Discoveries in Health Policy

Friday, May 8, 2020

CMS Schedules Annual New Lab Codes Meeting: June 22, 2020

Update: Around May 29, CMS added some 30 new codes to the agenda. Here.

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Each summer, CMS holds two types of meetings for pricing new clinical laboratory tests. The first is a public comment meeting, held in the second half of June. Generally, CMS accepts new codes passed by the AMA CPT as recently as the early May CPT meeting the month prior. This year's public comment meeting is June 22, 2020.

CMS holds a second type of meeting, typically in July, of its advisory panel on how the new codes should be priced. They consider public comment from the June meeting as well as their own expertise. In the last several years, this meeting has lasted two days. This year, it will be July 29-30, 2020 (see page 26466).

Federal Register 86 FR 26475-77 (here)

CMS will hold a VIRTUAL public meeting on Monday, June 22. (No need to fly anywhere on Sunday, June 21). The meeting will be 830 am to 500 pm (ET).

Sumissions of presenters must be made by June 4, 2020, 5 pm ET. What is the agenda of the meeting? CMS is supposed to publish it 30 days in advance, e.g. by May 22, 2020. You can submit commenters as a presenter (e.g. asking for a speaking slot) or as written comments only. For presenters, comments must be brief and if there are time limitations, CMS may use a first-come, first-serve approach.

CMS will publish its draft price proposals in early September and take comments on those until early October.

Nerd Notes

Agenda

I've seen it written that CMS must post the agenda 30 days in advance, letting it add mid-May AMA CPT PLA codes in time for a late-June meeting. This year's Fed Reg announcement says that CMS will announce the meeting and post the agenda (of codes) on the same day - e.g. that day was May 8.

CMS has posted a Zip file agenda online updated as of May 4 - here. (It's on this webpage as CY 2021 Clin Lab Fee Schedule Test Codes.zip). The PLA codes on the list run up to 0201U, which was the last PLA code released by AMA on April 1, 2020. CMS may or may not update the last for the PLA codes being approved by AMA CPT now in 1H May. In past years, CMS has updated the list with PLA codes approved by AMA CPT in 1H May.

I've put my cloud copy of the May 4 excel code list agenda in the cloud here.

Agenda Breakdown

Six codes are "Reconsiderations," a larger number than I've ever seen, These are 81307 (PALB2 breast cancer gene, full sequence), 0071U (CYP2D6), 0101U-0103U, 0129U (HBOC and Lynch panel codes).

Based on past experience, while reconsidered codes were requested in December 2019, I recommend companies with reconsidered codes to resubmit their pricing arguments for the June meeting, lest CMS say "no arguments were received."

28 codes are new CPT codes (not of the PLA type). These include new single-drug drug tests codes, some microbiology codes, some single-gene codes, and a few others. CMS also lists 0001U and 0002U, which are CMS-created U codes for COVID testing. These codes have been priced so far by MACs uniformly at around $35 (0001U) and around $50 (0002U) so it would be interesting if CMS chose a different administrative price. High volume COVID codes 0003U and 0004U were both priced at $100 even, based on a CMS Administrator's Ruling (here).

62 Codes are PLA Codes. These are codes released by AMA on October 1, January 1, April 1.

As I mentioned earlier, CMS usually has included PLA (and CPT) codes approved in the early May AMA CPT cycle; we'll see if that occurs this year. AMA had 26 PLA codes its April/May 2020 review cycle (here).

In short, there are 6+28+62 codes, or 96 codes so far, about the same number as last year. Whether this grows even further depends on whether CMS updates the code list for early May AMA CPT decisions as it did in the past.

CMS's PPT Template

Note: CMS "requires" a standard PPT template to be used (see announcement and links therein); however, I can say that, in every recent past year, CMS has also allowed additional slides (though your time is brief) in addition to the template slide.

Wednesday, May 6, 2020

FDA EUA for Biofire Panel Plus COVID: What's It Look Like?

A couple days ago, it was announced that Biofire had obtained an FDA Emergency Use Authorization for an elaborate respiratory pathogen panel - push the COVID virus, SARS-CoV-2. See e.g. Genomeweb here. And Biofire has a webpage for its COVID-related test solutions, here.

