Tuesday, October 17, 2017

Very Brief Blog: The Expedited Process for NCD Removal (2013 forward)

I was on a CMS call recently discussing the process for removal of an obsolete NCD. 

CMS published an updated NCD application process in August 2013, which includes a process for  deletion of obsolete NCDs after a short public comment period.   The August 2013 policymaking is online here (78 FR 48164, 8/7/2013).   NCDs can be removed because they are generally acknowledged as obsolete, because a product is no longer marketed, or because local contractor discretion would better serve the needs of the Medicare program.

CMS has thereafter used the obsolete NCD removal process at twice (home page for NCD removal, here). 


  • In November 2013, they published a list of NCDs for expedited removal, and allowed a 30 day public comment period.  See the document online here.  (The process generated 7 public comments, here.)  They deleted 5 of the NCDs shown below, keeping the ones on L-DOPA, Laser procedures, and Carotid function (here).   
  • In November 2015, they proposed to delete the apheresis NCD and part of one other NCD (here), but they kept the apheresis NCD in place pending a fuller consideration than the expedited deletion process (here). 


click to enlarge

The expedited deletion process allows CMS to propose NCDs for deletion with no further explanation of rationale than the indication that the NCDs meet one of the deletion criteria such as obsolescence.

Does FMI Abstract Give Insight to Pending FDA Approved "Foundation One?"

The International Association for the Study of Lung Cancer is holding its 18th World Conference this week in Japan.   Foundation Medicine has an abstract, available open access online, for a "universal combination diagnostic platform developed and performed in compliance with FDA 21 CFR 820" that interrogates 324 genes.   The authors write, the test "is anticipated initially to have 8 CDx indications."

Whether this matches exactly what comes out of the FDA's approval process...is up to the FDA.  As of September 2017, CMS has said that the FMI test is in parallel review for FDA approval and a CMS national coverage decision and that the results will be public soon (here). 

The FMI abstract is online here.  (At the conference link, click "plus signs" to see the full text.)

click to enlarge

Friday, October 13, 2017

What's Up with Use or Mis-Use of CMS's Edit Against Code-Stacking of 81211-81213: BRCA Testing?

For the last several quarters, I've been tracking a Correct Coding Edit on the CMS website that appears to date back several years and would normally operate to block use of the BRCA sequencing and BRCA duplication-deletion codes together (codes 81211-81213).

Updated through the current October 2017 instructions, note that there is a block against using 81211 and 81213 together:

click to enlarge
The edit against co-payment of 81211 and 81213 together can be overcome by using a -59 modifier, but according to CMS instructions, the -59 modifier isn't supposed to be used routinely.  (CMS article here and here; OIG report here.)[*] 

I went back to the transcript of the August 26, 2015, meeting, where these codes were discussed by Dr. Phurrough of CMS (see archive here, here).  Dr. Phurrough stated:
"If they [a lab] were to do one of the individual tests, 81211 or 81213, not on the same day, then they would be paid separately. 
If they were to do both of these codes, then correct coding, non-fraudulent coding would be the new code 81162. And to code both 81211 and 81213, when you did both of them, on the same patient, the same sample, would be incorrect coding."
It looks like Dr. Phurrough and the CCI edit author were on the same page.  Both are public record and easily found online at the links above.

For data on use of codes 81211 and 81213 by various labs in CY2015, see an earlier analysis, here.

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[*]  The 20130401 number indicates the edit dates from April 2013, and the * indicates it has no termination date.  The next column "1" means that a Mod 59 will flag for payment of both codes due to a special circumstance.  A "0" in that column means that payment for both codes is never allowed.

AMA CPT Revises BRCA Panel Code for 2018

AMA CPT handbooks for CY2018 are out, and one change in molecular coding is a revision of the code for BRCA gene panel testing (hereditary cancer gene panels). 

The new code reflects a shortening of the required-genes list.   This revision was classed as an editorial change and therefore did not trigger any action in the CMS crosswalk/gapfill process this fall.

The new code will be

81432
Hereditary breast cancer-related disorders
(E.g. hereditary breast cancer, hereditary ovarian cancer, hereditary endometrial cancer)
Must including sequencing of at least 10 genes.
Including: 
BRCA1, BRCA2
CHD1, MLH1, MSH2, MSH6, PALB2, PTEN, STK11, TP53.


Prior to January 2018, the gene list used to include:
ATM, BRIP1, NBN, RAD51C.


CMS Requires MACs to Gather Data About Lab Tests with Unlisted Codes

On October 13, 2017, CMS released CR10232/Transmittal 3881, updating the Claims Processing Manual to require submission of data for lab tests processed with "unlisted codes."

The Transmittal is online here.  A cloud archive copy is here.  The relevant new text is:

Instructions for Not Otherwise Classified (NOC) Codes – Any unlisted services or procedure code. Note:  When reporting NOC codes, this field must be populated as specified below. 

When billing for unlisted laboratory tests using a NOC code, this field MUST include the specific name of the laboratory test(s) and/or a short descriptor of the test(s). Claims for unlisted laboratory tests that are received without this information shall be treated according to the requirements found in Pub. 100-04, Medicare Claims Processing Manual, Chapter 1, Section 80.3.2 and “returned as unprocessable.” Section 216(a) of the Protecting Access to Medicare Act of 2014 (PAMA) requires reporting entities to report private payor payment rates for laboratory tests and the corresponding volumes of tests. In compliance with PAMA, CMS must collect private payor data on unique tests currently being paid as a NOC code, Not Otherwise Specified (NOS) code, or unlisted service or procedure code. 

Note the language the instruction is couched in:  Labs are required to report private payer rates...CMS must collect private payer data on unique tests paid with a NOC code.

This is a change in interpretation, as CMS did not previously require this reporting in the interval since PAMA was passed in 2014.  In June 2016, CMS wrote, "Data on tests that are billed using unlisted CPT codes or NOC codes would not be considered applicable information and would not be reported."  (81 FR 41053, 6/23/2016).

Almost All CMS Unlisted Code Payments Fall Under MOLDX

In CY2015, CMS paid $165M under molecular unlisted code 81479 (here).  However, nearly all of this was paid under the MolDX program (here).  Thus, as a practical matter, the CMS transmittal will have little impact outside of MolDX states.

MolDX has a special coding rule that 1-4 genes should be reporting with an unlisted code (here) rather than CPT stack coding. For example, we've previously noted that Ambry Genetics bills 80% of its Medicare services as MolDX NOC codes (here).   In addition, MolDX requires at least six tests to be submitted with -22 modifiers (e.g. Qiagen KRAS 81275-22; here.) 

Foreseeable Problems

Parallel instructions (in the same claims manual) require reporting of drug name with each unlisted code use of a drug.  On the other hand, drugs have fixed precise names, whereas lab tests often do not, although they might have generic names (EGFR sequencing) or in some cases trademarked brand names.
  • Labs may repeatedly update versions of their test (e.g. a tumor gene panel test may be frequently updated, with 30 genes, 31 genes, 32 genes...) so there will be some questions about what CMS intends a "unique" test to be.  
  • In addition, CPT instructions require all additional tests performed, that don't have individual codes, are to be billed with ONE NOC code (or NOC code, unit of 1) so many individual tests may fall under one NOC code on one claim.  CMS seems to recognize that, asking for collection of data on the "test or tests" billed with the NOC code.
    • The MolDX program is sometimes exuberant in its required use of NOC codes even when services could be otherwise described by CPT gene stacking or CPT panel codes. 
  • CMS might use the data to retrospectively enforce whether gene panel tests are correctly coded, e.g. BRCA or Lynch gene panels.


