Thursday, March 30, 2017

CMS Extends Deadline to Submit PAMA Pricing by Two Months (May 30)

https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/Downloads/2017-March-Announcement.pdf


Note that technically, CMS is not "extending the deadline" but rather saying they will "not enforce late penalties" except for submissions that arrive after May 30.

Subject: 
60-Day Enforcement Discretion Period Announced for Laboratory Data Reporting

CMS Announces 60-Day Period of Enforcement Discretion for 
Reporting Applicable Information Under the 
Medicare Clinical Laboratory Fee Schedule

Today, the Centers for Medicare & Medicaid Services’ Center for Medicare (CM) announced that it will exercise enforcement discretion until May 30, 2017, with respect to the data reporting period for reporting applicable information under the Medicare Clinical Laboratory Fee Schedule (CLFS) and the application of the Secretary’s potential assessment of civil monetary penalties (CMPs) for failure to report applicable information. This enforcement discretion applies to entities that are subject to the data reporting requirements adopted in the Medicare Clinical Diagnostic Laboratory Tests Payment System final rule published on June 23, 2016 (81 FR 41036).

Industry feedback suggests that many reporting entities will not be able to submit a complete set of applicable information to CMS by the March 31, 2017 deadline, and that such entities require additional time to review collected data, address any issues identified during such review, and compile the data into CMS’s required reporting format. This 60-day enforcement discretion period is the maximum amount of time CMS can permit to still have sufficient time to calculate the CLFS payment rates scheduled to go into effect on January 1, 2018.

This enforcement discretion period does not prevent reporting entities prepared to report applicable information from doing so before May 30, 2017. CMS is committed to the successful implementation of the new private payor rate-based CLFS and looks forward to working with the laboratory industry to ensure accurate payment rates. CMS will continue to closely monitor this process and provide guidance as necessary.
  

Wednesday, March 29, 2017

Head of FDA: Scott Gottlieb's Senate Hearing Set for April 5, 2017

Dr. Scott Gottlieb, the administration's nominee to head the FDA, has been scheduled for Senate hearings on April 5.

Media coverage has focused on Gottlieb's extensive industry consultations and ties during the 8 years since he served in the Bush administration.  Current news articles refer to a 41-page federal ethics filing.   For more details see:
In 2006, Gottlieb became a Hodgkin's lymphoma survivor.  Observer.com cites Gottlieb's nomination as "a big win for science" (here),   Global Healthy Living Foundation endorses him (here) as does Patients Rising (here) and DrugWonks (here).  Some other sources praise faintly ("To his credit, Gottlieb is not certifiably crazy...;" MedPageToday, here.)  One of Gottlieb's major position pieces, on changing the FDA's culture, appeared in National Journal in 2012 (open access, here.)

Per the NYT, Gottlieb's financials from January 2016 to February 2017 included $1.8M from investment firm T.R. Winston, and additional compensation from venture capital firm NEA, direct pharma consulting, and positions on boards.  His position as a scholar at American Enterprise Institute is also compensated.   Gottlieb is a graduate of Mt. Sinai Medical School and its internal medicine residency, maintains a Connecticut medical license, and has often worked weekend shifts at a hospital there while maintaining other positions such as a senior policy position at FDA during the Bush 43 administration.   In 2016, Gottlieb donated to support Congressman Ben Sasse, who was one of the most vocal opponents of the Trump candidacy (US News, here.)

Tuesday, March 28, 2017

National Academy Releases: "Evidence Framework for Genetic Testing"

On March 27, 2017, the National Academies (of Science, Engineering, Medicine) released a 149-page ebook on "Evidence Framework for Genetic Testing."  The federal consensus report  was requested by the Department of Defense Office of Health Affairs.  Download the free ebook here.



My 2014 coauthor Felix Frueh and I were surprised and pleased that an evidence framework we published was cited as one relevant example among six or seven approaches to assessing genetic tests.

