CMS Posts Final Pricing of New CY2021 Lab Tests

 

On November 20, 2020, CMS closed out the new codes crosswalk/gapfill process for CY2021, by posting final pricing decisions.   

In a striking contrast from Fall 2019, CMS did not change any of the pricing decisions proposed in September 2020.

• Last year, CMS disagreed with the advisory panel about half the time in its proposed decisions (September 27, 2019).  Last year, CMS changed about 20 codes between proposed and final (mostly by changing crosswalks to gapfills; December 4, 2019.)

This year, of 132 posted decisions, CMS disagreed with the panel on 8:

• On 8X008, JAK2, exons 12,13, and on 8X006, MPL, common variants, CMS crosswalked to Tier 2 codes rather than specific crosswalks (agenda 95,96).  
• Agenda items 40-45 were crosswalked to drug code G0480 rather than gapfilled as recommended  by panelists.

I tally 53 gapfill codes, which will keep MACs busy with pricing exercises in 1H2021.  

Most codes priced by CMS were simple single crosswalks. Of 78 crosswalked codes, the several exceptions were these:

• Two CPT codes were added together to price 3 new tests. 
• CMS used fractions three times: 
• One code was multiplied by 2.5x, and two codes were a base code and fraction of a second code. 

Category I MAAA code, 81XX1, agenda 66, 190 genes for pulmonary fibrosis, was converted to an ADLT code.  It's ADLT'd at $5500 (here).  It's the 7th ADLT.  The prior ADLT was back in 12/2019, the Myriad MyChoice FDA-approved enhanced BRCA test, $4040.  The highest priced ADLT is a melanoma MAAA test at $7193.

COVID to GAPFILL

Of high interest to many, CMS COVID codes U0001-U0004 were set to gapfill, as proposed in September, and as recommended by many panelists.  However, at least until the end of the public health emergency, prices of U0003-U0004 are set by administrative order ($100 in 2019, $75 in 2020 if >72 hours but allowing a $25 rapid test report supplement if faster).  I believe these codes would be come unpriced at the legal ending of the PHE which is why CMS is putting them through the CLFS process.

FIND THE DATA; APPEAL IF YOU LIKE

Find the spreadsheet at this CMS webpage HERE, scrolling down for the Zip file of the Excel file "CY 2021 - Clinical Laboratory Fee Schedule Test Codes Final Payment Determinations (ver. 1) (ZIP)."  CMS occasionally finds errors and updates the file.  Final prices will also appear in December on the release of the entire CLFS (including both new and old codes) for CY2022.

Stakeholders can appeal the method of payment until January 20, 2021 (see spreadsheet, top row for instructions).  Appealed codes are simply put back into the CLFS pricing process again in June 2021.

Very Brief Blog: AMA Posts Lab Test Applications for February 2021 CPT Cycle

There are three AMA CPT editorial meetings per year, with application deadlines several months in advance.  AMA has posted for review and comment the lab test applications for the February 2021 CPT meeting.   If you are a stakeholder with a material interest in one or more of these codes, by November 20 you may request the application packet from AMA CPT.   Then, after reviewing the packet, you may submit comments to AMA CPT by November 30.

The PDF announcement is here.  As instructed there, you'd submit a request-to-comment to AMA staffer Michael Pellegino by November 20.

There's an application for IL-6, an immunoassay which has never been coded, but there's a new IL-6 test (from Roche) that has an FDA EUA for COVID assessment.  There are about a dozen other applications, interestingly, none of them for molecular or MAAA tests.

There are separate and later AMA review dates for all codes that are not lab codes.  This is because lab codes starting going through special subcommittees in December (e.g. "Pathology Coding Caucus.")  

Patient Access to Cancer Genomics: New Industry Coalition Formed

On  November 17, 2020, several press releases and news stories about the creation of a new coalition focused on access to comprehensive genomic profiling (CGP).  CGP is usually understood to mean large gene-panel tumor tests that include sequencing, dup-del analysis, and fusions.   The Foundation Medicine F1 test is a classic example.

