Brief Blog: Keeping Up with the MED-C Cancer Genomics Registry

MED-C was initially established almost two years ago (here).

MED-C took on renewed importance when MOLDX issued a revised lung cancer gene panel LCD in September 2016.  In return for greater coverage, labs are to follow new, expanded and detailed requirements for patient  genomic and clinical outcome data which is to be contributed to a public non profit registry that must meet an extensive list of requirements (here).

To help you keep up with MED-C, here are some key links.

• MED-C organization website, here.   
• Press release on the recently expanded MED-C expert panel, here.
• Press release on MED-C's IRB approval, here.
• ClinicalTrials.gov page for the MED-C registry (NCT02900248), here.

• MED-C announces "Biomedical Data Commons," or "BDC," here.
• 23-page deck about MED-C, by MED-C, here.
• March 2016 article in NATURE about pragmatic registries, including TAPUR and MED-C, here.

Brief Blog: NPR Forecasts "Uncertain Future" for CMMI

On November 30, 2016, NPR ran an article with the title, "Obamacare's Test Kitchen for Payment Experiments Faces an Uncertain Future."   For the full NPR article, here.

The center has been controversial because of its authority to conduct demonstration project that waive any applicable Medicare law.  Some have argument that this is an unconstitutional delegation of authority from Congress to an agency.   Others have raised concerns that a "demonstration project" is not defined and could be of nearly unlimited scope and duration.  On September 29l, 2016, several dozen members of Congress wrote the current (outgoing) head of CMS that they had serious concerns about the behavior of CMMI (here).

See also a November 2016 21-page white paper from the Healthcare Leadership Council on "Accountable Innovation: Reforms to Strengthen and Sustain the CMMI."   White paper here.   With HLC funding, the white paper was created by the consultancy Xcenda, a division of AmerisourceBergen.

CMS Posts CY2017 CLFS File (November 29, 2016)

UPDATE:  AS OF DECEMBER 13, THE CY2017 CLFS FILE (posted Nov. 29) IS OFF THE CMS WEBSITE.  PROBABLY CMS DISCOVERED MINOR ERRORS.

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Original November 29 article follows.


CMS has, in recent days, released final Gapfill/Crosswalk decisions for the year, and published the results of the MAC gapfill process as well, which included some favorable appeals that raised prices finalized by MACs earlier this fall.  (Story at Genomeweb, November 22, here.)

Today, November 29, CMS posted the full A to Z CLFS fee schedule for 2017.

• The file is available at CMS, here.

Below are genetic tests > $1000 and those genetic tests - mostly Genomic Sequencing Procedures (Panels) not priced by CMS. (Click to enlarge).

Seema Verma, Indiana Health Policy Expert, to Head CMS under Trump

Seema Verma, a health policy expert and health strategy consultant running her own firm in Indiana, has been announced as the next leader of CMS.  Verma's selection brings the agency one of the first administrators with extensive Medicaid experience, and an individual who is a national authority on the use of states as models for managed care innovation.

• News story at Politico, 11/29/2016, here.
• Coverage at STAT here.  NPR here.   Healthcare Informatics here and also here.  Health Affairs here.
• The Indiana Star has reposted and updated its 2014 profile of Verma and her achievements, here.
• Her Linked In Profile is here.  Her Wikipedia page here.
• For a August 29, 2016 blog at Health Affairs on Medicaid reform by Verma, see here.

• Her consulting firm's website, SVC Inc., is here.

The likelihood of major Medicare legislation has been debated into early December in different forums; Paul Ryan wants to move [60 Minutes], but the Senate may be reluctant [Politico].  WSJ writes, "Dems gearing up for Medicare fight," here.

Tevi Troy: Democratic Politicians Can Spread Plenty of Fake News, Too

Tevi Troy: Dems and Fake News

A well-known Republican health policy expert wrote a few years ago that misleading and damaging rhetoric is not limited to any one shrill stakeholder group, or to the current waves of disinformation and "fake news." 

In his book "US Health Policy: An Insider's Perspective"  Republican health expert Tevi Troy argues that in various instances, Democrats wrongly smeared various Republicans as "wanting to kill Medicare" or "destroy Medicare" by print or commercials in the past decade.  In some cases, these contributed to the politician's political demise.  