At the time, Frueh and I were dissatisfied that the conventional framework of "analytical validity, clinical validity, clinical utility" - while "true" - lacked much guidance for resolving disputes.   We suggested that dividing analysis into six questions was a happy medium - one or two questions is not enough ("Does the test have clinical utility?") while a list of twenty to forty questions was not really manageable.   The six questions, developed entirely by Frueh, were:

  1. Who should be tested and under what circumstances (e.g. population, scenario)?
  2. What does the test tell us, that we did not know without it?
  3. Does the outcome change in a way we find value in?  
  4. Can we act on the information provided by the test?  (E.g., ideally)
  5. Will we act on the information provided by the test?  (E.g. decision impact studies)
  6. If the test is employed, is it affordable?
In my experience, at least at the time, a successful test like Oncotype DX allows fairly straightforward answers to all six questions, whereas a generally unsucessful test (with payers) like beta-amyloid PET tracers, was hard to answer for nearly any of the six questions.   Perhaps understanding the test pretty well and then taking five minutes to jot down freehand answers to the six questions would be a good predictor of payer success or failure.   

We noted that tests have many ways in which they can represent improvements (more accurate, faster, providing results that were unknowable before) and that since tests map to such broad health scenarios, the range of relevant health outcomes is also broad (whether survival, pain, shorter hospital stay, etc.)   We believed that if payers and lab developers communicated on the various axes, there would be fewer situations where the payer can do no more than state vaguely "there is not enough evidence" and where the lab complains equally vaguely that "payer standards are too high."   

Frueh-Quinn was published here.

Brief Blog: CMS Rolls Out CGM Coverage; Window into Numbingly Complex Policies

In the summer of 2016, CMS began losing administrator judge cases when it tried to defend its poorly-enunciated policy that continuous glucose monitors were not a medical product  category eligible for Medicare payment.

In January 2017, CMS released a lengthy, legalistic ruling reversing its position.

On March 23, 2017, CMS DME MACs released a provisional policy that describes actual coverage of CGM through claims processing.

Details after the break.

Brief Blog: ACLA asks CMS to Delay PAMA and Expand Hospital Lab Reporting Too

Last week, ACLA held its annual meeting in Washington.  ACLA has formally asked CMS to delay PAMA for a year - and not only delay it, but re-write the rules on the scope of labs which will be obligated to report.   A CMS administrator made comments suggesting that CMS was considering the possibility of a PAMA delay.

  • See open-access coverage at Dark Daily (here). 
  • See also a flurry of several press releases in recent days on the ACLA news website, here.
  • Subscription coverage at Genomeweb (here).

Senior CMS administrator Carol Blackford, head of all outpatient services for Medicare, spoke at the conference.  According to the news reports, Blackford publicly acknowledged some difficulties in computer processes supporting PAMA data submission, such as periods when the systems have been down.  Overall, data submission so far is less than anticipated by CMS.   The current deadline for data submission is Friday March 31, and failure to submit carries substantial penalties.

CMS Has Difficulty Handling 81162 Claims

Blackford's comments included the fact that "files were rejected based on a valid HCPCS code 81162."   81162 is one of several confusingly priced CPT codes related to BRCA testing (here).  

ADLT Instructions: In the Pipeline

Blackford also noted that while no instructions for applying for Advanced Diagnostic Laboratory Test (ADLT) codes have been provided, a submission form has been created by now, and is being reviewed by general counsel at CMS before release.  ADLT codes received privileged coding and pricing processes under PAMA.

OIG Reports from September 2016

Genomeweb's article pointed me to two September 2016 OIG reports that relate to PAMA changes; I had missed these.  OIG home page for the articles, here.   OIG issued one report (16-00040) on 2015 baseline CLFS payments, here, and a second report on "CMS Progress in Implementing PAMA (16-00100), here.   ReedSmith summarized the two OIG reports last October, here.

Brief Blog: New Term, Narcissome (Genomeweb)

On March 28, 2017, Genomeweb's Julia Karow runs an article on discussion of elective exome or whole genome screening, a topic of discussion at American College of American Genetics (ACMG) last week.  New term:  "Narcissome."  Subscription article here.

Separately, in a meeting last week, I heard a reference to the "economicsome," the payment system for advanced lab tests.