What's the actual FDA paperwork look like? FDA has a lengthy dedicated webpage for COVID EUA's - here. Scroll down and you'll find In Vitro Diagnostic EUAs, which FDA divides into institutional (aka LDT - see Mayo Clinic, Exact Sciences, Stanford...) and IVDs (e.g. kits running on platforms.)

IVD EUA's generally generate four pieces of FDA paperwork: (1) And EUA letter, (2) Instructions to healthcare providers (HCPs), (3) Instructions to patients, and (4) Instructions for use (IFU: for the machine and platform.) Institutional EUAs have the same paperwork but lack #4.

For the Biofire panel, called RP 2.1,

HCP fact sheet here.
Patient fact sheet here.
Panel platform IFU - in this case, 55 pages. Here.
Brief FDA authorization letter here.

Interpretation of results show "interpretation" on page 13 forward. For SARS-CoV-2, spike protein (S gene) and membrane protein (M gene) are detected, and reported as positive if either is positive. There are elaborate instructions for the testing and interpreting of the other panelized pathogens.

Extensive limitations, many pathogen-specific for the panel tests, are at page 17 forward.

Extensive tables of expected values follow, but on page 20, it's noted that "expected values for SARS CoV 2 have not been determined." However, concordance (48/49) for other platforms like Panther Fusion and ROche are shown in Table 10, page 23. There are also comparisons of the performance of Panel 2.1 versus the original panel 2.0 (2.1 having had SARS CoV 2 added).

Example Screenshots

Table 6, Panel Testing with Actual Specimens

Table 8, Co-Positive Specimens (Library of 1612 specimens)

Table 10, SARS CoV 2 Orthogonal Accuracy

Political Snapshots: Rick Bright Resigns BARDA, See 89pp Statement. Christine Grimm and Fireworks at HHS OIG.

There was a flurry of political news coming out of HHS the past couple weeks, and enough dust has probably settled for a quick lookback and update.

Rick Bright, Head of BARDA, Abruptly Out; Files 82 Page Complaint

Update: Bright testified on the Hill, May 14, here.

Rick Bright MD, a career government official, has been at the billion-dollar biodefense agency BARDA since 2010, and became its director in 2016 (here).

On April 21, it was announced he was moving to a new position at NIH, in charge of COVID test R&D (contemporary article here). However, by the next day, April 22, news stories announced that Bright viewed the shift as "retaliation" - here. Bright released a press release vetted by his several attorneys.

New York Times, Washington Post, and other major sources filled with conflicting quotes from inside HHS, some stating that Bright was a top notch leader, and other sources saying he should have been fired long ago. One source leaked his 2019 job review, which was rated strongly favorable.

Later, a story came out that HHS administrator Alex Azar and mentioned the shift to the White House, just before it occurred, as a promotion or lateral shift, making the news cycle blow-up seem even bigger and more unexpected.

On May 6, NYT tries to make sense of it all with an article, "Who Is Rick Bright?". NYT and other sources also post his full 89 page complaint - here (redacted).

CNN states Bright will be testifying before the House on May 14. Allegations include contracts "steered to cronies."

Christine Grimm, Principal Deputy Inspector General - Stays or Leaves?
The HHS OIG was under the leadership of Dan Levinson for a long time, 15 years. He announced in April 2019 he was resigning, effective May 31, 2019 (here)

Joanne Chiedi, at HHS since 2010, became acting Inspector General for about six months, until December 2019 (here). She joined DLA Piper law & lobbying firm (here).

On May 2, 2020, President Trump announced he was proposing Jason Weida, an assistant US attorney in Boston, to be the next permanent Inspector General at HHS (here). He is expected to replace Christi Grimm, who has been both principal deputy director of HHS/OIG and also the Acting Inspector General since Chiedi's retirement in December - here.

Some news sources (like NYT on May 1, here) reported the news that President Trump wanted Grimm "fired," not merely returned to her full time deputy roll. On May 2, an HHS spokeswoman told CNN that Grimm "will continue to serve as" deputy IG.