Very Brief Blog: AMA Posts Summary of September 2017 Code Decisions

On schedule, about a month after each CPT meeting, AMA has posted results of the AMA CPT September 2017 editorial panel.   Results are here (8 page PDF).

In overview, of about 58 agenda items, about 17 were withdrawn, 9 rejected, and 2 postponed.  Typically, while a code application may be submitted on a 25-page form by any stakeholder, if the corresponding clinical association does not support the code proposal, it is withdrawn rather than brought to discussion for rejection. 

In diagnostics, one proposal was tabled, one withdrawn, while new codes will be created for TGFB1 (in corneal dystrophy), MYD88 (lymphoma), a breast cancer Cat I MAAA, and a prostate cancer Administrative MAAA.  No non-genomic codes were  up.

Separately, in the Proprietary Lab Analyses coding process (PLA),  23 test codes have been created, about 15 of which have already entered this year's CMS crosswalk pricing process.

The next PLA submissions will be January 12 and April 11.  The next CPT submission is November 9, after that March 1.


Very Brief Blog: Precision Medicine and Big Data (Washington DC, Oct 31-Nov 1)

Interested in the intersection of Big Data and Precision Medicine?  There's a conference for you, to be held in Washington on October 31-November 1.   See full website here:




Very Brief Blog: Health Affairs' Rapid Coverage of Executive Branch Obamacare Changes

Numerous news outlets cover the Executive Branch's changes in Obamacare policy in real time.  However, it can be difficult to find the original sources, such as the actual text of the Executive Orders.  ( recently gave an example in this blog that links to the executive orders, past executive orders, rulemaking, regulation, etc, on the Contraceptive Religious Exemption issue, here.)

For several years, Timothy Jost, emeritus professor at Washington & Lee Law School, has provided rapidly updates on federal health policy at the Health Affairs blog (here).   Lately, his lengthy analyses have been appearing in record time, often less than 24 hours.  He provides links to original documents that are often missing in journalists' articles.
  • Jost's October 12 analysis of the executive order asking for creation of lighter less expensive health plans is here.   (Linking to the actual executive order, here.)
  • Jost's October 13 analysis of the Executive Branch decision to immediately end cost-supporting payments for low income persons in Exchanges is here.
    • The issue has been progressing through federal court ligitation with differing opinions as to whether the cost-supporting payments are properly authorized and appropriated under current law.
    • Jost also links to the current Attorney General opinion that payments should stop, here (J. Sessions, 5p).
    • May 2016 38-page ruling that payments were unauthorized, here (Judge Collyer, DC, 38p).
    • Article on the Collyer ruling, here.
    • The price supports for low income persons apparently tally only $7B a year, a tiny part of our $3T healthcare system or the circa $3T federal budget.
  • Jost's October 14 summary analysis and outlook is here.


Footnote - 

Often lost in the excitement about Executive Orders is that they can differ greatly in their actual content and effect.   For example, if there was an Executive Order to immediately close the border with Mexico to all traffic, due to emergency conditions, that would have a huge immediate effect.  Other policy measures are couched as Executive Orders (with pomp and circumstance) but need not be in that format.  The E.O. regarding lighter health plans, for example, directs the HHS to "consider proposing regulations, or revising guidance" on the topic.  This could be conveyed equally effectively by a press conference remark, internal instructions, an action item delegated at a Cabinet meeting, a paragraph in a speech, or even a tweet.  It gets higher visibility by being couched in the format of an executive order.

Footnote -

As discussed in the citations to Sessions and Collyer above, the ACA issue is that the ACA created tax credits for individuals (S. 1401) and funding for low income persons directly paid to insurers (S. 1402; also called CSR's, cost-sharing reduction), but the ACA provided a clear appropriation of funds only for S. 1401. 

Til now, payments have nonetheless been issued as due under both S. 1401 and S.1402.  In layman's terms, the issue involves what to do when there is an apparent error in law.  On the one hand, we want laws to be enforced as written; on the other hand, we don't want national processes to grind to a halt every time there is a typo.  (Sessions directly discusses the Supreme Court decision in King in this regard; link above).  Alternatively, the law could be correct as written; S.1402 could be quite deliberately dependent on annual appropriations from the House -- appropriations which the House isn't making.  (Another topic in the court action is whether the House had standing to sue the executive branch in this way.)

With a Republican House not wanting to make the fiscal appropriation and a Republican President not wanting to make the payment, and a Federal Court injunction that the payments shouldn't be made, the outcome this week was pretty foreseeable.

Thursday, October 12, 2017

Legislation and Medicare LCD's: From 21CC to New Legislative Proposals

In brief:
  • The 21st Century Cures Law, signed in December 2016, put into law some legal obligations for clarity in LCDs, many of which were already being practiced.    LCDs must be posted in advance, follow comment periods, post responses to comments, provide rationales, and provide links to the draft LCD along with the final LCD.   Final LCDs must be posted for an interval before they are effective.   
  • College of American Pathologists and others are supporting a new proposed law, the LCD Clarification Act,  which overlaps some with topics in 21CC, but also expands requirements for LCD clarity and process, including open CAC meetings and more eyes on the reconsideration process, along with definitions of "evidence" that includes consensus opinion.

21st Century Cures and LCDs

The 21CC (HR 34) became law on December 13, 2016.  The full text is here.  Section 4009 is titled, "Improving Local Coverage Determinations."    It's only 197 words long (LCD full text here).    It's codified at SSA 1862(1)(5) [el 5].

CMS must require that before an LCD is finally effective, the MAC must post the LCD in advance in its entirety, along with a copy of its original LCD proposal and date, links to that proposed LCD and to public comments and response to comments, provide a "summary of the evidence considered" and "a rationale for the determination."   These requirements became effective in July 2017 for all LCDs that are either "proposed or revised."   

Analysis.  MACs already posted LCDs in advance, and there was already a 45 day public notification period before a final LCD becomes effective.  MACs already cited literature and rationale in the LCDs (per CMS manual instructions), and for at least a couple years a Q&A on public comments has been posted.    I've heard a MAC medical director refer to 21CC as a big change they were still figuring out, but it seems to require very little.   Before this, rationales could have been scanty or confusing, and I suspect that under 21CC a "rationale" can still be scanty and confusing.   The legislation does seem to target LCDs that simply provide laundry lists of non-covered services with no rationale or literature cited.    The current LCD instruction manual is online here, and as of October 2017, hadn't been revised to account for 21CC yet.  21CC Section 4009 is already codified at SSA 1862(l) where it adds to the existing section defining NCDs and LCDs (here).