NEW YORK (GenomeWeb) – Exome and whole-genome sequencing have been firmly established as diagnostic tools for rare genetic diseases that can pinpoint molecular causes missed by more targeted tests. More recently, though, several labs have started to move genome-scale sequencing into preventive medicine, with the goal to detect increased disease risks and predict atypical drug responses in seemingly healthy individuals.
At the American College of Medical Genetics and Genomics annual meeting in Phoenix, Arizona, last week, representatives from Harvard Medical School, Illumina, Baylor College of Medicine, the HudsonAlpha Institute for Biotechnology, and the National Human Genome Research Institute talked about their experience with genomic tests catering to individuals that neither have cancer nor a rare inherited disorder, variedly referred to as "genome screens," "elective genomes," or >>> "narcissomes." In addition, several commercial labs spoke about recently launched or planned genomic tests for so-called healthy adults at the conference, including WuXi NextCode, Ambry Genetics, and Invitae.

Friday, March 24, 2017

How To Quickly Explain Medicare BRCA Pricing Policy to Your Sixth Grader

My kids are in high school, but you may need to explain Medicare BRCA pricing policy to your sixth grader, when they are learning bar charts.

Medicare currently pays for BRCA genetic testing services at any of four different price levels, depending on coding choices and the state where the lab is [click to enlarge]:


In 25 states, the MolDX program lists 81433 as a nonpayable code, so the $931 cap applies for panel testing in those states.  I use the MolDX pricing in the next two charts.

Here's a bar chart where the price axis is normal, and the work of genes tested is unnaturally expanded or compressed (a couple genes is very tall and a dozen genes is very tiny):


Here's what it looks like if you set the bar charts to show the laboratory work -- more genes makes taller bars than a couple genes -- this will make the Medicare price axis turn UPSIDE DOWN:

Based on 2015 claims data, Medicare paid well over $50M for BRCA testing services.  If the MolDX price policy were applied with consistency, Medicare would have paid only $18M - saving over $30M per year or $300M over ten years.  

Was Implementation of Panel Pricing Policy Frozen by Executive Order?

If CMS was planning to implement its long-standing panel pricing policy for genetic testing 1Q2017, it may have been derailed by the executive order to freeze federal agency rulemaking and policymaking.


EXTRA CREDIT QUESTIONS

In August 2016, CPT Assistant, the AMA's correct coding resource, fielded a question on what to do with multiples of genetic tests that didn't meet a gene panel code.   AMA responded that Tier 1 codes should be stacked, Tier 2 codes used in multiples as necessary, and additional services represented by an unlisted code (81479).

Let's say a lab does a panel of 9 or 10 genes, including BRCA 1 & 2, so the lab is performing a panel that falls short of the AMA CPT panel definition for 81432 ($931).   And let's assume the 7 genes after BRCA 1 & 2 are on fee schedules at $400 each.  

Then you get the following charts, with the hypothetical 9-gene stack coding paying about $4800 - and this is still less work than the 14-gene panel which would pay only $931.   In some places, without special manual edits, CMS or other payers' computers might autopay the price in the left bar.


We can also map this approach onto the format with a reverse-price axis on the left, running the payment from about $5000 (for nine genes at far left) to $2500-2700 for two genes and down to only $931 for 14 genes (at far right):



Thursday, March 23, 2017

CAP, AMP Release New Gene Panel Validation Guidelines

On March 23, 2017, CAP and AMP released a new, 25-page guideline to validation of next generation sequence panels.   The article, Jennings et al, has its journal home page here, PDF link here, and in the cloud, here.

For coverage at Genomeweb, here.  This is the third recent guidance for standards in next generation sequence; see also Ritter et al. for guidelines on new standards for annotating and curating somatic tumor variants (here) and Li et al. on new standards for clinically reporting somatic tumor variants (here).

Abstract of Jennings et al. clipped after the break.

Guidelines for Validation of Next-Generation Sequencing–Based Oncology Panels

A Joint Consensus Recommendation of the Association for Molecular Pathology and College of American Pathologists



Wednesday, March 22, 2017

Rapid Transcript HERE: CMS Diabetes Prevention Program Webinar (3/22/2017)


The home page for the Medicare Diabetes Prevention Program is here:

CMS is in the process of policy and rulemaking to implement the program nationally in January 2018.   CMS held a webinar on the collaborative roles of CDC and CMS on March 22, 2017.   The webpage for this webinar is here:  https://innovation.cms.gov/resources/dpp-cdc-expansion.html

CMS is expected to post slides and an official transcript in the near future.  
In addition, CMS stated it was preparing an updated and expanded FAQ.   


