Streaming Webinar for "The Right Price" Neumann et al. 2021.
Monday, June 28, 2021
Sunday, June 27, 2021
Tracking COVID; Los Angeles County Epidemic Focuses on North County, Lancaster/Palmdale
An article released June 27, 2021, in the LA Times describes the rise in Delta COVID from May to June, rising from 5% to 14%, reporting statewide data. In LA County, there have been 123 Delta cases, 49 in Palmdale/Lancaster. Lin, Money, Wigglesworth, here:
A key fact is mentioned in passing: 49 of 123 Delta cases in North County.
It's more than just that. One of the biggest facts about the current COVID status in LA County is the packing of so many current COVID cases into just 5% of the population, those in Santa Clarita, Palmdale, Lancaster. Together, these areas have 500,000 residents, only 5% of the population of LA County, which is 10 million.
Los Angeles county is around 4,700 square miles; as a square, that's about 70x70 miles. Santa Clarita (about 200,000) is at the far north rim of the San Fernando Valley, while Palmdale and Lancaster are 30 miles further out across the sparse high-country desert.
LA Times tracks statewide data here:
https://www.latimes.com/projects/california-coronavirus-cases-tracking-outbreak/
And county data here:
https://www.latimes.com/projects/california-coronavirus-cases-tracking-outbreak/los-angeles-county/
While pandemic-long data shows a fierce concentration of cases in North County and South Central LA, the current heat map is focused only on North County. Compare left - the full 18 months - with right, the current 2 weeks.
 |
| 18 month, left, 2 week, right |
LA Times provides a long roster of cases per city or urban zone on the County webpage linked above. I've put a cut/paste Excel version in the cloud here.
Palmdale, with 150,000 residents, has 209 cases in the past 14 days; Lancaster, about the same size, has had 173. Santa Clarita, larger at about 200,000 residents, has had 126 cases.
In contrast, Santa Monica, with almost 100,000 residents, had only 16 total cases in the past 14 days.
Pacific Palisades, with a small population at 30,000, had 3 cases. Together, though, Santa Monica and the Palisades are roughly comparable to the size of a Palmdale or Lancaster, each of which has ~200 cases.
Burbank, with about 100,000 residents, had only 21 cases relative to the hundreds in Palmdale or Lancaster.
Using the LA Times tabular data, I added up 3414 cases in 14 days, of which 508 or 15%, occurred in Santa Clarita, Palmdale, Lancaster, with only 5% of the population. And most of those 508 cases are in just Palmdale/Lancaster, with only 3% of the county population.
Saturday, June 26, 2021
Translating 21CC MCIT Proposal (June 2021), Comparing MCIT, HR533, 21CC V2
This nerdy blog compares the new 21CC proposal (which is stated to be only a draft for comment), prior bill HR5333, and MCIT. To cut to the chase, I report on 5 points.
NOTABLE
* MCIT had no "new benefit category" creation, but HR333 and 21CC do. But, doing this raises some odd nerdy problems if it is tied to one unique index device.
* MCIT had no numerical limitation, and neither does 21CC. However, HR5333 had a numeric limit of 5.
* MCIT had no coverage & evidence requirements, but these are prominent in HR5333 and 21CC.
TRIVIA
* MCIT had a two year lookback, but 21CC had a hard date of March 2021.
* MCIT was for a life of four years, 21CC/HR5333 for 3 years after a payment change is implemented.
* 21CC/HR5333 allow breakthrough lab tests to be paid higher than fee schedule rates, but no obligation, targets, or rules for this.
Status Quo Now
Medicare coverage is currently "in place" - inscribed in the Code of Federal Regulations - per January 2021 final rule. However, it is "stayed" (delayed) until December 2021 per a May rule.
See 86 FR 2987, January 14, 2021, creating regulation at 42 CFR 405.601-607.
Brief Description for 21CC Version 2 (June 2021)
Section 404. Coverage and payment for Breakthrough Devices under the Medicare Program.
Working with Reps. DelBenes (D-WA) and Bilirakis (R-FL) to include the Ensuring Patient Access to Critical Breakthrough Products Act. This policy would codify current Medicare coverage of innovative technology (MCIT) at CMS.
Status of Critical Breakthrough Act
See December 2019, HR 5333.
https://www.congress.gov/bill/116th-congress/house-bill/5333?s=1&r=3
Congressional summary as,
The bill allows designated medical breakthrough devices to be temporarily covered under Medicare during a three-year transitional period. The Centers for Medicare & Medicaid Services (CMS) must assign payment codes for such devices within three months of FDA approval. The CMS must also establish a process to allow for continued coverage after the transitional period has expired, taking into account any additional evidence or data the CMS deems necessary.
The CMS must also provide for temporary and, where appropriate, permanent Medicare coverage of breakthrough devices for which there is no existing benefit category (i.e., classification).
