinical question and ends 11 steps later with the documentation of the impact on clinical care.  Well - yes!

Below is the key figure from a 1994 review, open access online, by Schumacher & Barr.  The themes under "Total Test Process" originate from Barr's foundational work as early as 1981 (Amer J Med Tech 47:619).  The full 1994 paper is just five pages long, is available free online, and is well worth reading.  Paragraph after paragraph I was circling an idea that was contemporary and relevant and that matches exactly to a payer/new test/evaluation problem we face every day.

1994 summary article, here; from Clin Chem 1998 44:370-4.

Barr and Schumacher was were both at the College of Pharmacy at Northeastern University where they served as Associate Dean and Dean, respectively.  Their interest in the value of therapeutic drug modeling led to authoring several decades of progressive work on diagnostic tests, like this one.  They also published important early on decision modeling analysis for medical diagnostic tests (here).  (I had the chance to correspond with Dr. Barr, who is now professor emeritus.)

CDC Holds Webinar: Will Genomics Improve Public Health? May 3, 2016 2 pm

The CDC Genomics program under Muin Khoury manages a web page for national and some international genomics policy events, here.   At 2-3 pm eastern, on May 16, 2016, the CDC will host a one hour webinar on the topic, "Will Precision Medicine Improve Public Health?"   See the home page for this webinar here.  Registration is open now, and is free.