The group is called Access to Comprehensive Genomic Profiling (ACGP). Members now include Exact Sciences (NASDAQ: EXAS), Foundation Medicine, Illumina (NASDAQ: ILMN), LabCorp (NYSE: LH), QIAGEN (NYSE: QGEN), Roche Diagnostics (SIX: RO, ROG:OTCQX: RHHBY), and Thermo Fisher Scientific (NYSE: TMO).

See links below:

• Press release here.
• Article at 360DX here.
• Website for organization, here.
  

Sound bite:

"Cancer is a disease of the genome, not solely the tissue. Tumor profiling has evolved tremendously in the last decade," said Jim Almas, MD, vice president and national medical director of clinical effectiveness at LabCorp, and the chairman of ACGP. "The manufacturers and laboratories forming the coalition have produced incredible assays to help identify the mutations driving advanced cancers, leading patients to better care through targeted cancer treatments." 

Despite evidence of the benefits of this approach, some health insurers still use an outdated framework to evaluate coverage for CGP, creating a disparity in access across patient populations. Many commercial insurance plans do not cover this type of testing, while public or government plans like Medicare do. Limited insurance coverage options may prevent some treating physicians from ordering CGP for their patients.

CMS Introduces New Office For Technology Policy, Coding, Pricing.

If you look at the full Org Chart for CMS, it's pretty doggone complex - PDF here, with over 15 divisions reporting to the Administrator.  In one of the largest, Center for Medicare, there's a new division called "Technology Coding and Pricing Group," headed by long-time CMS policymaker Jason Bennett. 

TCPG is going to be  "...focused on helping shepherd medtech innovators through what can be a byzantine reimbursement process that wasn’t necessarily structured with next-generation technologies in mind...."

What's up?

_______

New Pages on the CMS Org Chart

The full org chart for CMS is online in a PDF here.  For example, offices as diverse as "Office of Legislation" and "Center for Program Integrity" report to the Administrator, who reports to the Secretary of Health.  Two of the largest centers are Center for Medicaid and CHIP Services (CMCS) and Center for Medicare (CM). 

Center for Medicare has its own  division webpage here .  Within that you'll find the familiar "Hospital and Ambulatory Policy Group" - HAPG - which runs inpatient and outpatient policy, under Carol Blackford.  There's the "Medicare Contractor Management Group," under Larry Young (keeps your MAC up and running, recontracts, and handles complaints.)  And so on.

But wait, there's more.  This fall, there is a new group here inside of "CM," the "Technology Coding and Pricing Group," TCPG. What's that?

The TCPG Is Headed by Jason Bennett

It's headed by Jason Bennett, who has a master's in public policy and has held over a decade's worth of positions at HHS and CMS - his Linked In here.

There was a brief announcement about the new TCPG, and Bennett's appointment, at Fed Health IT News, here.

How CMS Describes the Mission of TCPG

I haven't seen a full CMS press release on the TCPG position, but interestingly, there was a Linked In job listing that described the roles of the director, which is pretty much the mission statement for TCPG.  The job opening is closed, but the listing is still online here.   (My cloud copy here).

Here's how CMS presented the TCPG:

As the Director, Technology, Coding and Pricing Group, you will provide executive direction for the consideration of new technologies and their treatment in the Medicare program. You will lead the development and evaluation of national Medicare policies and standards on certain benefit structures and payment methods; the maintenance of medical coding systems; and the assessment of applications for special payment consideration for new technologies under several payment systems.

For example, I'd guess this group was involved in a set of new policies for DME coding and regulations proposed a few weeks ago in annual rulemaking (here, here.)

I list more about TCPG from Linked In, further below.

Interviews with Jason Bennett

See an interview with Bennett about the new Medicare Coverage for Innovative Technology (MCIT) program for breakthrough devices,  here.  