Troy is CEO of the American Health Policy Institute.  The 2014 book, "US Health Policy: An Insider's Perspective," is a collection of his journal articles and op-eds.

In addition to serving in a senior HHS position in the Bush II administration, Troy has written a number of books on history and policy, such as "Intellectuals and the American Presidency" and "Shall We Wake the President?  Two Centuries of Disaster Management."    

Trump Chooses Tom Price as Secretary of HHS

Late on November 28, 2016, major news outlets like NYT and WSJ broke articles that the Trump administration is choosing Tom Price MD, a surgeon and senator from Georgia, as Secretary of Health & Human Services.

Price has proposed health policies such as age-adjusted tax credits for people to buy insurance, or allowing people to "opt out" of Medicare in return for a tax credit.   WSJ coverage here.  Profile at HealthcareDive, here.  Profile at Health Affairs, here.

Price, who has served six terms in the House, was an early and consistent supporter of Campaign Trump.

For links to sources on Republican health policies, here.

CDRH/Payer Summit: Washington, December 14, 2016

There is a longstanding annual winter conference in Washington called "FDA/CMS Summit," held this year on December 14/15, 2016 (here).

This year, there will also be a first annual "CDRH/Payer Summit for Medical Devices," held on December 14.   The goal is described as, "facilitating direct dialogue between medical device executives, payers, investors and CDRH regulators to explain complex regulatory and reimbursement policy."   

While this is a commercial summit (sponsored by Informa), CDRH has launched multiple initiatives between FDA and Payers over the past year (for some examples see here), in addition to making FDA/CMS parallel review permanent a few weeks ago (here).  

From FDA, a redacted set of 190 slides used at the conference is in the cloud, here.

21st Century Cures Passes House and Senate; Signed by Obama (Updated)

Coming out of the Thanksgiving holiday, many news reports say that the 21st Century Cures Bill, under discussing throughout 2015 and slowed down during 2016, is likely to move forward was passed by the House on November 30 (392-26), and was passed by the Senate on December 7 (94-5). It was signed by President Obama on December 13, 2016.

• See coverage at Kaiser Health News, here.
• At Biopharma Dive, here.
• At the Endpoints industry blog, here.
• At STAT, here.  "House and Senate Republicans agree, but Dems push for changes."
• As provided by Endpoints, links to:
• A 44 page legislative summary as PDF, here.
• A 996-page House version as PDF, here.
• As noted by Harvard professor Rachel Sachs, some issues are still up for debate, here.
• A detailed but manageable summary at RAPS, here.
• The House E&C Home Page for 21CC is here.
• NIH leaders Kathy Hudson and Francis Collins write on 21CC from an NIH view, NEJM, December 13, 2016, here.

More after the break.

CMS Publishes Final Pricing for CY2017 New Lab Codes (Effective 1/1/2017)

On November 21, 2016, CMS released final pricing decisions for new CPT codes for lab tests (codes effective on 1/1/2017).

The CMS 12-page PDF is online here.  More after the break.

Brief Blog: Cancer, Emperor of All Maladies at PBS

"The Emperor of All Maladies," the 600-page 2010 book on cancer by Dr. Siddhartha Mukherjee, was brought to the screen as a four-part, seven-hour documentary last year.

The PBS homepage is here.  As of November 2016, it still streams for free online.  The Wikipedia page for the film is here.   It's directed by Barak Goodman and produced by Ken Burns.  It was narrated by actor Edward Hermann, who died of cancer before the film's release.

Even for those who work in oncology, or might have read the book, the film brings to life a wide range of topics in cancer - from the pioneering efforts to introduce toxic chemotherapy in leukemia in the 1940s and 1950s, to the recent discoveries of genomics and targeted therapies.  But the palette is broad, and includes the patient and family view, the special issues of pediatric oncology, the important role of prevention, the sociopolitical origins of Nixon's War on Cancer, the role of hospice, and issues of economics.  

Also available on DVD, Amazon pay-for-download, and other formats.

