Brief Blog: CMS Candidate Seema Verma Testifies at Senate Finance Committee

On February 16, 2017, CMS leadership candidate Seema Verma testified in a nearly three-hour session of the Senate Finance Committee.

• C-Span archives the entire video here. [*]
• For a cloud 59-page unoffical transcript of the hearing, annotated and provided by this blog, here.    
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• The Administration's "Transition 2017" Youtube channel has a few brief sound bites online, here.
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• Early coverage at Modern Healthcare, here; at Reuters, here.
• Opening Statements (Senate Webpage here.)
• Senate Hatch: here.   Senator Wyden: here.  Verma: here.
• All together in one PDF (13pp): here.
• Later coverage at Fox Opinion (here), Becker's (here), CNN (here), and Atlantic (here).

My original November 2016 collation of articles on Verma, including some updates, is here.

More after the break.

Brief Blog: Narrow Networks in Laboratory Medicine

For several years, Dark Report and other trade journals have discussed the rising role of narrow-network payers and the impact on the lab industry, which often has little control over which payers support the patients whose samples arrive at the lab.

Dark Daily, the open access blog associated with Dark Report, runs an article on narrow networks today, with citations to a study by McKinsey and company.

• Dark Daily Blog here.
• McKinsey webpage here and PDF version of the data here.

For a 2014 article at Dark Daily on the same topic, here.  For a 2015 open access article at Health Affairs, not specific to the lab industry, here.

Thanks to Katherine Tynan for highlighting.  This weekend, February 19, several colleagues and I will have the opportunity to teach a short course chaired by Tynan on lab regulatory and reimbursement trends at the Molecular Med TriCon conference in San Francisco. 

Brief Blog; CMS Candidate Seema Verma; Senate Confirmation Hearings Will Be Feb. 16

President Trump's candidate for head of CMS, Seema Verma, is scheduled to interview with the Senate Finance Committee on Thursday, February 16.  Story at National Law Review (open access, here).

Verma is nationally known for her consultancy that helps states develop, implement, and manage Medicaid reforms (here).

Brief Blog: Evidence Street and MolDX

In a publicly available deck from December 2016, Dr. Louis Jacques, Chief Clinical Officer at the consultancy ADVI, predicted that in 2017 the BCBS Evidence Street program and the CMS MolDX program would "develop a common portal for lab test dossier submission and review."  (Here, p. 4.)

In a deep-dive subscription article at Genomeweb, journalist Turna Ray updates on the Evidence Street program through interviews with BCBS, Dr. Jacques, and other stakeholders.   For the subscription article, here.

BCBSA Evidence Street displaced the prior BCBSA TEC website, which had been largely open access, with a subscription model.   The Evidence Street website is here.  Favorable reviews are available to companies and can be brought to the public's attention through press releases (e.g., here and here.)   BCBSA itself is careful to position the reviews as evidence reviews, not endorsement of the test relative to any particular higher or lower bar for a coverage decision.

Brief Blog: 21st Century Cures and the CMTP Focus on Real-World Evidence

Real world evidence has been extensively discussed in recent years, two Washington highpoints being a June 2016 white paper on RWE by the Bipartisan Policy Center (here) and 21st Century Cures, Section 3022, encouraging the FDA to look deeper into RWE in approval decisions (here, here).

(The FDA weighed in on its view of RWE in the New England Journal, December 8, 2016, here.)

The Green Park Collaborative, organized by the Baltimore-based Center for Medical Technology Policy (CMTP), has set up a resource webpage with multiple detailed documents to help parties assess and validate the quality of Real World Evidence.

Website here.  39-page white paper on the RWE Decoder project, here.

For a video on the evidence framework goals of CMTP, see an interview with its leader Dr. Sean Tunis, here.

For a February 21, 2017 editorial in JAMA on observational evidence, see here.  For a July 2016 FDA guidance on RWE, here.

The FDA"s Regulation for Expanded Carrier Screening

Last summer, there was a publication in JAMA by Haque et al., the largest study ever undertaken of recessive carrier genes distributed over a population of over 300,000 individuals (here).

After a well-known intervention at 23andMe, the FDA released self-implementing regulations for autosomal recessive test systems.  The regulations are unusual and innovative, dependent in large part on the laboratory's webposting of accuracy and validity data.

Most FDA product category regulations (21 CFR 800ff.) are only a few words long, at most a couple sentences.  For example, Agendia Mammaprint and Nanostring Prosigna breast cancer prognostic tests are cleared under 866.6040:

A gene expression profiling test system for breast cancer prognosis is a device that measures the ribonucleic acid (RNA) expression level of multiple genes and combines this information to yield a signature (pattern or classifier or index) to aid in prognosis of previously diagnosed breast cancer.

In contrast to that type of product classification, the regulation for expanded carrier screening is 3000 words long and runs six pages when clipped into a single-spaced word document.