See a longer and very interesting interview with Bennett about the TCPG at MyStrategist.com here. In the latter interview, we read, 

• "The Technology, Coding, and Pricing Group launched last month within CMS’ Center for Medicare. It puts under one roof functions relating to medical technology that have previously been housed in disparate parts of CMS. In conjunction, the agency has brought together a smaller, dedicated team of “navigators” who, for the next six months at least, will be focused on helping shepherd medtech innovators through what can be a byzantine reimbursement process that wasn’t necessarily structured with next-generation technologies in mind."

The TCPG, we read, was rolled out publicly in a session of the annual  October AdvaMed conference a few weeks ago.

_______

More About TCPG:

And more from Linked In job listing:

Responsibilities [ of Head of TCPG ]

- Develop and evaluate national Medicare policies and principles for payment of new technologies for various provider types under prospective payment systems.

- Develop methodologies to adjust payments based on statutory and regulatory criteria.

- Develop, evaluate and review payment and benefits policies, regulations and instructions concerning durable medical equipment, prosthetics, orthotics and supplies items and services.

- Develop, evaluate and review policies, regulations, requests for codes, and instructions concerning HCPCS and ICD-10 coding.

- Develop, evaluate and issue data collection methods for clinical laboratory services and part B drug average sales price (ASP). Calculate payment amounts based on the collected data as required by regulation and statute.

- Oversee ambulance payment policy and required cost data collection for ground ambulance providers and suppliers.

- Oversee the data analysis contract used to monitor DMEPOS competitive bidding and other payment system assessment topics to support ongoing policy changes and monitor the impact of such changes.

- Maintain continuing liaison with provider groups, industry associations, patient organizations, medical associations, and other stakeholders that relate to Medicare benefits.

- Evaluate applications for new technology payment status under the inpatient and outpatient hospital prospective payment systems and the End Stage Renal Disease prospective payment system.

AdvaMed's Elaborate White Paper on Digital Health and Medicare Benefits

 In September 2020, Advamed issued a complex and thought-provoking 56-page white paper on digital health and its interactions with existing Medicare benefit categories and payment systems.

See the white paper here:

https://www.advamed.org/sites/default/files/resource/advamed-modernizing-medicare-coverage-of-digital-health-technologies-september-2020.pdf

Representative analysis (one of many):

It's a tour de force through many aspects of CMS policy from the perspective of the rapid churn in tecnologies and use cases for digital health.

Very Brief Blog; Consultancy DECIBIO Releases Data on Uptake of Clinical Genomics

The Los Angeles-based specialty consultancy DECIBIO (here) publishes a very interesting blog on the recent changes and uptake of precision medicine genomics in the clinic.   

Find it here.  Good graphics and key takeaways.

Highlights include (1) marked uptake of biomarker test adoption; (2) NGS is becoming a standard method, but decentralization is slow; (3) LBx is coming on strong; (4) we'll eventually see more digital pathology and AI; (5) "the role of the pathologist is changing." 

See Deciobio article; sample graphic here.

_

With regard to #5, "The role of the pathologist is changing."

I've seen several articles with titles like "The Role of the Pathologist in XYZ" in 2019/2020.  See "Traditional diagnostics vs disruptive technology: Role of the pathologist in the era of liquid biopsy," Sholl, 2020, (subscription), here.   See a similar European paper on the role of the pathologist in contemporary oncology (Matias-Guiu et al., open access, 2020, here).   See "The changing role of pathologists" in precision medicine, Masood, 2019, open access, here.  See "Next generation pathologist," Fassan, 2018, open access, here.   Or "Evolving role of the pathologist," Piana, 2019 in ASCO Post, here.  