In the meantime, this blog provides a rapid unofficial transcript of the March 22, 2017 webinar.

The rapid unofficial online transcript is in the cloud: here.


Thursday, March 16, 2017

12, 8, 4, and 2: Revisiting BRCA Policy and Pricing

Today, March 16, the USPSTF task force released for public comment the framework for an updated assessment of BRCA risk assessment, testing, and counseling (here).  It's the 12th anniversary of the USPSTF first guidance statement, in 2005 (here). Meanwhile, BRCA policy mavens will recall that this year is the 8th anniversary of AMA/ACLU filing a court case challenging the validity of some claims of the BRCA patent (here).   And in a couple months we hit the 4th anniversary of the Supreme Court decision that followed (here, here).   Meanwhile, we just crossed the 2nd anniversary of the resolution of several ongoing aspects of the patent litigation (e.g. Cook-Deegan, here), and College of American Pathologists/CAP TODAY just published an article on how the SCOTUS case has impacted diagnostic pathology (here).

I recently reviewed the cumbersome CPT/CMS approach to coding and pricing BRCA testing (here).  The flurry of anniversaries and events led me to look up some of the original SCOTUS documents this evening.


Comment Through April 12 on USPSTF BRCA Research Plan (Risk Assessment, Counseling, Testing)

USPTF has a December 2013 current recommendation on BRCA-related cancers, covering risk assessment, counseling, and genetic testing.  Based on an earlier ruling of HHS, and now pretty clearly incorporated in the 2013 guideline,  HHS and USPSTF view genetic testing as part of the preventive guideline, which makes it copay-free under most insurance plans.

On March 16, USPSTF released a new plan to update its guidance.   The public can comment through April 12.   Arising issues include restriction of preventive screening to high-risk families versus population-wide screening.  As far as the draft plan goes, it continues to focus only on increased-risk families.

Comment here:
https://www.uspreventiveservicestaskforce.org/Page/Document/draft-research-plan/brca-related-cancer-risk-assessment-genetic-counseling-and-genetic-testing1



In general, under ACA, most health plans are required to provide USPSTF A and B preventive benefits and without copay.  CMS can adopt (import) USPSTF A and B benefits into Medicare via the NCD process. To date, it has done that for quite a few preventive services, but not for BRCA preventive screening.  CMS does cover BRCA testing in women already diagnosed with breast cancer, where results can guide ongoing management decisions.

Wednesday, March 15, 2017

Do CMS Panel Pricing Policies Apply to Gene Panels?

In a previous blog, here, we discussed that CPT and CMS had generated a complex web of coding and pricing options to pay for BRCA testing, one of Medicare's top three genetic tests (by dollar volume).

Beginning in January 2017, CMS has a fee schedule priced gene panel test that includes BRCA-1 and BRCA-2 testing, but has a much lower total price.

Does this conflict with CMS's decades-old policy to never pay more for components of a panel that it would pay for the entire panel?

My answer is "probably so," but CMS has not faced the issue yet.  Research on the topic indicates that CMS's lab panel pricing policies are memorialized in varies program documents, but not fixed in law or regulation.

Because PAMA is a law, and raises some thorny issues for CMS regarding the interaction of PAMA law and CMS internal lab test policies, CMS should probably put its panel policies into formal, enforceable regulations.   When doing so, CMS should assess the fit of its panel policies to gene test panels.  It looks like this could quickly become a multi-hundred-million dollar issue for CMS.  Details after the break.


It's a Chaotic Mess: CMS Pricing of BRCA Testing

When assessed by CY 2015 payments in the fee-for-service Medicare Part B system, BRCA testing is the third-largest expenditure, at about $52M per year.  However, the situation for CY 2017 is going to be much more complex, as there are now three different coding approaches, all recognized by CMS, resulting in drastically different Medicare expenditures for BRCA testing.

Depending on which set of rules and codes are applied,  payments could be anyone from $931 all-in for a BRCA panel including full dup-del analysis, all the way up to $2,780 for individual genetic components of BRCA 1 and BRCA 2 testing.

Assuming similar test utilization in 2017 as in 2015, Medicare's total payments could be as low as $17.9M this year or as high as $51M.   This article discusses how Medicare backed itself into this mess.   A shorter second blog (here) asks whether CMS panel pricing rules can or should apply to BRCA testing.