The OIG Report on Hospital Shortages - Incendiary or Routine?

The brouhaha over Grimm centered around a report released by OIG on Friday, April 3, and mostly covered in news stories on Monday, April 6. The report surveyed a selection of hospitals for a week in late March and rapidly summarized data that protective equipment was in short supply. See the report here, and news stories at the time here and here.

I said at the time that this was in fact a routine report, and OIG was provided it to shore up activities of other agencies. For example, at about the same time, HHS released its first massive "interim final rulemaking" under its emergency powers at SSA 1135.

By using the OIG staff to push out a stat report on shortages in only a few days, HHS officials could thus cite this same federal report about shortages (justifying emergency rulemaking) rather than citing anecdotal information or even worse, god forbid, citing NYT or CNN as sources for information about supply shortages. Much better to footnote a federal report.

OIG or GAO or other federal bodies routinely do reports that shore up administrative actions that are about to be taken. For example, in 2013, OIG released a report that large commercial labs get much lower payments from commercial payers than the Medicare lab fee schedule, and this supported legislation a few months later lowering Medicare lab fee schedules (PAMA Section 216). Similarly, OIG/GAO reports on overpayments on DME then promptly were used to support legislation on DME competitive bidding.

These are just quick recent examples; the concept goes back to the 1870s and 1880s. When Nixon launched the legislation for "War on Cancer" in 1973, it followed several years of white papers, reports, and hearings designed to lead to legislation for a war on cancer. So to me, the Grimm report was actually routine, part of the wheels and cogs turning normally, and not "incendiary" or the work of a renegade.

I would say I was surprised, except you really can't be surprised, to see a NYT report much later, on May 1, that President Trump now wanted Grimm fired (here; see quotations at bottom*). Grimm might be fired; or she might find it is a good time to move to her own version of DLA Piper, as Chiedi did; but I suspect the OIG supply shortage report was actually part of a coordinated effort to support federal emergency actions occurring or about to occur, and not a secret wingnut activity undertaken as a rogue action.

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NYT May 1 *

“It’s just wrong,” the president said when asked about the report on April 6. “Did I hear the word ‘inspector general’? Really? It’s wrong. And they’ll talk to you about it. It’s wrong.”

He then sought to find out who wrote the report. “Where did he come from, the inspector general? What’s his name? No, what’s his name? What’s his name?”

When the reporter did not know, Mr. Trump insisted. “Well, find me his name,” the president said. “Let me know.” He expressed no interest in the report’s findings except to categorically reject them sight unseen.

After learning that Ms. Grimm had worked during President Barack Obama’s administration, Mr. Trump asserted that the report was politically biased. In fact, Ms. Grimm is not a political appointee but a career official who began working in the inspector general office late in President Bill Clinton’s administration and served under President George W. Bush as well as Mr. Obama.

She took over the office in an acting capacity when the previous inspector general stepped down.

Mr. Trump was undaunted and attacked her on Twitter.

“Why didn’t the I.G., who spent 8 years with the Obama Administration (Did she Report on the failed H1N1 Swine Flu debacle where 17,000 people died?), want to talk to the Admirals, Generals, V.P. [Pence] & others in charge, before doing her report.”

Tuesday, May 5, 2020

Very Brief Blog: Another Report Compares Medicare Prices and Other Prices

Reports that compare Medicare prices with commercial payer prices or other prices (Medicaid, Medicare Advantage) appear at regular intervals.

There's new interest in commercial vs Medicare rates, often on the view that nationalized Medicare-for-All rates would save money for the economy as a whole by lowering healthcare prices.

Here's a new report from Harvard, and some links to older recent ones.

New Harvard Report Comparing Prices - Chernew et al., 2020

Chernew et al. look at inpatient and outpatient prices and compare them to commercial prices. They find there is wide state-to-state variation. For example, in Alabama commercial and Medicare prices are fairly close; but in Wyoming, Indiana, Oregon, and Colorado, commercial prices are much higher than Medicare. (One might imagine, for example, that where there are highly consolidated hospital systems that might raise prices; where there is a highly consolidated private insurer, that might lower them.)