From Arch Path Lab Med, see "A Validated Exam to Assess Pathologist Knowledge of Genomic Oncology," 2020, Haspel, open access, here.  "Role of the pathologist in genetically mutated breast cancer," Masood, 2020 (subscription), here.  "Morphology and molecular testing, a practical approach," Gullo, 2020 (subscription), here.

Also striking a note close to the Decibio study, see Vashistha, 2020, "Medical oncologists' perspectives on the VA National Precision Medicine Program, open access, here."

Very Brief Blog; Yet More AMA COVID Codes; So Far, Few Codes Under CMS's 2-Day Penalty

 On November 10, 2020, AMA again increases the number of codes available for COVID services.  

• See the AMA COVID home page here.
• See the latest update of COVID code listings here.
• See a November 10 special coding instructions update (for 87428) here. 

As AMA explains, there is an existing influenza antigen code 87400 and a CoV-2 antigen code 87426.   A new code, 87428, describes multiple testing for both CoV-2 and INF A/B.  

Other parts of the new codemaking are related to COVID Vaccines, and there are quite a few codes.  See the AMA COVID home page.

CMS Proposed Penalty for Slow Testing

In mid-October, CMS posted a new rule that beginning January 1, 2021, payments for high throughput testing drop from $100 to $75 if the test is not completed in a two-day turnaround time.   Here, here.  The $25 penalty applies only to CMS codes U0003, U0004, and not to any of the other numerous COVID codes.   CMS's rationale is likely that only its own codes CMS U0003 U0004 contain (contained) a bonus payment for "high throughput technology," so only those two codes of all the COVID codes should get a clawback penalty for slower performance.   

In any case, for example, you can get $100 for a COVID high throughput test performed quickly, before a discount hits you, but you can get $142 for a COVID + Influenza PCR test (87637), which is more money to start with, and with no risk of a time based penalty in 2021.

  

Very Brief Blog / Biden Names Healthcare Transition Advisors, COVID Advisors

Biden has named a roster of health policy transition advisors, led by Chiquita Brooks-LaSure, of the Manatt Phelps Phillips law firm.  One particularly familiar name may be Jonathan Blum, who was Deputy Administrator of CMS under Obama and held a senior position at CareFirst BCBS.

https://buildbackbetter.com/the-transition/agency-review-teams/

Department of Health and Human Services

The Department of Health and Human Services team will also review the Consumer Product Safety Commission.

Name	Most Recent Employment	Source of Funding
Chiquita Brooks-LaSure, Team Lead	Manatt, Phelps and Phillips, LLP	Volunteer
Robert Gordon, Team Lead	State of Michigan, Department of Health & Human Services	Volunteer
Kathryn Alvarez	The Aspen Institute	Volunteer
John Auerbach	Trust for America’s Health	Volunteer
Lisa Barclay	Boies Schiller Flexner, LLP	Volunteer
Jonathan Blum	Health Management Associates	Volunteer
Lu Borio	In-Q-Tel	Volunteer
Perrie Briskin	University of California, Berkeley	Volunteer
Ken Choe	Hogan Lovells, LLP	Volunteer
Henry Claypool	Self-employed	Volunteer
Jose Cordero	University of Georgia	Volunteer
Sarah Despres	Pew Charitable Trusts	Volunteer
Eliot Fishman	Families USA	Volunteer
Cristal Gary	AMITA Health	Volunteer
Mina Hsiang	Devoted Health	Volunteer
Tom Inglesby	Johns Hopkins University	Volunteer
David C. Kaslow	PATH	Volunteer
Natalie Kates	Alloy	Volunteer
Jeremy Konyndyk	Center for Global Development	Volunteer
Anna Martinez	State of New Jersey, Department of Children and Families, Division on Women	Volunteer
Sarah Nolan	Service Employees International Union	Volunteer
Yngvild Olsen	Institutes for Behavior Resources, Inc.	Volunteer
Edwin Park	Georgetown University	Volunteer
Sharon Parrott	Center on Budget and Policy Priorities	Volunteer
Chuck Peck	Guidehouse, Inc.	Volunteer
Anne Reid	Co-Equal	Volunteer
Geoff Roth	Self-employed	Volunteer
Meena Seshamani	MedStar Health	Volunteer
Cyrus Shahpar	Resolve to Save Lives, an initiative of Vital Strategies	Volunteer
Mary Wakefield	University of Texas at Austin	Volunteer