HR 5333 had a limitation that "no more than 5 devices" would be covered and paid under the rule [at (a)(2)]. Coverage began on the approval day and ends 3 years after CMS updates the relevant payment system.
CMS could require additional data, to be planned no longer than 1 year after the FDA approval, and such data minimizing burden and not duplicative of any required FDA trials.
Coverage had to be "proposed" for what would occur after the 3 year period (not just passive). Payment after three years followed applicable rules, "taking into account additional data and evidence collected." Note that CMS payments generally are unrelated to medical evidence (e.g. based on invoices, costs, or time, not on quality of clinical trials.)
There is a specific remark that additional amounts may be paid [(d)(3)(D)] for clinical laboratory tests relative to fee schedules, perhaps recognizes that clinical laboratory tests are often paid based on generic fee schedules (e.g. 81415, exome test, $4780). However, there is no word as to what such an additional amount ought be or if it was voluntary for CMS.
The proposal defines "specified breakthrough products" as a term of art of breakthrough products with no benefit category under Medicare. "The term ‘specified breakthrough device’ means a breakthrough device with respect to which no Medicare benefit category exists." [at (e)(1)]. Since devices with no benefit category likely have no payment modality or rules, the bill states:
The Secretary may use methodologies under existing payment systems established under this title, may provide for appropriate adjustments to such methodologies, or may establish a new payment methodology under this title, to provide for payment for a specified breakthrough device to ensure the payment basis for such payment covers costs of the specified breakthrough device are covered by such payment.
Coverage (and payment) for a breakthrough device can continue after the 3 year period if it is shown to:
(1) improve quality of outcomes, OR, (2) improve the delivery of care, OR, (3) reduce spending without lowering quality of care.
Regarding the option to form, during this process, a "new payment methodology." CMS has wrestled with payment methodologies for AI-based services already. See an interesting discussion that occurred in a RAND-sponsored white paper on defects in the current RVU pricing system (here). For example, CMS was concerned that if they paid $50 per-click license fees (for software) as a practice expense, it would trigger indirect costs (for nurses, for rent) that don't exist.
Note the legislation around breakthrough devices seems to assume they will have higher prices than existing products; for example, if a DRG was built around a $2000 product and a BT device was better but cost $1000, the rules seem to fall apart as regards payment, or might even require lower payment if read strictly, carved and set to the device cost, but the coverage would still be required.
Comparison of 21CC and MCIT and 5333
In the lay summary, 21CC is billed as enacting into law MCIT. However, there are a range of provisions in 5333, not found in MCIT, which are used. In addition, there is at least one notable change from 5333.
MCIT versus both 21CC and 5333
With regards to MCIT, that regulation at 405.601-7 was very short, and simply provided 4 years of coverage for BT devices from the day of FDA approval and per the indicated use allowed by FDA. Any existing payment rules would apply - period. There was no provision for BT devices outside a benefit category, they were null under MCIT. There was no required data (which CMS can require under 5333 and 21CC) and there was nothing in the MCIT rule about CMS planning for and acting toward the post-coverage period.
MCIT had a two-year lookback period (if half the four-year period was still viable, the MCIT device was covered). 21CC is for devices after March 15, 2021.
21CC vs 5333
The most notable difference is that HR5333 had a "limitation on number" near the top of the bill, limiting devices to know more than 5. This is simply deleted from 21CC. Yay.
The Odd World of "Specified Devices" = Those Without Benefit Category
The same oddity occurs in HR5333 and 21CC. There is explicit coverage for devices that have no benefit category (and text regarding the need to whip up a payment system on the fly for the same). This coverage (i.e. this de novo benefit category" can be extended infinitely if the device improves quality, as described above. However, the benefit category train track appears to apply ONLY to the SPECIFIC device approved in the breakthrough pathway. If the company later updates to a new model, not under BT approval, the benefit category status appears to be lost. Let's say 3 or 4 companies enter that category, and create even better and more effective devices, but not BT devices any more. They wouldn't be covered under the benefit category, since it seems to be verbally tied specific to only the index first breakthrough device. If this power to create a benefit category is kept in the legislation, this section needs some careful thought and revision.
___
It's probably too nerdy to worry about, but MCIT clearly included diagnostics in its final version (January 2021). HR5333 and 21CC refer early on to being valid for devices "approved or cleared for use in treating an indication." Since sometimes regulatory text carefully discusses "treating or diagnosing" a disease as two different things, this HR5333 phrasing might be interpreted by a overtrained policymaker as meaning only therapeutic devices not diagnostic ones. This wouldn't be consistent with HR5333/21CC as a whole, since it has explicit sections on payment rules for clinical lab tests.