Find Chernew et al. 2020 in Health Affairs here (subscription). Find a report on the study in Healthcare Dive here.

Additional Earlier Reports

Lab - OIG 2013

If you track the lab industry, find an opposite report by OIG in 2013 asserting that Medicare lab prices back before PAMA were higher than commercial lab prices - here. This report was critiqued in the lab industry, which even offered rebuttal data. But there was great concern that pegging CMS prices to PAMA-survey prices of commercial labs would lower CMS prices too much - acknowledging at a minimum that big commercial lab prices were, in fact, lower than Medicare for lab tests, whereas it's widely accepted the opposite is true for hospital outpatient and inpatient services.

Rand 2019

2019 RAND Report. See a large study by RAND in 2019. Covered at Advisory Board here. RAND Report here.

CBO 2017

2017 CBO Report. See Healthcare Dive on a 2017 Congressional Budget Office report, here. See the report on physician payment rates (commercial) here. See the report on Medicare Advantage rates here.

Monday, May 4, 2020

Very Brief Blog: Sudden FDA Pivot on Serology Testing; and Roche Describes Very Accurate Serology Test

It's commonplace in the healthcare, Covid, and lab industries that FDA was far too restrictive on molecular LDT COVID tests in February and March, gradually changing rules and speeding access to Emergency Use Authorization tests. Feedback against the FDA was bitter. Then, serology tests began emerging, with few or no FDA controls, and another fiasco occurred. Serology tests with unknown or frankly inadequate performance exploded in the marketplace. (See the serology test shoot-on-sight article in NYT, April 24, here.)

When I say it's a commonplace, it's so common it was clearly described in just these terms on HBO's comedy news show, Last Week Tonight, on May 3, 2020.*

1. Roche Launches Accurate Serology Test; FDA Cracks Down on Serology Tests

On the same day, WSJ published an article that Roche is releasing a new, highly accurate serology test. (Open access at Quartz, here.)

2. FDA Makes Sudden, Tight Pivot

And just after that WSJ published an article that FDA was making a tight pivot and would require performance controls and EUA on serology tests.

FDA will require serology tests on the market to be 90% sensitive and 95% specific.

3. More on Roche:

Roche expects to manufacture its tests (which run on platforms, not point of care) "in the high double digit millions" by June (e.g. 50M? 75M?). The Roche test validated for patients tested 14 days after infection, and validated on 6000 patients. Roche states it's 100% accurate at detection while being 99.8% specific (0.2% false positives, stated 0 false negatives).

4. More on FDA Crackdown:

For additional sources on the FDA serology crackdown -

FDA here.

Note that FDA article is first-authored by Anand Shah MD, who until recently served as senior medical officer for innovation at CMS.
FDA EUA Homepage here.
FDA guidance (rules), updated, homepage, here.
The actual May 4, 41-page PDF, here.

Washington Post here. Politico here.
NYT here.
MedTechDive here. Biopharma Dive here.
Endpoints here.

5. Biofire snares EUS for Respiratory Panel, Including COVID

Somewhat lost below the Roche news, Biofire announced it has a respiratory viral panel in a version that includes SARS-CoV-2. See coverage at Genomeweb, here. The test should be covered under CMS's broad emergency coverage rules for COVID-related testing, released a few days ago (here).

6. Gottlieb on Antigen Tests

Meanwhile, also May 3, Scott Gottlieb publishes WSJ Op Ed that we need to pivot to antigen tests. Antigen tests (e.g. point of care laminar flow, like pregnancy tests) may be less accurate but would be a rapid directionally correct test for further actions and testing.

Dr. Deborah Birx, the White House task force coordinator, made this point on Meet the Press April 26, as well.

7. Quote from FDA 41-page new guidance:

(p. 7) "FDA has become aware that a concerning number of commercial serology tests are being promoted inappropriately, including for diagnostic use, or are performing poorly based on an independent evaluation by the NIH,8 indicating that greater FDA oversight of commercial serology tests is important to protect the public health."

(p. 14) Tests on the market are given 10 business days to submit an EUA.

(p. 15) Focus on commercial kits rather than in house LDT tests.