# # # # # # #

Biden also named a 12-member COVID advisory panel including leadership by former surgeon general Vivek Murthy, former FDA commissioner David Kessler, and Yale's Marcella Nunez-Smith.  Others include Obama advisor Zeke Emanuel and former BARDA executive Rick Bright.

For a full listing see:

https://www.fiercehealthcare.com/hospitals/these-are-healthcare-experts-biden-named-to-his-covid-19-advisory-board

Former U.S. Surgeon General Vivek Murthy, M.D., and former Food and Drug Administration Commissioner David Kessler, M.D., will be among the public health leaders guiding the transition team for President-elect Joe Biden regarding COVID-19.

 

Murthy and Kessler, as well as Marcella Nunez-Smith, M.D., who is associate dean for health equity research at the Yale School of Medicine, will co-chair a lineup of familiar and high-profile public health experts in offering guidance on the COVID-19 response, Biden's transition team announced Monday.

“The advisory board will help shape my approach to managing the surge in reported infections; ensuring vaccines are safe, effective, and distributed efficiently, equitably, and free; and protecting at-risk populations," Biden said in a statement. 

The team also includes:  

Rick Bright, M.D. (PHE.gov)​​​​

Rick Bright, M.D.: Bright, an immunologist and virologist, was the director of the Biomedical Advanced Research and Development Authority from 2016 to 2020 and the deputy assistant secretary for preparedness and response at the Department of Health and Human Services (HHS). Bright was ousted earlier this year and said he was pushed out after he raised concerns about the safety of projected vaccine development timelines. 

 

Luciana Borio, M.D.: Borio is a former director of the FDA's Office of Counterterrorism and Emerging Threats and the former assistant commissioner for counterterrorism policy and acting chief scientist at the FDA. She has previously been involved in the response to such threats as the spread of Ebola several years ago. Borio is the vice president of technical staff at In-Q-Tel and a senior fellow for global health at the Council on Foreign Relations.

 

Ezekiel Emanuel, M.D., Ph.D.

(JAMA)

Ezekiel Emanuel, M.D., Ph.D.: Emanuel is an oncologist, vice provost for global initiatives and chair of the Department of Medical Ethics and Health Policy at the University of Pennsylvania. He served as special adviser for health policy to the director of the White House Office of Management and Budget from January 2009 to January 2011 and was an architect of the Affordable Care Act. Emanuel has said he doesn't necessarily think front-line healthcare workers should be first in line for COVID-19 vaccines, but instead said the immunizations should be prioritized to those most likely to spread the illness, and he has raised questions about the ability to use "immunity passports" in the absence of enough science. 

 

Celine Gounder, M.D.: Grounder is a clinical assistant professor at the NYU Grossman School of Medicine and a physician at Bellevue Hospital Center. She is the former director for delivery for the Gates Foundation-funded Consortium to Respond Effectively to the AIDS/TB Epidemic and later served as assistant commissioner and director of the Bureau of Tuberculosis Control at the NYC Department of Health and Mental Hygiene, officials said.

 

Atul Gawande, M.D.: A professor of surgery at Harvard Medical School and professor of Health Policy and Management at Harvard T.H. Chan School of Public Health, Gawande also is a high-profile writer for The New Yorker. In 2018, he was named to head up a healthcare company called Haven created by Amazon, JPMorgan Chase and Berkshire Hathaway but stepped down from the role in May. He is the founder and chair of Ariadne Labs, a joint center between Brigham and Women’s Hospital and the Harvard T.H. Chan School of Public Health for health systems innovation, and of Lifebox, a nonprofit organization making surgery safer globally. He previously served as a senior adviser in HHS during the Clinton administration.