Patrick Soon-Shiong Meets with Trump: Biotech, Genomics, and the Trump Administration

The weekend of November 20, biotech industry leader Patrick Soon-Shiong had dinner with both President-Elect Trump and Vice President-Elect Michael Pence.

• For coverage at John Carroll's blog Endpoints, here. 
• For coverage at the Trump website GreatAgain, here.
• For Dr. Soon-Shiong's tweet, here.

GreatAgain writes,

Dr. Patrick Soon-Shiong joined President-elect Trump and Vice President-elect Pence for dinner this evening. 

The renowned doctor has appeared on the cover of Forbes for his advances in finding a cure for cancer. They discussed innovation in the area of medicine and national medical priorities that need to be addressed in our country.

Soon-Shiong's Nanthealth, which IPO'd in June 2016, aims to provide a range of services for health innovation from digital to genomic.  One is its panomic oncology test GPS, which assesses DNA, RNA, and protein.   Nanthealth has been discussing the potential of GPS to assign best-odds cytotoxic chemotherapies (here).   

Like all genomic tests performed on cancer tissue biopsied in a hospital inpatient or outpatient setting, such tests collide with Medicare's bizarre 14-day rule, delaying testing, treatment, and reimbursement for Medicare beneficiaries with cancer.   Maybe in the coming months the genomics and biopharma industry can get get the President's ear on this, for a quick action point that could make a real difference for innovation and health outcomes.

Appropriate Use Criteria by Force of Law: Should Everyone Be Paying Attention?

Outside the imaging community (including radiology and cardiology), I've seen relatively little discussion of the mandatory Appropriate Use Criteria imposed by Section 218 of the PAMA law.   CMS devoted almost 30 pages of discussion in the November 2016 final PFS rulemaking, and implementation is coming over the next year or two.   The issues could be applicable to areas like genomics or even non-diagnostic areas of clinical decision making.

The original law, PAMA Section 218, is here.  November 15, 2016, CMS policymaking stretches from page 80403 to page 80429 of the Federal Register.  (Original Fed Reg link here; for a downloadable subsection in the cloud, here. CMS homepage, here.)  For reaction to the rulemaking at Imaging Technology News, here.  For coverage at American College of Cardiology, here.   For coverage at Advisory Board, here.

The law requires ordering professionals to consult with AUC criteria, through a Clinical Decision Support Mechanism (CDSM), for all Medicare patients receiving advanced imaging, such as cardiac nuclear imaging, CT, and MR.   AUCs may vary in scope (e.g. pan-imaging AUC or orthopedic or cardiac), and must be developed by a "provider led entity" or PLE.  Exceptions are limited, e.g. rural physicians without access to internet.   More after the break.

Brief Blog: Trends for 2017 - Digital Therapeutics

One of the emerging buzzwords in healthcare is "digital therapeutics," which is now appearing in the titles of industry reports.  The Healthcare Blog writes that:

      Most digital health companies deploy software modules as an enhancement, or even a substitute, to a prescription drug. They are affordable and effective and poised to become a critical component of digital health, thereby substantially improving the efficiency of American healthcare. Digital therapeutics is already roughly a $500 million market and positioned to balloon into a $6 billion market, according to a research report by Goldman Sachs, supported by analysis by digital health venture firm Psilos Group.
      Digital therapeutics improves health outcomes by addressing chronic conditions such as Type 2 diabetes, depression and anxiety, and drug addiction through behavioral changes, before they become worse and require elaborate treatment. This 21st century modality marries the latest developments in behavioral economics, smartphone apps, gameification, biometric sensors, data analytics and artificial intelligence. In some cases, digital therapeutics modalities get approval from the U.S. Food and Drug  Administration.

See the New York based venture capital firm Psilos here.   See the San Francisco incubator and dHealth early investor Rockhealth here.

For an 8 page report by Psilos, here.   For a 54 page report by Goldman Sachs, here.  For a 200-page, $5000 commercial report, from July 2016, here.

Dark Report Cracks the Mystery on PAMA Pricing; Genetic Coverage Still Tough Going

In a special 24-page issue devoted entirely to PAMA, Dark Dilay (November 7, 2016) provides the largest insights yet available as to what will happen under PAMA CLFS price reporting.  Dark Report is available by subscription only; here.