"At this time, we believe it is most beneficial to focus our EUA review and authorization efforts on tests from commercial manufacturers, which have the potential to be distributed more broadly, rather than laboratory-developed serology tests that are not for diagnostic purposes, are being performed at one laboratory that is CLIA-certified to perform high-complexity testing, and that are validated in-house. However, if FDA becomes aware of questions or concerns about a laboratory-developed serology test, such as poor performance or misleading statements about the test, FDA will communicate those concerns to the laboratory and provide the laboratory an opportunity to address the questions or concerns. If the concerns cannot be or have not been addressed in a timely manner, FDA intends to remove the laboratory from the website listing of notifications and may take additional actions as appropriate."
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* It's also a truism that FDA has been buffeted by criticism it is too rigorous, or too lenient, often at the same time, for generations.

Sunday, May 3, 2020

Offbeat Blog: McKinsey & Co Bonanza of COVID Business Strategy Articles

One of the news feeds I track is McKinsey & Company, the global consulting firm.

Sunday's view provided thirteen articles.

Thirteen.

Talk about pivoting your focus to where the market will be and tailoring your collateral to customers' interests. (I might also guess they have some off-client staff in surplus and used the past two weeks to produce a cornucopia of thought capital for the next ramp-up in the consulting sales cycle.)

I've clipped the bevy of titles and links here. But the point is more the "pivot" and marketing vision, than any one particular article.

Update: McKinsey also managed a WSJ article on May 11 - here.

How to demonstrate calm and optimism in a crisis

1K 7h

Six practices can help leaders build their self-awareness and guide their organizations through the challenges ahead.

From surviving to thriving: Reimagining the post-COVID-19 return

500+ 7h

For many, the toughest leadership test is now looming: how to bring a business back in an environment where a vaccine has yet to be found and economies are still reeling.

General James Mattis on leading in a crisis and thriving in the next normal

400+ 7h

The former US defense secretary shares lessons on how to emerge from the pandemic and prepare for what comes next, in a conversation with McKinsey global managing partner Kevin Sneader.

How North American claims organizations can respond to the coronavirus

40 7h

Claims leaders have to take action to manage uncertainty and prepare for the future—here is where to start.

The PE company CFO: Essentials for success

Private equity portfolio companies are crucibles for CFOs. Here are four essential priorities to get started on the right foot.

Tuning in, turning outward: Cultivating compassionate leadership in a crisis

400+ 7h

Four qualities—awareness, vulnerability, empathy, and compassion—are critical for business leaders to care for people in crisis and set the stage for business recovery.

Major challenges remain in COVID-19 testing

100+ 7h

There remain challenges and risk in considering “widespread testing” as the sole criterion for returning to work and activities.

Beyond coronavirus: The road ahead for the automotive aftermarket

20 7h

Traffic will return to the roads when the coronavirus pandemic abates, but the automotive aftermarket will be fundamentally changed.

The SG&A imperative in times of crisis

A crisis presents unique challenges in making wise spending decisions. Zero-based principles can help leaders move SG&A investments where they should be—rather than where they have always been.

Best practices for an unusual US admissions cycle amid coronavirus

42 7h

COVID-19 and changes to the NACAC code of ethics have created new challenges and uncertainties for institutions seeking to enroll students for fall 2020. Applying best practices can help universities even beyond May 1.

The B2B digital inflection point: How sales have changed during COVID-19

COVID-19 is changing how B2B buyers and sellers interact. Savvy sales leaders are learning how to adapt to the next normal.

The power of through-cycle M&A

How companies can use deal making to accelerate strategic shifts during the COVID-19 crisis.

How can the economies of emerging Asia respond to COVID-19?

The region’s informal, cash-based economies and the unique vulnerabilities of their populations make resolute action more essential now than ever.

END OF FEED

Here's another one, on "rapid recovery" from a marketing perspective - here.

Here's one more from slightly earlier, not on the list above, with interesting graphics -

How to Restart National Economies During the Coronavirus Crisis - April, here.

If there's not a 2x2 or 3x3 grid, it might not really be "consulting." There's a 3x3 grid: