An Excellent 10 Page Summary of the New PAMA Lab Pricing Rule

On June 17, CMS released a lengthy rulemaking to implement PAMA 216, the market based reform of the clinical laboratory fee schedule.

The policy implementation has many twists and turns.

For an excellent ten page summary produced by the health policy consultancy ADVI, see here.  (Download by clicking the small upper down-arrow).   For the home page see www.advi.com

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Some Quick Thoughts on Special Features of the Final PAMA Rule

On Friday evening, June 17, 2016, CMS released the final PAMA rule.  (For links see HERE).

While encyclopedic summaries are available at several websites - see HERE - below the break are my thoughts on ten or twelve aspects of the rule that may have particular interest.

CMS Posts Final PAMA 216 Lab Pricing Regulations: With Some Key Links

On June 17, 2016, at 4 pm, CMS posted the final 245 page rule making for PAMA Section 216, the massive overhaul of laboratory test pricing.

The Federal Register publication dated June 23, 2016 is HERE.   81 Fed Reg 41036-41101.

Note that CMS also provided a complementary, ten page Q&A document, here.  The CMS webpage for PAMA 216 is here.

• Detailed coverage at Genomeweb, June 20, here.
• Excellent ten-page summary by the consultancy ADVI, here.
• An excellent eight-page summary by the consultancy QUORUM is here.
• McDermottPlusConsulting's 33-slide deck, here, and 7-page summary, here.
• A summary by Mintz Levin, here.
• My own comment which focuses on some "quirks" and "ins and outs" hidden in the rulemaking and its future implementation... here.

CMS published a "Medlearn Matters" 13 page document on lab enrollment and reporting in August 2016, online here. It gives examples for various combinations of CLIA license, NPI, TIN, etc.

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Mini link for this blog page...  http://tinyurl.com/pamafinal

CMS Posts MAC Proposed Gapfill Prices for New Molecular 2016 Codes

Last summer, CMS shunted a number of new incoming 2016 CPT codes for molecular tests to the MAC Gapfill process.

CMS has posted the MAC proposed pricing on its website, here.  Download the link there marked "2016 Gapfill CLFS."  CMS is accepting comments until July 10, 2016 ...revised by CMS to August 10, 2016.   CMS will post final MAC price revisions around September 1.

I have also posted the CMS Excel spreadsheet in the cloud,  here.

Click on the picture below to enlarge.

Genomeweb: The Appearing, Vanishing Medicare Breast Cancer LCD (May 2016)

Genome has two articles on the appearance and disappearance of Noridian MolDX LCD DL36730, which briefly proposed to lockstep Medicare breast cancer test coverage to recent ASCO guidelines.

Genome's May 20 article is here, and their May 25 article is here.

Jennifer Lawrence Signs On for Theranos Biopic

June 9, 2016

"Jennifer Lawrence Signs On For Big Screen Theranos Adaptation."

Engadget.  By Andrew Dalton.  Here.  (Deadline Hollywood, here.)

Clever Blog on PBMs: the Junction of Economics, Analytics, Health Outcomes, and Policy

There is a lot going on at the junction of pharmacoeconomics and health policy, as seen in the ever-present dialog over drug prices and health value.   A great case study for this intersection is a blog this week in Health Affairs by Chung, MacEwan, and Goldman on: "Does A One Size Fits All Formulary Policy Make Sense?" - here.   At first this sounds like something to do with precision medicine - moving past one size fits all.

But the article is actually a case study for bringing together pharmacoeconomics, business economics, human behavior, and health policy in a way that matters to consumers and physicians as well.

"Why this matters" after the break.

New York State's Proposal to Redefine Approval Processes for Advanced LDTs

On March 1, 2016, the New York State Department of Health - which has special rules that apply nationally to labs processing New York origin lab specimens - proposed a new "risk based policy" for LDT evaluation.

The home page for the effort is here.  The Agency accepted comment last spring, through April 29.

The full four page risk assessment proposal, as originally drafted for comment, is online here.

Tests that are LDTs will be quickly classified as low risk, moderate risk, or high risk "by CLRS staff."  Low risk LDts will will receive full approval and "validation will be reviewed as part of routine laboratory surveys."  Moderate risk LDTs will receive "conditional" review but this is discretionary on the judgment of staff.  High risk LDTs will not have the conditional approval option: they will need to complete a full CLRS review process before approval.

Although the PDF is the best reading format, I've clipped the text online, below the break.