CMS requires US labs to report pricing by payer and by test for tests paid in 1H2016; reporting occurs in 1Q2017, and CMS will announce results around August/September 2017.   Until now, some data was published in a government report (OIG, here) and a report by ACLA/Avalere (here).  Dark Report goes into far more detail and is probably more relevant.  In collaboration with XIFIN, the articles assess average commercial pricing for general independent labs, hospital outpatient labs, special genomic labs, and drug tox labs.  In general, commercial prices are circa 20% lower for independent labs, relative to the CLFS, and circa 20% higher for other lab categories.   The special issue will probably be mandatory reading for industry observers.

However, there is considerable variation.  For example, in the specialty genomics category, of 20 top genetic codes, commercial average payments in the Xifin database on a per-code basis vary from -65% to +230% relative to the CLFS.  This suggests that contracts are not made solely as flat percents of the CLFS.       (More after the break).

FDA Will Not Finalize LDT Guidance

On November 18, 2016, Genomeweb broke an important new announcement: that FDA will not finalize its 2014 proposal to regulate laboratory developed tests (LDTs).   Genomeweb's story is here (subscription required).  See a rapid press release from ACLA, here.  AMP thanked the FDA for its decision here.  Further coverage at WSJ, here, and RAPS and STAT, open access here and here; Bloomberg here.

As I had noted to clients earlier this week, the election sharply raised this outcome.  If anything were to happen in the next year, it would resemble the Senate proposal to upgrade clinical utility review under CAP (or other outsourced bodies like New York State) - but even this is unlikely, following the reasoning below.

Will Chemotherapy Biomarkers Remain the Wallflowers of Personalized Medicine?

Recently, I've heard several different sources emphasize that chemotherapy biomarkers (for platinum drugs, taxanes, etc) would have enormous impact on cancer care if such biomarkers could be validated for impact and become reliable enough.   Several skeptical articles on precision oncology (here) have noted that only a relatively small proportion of, for example, lung cancer patients are eligible for targeted therapies.  For example, 10-15% have EGFR-related mutations, another 3-5% have ALK-related mutations, leaving a quite large proportion of cases in the world of traditional chemotherapy.

In the November issue of Annals of Oncology, Olaussen and Postel-Vinay of INSERM review the landscape for chemotherapy biomarkers.  Their 12-page article is open access (here).

After discussing some ten chemotherapy biomarkers, across some 126 journal citations, they conclude, "none of these biomarkers has till now been validated [prospectively]...none of them is currently ready for implementation in routine clinical practice."   Nonetheless, the eventual returns could be big.  More after the break.

Brief Blog: Links to Republican Health Reform Plans and Principles

On November 13, 2016, the Wall Street Journal published an op-ed by Trevi Troy and Lanhee Chen deriding the idea that the GOP had pointlessly passed bills to appeal the Affordable Care Act without having a replacement plan.  Troy is at the American Health Policy Institute (here) and Chen is at the Hoover Institute (his home page and article links here).  See their WSJ op ed here.  They argue that collectively, Republicans have a lot of good ideas waiting to be marshalled together.

For further background, there are a number of key Republican Health Policy references from the past year:

• For a December 2015 Health Affairs blog by REpublicans Lantos et al., see here.
• For the American Enterprise Institute home page for Republican health reform, here.
• For a 75 page white paper on conservative views on health care reform, here.
• From the GOP policy center, Better.gop, see the health care page here.  
• For a 37-page GOP task force report from June 2016, see here.
• And...
• For a readable summary of seven Republican approaches by Sarah Kliff at Vox, here.  For a similar summary at Huffington Post, here.
• James Capretta and Scott Gottlieb list 4 principles of Republican health reform at WSJ, here.  Gottlieb is on the Trump HHS transition team.
• Other voices.  Obamacare architect Ezekiel Emanual says Republicans have a chance "to do enormous good" with Obamacare reform, Salon, here.  For a detailed non partisan view of repeal & replace options, Timothy Jost at Health Affairs, here.
• Medicare Reform.  Within the general topic of health reform is the specific topic of Medicare Reform.  Reports that Republicans on the Hill might prioritize Medicare reform within 1H2017 were published by The Hill November 17 (here) and picked up the same day with some elaboration at HealthcareDive, here, and by NYTimes on November 24, here.
• Finally, while explicitly not a "Republican health plan," see a November 18 "National Coalition on Healthcare" article on 2017 health policy trends and viable policy options, here.