Tuesday, March 14, 2017

Brief Blog: A Large Scale Private Payer CED Project: Genetically Informed Mammography

On March 14, 2017, Health Affairs runs a detailed blog by Rosenberg-Wohl et al. (here) about a "Coverage with Evidence Development" study supported through the collaboration of diverse stackholders, including multiple University of California campuses, Blue Shield of California, and other collaborators.

The study, WISDOM (see website here), looks to assess the impact of randomized use of a genetic breast cancer risk profile on mammography outcomes.   The idea is simple: if breast cancer is risk based, then one-size-fits-all screening based on projected risk/benefit is like one-size-fits-all clothing or shoes.   The authors describe the study as benefiting from the use of $225 breast cancer genetic risk testing.  There will be 100,000 total participants, with half of them receiving the test.

The authors explain that imposing numbers of hurdles that had to be maneuvered to launch the program.   The 5-year study is new and will be enrolling into 2017.






Brief Blog: Seema Verma Confirmed As Head of CMS

On March 13, the Senate voted to confirm Seema Verma as head of CMS.

Coverage at Medscape here, at Becker's Hospital Review here, at New York Times, here.


Verma built an Indiana-based healthcare consulting helping multiple states redesign their Medicaid programs.   For a full transcript of her Senate interview testimony, here.   For an earlier blog on her background, here.  For her August 2016 blog on Indiana's Medicaid reform, in Health Affairs, here.

Monday, March 13, 2017

CMTP/Green Park Issues White Paper on Genomics, Liquid Biopsy

On February 7, we covered a Real World Evidence information center set up by the Green Park Collaborative and the Center for Medical Technology Policy (CMTP).

On March 13, the GPC and CMTP issued a 19 page white paper summarizing their November 2016 two-day stakeholder workshop on the adoption of genomic technologies.  One focus of the workshop was Liquid Biopsy.   See the web page here, the white paper here.  Table of contents is clipped below the break.



Friday, March 10, 2017

Brief Blog: Could GINA's Genetic Privacy Protections Change?

This week, a flurry of articles on an obscure legislation proposal that could chip away at GINA's protections regarding genetic privacy in the workplace and with health insurance.


See coverage at PLOS.ORG here, at Genomweb here, at STAT here, at Dark Daily, here.

STAT writes,
A little-noticed bill moving through Congress would allow companies to require employees to undergo genetic testing or risk paying a penalty of thousands of dollars, and would let employers see that genetic and other health information.
Giving employers such power is now prohibited by legislation including the 2008 genetic privacy and nondiscrimination law known as GINA. The new bill gets around that landmark law by stating explicitly that GINA and other protections do not apply when genetic tests are part of a “workplace wellness” program.
The PLOS article quotes from a letter from the President of the American Society for Human Genetics to the Hill.
Nancy J. Cox, PhD, ASHG president, in a letter to the U.S. House Committee on Education and the Workforce, provides a frightening overview:

“If enacted, this legislation would undermine fundamentally the privacy provisions of the Genetic Information Nondiscrimination Act (GINA) and the Americans with Disabilities Act (ADA). It would allow employers to ask employees invasive questions about their and their families’ health, as well as genetic tests they and their families have undergone. It would further allow employers to impose stiff financial penalties on employees who choose to keep such information private, thus empowering employers to coerce their employees into providing their health and genetic information.”

Brief Blog: Scott Gottlieb Announced as FDA Nominee

Early on March 10, Bloomberg ran an article citing Scott Gottlieb as the leading candidate for head of FDA.   See the open access article here.   Around noon, WSJ stated that Gottlieb is the expected FDA nominee, here.   And the NYT also, here.  WaPo. here.  At around 5 eastern, Reuters posted that the White House has confirmed that Gottlieb "is" the nominee.  Further analysis at Endpoints, here, and Vox, here.  A later update at Endpoints (on March 29, here) covers some of Gottlieb's pharma connections that have to be unwound.

Wall Street Journal hails the nomination as potentially "one of Trump's most important appointments" (here).  See a detailed analysis of Gottlieb's views on drug pricing is providing by the DrugChannels blog (here), with a callout to Gottlieb's insightful 10/2016 Hill testimony (here).