One major stakeholder submitted a comment that test review times may now already take over a year and that this timeline could get worse due to understaffing and new rules.

Registration Open: Sign Up for July 18 CMS CLFS Meetings

On June 6, 2016, registration opened for the paired CMS CLFS meetings to be held on the campus in Baltimore on July 18, 2016.

The public meeting day will open in the morning with the annual new code "gapfill/crosswalk" meeting.   Registration is here (see link for "Register Here").  To present at the morning meeting, submit Powerpoint to CMS by July 1; for details here.

In its announcement of the afternoon session of the PAMA Clinical Diagnostic Test Advisory Panel, CMS stated its registration would be open on June 6 on that website, which is here.   If they really intended to run a separate registration for the afternoon session, it isn't posted yet (12 noon ET June 8).

CMS Posts Draft Decision on Gender Dysphoria Surgery (Leave at MAC Discretion)

On June 2, 2016, CMS posted a proposed National Coverage Decision for gender dysphoria surgery (e.g. gender reassignment surgery).  The proposed decision is here.

The decision may be one of the agency's longest, at 50,000 words (for me, 94 pages when clipped into Word).   I tally 510 references cited.   The conclusion is that there is only indefinite evidence of the benefit for Medicare patients in particular cases, and under such circumstances, decisions to cover surgery should be undertaken by local MACs rather than under an NCD.   There is an interesting backstory to the 1980s; details after the break.

UPDATE: THE FINAL NCD (SIMILAR TO THE DRAFT) IS ONLINE HERE.

THE FINAL DOES HAVE VARIOUS REDLINE EDITS; SEE THESE CAPTURED AT MY LATER 2022 BLOG here.

NantHealth Has Successful IPO; Raises $91M; Stock Pops

NantHealth scores $91M in its June 2, 2016 IPO.   From an offering price of $14, the share price jumped to almost $18.   With about 5% of the company offered, that suggests a market value in the $2B range.  Open access story at FierceBiotech, here.  LA Times, here.  Nanthealth will provide a broad suite of integrated genomics testing, informatics, EHR, and other services.

Highlights from the SEC IPO prospectus were highlighted on this blog a few weeks ago (here).

In June 2015, the sister company NantKwest went public with a valuation of about $2.6B (here).  The current market cap of NantKwest is less, at $623M (June 3, 2016).  

Follow up - to give a snapshot as of June 9, the stock traded at $15.40, down a bit from an early peak of $18.59, but still representing a market cap of $8.57B.  

CMS Posts Info for Lab Advisory Panel Meeting July 18 (Same Day as Gapfill Meeting)

CMS has posted a formal announcement that the Advisory Panel on Clinical Diagnostic Laboratory Tests will meet on July 18, 2016, at CMS in Baltimore.   The Federal Register announcement is here.

This has low surprise value; on May 13, CMS announced the annual New Test Crosswalk/Gapfill meeting would be held on July 18 and that the Advisory Panel would fall on the same day, each using half the schedule.

During the afternoon session, the Panel will deliberate and make recommendations regarding the new and reconsidered laboratory codes for CY 2017. The Panel may also hear public presentations on additional issues concerning the CY 2017 CLFS that are designated in the Panel’s charter and specified in the Panel meeting agenda for the afternoon session.

CMS appears to be offering separate registration for the two meetings (which are held in the same room and were contiguous/continuous last year).  Per the announcement, meeting registration opens on June 6, 2016.  CMS reserves the right to add publicly announced issues to the panel agenda as late as 3 weeks before the meeting.

Beginning Monday, June 6, 2016 and ending Friday, July 1, 2016 at 5:00 p.m. EDT, registration to attend the Panel meeting in-person may be completed online at http://cms.gov/Regulations-and-Guidance/Guidance/FACA/AdvisoryPanelonClinicalDiagnosticLaboratoryTests.html. On this webpage, under “Related Links,” double-click the “Clinical Diagnostic Laboratory Tests FACA Panel Meeting Registration” link and enter the required information.

CMS Payments for Clinical Trials: Keeping Up With New Category A, B Policy

From December 2015 to June 2016, CMS and FDA update policies that describe when Medicare can cover healthcare payments for patients in clinical trials.    Details after the break.

Judges Find Medicare Law Impenetrably Confusing

This week, Politico Pro picked up on a California judge's ruling that Medicare is...confusing and impenetrable.   There are several famous quotes on this topic, which I've collated after the break.