The regulation (866.5940) is copied below, after the break.   The original Federal Register publication (80 FR 65626ff, October 27, 2015) is here.

The regulation requires hyperlinked reference to credible sources of validity information "such as GeneReviews" that is not otherwise reviewed by FDA before presentation to physician and patient.  This is similar to new guidance on biopharma communications with payers on economic evidence, which must be based on "competent and reliable scientific evidence" (CARSE) not otherwise reviewed by FDA (here).

Brief Blog: PMC Publishes Two Open Access Papers on Access to Personalized Medicine

The Personalized Medicine Coalition has published an open-access white paper and an open access journal article on the integration of precision medicine in healthcare.

The five-page white paper is online at PMC, here.  See the contributors list for a who's-who of thought leaders.

The 12-page academic article, by Pritchard et al, is online at the journal Personalized Medicine (14:141-152), here.

• In addition Pritchard et al:
• See similarly, a six-page new article in Journal of Precision Medicine by Subha Madhavan, "Barriers to Implementation of Precision Medicine in the US Health System," here.
• See similarly, a ten-page review in Genome Medicine on barriers to precision cancer medicine, by Bertier et al, here.
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• In October 2016, JAMA op ed by Dzau et al. on barriers to the full potential of personalized medicine in healthcare, here.
• On a different note, in April 2017, in NEJM Parikh et al. argued that "precision healthcare" should go far beyond "genes" and integrate diverse customization efforts, here. 

Abstract of Pritchard et al., after the break.

Survey Finds 72% Favor Gottlieb for FDA Chief

Biopharma companies do not pick the next head of FDA - the President nominates and Congress confirms.

That said, columnist John Carroll reports a survey in which 72% of biopharma executives favored Dr. Scott Gottlieb as head of FDA.   Other candidates discussed in recent media tracked far behind - Jim O'Neill at 8%, Joseph Gulfo at 9%, and Balivas Srinivasan at 2%.

See Carroll's article, here.

Digital Genomics: DarwinHealth as an Oncology Case Study

In early 2016, I gave a talk for the first time on Digital Genomics, creating a short white paper as a leave-behind for attendees (here; see also here).  This coming summer, I have the opportunity to chair a panel on Digital Genomics at the 1000-person NextGenerationDX conference in Washington August 15-18 (here).

The new issue of Nature Reviews Cancer contains a fascinating deep-dive article on the concept lof clinical digital genomics by authors at Columbia University and DarwinHealth, a New York-based genomics startup.

More after the break.

Brief Blog: CMS Launches Clinical Lab Center Webpage

CMS announced the launch of a Clinical Labs Center webpage.

The webpage has modular organization and provides separate zones for key links for billing, coding, manualized lab policies.   The page includes link to common CMS websites like HCPCS and Transmittals.  

Quirkily, but helpfully, they provide several links to 2001 documents for "Negotiated Rulemaking for Labs."  This was intended to provide uniform national claims requirements so labs could submit claims similarly in all 50 states.  Ironically, 15 years later,  25 states follow special MolDx rules like Z codes (without which, claims are rejected as unprocessable) and 25 states don't.  

CMS has also done some webmastering of its CLFS Meetings page, which tended to have a jumbled collection of erratically named links at the bottom. Now there are clear links for things like this year Proposed and Final pricing recommendations, and handy ZIP files with back-years of annual pricing policies (2012-2016).   2015, 2016 gapfill determinations are listed here (Excel by MAC).

• The new Clinical Lab Center Webpage here.
• The improved CLFS Meetings page, here.

Brief Blog: The Short and Obscure Life of the CMS Date-of-Service Demo

In 2007, Medicare introduced a date of service rule for laboratory tests that locked the date of service to the date of specimen collection.  If the date fell within a hospital inpatient stay, the service was unbillable separately due to DRG bundling, even if performed after the patient left hospital (because the "date of service" remained back during the hospital stay.)   Outpatient lab tests shipped to reference, or sole-source labs, could only be billed by the hospital, since the patient was "at the hospital" on the day of service when the tissue was taken or the blood was drawn.

The Affordable Care Act included Section 3113, a demonstration program for up to two years and up to $100M of lab tests, under which reference labs could direct-bill CMS for advanced lab tests.  Because the project blocked tests using "unlisted codes," tests like Oncotype DX could not use the demo, since they did not yet have CPT codes.   CPT assigned the eligible CPT codes primarily as the historic molecular "stack codes," which were deleted by CMS and CPT in mid-demo.

Nonetheless, consistent with Congressional intent, CMS released a report on the demo project.  The report has a cover date of 2015 and a PDF edit date of January 6, 2016.  The report concludes that due to "extremely low utilization" no conclusions on impacts of the demo project could be made.

CMS noted that during the period, 1,476,590 beneficiaries were billed with molecular stack codes, and 458 beneficiaries were billed with molecular stack codes under the Demonstration Project.  CMS states that patients for whom claims were submitted under the demonstration program died at a "much higher" rate than non-demonstration patients.