This blog highlighted Gottlieb's promising candidacy on December 13, January 21, and February 6.

For MedCityNews, "Statistical Guide to Scott Gottlieb," March 15, 2017, here.


A interesting pre-election (9/2016) interview with Gottlieb is online, here.

A colorful article about the new administration, Peter Thiel, and FDA, at Vox, here.  A negative article on Gottlieb at LA Times, here.

Thursday, March 9, 2017

Brief Blog: AMA Releases Results of February 2017 CPT Meeting

The AMA CPT Editorial Panel meets three times per year, most recently in early February in New Orleans.  A number of molecular codes were on the agenda, for single genes, for MAAA tests, and for genomic sequencing procedure panels.   
  • The results of the AMA panel were posted today by the AMA, on this webpage, here.  
  • See the document, 2017 February: CPT® Editorial Summary of Panel Actions.

Wednesday, March 8, 2017

Brief Blog: Comparing the FDA BRCA Approvals for Myriad & Foundation Medicine

Myriad Genetics received FA approval for its BRCA1/BRCA2 companion diagnostic (BRACAnalysis CDx (TM)), on December 19, 2014.

Foundation Medicine received FDA approval its its NGS-based BRCA1/BRCA2 companion diagnostic (FoundationFocus CDx[BRCA] Assay (TM)), on December 19, 2016.


The tests fall under different FDA PMA classifications (Cancer Germline Detection System, for Myriad; and Next Generation Sequencing Oncology Panel, Somatic or Germline Variant Detection System, for Foundation.)

Each has detailed Safety & Effectiveness documentation and Labeling documentation online at FDA (these are 34 and 16 pages, respectively, for Myriad, and 31 and 18 pages, for Foundation).
  • The FDA homepage for FoundationFocus (P160018) is online at FDA here.

  • The FDA homepage for BRACAnalysis (P140020) is online at FDA here.  
    • This approval also has 8 links to minor supplements (such as changes in software or polymerase reagents.)
The FMI approval order is linked directly to clinical use with Rubrca, and the Myriad approval is linked directly to clinical use with Lynparza.

  • A collated ZIP file with the five core FDA documents for each product (and the 8 minor supplements for Myriad) is in the cloud, here.
Update: An April 27, 2017 article in Genomeweb discusses that FMI's test is less-validated for longer insertions and deletions or large rearrangements, and that Clovis Oncology is getting approval for on-label use of the Myriad test with its PARP inhibitor Rubraca (here).

Tuesday, March 7, 2017

Brief Blog: PMC Releases 2017 Policy Report, Holds Hill Briefing

Last month, on February 7, the Personalized Medicine Coalition released a report on barriers and disincentives to personalized medicine (here).  The report was based on multi-stakeholder workgroups and interviews, and appeared as a 5-page summary plus a 12-page academic paper in the journal Personalized Medicine.   The paper by Pritchard et al. is entitled, "Strategies for Integrating Personalized Medicine into Healthcare Practice."

Now, on March 7, PMC released its annual full-length report on the personalized medicine movement in healthcare (64 page PDF, here.)

Also today, PMC will hold a 90 minute Hill briefing on issues in personalized medicine (here).   The Hill briefing, co-hosted by Sen. Markey (D-MA), will include four panelists:

  • Stephen D. Eck MD PhD, Astellas Pharma
  • Emily Kramer-Golinkoff, Co-Founder, Emily's Entourage
  • Miachel Sherman MD, Harvard Pilgrim Health Care
  • Jay Wohlgemuth MD, Quest Diagnostics
[Update, Coverage of the Hill hearing by "Science & Enterprise," here.]

The 64-page annual report discusses opportunities and challenges.  Opportunities include medical benefits and the fast past of science.  Challenges include regulatory policy, coverage/payment policy, clinical adoption rates, and health information technologies.


Coverage at Genomeweb, here.  At STAT, here.

Wednesday, March 1, 2017

Brief Blog: Grail Raises $900M For Advanced Liquid Biopsy Sequencing

As it promised to do at the beginning of the year, GRAIL has raised almost a billion dollars to push the horizons of next-generation sequencing from blood samples.   The press release is clipped after the break.


Grail recently announced it was hiring Elizabeth Mansfield PhD, one of the senior leadership team for precision medicine at the FDA over the past decade (here).