  • A newly issued LCD by the NGS MAC (NY, New England, and several midwestern states) is 21CC-compliant and shows that the contractor takes the "evaluation of the evidence" and "rationale" mandate seriously and diligently.   I've put a PDF copy in the cloud here and a web cut/paste here.  Scroll down the LCD to see the detailed article-by-article evaluation and analysis.


The Local Coverage Determination Clarification Act of 2017

The LCD Clarification Act was announced in a press release in March 2017 (here).   Senate sponsors include Isakson (R-GA), Carper (D-DE), Stabenow (D-MI), and Boozman (R-AR).   The College  of American Pathologists (CAP) describes "the LCD process [as] broken" and "lacks transparency, accountability, and stakeholder input."

CAP Infographic.   CAP has an elaborate PDF Infographic on the law which calls out for criticism a Palmetto LCD on special stains (here).

Under the proposed law,
  • MAC Contractor Advisory Meetings must be open to the public and on the record.
  • MACs must provide evidence relied on, in the proposed LCD.  If facts are withheld til the final LCD, it would impair the ability of the public to comment.
  • LCDs must be reviewable by a "qualified disinterested party."   
  • Carbon copy adoption of LCDs from MAC to MAC overrides the ability of stakeholders to have meaningful and independent comments and creates "de facto NCDs."
  • Supporters are cited as CAP, ASCO, American Society of Radiation Oncology, and others.
As of October 2017, the bill is tracked as S. 794 and as H.R. 3635.  Text also archived here.   As of October 2017, there were 10 current Senate sponsors and 12 current House sponsors.  The bills are about 2300 words long.  Tidbit: Although introduced later (8/2017), the HR3635 bill includes dated "carrier, fiscal intermediary" language whereas the S794 bill is for MACs.  

Analysis.   The LCDCA defines "qualifying evidence" as including both peer reviewed scientific publications AND a general consensus of the applicable medical community.[*]   While MACs are requirered to "reconsider" LCDs now, the law provides a more detailed process and provides guardrails such as "Agency Evaluation of a Reconsideration Decision" and creation of a CMS "Ombudsman" for LCD issues.   Currently, CMS coverage staff will often state they do not have authority to evaluate an LCD or a reconsideration decision (other than creating a new and over-riding NCD.)   

CAP infographic (in part):

click to enlarge
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[*] For a 2015 book on the development of consensus bodies and guidelines, see Miriam Solomon, "Making Medical Knowledge," Oxford.




Monday, October 9, 2017

Very Brief Blog: The 122-page Transition Overview of HHS from November 2016

The outgoing administration's November 2016 overview of HHS - weighing in at 122 pages - is still online at HHS.

  • Online at HHS here; cloud archive also here.

It's a handy overview of the whole department, from the roster of presidential appointees (Surgeon General, Head of NIH) to the healthcare spending and the "discretionary" spending (e.g. NIH, FDA).


HHS expected to have 76,342 employees in 2017.  An Org Chart of HHS is here.  Dr. Don Wright was the Acting Secretary briefly in early October; replaced by Eric Hargan on October 10 (here). Jeffrey Davis is Acting General Counsel, hereRandy Pate heads CCIIO, which oversees many aspects of the Exchanges.


Tidbit
The current surgeon general, Vice Admiral Jerome Adams, took office on September 5, 2017 (here).

Very Brief Blog: JAMA Publishes Favorable RCT on Warfarin Genetics

In a multi-center study involving Washington University, Intermountain, New York Presbyterian, and other centers, the GIFT trial, genotype-guided warfarin dosing was found to have clinical benefits.

GIFT randomized over 1600 patients undergoing either hip or knee arthroplasty.  Composite adverse events fell from 15% to 11%. 

Studying the value of genetic guidance in RCTs is problematic, because hospital based RCTs always insure that standard of care is optimally applied in the non-genetic arm.  Genetic dose guidance might have more impact in the real world where standard of care is less monitored and controlled in typical patients.  Some prior RCTs have been inconsistent; for one entry point, here.

The study by Gage et al. is online here; see also an Op Ed by Emery, here.  Open access coverage at Genomeweb, here.

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For a 2013 review at Genomeweb [subscription], here.

CHRONIC CARE Act (S.870) And Flexible Digital Benefits in Medicare Advantage

The CHRONIC Care Act (S.870) is a major piece of Medicare legislation that has now passed the Senate.   It passed the Senate Finance Committee last spring, and has a budget-neutral score from the Congressional Budget Office.   It provides improved benefits in traditional Medicare for home-based chronic care management and telemedicine, and provides pathways for broader elective benefits for Medicare Advantage plans.

CHRONIC raises a larger issue, though. 

Financially, Medicare Advantage plans and services are divided in two for budget and contracting.  There is one set of financing rules for benefits that match Traditional Medicare parts A&B; and a separate set of rules that provide\ carved-out "enhanced benefits" such as dental or vision.   The fact that individual pieces of "one-off" legislation are required to allow M.A. plans to provide telemedicine benefits points to a cumbersome problem that reflects an outdated framework.

Here, I argue that M.A. plans should be able to provide additional benefits such as digital health delivery within their regular M.A. funding without interference from CongressM.A. plans would continue to be required to provide all the Part A, Part B benefits of traditional Medicare and of course, to meet all M.A. quality metrics.

The CHRONIC Care Ac of 2017

For an up-to-date summary by Billy Wynne at Health Affairs, see his October 5, 2017 post here.  See a June 2017 article by former senators Daschle and Frist here, and a deep dive analysis by the Bipartisan Policy Committee, here.  The budget neutral CBO analysis is here, and the full bill can be found here.

Medicare's Excessive Controls on Telemedicine Delay Innovation - By Handcuffing the Payment System

Medicare has a number of delivery methods that are designed to enhance innovation, such as Accountable Care Organizations and Medicare Advantage.  However, telemedicine can't improve quality and reduce costs in these systems unless the law makes it feasible.

  • For example, ACO's get small rebates from CMS for saving costs.  
  • If the ACO can save Medicare $10 and get a $3 bonus by converting a $100 office visit to a $90 telemedicine visit, the ACO loses a ton of money if it gets no reimbursement at all for the $90 telemedicine visit.  Similarly for Medicare Advantage. 
Section 303 of the CHRONIC Care Act Will Allow Telemedicine in M.A. Base Bids

Section 303 of CHRONIC would be effective in Plan Year 2020, and would allow M.A. plans to include the costs of telemedicine in their base budget, which is funded in a risk-adjusted and capitated way, pegged at a level similar to the regional costs of traditional Part A, Part B. 

Under Section 303, base bids will be able to include "additional telehealth benefits" which would be outside the telehealth benefits in traditional Medicare as enumerated at SSA 1834(m), that is, outside an A/B benefit.  At Section 303, additional telehealth benefits are defined as "clinically appropriate [services furnished by] electronic information and telecommunications technology when a physician or practitioner is not at the same location as the enrollee."   Further definition would be undertaken through notice and comment regulation. 

Analysis

Medicare Advantage plans were set up with concerns that providing capitated payments to health plans would incentivize the short-changing of medical services to raise the profitability of the M.A. plan.