Only 173 of the 458 beneficiaries with "tests billed" had "tests paid."  Total payments under the $100M demo were $35,000 for independent laboratory claims and $5,500 for hospital outpatient claims.

The report is online here.

Brief Blog: AJMC Publishes Special Issue on Diabetes Prevention

Diabetes prevention has been rising in public policy circles, with landmarks like Medicare's creation of a new Diabetes Prevention Program benefit through its Center for Medicare Innovation (here).   The program will include virtual prevention programs (e.g. see Omada) as well as brick-and-mortar one.  In the digital space, other alliances are forming, such as between hardware manufacturers of blood glucose monitors (like Ascensia and Roche) and app/cloud/physician platforms like Glooko (here).   Glooko is deliberately designed to work across many devices, so it can be used by ACOs or clinicians with large numbers of Type 1 and Type 2 patients on diverse meter hardware.

Despite multiple studies with up to ten year outcomes (here), some questions are still raised about the real-world long term impact of diabetes prevention programs, as flagged in a BMJ review article in January 2017 (here).  

In December 2016, American Journal of Managed Care has published a full special issue on diabetes prevention & management, including in the ACO setting (to reach it, click through this article to the PDF button at the end: here).  AJMC also has a special website for diabetes-related articles and news, here.

 

Also in December, AJMC covered whether the competitive bidding program for diabetes supplies has impaired health access for Medicare beneficiaries; here.

The 21st Century Cures legislation has an "Easter egg" benefit for Medicare diabetes patients on insulin pumps at Section 5004.  It changed reimbursement for pump-based drugs in technical ways which, on average, will save CMS money on drug costs, but will raise Medicare payments for insulin closer to market rates today.  Multiple sources had reported that due to arcane accounting mechanisms, static Medicare rates for pump-based insulin had become so low that access for beneficiaries was notably impaired.

Brief Blog: ICER Releases Value Framework Update For Public Comment

Boston's ICER, the Institute for Clinical and Economic Review, released an updated "value framework" on February 1, 2017, with comment open until April 3.  ICER promises to post finalized updates to its value framework by April 15.   (It gives itself 12 days or less to review and revise based on public comments.)

See:

• ICER press release here.
• Project home page, here.
• 24-page update PDF, here.
• Coverage at Modern Healthcare, here.

For mostly favorable 2016 articles at STAT, here (April) and here (August).  2016 interview with ICER's head, Steven Pearson, at AJMC, here.  2016 blog at Health Affairs by Pearson, here.  A few weeks ago, Pearson published in JAMA Internal Medicine that national guideline committees for hepatitis and cholesterol management did not fully meet IOM conflict of interest criteria (here).

Assuming that favorable aspects of the work speak for themselves, some contrary viewpoints are:

• A disgruntled blogger, here.
• Critical article in Huffington Post, here.  

Some additional notes after the break.

Brief Blog: ACS and Others Ask Hill for LDT Oversight

In November, post-election, the FDA announced it was tabling the release of final guidance documents on LDT regulation (here, here).   Two months later, in mid January, the FDA released a white paper on its latest thinking as a result of two years of back-and-forth on LDT regulation (here, here, here, here).

On January 24, 20-17, 30-plus organizations, including the American Cancer Society, urged that "updating the LDT framework" be a priority of this Congress.   The two-page PDF is online here.

These stakeholders write,

There is no systemic way to be sure of the accuracy and reliability of these tests. Several cases illustrate the challenges with this lack of oversight. Researchers sent samples from the same cancer patients to different LDT providers for cancer testing, and found only 25 percent of the drug recommendations based on test results overlapped.

...The current system of LDT oversight is inadequate and needs updating.

The letter is addressed directly to the Senate Majority Leader and the Senate Minority Leader, rather than to committees in the House or in the Senate.  Coverage at Genomeweb, here.

On February 1, 2017, the trade journal CQ Healthbeat ran an article that LDT regulation is again on the Hill agendas for this year, given the support both of the clinical groups cited above and the joint support for some level of regulation revision at both Advamed and ACLA.

Brief Blog: A Trending Buzzword in Healthcare: Systemness

For its January 30 issue, the back page of the hospital trade journal Modern Healthcare has a full page advertisement for a "Systemness" website.   Turns out, the term has a few years of history in US healthcare and may be a trending buzzword now.

For example, Modern Healthcare ran an opinion piece introducing "systemness" to its readers in 2011.  In a 2013 publication, the ECRI Institute has a cover story on "Systemness," here.  Becker's Hospital Review ran a story in 2014, here.  

A new Modern Healthcare special website is here, sponsored by Dignity Health, with an 11 page PDF white paper here.

Footnote:  In the same vein.   For an interesting new blog on using big data for better healthcare, rather than administrative pains, pointless metrics, and gaming, see Tom Burton of HealthCatalyst, here.