 

Julie Morita, M.D.: Morita is the executive vice president of the Robert Wood Johnson Foundation and previously served as the health commissioner for the city of Chicago, officials said. 

 

Michael Osterholm, Ph.D.: Osterholm is the director of the Center for Infectious Disease Research and Policy at the University of Minnesota and previously served as a science envoy for health security on behalf of the U.S. State Department, officials said. He served as state epidemiologist for the Minnesota Department of Health for 15 years. 

 

Loyce Pace: Pace is the executive director and president of Global Health Council and previously served in leadership positions at the LIVESTRONG Foundation and the American Cancer Society, officials said. 

 

Robert Rodriguez, M.D.: Rodriguez is a professor of emergency medicine at the UCSF School of Medicine and authored more than 100 scientific publications, including researching the impact of the COVID-19 pandemic on the mental health of frontline providers. In July 2020, Rodriguez volunteered to help with a critical surge of COVID-19 patients in the ICU in Brownsville, Texas, officials said. 

 

Eric Goosby, M.D.: Goosby is the former U.S. global AIDS coordinator, the former interim director of the White House’s Office of National AIDS Policy and was the founding director of the Ryan White CARE Act. He was also previously appointed by the United Nations secretary-general as the special envoy for TB, officials said. The infectious disease expert is a professor of medicine at the UCSF School of Medicine.

Very Very Brief Blog: Annual Physician and Outpatient Rules Running Late This Year

 Historically, CMS has released annually rulemaking for the Part B services - "Physician" rulemaking and "Hospital Outpatient" rulemaking - plus or minus July 1, and finalized these rules on or very close to November 1.   The schedule works backwards from January 1:  the rules are supposed to be published 60 days before the next calendar year (November 1) and they have 60 days public comment (e.g. July 1 - August 30), given CMS about six weeks (September - October 15) to sort out comments and generate and approve a final rule on dozens or hundreds of topics.

This year, the rules did not appear on or near November 1.   

It's not unheard of that they appear in mid November, but it's not typical.  Most years, they respect the 60 day notice period prior to the next January 1.

The proposed rules appeared August 4 for outpatient (here) and August 3 for "physician" (here).  That means the comment periods didn't close until circa October 1.

Very Brief Blog: AMA Posts Results of Panel Actions, October 2020 CPT Meeting

AMA holds CPT editorial meetings three times a year for the review of new code proposals.  Meetings in May and October 2020, and planned meetings for February and May 2021, were or will be virtual.

A month before the meeting, CPT publishes abbreviated descriptions of code proposals, and a month after the meeting, CPT publishes results.  These are called "Summary of Panel Actions."

CPT has published Summary of Panel Actions for the October 2020 meeting - here.

___

It's a 15 page document with 96 action items.  The October meeting is now the last meeting for codes for the next CPT year (2022); the February meeting used to hold that position.

Digital medicine

Item 95 is a new "Digital Medicine Taxonomy" which will appear in October 2021 for the 2022 code book.  (Occasionally AMA elects to publish items like that in advance, as well).   Appendix P is updated with 18 additional codes for "synchronous telemedicine services."  

Remote physiological monitoring codes get a set of 5 new codes in the format of remote "therapeutic monitoring" codes.  

Withdrawn or Rejected

Typically, applicants withdrawn codes if it's clear they will be rejected by the panel.  This is akin to resigning in chess when it's clear it's "mate in two."  27 applications were withdrawn.  5 were rejected.  In total, 32 of 96 were withdrawn or rejected.  

Lab Codes

For pathology consults, four new codes will be added and legacy clinical pathology consult codes 80500, 80502 are deleted.  I wrote in July that this is potentially a big deal in some circles (here).