Therefore, M.A. plans are required to provide all available Part A and Part B services to Medicare patients.  Budgets are closely monitored (including loss ratios) and plans aren't allowed to keep profits by restricting services.  Rather, unspent money is given back to Medicare or distributed as "extra benefits" to members (such as dental or vision benefits) or distributed as lower copays.   The mechanisms to control and budget the base spending (the A and B equivalent spending) and to control any excess profits and define "extra benefits" are a lot of red tape. 

When the issue is ensuring that M.A. patients get "enough" healthcare, the rules make sense.

When health systems and plans can innovate better ways to deliver similar or higher quality care, regardless of convoluted A/B rules, the system doesn't make sense.   Medicare Advantage plans should be able to deliver care through the best and most modern available channels.   Today, where Part B carve-outs and carve-ins and extra benefits are onerously defined by bits of legislation and by extra layers of contracting, innovation is impeded.   For example, the CHRONIC Care Act is a big step forward, but it defines telemedicine as practitioner-based, when it should include other kinds of benefits like preventive medicine and behavioral medicine (for example, diabetes and cardiac prevention programs.)   If a health plan has, say, $100M for physician visits, it should be able to flexibly adapt between telemedicine and in person visits depending on the location, patient mix, clinical circumstances, etc.   No government purpose is served by making the combinations as difficult and over-regulated as possible.   CHRONIC Section 303 is a step in the right direction, but M.A. plans should be given more freedom, within their fixed budgets and existing quality rules.  Section 303 is scored by the highly conservative Congressional Budget Office to save $80M - we should let M.A. plans save money through new technologies whenever they want. 

Legacy Rules Depended on Legacy Bookkeeping

Whatever the intention of the original rules, they depended on legacy fee-for-service bookkeeping, which is increasingly out of step with modern bundled and capitated payments. It may be increasingly impossible to enforce the rules under modern health systems medicine.
Let's say an M.A. plan in San Diego gets $10,000 from CMS per patient.  It passes on $3000 per patient to San Diego Physicians Associates to manage office and outpatient care.    
San Diego Physicians Associates seamlessly provides a range of telemedicine, concierge-like, and preventive services for its $3000 per year per patient capitation.   But these aren't called out separately in its contract with the M.A. plan.  
Thus, it's impossible for the M.A. plan to try and allocate costs among covered and "non covered" telemed and preventive services, because they're capitated somewhere downstream in a modern risk-sharing and bundled system.  
CMS Could Still Track to A/B Finances, But With Less Red Tape and Legal Paperwork

To the extent necessary (and possible)... CMS could still track benefits that fall outside of traditional Part A and B, but this could be kept to the financial reporting level and not the contracting level.  And after M.A. plans provide all A/B services, just like to day when they want extra money that is above their capitation it would require extra contracting.  Just like today.

But let's modernize.  When M.A. plans can provide some selective, cost-saving services within their capitated budget, then they would be free to do so, without additional contracting. 

____

Several blogs appeared in Health Affairs a few days after this October 9 essay and touch on related themes.  On October 17, John O'Shea of Heritage Foundation argues for more flexibility in Medicare Advantage, which will help achieve the goals MACRA is lumbering towards (here).    On October 12, Huilgol et al. make yet another plea for more flexibility in telemedicine benefits, including in urban areas (here).  On October 17, Chernew and Barbey argue we need a better framework for "understanding savings" in value based environments like ACOs (here).

Very Brief Blog: Q3 Digital Health Investment Reports; MEDPAC disses MIPS

Several reports on the digital health industry and investment climate appeared around October 1, along with trade press.

Rock Health Digital Health Report

San Francisco-based Rock Health released its quarterly report for Q3, tallying Q3 funding for digital health at $1.2B, with an annual total of $4.7B, which will push beyond the CY2015 peak of $4.6B in a year.   On the other hand, there were no IPOs logged.   Rock Health defines digital health broadly, for example, including $100M in new funding for 23andMe.

  • Rock Health here.
    • Trade press at Becker's here.   
    • At HIT Consultant, here.  
    • At Healthcare Dive, here.  
    • Another article, "Is Digital health industry failing or flourishing?" here.
    • The online summary is pretty extensive; the full report is $1499.
  • Separately, the Digital Health Maven Project also issues a Q3 report.  Download this 18 page report with free registration, here.
Ernst & Young Releases 94-page Annual Medtech Report

Colncident with the fall AdvaMed conference, Ernst & Young released its 2017 annual report on the Medtech industry, here.


More Hate Mail for MIPS and MACRA

Related to digital health are the digital physician metrics and EHR metrics wired into the MIPS quality reporting systems at Medicare, created inside the 2015 MACRA law.   Last week, the influential MedPAC panel joined the voices of many physician organizations in asking that the cumbersome and overly complex MIPS system be scrapped (here, here; CMS website [one of many] here.)    While MIPS is largely structured by recent statute, ending it would fit the administration's goals of reducing burdensome regulation.

MedPAC's fall meeting echoes themes on MIPS in its June 2017 report (here).  

Sunday, October 8, 2017

Very Brief Blog: Transcript of Sept 25 CMS Lab Crosswalk Extra Meeting

Because many people follow this blog by a web news feed, this is notice that I have newly posted a transcript of the September 25, 2017 "extra" CMS laboratory policy meeting on crosswalk-gapfill issues related to PAMA.   The public meeting was held by CMS as a webinar.

On September 25, 2017, CMS held a webinar-based advisory workshop and public comment session on its proposed crosswalks for codes that lacked data in the regular PAMA data capture process.

Unofficial Uncorrected Transcript, 
based on CMS Youtube video archive, 
posted in the cloud HERE.

For more background on the September 25 meeting, see original post here, which also now includes a transcript cloud link. 