Restaffing CMS at the Top

Of the 4000 political appointees to be installed under a Trump administration, an informal estimate suggests about 10 are at CMS.   These include the highest position, Administrator, which must be confirmed by the Senate for both FDA and CMS.   Below that are several positions that are political appointees.   Below that are a few positions that are sometimes called "quasi political" because they are subject to reappointment and change, but may be low enough visibility that the previous incumbent continues in them.   More after the break.

Brief Blog: Nails in the Coffin; Anthem Widens its Exclusive Narrow Networks

For the last four years, Dark Report, via Dark Daily blog articles, has discussed the effects on the lab industry caused by narrowing networks and more adverse out-of-network penalties. A few examples are:

1. 8/2012: Aetna sued by California clinical groups over adverse OON policies; here.
2. 6/2013: Doctors now excluded by narrow networks, clinicals already there; here.
3. 10/2014: Narrow networks mean shrinking opportunities for labs; here.
4. 10/2015: Payers hit labs with recoupments and penalties; here.
5. 12/2015: Labs, Pathologists, Insurers at odds over balance billing; here.

On November 11, 2016, Los Angeles Times runs a story on how Anthem abruptly switched 500,000 members from PPOs (which by definition have benefits, but different, for preferred and other providers) to EPOs (exclusive provider networks) with NO out of network benefits.  The article, by Melody Peterson, is here.  A California watchdog group brings the issue before a state superior court judge in November.  

The case hinges on the timing and the fact pattern; while one group asked for a restraining order, "Anthem said it had explained the change to consumers in renewal letters" and that "state officials had approved the change to EPOs."   

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For an NEJM article, November 2016, on going to an in-network E.R. but getting out of network doctors, see here.  For follow-up in NYT, here.  NYT writes, "Once patients get to the emergency room, they have little choice over who treats them. “To put it in very, very blunt terms: This is the health equivalent of a carjacking,” said Zack Cooper, an assistant professor of health policy and economics at Yale University, and a co-author of the [NEJM] paper."

Brief Blog: Crisp Review of Pharma, Medtech, and Value-Risk Contracting

Precision Health Economics continues to put out concise but satisfying reviews of key policy topics in value based reimbursement and health system change.

Last June, they produced an interesting, multi-faceted blog on PBMs, prior authorization, and copays, pulling together perspectives of patient, pharma, PBM, health plan, health system, and public health (here).    Now, this November, a different team at Precision Health Economics provides an open access review of  the challenges and regulatory barriers involving "value based agreements" between pharma and payers.  See the full article at Health Affairs Blogs, here.

The article is authored by Alison Sexton Ward, Mark Linthicum, and Alison Silverstein of PHE, and by Michel Drozd and Joe Vandigo of PHRMA.  They link back to a 2013 "good practices" memo on value-based risk sharing by ISPOR (Garrison et al., here), and provide an update and multi-viewpoint strategic and tactical assessment.

While the title of Ward et al. is value-based agreements for drugs, many of the principals will apply in medtech (or genomics) as well.  For another open-access work by EY on strategic drug pricing, by Licking and Garfield, here.

Abbreviations to track include -

• VBP - Value-Based Purchasing
• VBA - Value-Based Agreements
• PBRSA - Performance-Based Risk-Sharing Agreements

Brief Blog: Walgreens Sues Theranos for $140M

On November 8, 2016, Walgreens announced it was suing Theranos for $140M.   Open access coverage at Reuters, here.   Wall Street Journal report, here.

Walgreens requested the case be filed under seal, as it involved mutually confidential agreements ("Theranos could claim we breached the NDA"), here.

Update:  

Further news; PDF of complaint; Mattis board member.

November 15, 2016
"Walgreens Trashes Theranos in Their Fiery $140M Lawsuit Battle."
Fortune.  By Sy Mukherjee.  Here.