There is a new code for liver or small bowel allograft rejection (Tab 45), breast cancer via RNA sequencing MAAA (Tab 46), a breast cancer MAAA rejected (Tab 47), an Admin-MAAA code for  diffuse B cell lymphoma, 20 genes (Tab 49).  

Cat III

I tallied addition of 11 Category III code proposals, many of these for code sets.

Cat III to Cat I:  Surg Tech and Imaging Tech Withdrawals

An application to upgrade the Aquajet prostate ablation service from Category III to Category I was withdrawn.   

A proposal to upgrade the Heartflow service (0501T-04T) to Category I was withdrawn.  

Noridian MAC Announces Several COVID Test Prices

 Last spring, when the first AMA CPT COVID codes were created, CMS quickly asked its MACs to set prices for them, and CMS published the prices quickly.

For more recent codes, I don't think CMS has organized price publications as efficiently or with the same priority.  However, today at the California Clinical Lab Association meeting, Noridian MAC was asked if it had set prices for CPT COVID codes 87636, 81637, and 87811, and it quickly provided them.

Here's what I jotted down:

o   87811

§  Infectious agent antigen detection, direct optical ie visual, COVID 19

§  $41

o   87636

§  Infectious agent, DNA/RNA, COVID 19 + Infl A,B, Multiplex

§  $142

o   87637

§  Infectious agent, DNA/RNA, COVID 19, Infl A,B, and RSV, Multiplex

§  $142

See the October version of the AMA CPT code list for COVID, link below.  Check AMA regularly for updates.

https://www.ama-assn.org/system/files/2020-10/coronavirus-long-descriptors.pdf

__

In other CCLA meeting news, Noridian reiterated that it doesn't cover high-target respiratory virus codes, only 3-5 targets.   They noted they get some blowback on this, and that cases were marching into appeals.  I noted that to my eye, CMS has a publication listed the high-target respiratory viral codes as covered under CMS COVID policy, but (as Noridian reiterated) they are not covered by the Noridian MAC.  My blog here.

Very Brief Blog: Avalere Data on Medicaid, Medicare COVID DRG rates.

Early COVID law implemented a 20% increase in Medicare inpatient DRG payments, if the patient has a COVID diagnosis.  In August, CMS clarified it wanted a documented direct COVID test in the patient's record before certifying the case rates the 20% supplement (here).[FN1]

While it was published in September, Avalere has an excellent discussion of average DRG payments for different types of Medicare and Medicaid payments - find it here.   

• Average COVID hospitalization payments were $23,489.
• Average COVID hospitalization payments were $11,370 for Medicaid.
• LOS with ventilator support was 14 days; otherwise, 8 days.
• Medicare payments were $12,140 without ventilator support, and rise to $31,174 with ventilator support.

For more facts and figures and budget impact data, see Avalere.  

___

FN1

In late October, the President asserted that doctors get $2000 more if they certify someone died of COVID (e.g. when it may have been secondary to age and other illness) - e.g. here.  

The closest parallel I see is that hospitals get 20% more from Medicare if the patient has tested positive for COVID (which would typically be $2000 or more on a base DRG).  I don't see any increase beyond that for asserting the patient died of COVID versus having COVID.   Scott Gottlieb discusses the same fact pattern in the November 1 link just cited.

CMS Releases Text of U0005, Speedy Payment for COVID Adds $25

 In mid-October, CMS announced a new policy that would cut the rate for high-throughput COVID testing (U0003,U0004) from $100 to $75, but simultaneously, create an add-on code for reporting in less than 48 hours, which adds back the missing $25.   Entry point and links here.

At the time, CMS did not appear to release the text of the new add-on code U0005.   However, U0005 appears inside an October 28 COVID billing update at CMS, on the bottom of page 12 of 152 pages.  Here.