Friday, October 6, 2017

Guide to Resources on New Religious Objection/Contraceptive Coverage Policy

On October 6, 2017, the Administration released two interim final rulemaking documents that codify HHS's waivers of the contraceptive coverage requirement of the ACA for religious or moral objectors.  The path to the different documents are usually not cited in press articles, and are provided here.  The regulations published include one document on religious exemptions and a separate, standalone document on moral exemptions; they total 263 pages.
  • Coverage at MedPage Today, here.  A deep dive 7000-word analysis at Health Affairs by Timothy Jost, here.  A follow up article on legal challenges, here.
  • White House Press Release October 6, here.
    • Link back to May 2016 Executive Order, asking HHS to undertaking rulemaking on the issue, here. [*]
      • The HHS responded with rulemaking over 150 days at 1.7 pages per day.  
      • 2.4 pages per day if working M-F.
  • The relevant law as written in the 2010 ACA itself (42 USC 300gg-13), here.
  • Note there are two new rules, one "Moral" and one "Religious."
    • New interim rulemaking, Moral Exemptions and Accommodations for Coverage of Preventive Services, here.   PDF here.  100 pp [!]
    • New interim rulemaking, Religious Exemptions and Accommodations, here.  PDF here.  163 pp [!]
    • Although there are the two documents, on page 82, the Moral document states: "We assume that no entities with non-religious moral objections...will  use the accommodation."  So an entity may have a moral objection to contraception that is religious in its basis, but is not expected to have a moral objection that has no religious basis.  The entity itself does not have to be a "religious" entity as long as its objection is religious in basis.   2013 proposed rulemaking was to apply only to religious organizations and entities (see e.g. page 17.)
    • The law cites precedent in other laws, e.g. individuals are protected from being forced to participate in abortions by their employer.  
      • The two documents are so long because they read like 150-page law review articles.  One footnote reaches 600 words.
    • The text of the actual regulations is clipped here (5475 words).
  • The statute (300gg-13 above) only states that the required preventive benefits for women shall be those that are created and endorsed by the Health Resources and Services Administration, HRSA.  
    • Those were created and published by HRSA in 2011, here.  They were finalized (and can be revised by HRSA) after public meetings in 2010/2011.   
    • They were updated in December 2016 (e.g. before the current administration), here.  
    • These guidelines appeared to already have footnoted exceptions for religious organizations.  
    • See also regulations at 45 CFR 147.130.  Prior to the current rulemaking, these were most recently dealt with in 2015 in rulemaking (80 FR 41317, here.)
  • Separately, The Center for Consumer Information and Insurance Oversight (CCIIO) released a new bulletin regarding of enforcement of non-coverage of voluntary abortions by federal insurance.   Health plans offering such coverage must clearly segregate it, in plan documents, and make ultra-clear it is financed separately.  The CCIIO document is here and the Health Affairs deep dive blog is here.
    • The goal is to ensure that these Hyde Amendment concepts are rigorously enforced.
_____

Intersection of Separately Describe Preventive and Drug Formulary Benefits?
The new regulations focus entirely on the special women's preventative health benefit, and allowing exemption from its requirement to cover contraceptives as a preventive (no copay) benefit.  Oral contraceptives are also drugs, and might also be regulated by the separate area of legislation that describes ACA drug formularies, which may have copays, but under which drugs must be covered at the greater of (1) one drug in every USP category and class, or (2) the same coverage as the drugs in that state's essential health benefits benchmark plan.  See e.g. Ung et al. 2015 (here).

Word Counts
In the Moral exception document, the word sincere appears 55 times; and 47 times in the Religious exception document.  The word religious appears 222 times in the Moral exceptions document and 305 times in the Religious exceptions document.

[*]  The May 2017 Executive Order was written in such a way as to allow HHS to create exemptions from coverage of all types of women's health benefits, not just contraception.  I did not identify a reference or crosswalk to the Formulary or Essential Health Benefits in the two new regulations. 

Wednesday, October 4, 2017

Brief Blog: OIG Issues Report on CY2016 CLFS Spending at Medicare

PAMA law requires the OIG to issue updates on payments for Medicare's top 25 lab tests, as well as reports on CMS's progress in implementing PAMA itself by creating new fee schedules.

I covered previous editions of these reports in a September 12, 2017 blog, here.

Around October 1, 2017, OIG issued its third annual update on spending on the CLFS, focusing on the top 25 tests, updated with CY2016 data - here.   The 10 page PDF shows that the OIG has already had access to 2016 data. 
  • In November 2017, the public will be able to see CY2016 Part B data for all CPT codes at the nationwide and the state-level.  
  • In about June 2018, the public will be able to see CY2016 Part B data right down to the individual provider & CPT code level.  
    • For details, here.  
In CY2016, CLFS payments were $6.8B, or about 2% of Medicare Part B payments.   This $6.8B is a bit less than the $7.0B logged in CY2015 and CY2014.  There were 473M test payments under 1,173 CPT codes.

While, of 58,593 labs, the average payment was $115,546, half of labs received less than $1,055.  Hospital labs were 26% of Part B payments and physician office labs were 18%.   1% of labs garnered 54% of payments.

The top 6 lab tests were $2.4B (out of $6.8B); the top 25 were $4.3B.   The highest-paid test was again TSH (84443, $22.89 per test, $482M total).  Two genomic tests made the top 25, being Cologuard at $62M, and Oncotype Dx at $60M.   They state there was a 2015-2016 drop in molecular pathology testing e.g. germline genetic tests (which they class differently from MAAA tests), from $260M to $165M.   We'll know more about which codes were involved when CMS released CY2016 for public view in November 2017.



Tuesday, October 3, 2017

Very Brief Blog: CMS Innovation Center Official Kills Part B Drug Demo; HHS Offers Public Its 4-Year Strategy

CMS has officially and finally withdrawn the "Part B Drug Demo" proposed in spring 2016 under the Obama administration.  Demonstrating the breadth and power of CMMI's authority to conduct demonstrations, the demo would have been national in scope, extended for years into the future, and substantially changed drug payment rules which are otherwise set by statute.   The withdrawal is online at Federal Register here; here article at Axios, here.  It's an official withdrawal after the review of 1350 public comments.  The withdrawal was signed by Tom Price on August 25.

CMS is currently seeking comments on ways it can renovate and redirect the Innovation Center; see here.

Separately, HHS has published a 65-page PDF on its four-year plan, 2018-2022, which is required by the 1993 Government Performance and Results Act (GPRA).  The website is here.  Coverage at Politico noticed the upshoot in references to unborn life and to religiously affiliated organizations.  I read it this way: wherever the phrase "community organizations" would appear, it's been written as "^faith-based and other  community organizations."  OK.   The 2014-2018 prior HHS plan is still archived online, here.  Most of these plans don't have much firm content.  There are five strategic priorities, each of which has about five sub priorities that each have several bullet points.  (It's bullet point nirvana.)  For example, there is a bullet point that HHS has a goal to control inflation of health insurance including both insurance costs and out of pocket payments.  It's a clearly stated goal; but that's the whole thing, the goal, don't seek an explanation of the means or the plan.   Comment is open til October 23.

Human Rights Campaign also noted that the plan deleted references to LGBT issues (here).  As of October 2017, however, the HHS website did have a general LDBT health and wellness section (here; cloud archive here.)

___

For an online copy of the 122-page HHS transition plan from the Obama to the Trump administrations, dated November 2016, online at HHS here; cloud copy here.





Friday, September 29, 2017

Very Brief Blog: Article on Growth of Reproductive Health Genetic Testing

A large area of germline genetics is in reproductive health testing.  Invitae recently acquired Good Start Genetics; independent Counsyl is one of the leading labs in this space.

In MedCity News, Christopher Leo (of Back Bay Life Science Advisors) provides an update on this business space.   Here.

One smaller company, not mentioned by Lee, is Genepeeks, which has an interesting advanced digital genomics approach to this space.

Thursday, September 28, 2017

Very Brief Blog: CMS Requests Nominations to Fill Seats on Lab Advisory Expert Panel

CMS has published an announcement that it is seeking new nominations for membership to its Advisory Panel on Clinical Diagnostic Laboratory Tests.   The online announcement is here.

The CMS home page for the panel is here.  The panel was recently renewed for the 2017-2019 period.   The panel is chartered to have "up to 15" individuals; the recent summer workshop had 9 one day and 10 the next.   "Nominees must demonstrate personal experience with clinical diagnostic laboratory tests and services through a past or present history of direct employment with an organization that furnishes clinical diagnostic laboratory tests." 