Redacted Walgreens Complaint (52pp), here.

Theranos board member James Mattis met with President-elect Trump the weekend of November 19; here; for discussions related to military and national security.  Mattis was named to Defense Secretary on December 1 (here).

Brief Blog: Growing Outreach and Collaboration between FDA and Payers

For several years, the FDA has floated a few initiatives to increase collaboration with payers.  This week, there is a joint op ed in JAMA from Robert Califf, head of FDA, and Andrew Slavitt, acting head of CMS.

• The JAMA article, "Knowing When and How to Use Medical Products: Shared Responsibility for FDA and CMS," is online here.   
• A concurrent article at Healthcare Dive notes that BCBS Association will also join the FDA Payer Communication Task Force (PCTF), here.
• Note: This Healthcare Dive article works, but it links to a dead BCBS website, on November 29.  To see the BCBS press release, here.
• For a commercially-sponsored December 14 "Summit" on CDRH and Payers, featuring Dr Shuren and other CDRH staff, here.

This Is a Continuing Trend

This is on ongoing policymaker attention to a trend we forecast.

• See our earlier blog, February 2016, "FDA Invites Payers to the Party," here.

UK Has Similar Ideas

In the U.K., there is also a plan to coordinate regulatory decisions with payer  decisions (NHS/NICE) to speed market access to important new medical products (here).  However, for an article on how accelerated approval wreaks havoc with NICE procedures (no data for cost/QALY), Pink Sheet, November 21 (subscription), here.

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For a November 29, 2016 article in Crain's Business on the FDA/Payer topic, see here.

For a November 21 article at Pink Sheet (subscription), here. and February 23 at MedTechInsight (subscription), here.  February 23 open access article at RAPS, here.

For FDA Payer Communication Task Force homepage, here.  For FDA/CRDH 18 page deck, here.

The Magnum Opus on the AMA RUC and RVUs: Laugesen's FIXING MEDICAL PRICES

Harvard University Press has published a 250 page book on the AMA RUC and RVU process, by Miriam Laugesen, associate professor at the Columbia School of Public Health.

"Fixing Medical Prices: How Physicians Are Paid" is the academic capstone on a number of public policy and trade journal articles over the last five years which take the lid off the RUC process and look inside.

The Amazon page is here; the Harvard University Press page is here; Laugesen's academic home page is here.  (At Amazon, it's "#1 in New Releases in Health Policy" and "Sold Out.")

See a review in Health Affairs, here.

For those who are unfamiliar, HIPAA law sets AMA CPT codes as the standardized code sets for communications between physicians and hospitals, and payers.

Then, for physician services (whether an office visit or a heart transplant), the physician fee is set by a process called "RVUs" or relative value units.  Generally, RVUs are delineated by elaborate committee processes within the AMA, and then passed on to CMS for validation and publication in a federal fee schedule.

Some notes on the book, after the break.

Brief Blog: FDA to Hold Workshop November 9-10 on Communications of "Unapproved Indications"

On November 9-10, FDA will hold a two day public workshop on communications about "unapproved indications."   This is the next step in a long-standing saga about the balance between First Amendment speech rights and the FDA's labeling authority and review process.

The workshop registration is closed, but it will be videocast.  The FDA webpage is here.  An article at FDA Law Blog is here, focusing on the evolution of FDA policy, some court cases recently lost by the government, and providing additional links.   (For a colorful 12 page discussion of the recent Vascular Solutions case lost by the government, by Duval FDA Law, here.  I had a chance to do some consulting for the winning side.)

The topic was featured in a NEJM op-ed on November 3, 2016, here.  For a trade journal's meeting preview, here.  For fairly detailed coverage at CNN.com, see here.

CMS Physician Fee Schedule Rule, CY2017; OPPS too

On November 2, 2016, CMS released the final rulemaking for Physician Fee Schedule CY2017.

The CMS webpage for the rule, CMS-1654-F, is here.

The Federal Register publication (November 15, 2016, 81 FR 80170) is here.

Hospital Outpatient Rulemaking (November 15, 2016, 81 FR 79562) is here.

The PFS rule is 393 pages, the OPPS rule is 331 pages.