CMS states:

On October 15, 2020, CMS released an amended Ruling (CMS 2020-1-R2) that created an add-on payment for COVID-19 CDLTs performed using high throughput technology (as described by HCPCS codes U0003 and U0004). This add-on payment can be billed using HCPCS code U0005 effective January 1, 2021, and is described as follows:

U0005: Infectious agent detection by nucleic acid (DNA or RNA); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]), amplified probe technique, CDC or non-CDC, making use of high throughput technologies, completed within two calendar days from date and time of specimen collection. (List separately in addition to either HCPCS code U0003 or U0004)

"Completed" is defined in Administrator's Ruling as, the test report is ready for release.  The start time is stated within the code as "time of specimen collection."  The timing is two days, not 48 hours, so I am assuming a specimen at 8 am on Monday could be completed by 11 pm on Wednesday.

SPEEDY ACT

Meanwhile, I missed on the first go-round that on October 1, several Representatives in the House released a bill called SPEEDY, which would pay a bonus for COVID tests under 24 hours, a basic rate after that, and drop to "no payment" after 72 hours.  See press here.  I haven't identified the full text of the legislative proposal.

CRITIQUE IN DARK REPORT

Dark Report (subscription), October 26, has a detailed article with multiple interviews with lab stakeholders who are opposed to the payment cuts.

NILA OBJECTS

In addition to concerns about the payment cuts, National Independent Laboratories Association (NILA) recently complained to CMS about the burden, confusion, and complexity of required COVID reporting for public health purposes (here).

CMS TEXT ONLINE (SCREEN SHOT):

Very Brief Blog: Biodesix IPO, Shares $18 to $14; First week

Diagnostics company Biodesix had its IPO on October 28, opening at $18 per share but slipping to about $13.50 over several days, giving the company a market cap of $360M.

• See the company's website here, here.
• See the S-1 here at SEC or here in the cloud.
• See the stock ticker at Yahoo Finance here.
• See an article by an investment watcher at Seeking Alpha here.

Policy Worth Watching: CMS Announces Diverse Modifications to DME Policies, including CGM

Earlier this week, CMS released a wide-ranging set of policy modifications to DME policy, ranging from HCPCS code procedures to benefit category determination rules to some specific policymaking, such as for Continuous Glucose Monitors (CGMs).

• See the CMS fact sheet here.
• See the CMS Press Release here.
• "Today, under the leadership of President Trump [etc]."
• See the Proposed Rule Homepage here.
• See the "inspection copy" or typed rule here [211 pages]. [Fed Reg Publication Nov 4]
• The official Fed Reg publication will be November 4 at the homepage cited.

CGM Revisited

CMS policy for CGM has been tortured, with non-coverage for a number of years under the vaguest of rationales, court cases, and interim policy changes on the CMS or the DME MAC websites.  The new rule classes CGM as DME.

I've covered CGM weirdness in a number of skeptical blogs since 2016, several being here, here, and here.  Parrish Law Offices has won a number of CGM cases for clients (here and here). The rule cites several CGM legal cases (e.g. "Finigan v Burwell 2016").

Elevated Volume of DME/HCPCS Rulemaking

In most years, a few pages of DME policy changes are tucked inside the annual summer ESRD rule.  This year, DME gets a standalone rule.   In addition, the rule contains histories of many of the obscure policy rules of DME, a history of CGM coverage that discusses DME payment concepts for glucose devices back to the early 1980s.

___

I've borrowed the phrase "Policy Worth Watching," from Indiana's Lance Geiger (here), who runs a YouTube channel of colorful ten-minute history vignettes several times a week (see "The History Guy" channel here), and his tag line "History that Deserves to be Remembered."

___

In last year's rulemaking, CMS proposed making a public advisory panel that would advise it on gapfill pricing for DME based on costs.  I was alarmed this could occur and could be later applied to genomics also.  For example, the panel might have little insight into costs and investments and return on risk capital; they were instructed to look at the end-product and estimate its costs.   Here.  CMS deferred action on the "pricing  panel."