CMS does not state how many seats are vacant, only that nominations are accepted on a rolling basis and seats will be filled "as vacancies occur on the panel" in order to "assure that we have a full complement of members for each panel meeting."  Association-based or self-nomination is possible.


Tuesday, September 26, 2017

Scott Gottlieb Proposes That LDTs Need New Legislation to Regulate Them

As reported by MedCityNews, at the annual AdvaMed conference, FDA commissioner Scott Gottlieb stated that it was time for Hill action on how LDTs are going to be regulated.    Full article here.

Sound bite clipped below:
At the annual conference hosted by AdvaMed, the largest devices and diagnostics lobby on Tuesday in San Jose, Scott Gottlieb declared his intent to have Congress legislate how LDT’s operate.
“I will tell you where I am right now is that I believe having been around this issue and having tried to grapple with it …we are at a point where we need some kind of legislation,” Gottlieb told the audience. “I think there’s a better consensus among the various camps around this issue that we could potentially get legislative consensus and I think that the time is right to do that. I will fully admit that I am working very hard toward that goal.”
He added that he has been and will continue to talk to folks on Capitol Hill.  “My view is that it would be a missed opportunity not to do it,” he said......

The "Official Prepared Remarks" are briefer on this topic and are posted at FDA (here).  The remarks focused on FDA's approach to digital health, and that a novel "pre-certification" process was under active development for digital health software.  Then, in the prepared remarks, Gottlieb was to remark that a similar "precertification" approach would be a good basis for a "the framework for a modern legislative approach" to LDTs.   

CMS Posts Web Video of Sept 25 Special Webinar on New Crosswalks for Missing PAMA Data

On September 25, 2017, CMS held a webinar-based advisory workshop and public comment session on its proposed crosswalks for codes that lacked data in the regular PAMA data capture process.

UPDATE:
Unofficial Uncorrected Transcript, posted in the cloud HERE.


For background on the special workshop, see here.

At Youtube:
  • The morning session is here.
  • The afternoon session is here.
Indirectly related to the above webinar, on September 22, CMS posted its preliminary gapfill/crosswalk recommendations for new codes that will be active in CY2018...here.   CMS also released PAMA pricing data for the thousand-plus codes for which PAMA data is available; it's the generally rare or even obsolete codes that didn't have PAMA data that are in the webinar and workshop above.



My personal running notes, typed during the meeting, uncorrected, are provided in the cloud, here.


Saturday, September 23, 2017

PAMA Raw Data Provides Unprecedented Instant View of US Lab Industry - For Free

On September 22, 2017, CMS released PAMA median pricing data that will be used to reset Medicare's national fee schedule for lab tests - both conventional tests and genomics.  (Here).

CMS also provides ALL the raw data in an open access web interface that allows filtering and data pulls.   The data website is here.  
(This is the same data I have reported on and used for physician and lab Medicare Part B claims, e.g. here.  I have some instructions for using the Part B data set, here; the PAMA dataset is nearly the same so the Part B instructions will help understand the PAMA web interface.) 
Between Medicare 2015 Part B claims data on line, and the new PAMA data for 1H2016, anyone can have an unprecedented view of the US lab industry - for free.   

Imputing National Volume Data from CMS Part B Public Data and New PAMA Public Data

For example, we already knew that in CY2015 data from CMS, there were about 19,000 uses of BRCA full sequencing under code 81211 (here).

I made a simple data dump of the new 1H2016 PAMA private payer data for BRCA and stored in the cloud here.  It shows 94,977 uses of 81211 paid by private payers.   (Remember, that's for 1H2016, a half year).  

This suggests that if we add CMS Part B 2015 data (19,000 uses) and we "double" the PAMA 1H2016 data to account for a full year (190,000 uses), there are about 219,000 uses of BRCA sequencing 81211 per year, and Medicare cases are about 10% of the annual total of BRCA sequencing cases.

Wild West of Price Ranges

You also see bizarre stuff.  For example, the table reports 22 payments for BRCA sequencing 81211 at $44,207.   And 27 payments at $30,969.   And 28 payments at $17,612.  But PAMA data also shows dozens of paid claims for 81211 trickling in at the triple digits ($150, $149, $145).



The density distribution of BRCA 81211 price points is non-normal (non-Guassian):


Sole-Source Labs

You don't see this detailed price distribution data for sole-source labs.  For example, if you filter the raw data for 81519, Oncotype DX Breast, you don't get any of the raw data - neither volumes nor prices.  

Nonetheless, in the PAMA zip file of data, CMS does provide summary statistics such as 25th percentile and 75th percentile for all tests, including sole source proprietary tests.  

For Oncotype DX 81519, this file shows a 2017 current Medicare price of $3443, with PAMA new weighted median of $3873, and a 25th/75th percentile range of ($3713, $4153), which is pretty tight.  However, CMS also tells us the minimum reported payment for 81519 was $1 and the maximum was $38,632 (click to enlarge):



Wild World of Clinical Chemistry Price Ranges

The spread and strangeness isn't limited to genetics.  I checked a routine clinical chemistry code, 86003 (blood-based IgE allergy testing) and while the PAMA price will eventually fall to around $4.50 from the current around $7, there were dozens of PAMA reported payments exceeding $500 per test, and even exceeding $1000.  

Did a Few Labs Report Total Revenue and Number of Tests, Rather Than Per-Test Price?

Possibly, some labs misread the instructions and reported total revenue and number of tests, rather than price and number of tests.  For example, a lab might have gotten paid for 10 tests at $10 and reported "10 tests, $100" to CMS.   This could have happened:


But in other cases, like for G0483 testing (drug test panel), there are many cases where only N=1 test is reported at astronomical pricing like $5,000:


Also, I noted in other analyses that some codes (like CYP testing and drug tox testing) seemed more prone to super-high prices while others (like cystic fibrosis testing) did not.   Drug screen 80303 had a median price of $623 but a 75th percentile price of $5812 and an average price of $2687, suggesting a highly skewed distribution of pricing.

In addition, I've been told that $10,000 and $20,000 and higher bills for lab tests do occur, so they don't have to be explained by mis-numbered multiples.

Very high payment tests, though a minority of all tests, could drive industry profitability (here).

Sifting the Large Data

Going back to the original CMS data website, in a few minutes I produced a table online of all CLFS codes, rolled up by HCPCS code (so the 5M lines become 1300 lines), then rolled up by Volume/Sum for each line and Price/Average for each line.  I exported this as a CSV file and quickly saved as an Excel workbook file.  I then multiplied volume x price to create a new column of "dollar volume."  I think doubled the utilization and payment columns to impute a full-year volume.   This summed up to $20B, which is about one-third of the US lab industry if you assume the latter is 2% of our $3% healthcare system.[*]    Is this perfect data?  No.  Is it fast?  Yes - what I just described took a minute or two.   The online sort and window function looked like this:


A data view of the Excel (262 kb) that I just described looks like this:




For example, the top ten codes add up to 41% of the $20B annual dollar volume in the data.  (Note, this is illustrative only; I think the online rollup function calculated an average price based on the number of prices, aka data lines of price, reported, not a weighted average price, so the totals and muliplications aren't exact.)  the point is you can get first-cut answers in seconds out of 5M lines of data.

The spreadsheet is in the cloud here.


Friday, September 22, 2017

Sept 22, 2017: CMS ISSUES PROPOSED PAMA RATES FOR 2018 AND PROPOSED NEW CODE RATES FOR 2018

On Friday, September 22, 2017, after market close, CMS issued PAMA data (covering the whole lab fee schedule) and also issued its proposed rates for new CY2018 codes.  The data is voluminous and this opens a public comment period through October 23, 2017.
  • CROSSWALK NEW CODE PRICING PROPOSALS
  • The home page for the Clin Lab Fee Schedule New Code Crosswalk/Gapfill process is here.
    • The PROPOSED CROSSWALK PRICES OF NEW CODES are here - a 51 page PDF.
      • I've posted a "rough" table of all crosswalks in Excel in the cloud, here.
    • Note that from page 32 forward, this PDF includes pricing for codes that received no (or "too little") PAMA data.  
      • For example, Genome 81425 is proposed is proposed to be priced on a crosswalk from "5-50 tumor genes" (81445, about $600) which sounds too low and is much lower than the PAMA price of Exome 81415 (see below).
    • There are many strange things in the crosswalk recommendations.  
      • For one example, nearly all stakeholders recommended crosswalking the new Mammaprint code 81521 to the Oncotype DX code 81519, but CMS chooses a crosswalk to Cologuard (about $500) because CMS states that it sees the Cologuard test as "more similar" to Mammaprint than Oncotype is.  
      • The gapfill process virtually disappeared.  (It shows up on one code, 0001U).
      • The Myriad Prolaris test 81541 received a proposed crosswalk to the Cologuard price (81528, about $500).  
        • However, that is only a proposed price and in the past CMS proposed low prices for MAAA tests then backed off to more reasonable crosswalks or to gapfills.  In addition, while Prolaris is an important future product, it is currently a negligible amount of total Myriad sales.
    • Several experts I surveyed all agreed that new crosswalks will FLOAT up or down based on the behavior of the target code under PAMA.  
      • For example, if NEWCODE 80001 is crosswalked to OLDCODE 80002, and OLDCODE will fall from $5 to $2 in steps of $4, $3, $2 over the next 3 years, then so will NEWCODE.

  • PAMA DATA FOR THE WHOLE FEE SCHEDULE

  • The home page for PAMA lab test pricing is here.
    • The PROPOSED NEW PAMA PRICES of the CLFS are in a zip file here.
    • I've posted a cloud version of the main Excel price table, here
      • I've highlighted large drops in red, large increases in green.  In addition, this version gives summary descriptors for each CPT code.
      • Tab 1 is fee schedule data x 3 years.   Tab 2 is analytics - mean, 25th and 75th percentile, etc.   Tab 3 is summary data where < 10 entities reported; these codes have only summary data and no data in the "raw data" online database (see immediately below).
    • CMS also provides the raw data via an open access, downloadable, and sortable data website, here.
      • Read about the incredible insights available in the raw data, here.
        • The raw data file has about 5M data lines.
        • This is the same type of raw data website used for annual Part B provider data (here).   
      • For example, there were several dozen payments for BRCA sequencing 81211 that exceed $15,000, here.  And dozens of payments for BRCA 81211 that were under $200.
      • Codes that had a small amount of data (<10 labs reporting) are not found in the raw data file.  
        • However, even for those codes, or sole-source codes, CMS does provide total usage and 25th and 75th percentile information in the zip file noted prior.
    • CMS gives us an 11-page summary discussion of the PAMA process, here.
      • For example, CMS ran sensitivity analyses if more hospitals had reported, etc.  CMS also discusses the total number of labs reporting by type (independent, physician office, etc.)
    • Press Releases and Trade Press.
      • ACLA rapidly issued a press release about its severe concerns, here.
        • An additional ACLA press release and study on the economic output o the lab industry, here.  Article on nursing home labs, here.
      • Coverage at Genomeweb, here.
        • Follow up coverage on industry impacts from Genomeweb, here.
      • Press release from Labcorp here.  (Labcorp share price slipped from $155 to $150.)  From Xifin, here.  From Quest, here.
      • The Coalition for 21st Century Medicine issued a press release commending CMS for releasing PAMA data and urged CMS to release detailed data for applications for ADLTs soon, here.

Early Comments - Genomic Codes
  • The price for Cologuard 83528 was essentially unchanged ($512 changing to $508).
  • The price of 5-50 tumor genes (81445) was essentially unchanged ($602 changing to $598).
  • The price of 50+ tumor genes (81455) was previously unpriced at CMS, but now has a new price of $2919.
  • The price of BRCA testing under legacy codes 81211, 81213 went up a little (from $2195 to $2395 for the first, +200, from $586 to $553 for the second, -33).
    • However, the price for consolidated BRCA testing in one code (81162) went down from $2503 to $1616.
    • The testing of a known BRCA familial variant rose from $93 to $375 (81215 or 81217).
  • Cystic fibrosis codes were never priced by Medicare.  They get pricing under PAMA.   81220 is CF gene, common variants, $557; 81221 is familial variant, $97; 81222 is DupDel variants, $435, and 81224 is intron analysis for infertility, $169.  In a strange rank-order anomaly, CF full sequencing 81223 is cheaper $499 than is common variants 81240 $557.
    • 81220 had 142,145 uses (in 6 months); 81223 had 13,000 uses (in 6 months). While the median and new CLFS price of 81220 is $577, there were 3,161 cases of 81220 paid over $3000. 
  • CYP variants at 81225, 81226, 81227 did not change much at all under PAMA: respectively being [$293, 291], [$454, $450], and [$176, $174].   Total cases in six months for 81225 were 33,354 cases.
    • But again, the raw data is interesting.  While the median price of CYP2C19 was just $291, there were 583 cases paid over $5000, and 164 cases paid at $46,827.
    • Put another way, someone could have bought 583 tests at the median price of $291 for $169,653, and billed them back to insurers at recorded actual top transaction prices for 583 tests, reaping $17,832,755.   
      • That's a multiple of 100X - pharma price-gouging territory.
      • For comparison, that transaction on 583 tests could in a day reap half as much as the annual revenue of the CareDx company, which has a market cap of $92M.
      • We noted that the highest private payer prices on cystic fibrosis germline testing were about 8X the median, whereas the highest private payer prices on CYP testing rose to 100X the median.
    • In new crosswalk, rather than PAMA data, three new CYP codes for 2018 are all proposed as crosswalks to the cheapest of the three current CYP code (81227, $174).
      • The new 2018 pharmacogenetic codes are 81230 CYP3A4, 81231 CYP3A5, and 81232 DPYD for 5FU metabolism.
  • Genomic Sequencing Procedure (GSP) Codes:
  • Some unbelievable prices appear in the Genomic Sequencing Procedures or GSP codes.  
    • I've put an informal table of all GSP codes, old price points (if available), and new PAMA prices or newly proposed crosswalk prices in the cloud here or in a web table here.
      • See Paired Bar Chart at bottom of blog for 2017 and PAMA GSP prices.
    • 81432 Hereditary Breast Cancel Panel (which includes BRCA1, BRCA2, and a dozen more genes) went down from $932 to $136.   The sister code for Dup Del analysis, 81433, went from $602 to $425.
      • If you go to the raw data website, and search for 81432, there is no data.  This may mean that no lab reported more than 10 cases (?).
      • The AMA definition of 81432 in 2017 required 14 genes, but beginning in 2018, the AMA definition of 81432 includes is easier to reach, requiring only 10 genes.
    • Incredibly, the code for Lynch Syndrome 81435, went from $802 to $38 (and its dup del code 81436, from $802 to $574). For 81435, again, the raw-data website has no data although Lynch syndrome panel testing is a very common service.
      • Hint:  The GSP panel codes were not very popular and gene by gene stack coding was more commonly used.  
    • BRCA codes for BRCA-1-only and BRCA-2-only also dropped through the floor.
      • While BRCA 1-2 sequencing plus common dup-del rose from $2195 to $2395 under PAMA, the pricing for BRCA-1sequencing  and common dup-del alone (81214) fell to a PAMA price of $74.95 and BRCA-2 sequencing alone (81216) fell to $185.12.  These add to $260.07, drastically less than the their rollup into 81211 $2395.  On the other hand, full sequencing plus dup del (81211+81213) rolled up as one code 81162 falls to $1615.
      • Another way of saying this is that full sequencing of BRCA1-2, common dup del, and uncommon dup del, could be equally billed as:
      • 81211+81213 = $2395+$553 = $2948
      • 81162 = $1615.
      • 81214+81216+81213 = $75+$185+553 = $813.
      • Note that 81162, the simplest code, can be decomposed into either 2 codes (much higher price) or 3 codes (much lower price).
    • 81445 (tumor, 5-50 genes) and 81455 (tumor, 51+ genes) were only reported in 1H2016 with 294 and 182 uses, respectively, for all commercial payers in the USA, suggesting very low use of these panels vis-a-vis reporting tumor panels by using each tumor gene coded by name.
    • Some GSPs rose.  
      • Noonan Spectrum Disorders 81442 from $602 to $2143.
        • 1 claim line for 81442 was reported.
      • Ashkenazi disorders panel 81412 rose from $602 to $2448.
        • This quadrupling in price for 81412 was based on 269 reported prices, of which 66% were >$2000. 15% were > $3300 and 10% were < $1000.  The two most common price points were $2448.56 and $4405.77, each with about 28 cases or about 10% of the total of 269 cases.
      • Mitochondrial gene panel (not previously priced by CMS) will be 81440, $3324. This is an example of many genetic codes never priced by CMS that receive CLFS pricing through PAMA.
    • Exome 81415 came out fairly well at $4780.  But oddly, 81415, exome comparator genome, is three times as much at $12,000.  
    • Genome 81425 did not have pricing data, according to CMS, so CMS proposed a crosswalk price of about $600 based on crosswalk to code 81445 (tumor, 5-50 genes).   
  • Sole Source Tests
    • Among sole-source tests, Oncotype DX 81519 rises from $3443 to $3873, and the Allomap cardiac transplant test 81595 from $2840 to $3240.  
  • Respiratory Virus Panels
    • The larger respiratory virus panels took a steep hit. 
      • 87631, 3-5 targets, $175 to $142.
      • 87632, 6-11 targets, $292 to $218 (-25%).
      • 87633, 12-25 targets, $571 to $229 (-60%).
The Biggest Loser

Code 81341, TRB gene rearrangement direct probe, falls from $68.02 CLFS today to $.01 under PAMA 2018.

85048 auto leukocyte count pays better - even after dropping from $3.48 to $1.60.

"Raw Data" Website - Big Insights into National Test Utilization

The raw data website is here.  For a separate blog focused on the raw-data website, here.

For example.  The raw data website tells us that BRCA Sequencing, 81211, was reported 94,977 times, and that the most common single price point was $1870, which was reported 10,111 times.  The consolidated BRCA code 81162 (which covers the performance of both sequencing and dup del in one code) was reported only 815 times (about 1% as often), and while the median price was lower at $1616 the most commonly reported price for 81162 was $2400 with 33 occurrences.  If BRCA 81211 was used 94,977 times in this PAMA data, that is for 1H2016, so the full year usage in commercial payers was likely circa 190,000.

The raw data website doesn't tell you the number of labs reporting, but gives you the number of times a particular price was reported.  For example, a lab might bill at test at $10 and be paid $8, $8.50, and $9.  It would report, and we would see on the raw data, $8x1, $8.50x1, and $9x1, so we would deduce that the utilization was 3.

MoPath Tier 2 Codes

While Tier 2 codes did not have CLFS prices before, they did have average observed Pt B prices.  PAMA prices are noisy, but on average 6% lower.


Highest Price Molecular Codes (Sorted by High PAMA Price)

See table, click to enlarge:


PLA Code Recommendations

The July crosswalk/gapfill meeting was the first time CMS has priced PLA codes, the new Proprietary Lab Analysis codes being released quarterly by the AMA.

There are over a dozen new PLA codes included in the recommendations, most receiving a crosswalk rather than a gapfill recommendation.  However, some of the recommendations make no sense, at least comparatively.   

  • 0004U is a proprietary infectious disease resistance test, assessing 27 genes, with crosswalk recommendations such as 10X to 27X 87150 ($48).  CMS prefers 1x87798 (infectious agent detection, amplified probe, other; also $48, thus 1X$48.)   
  • This is in contrast to the result for 0008U, an H.pylori gene-resistance panel, which CMS offers to crosswalk to 81445 (5-50 tumor genes, about $600).

Impact of New PAMA Prices on Incoming Crosswalks

CMS faces what to do with codes that are currently being crosswalked to codes whose prices may change radically under PAMA.  For example, CMS recommends the new code 81413 (cardiac ion channelopathies) be crosswalked to Lynch syndrome 81435.  However, Lynch syndrome 81435 will be dropping from about $600 to about $38 under current PAMA data.  Where does that leave 81413?  CMS remarks, "Maintain the crosswalk finalized in November 2016" but I'm not sure if that means the November 2016 price of that crosswalk or the new $38 price of the crosswalk. (See page 29 of the 51-page crosswalk/gapfill PDF).

Paired Bar Chart: GSP Codes in 2017 and Proposed Under PAMA

For full table, here.

In the chart below, 81416 Exome Comparator $12,000 is omitted to preserve the vertical axis.
Blue lines are current prices, Green lines are new PAMA prices.


The chart below is a dot plot of current 2017 prices for GSP's on the x-axis versus 2018 PAMA prices on the y-axis.  The red line is equal pricing under 2017 CLFS and PAMA.

For example, 81455 had "0" price in 2017 (x=0) and $2995 in PAMA (y=2995).



The chart below shows the relationship (or lack of one) between GSP panel gene count on the x-asix and PAMA price on the y-axis.  For example, the 9-gene Ashkenazi panel is $2448 (x=9, y=2448) and the 10-gene Lynch panel is $38 (x=10, y=38).




___

For a Sept. 20 article at Dark Daily, previewing PAMA, here.