Sunday, June 20, 2021
June 18, 2021. Precision Oncology News and Canexia: Disparities in Precision Oncology
See also:
Article in Genomeweb
June 8, 2021
This link (as of June 20):
Last year, by Precision Oncology News' count, the FDA approved 27 precision oncology drugs, a 35 percent increase in the number of approvals from 2019. Although more and more biomarker-informed therapies are being developed and launched on the market, not all patients have access to them due to numerous barriers, among them difficulties accessing genetic testing, limited physician expertise, challenges setting up clinical trials in the community, and reimbursement pressures. Patients' social determinants of health also continue to influence whether they receive, or are even offered, biomarker testing and downstream treatment options.
In this panel, experts in the community treating underserved populations and tracking access challenges will discuss the difficulties they are seeing and the solutions they're working on to improve equity in precision oncology.
Raymond Osarogiagbon, MD
Chief Scientist, Baptist Memorial Healthcare Corporation
Director, Multidisciplinary Thoracic Oncology Program & Thoracic Oncology Research Group, Baptist Cancer Center
Chief Scientist, Baptist Memorial Healthcare Corporation
Director, Multidisciplinary Thoracic Oncology Program & Thoracic Oncology Research Group, Baptist Cancer Center
Dr. Osarogiagbon is Chief Scientist at the Baptist Memorial Healthcare Corporation, Director of the Multidisciplinary Thoracic Oncology Program and the Thoracic Oncology Research (ThOR) Group at the Baptist Cancer Center, in Memphis, Tennessee.
Kellie Jack, MPH
Community Outreach and Engagement Program Manager
Weill Cornell Medicine
Community Outreach and Engagement Program Manager
Weill Cornell Medicine
Kellie Jack, MPH is the Community Outreach and Engagement Program Manager for the Sandra and Edward Meyer Cancer Center at Weill Cornell Medicine. She is responsible for implementing and evaluating initiatives that seek to reduce the cancer burden and mortality rates in communities across Brooklyn, Queens, and areas of Manhattan, in partnership with community-based organizations and key community stakeholders. A native of Queens, New York, she is deeply committed to addressing health disparities among low-income and racial/ethnic minorities in NYC with a particular emphasis on increasing the representation of these groups on clinical trials.
Rachit Kumar, MD
Director of Clinical Research, Medical Oncology
Maine General Medical Center
Director of Clinical Research, Medical Oncology
Maine General Medical Center
Dr. Kumar is a medical oncologist and hematologist who sees patients at the Harold Alfond Center for Cancer Care and the Alfond Center for Health in Augusta. A member of MaineGeneral Medical Center's active staff, he joined the cancer staff in July 2017 after completing a hematology/oncology fellowship at Georgetown University/MedStar Washington Hospital Center in Washington, D.C. He received his medical degree from Maulana Azad Medical College, New Delhi, India and then did his internal medicine residency and chief residency at Georgetown University/MedStar Washington Hospital Center. His interests include targeted therapies and immunotherapy.
Gregory Tranah, PhD
Executive Director of Precision Medicine
Sutter Health
Executive Director of Precision Medicine
Sutter Health
Dr. Tranah is the executive director of precision medicine at Sutter Health and an adjunct professor in the Department of Epidemiology and Biostatistics at the University of California, San Francisco.
In his position at Sutter Health, Dr. Tranah leads a research program dedicated to accelerating the translation of research discoveries related to health and aging to clinical settings across Sutter Health. The program focuses on novel treatments, diagnostic tests, wearable devices and other interventions that improve patient health and functioning.
As part of this effort he leads a team building a Sutter-wide biobank of 100,000 patients. This work has led to the launch of a large study of multiple sclerosis genomics to identify molecular predictors of disease progression and treatment response in patients from 10 Sutter clinics.
Dr. Tranah also leads the genomics core of a personalized medicine program at California Pacific Medical Center. The genomics core focuses on sequencing tumors to identify genomic predictors of treatment response for several highly malignant cancers. Dr. Tranah’s current research program focuses on identifying inherited and acquired genetic factors that impact aging and disease. The research program aims to revolutionize risk assessment by identifying widely applicable and inexpensive genomic tests that find those who would benefit from specific pharmacologic and behavioral treatments to prevent disability and disease.
See also:
Past National Academy of Medicine conference on disparities
2018
The goals of this workshop were to explore ongoing challenges with accessing genetic/genomic services, better understand the role of health care delivery systems and clinicians with delivering equitable access to genetic services, and examine new approaches that may help to reach medically underserved populations.
[PUBLICATION from WORKSHOP]
Understanding Disparities in Access to Genomic Medicine: Proceedings of a Workshop
Genomic medicine is defined as the routine use of genomic information about an individual as part of his or her clinical care as well as the health outcomes and policy implications of that clinical use. It is one approach that has the potential to improve the quality of health care by allowing practitioners to tailor prevention, diagnostic, and treatment strategies to individual patients. In recent years, research breakthroughs, technological advances, and the decreasing cost of DNA sequencing have led to the wider adoption of genomic medicine. However, as with the introduction of new technologies into health care, there are concerns that genetic and genomic testing and services will not reach all segments of the population both now and in the near future, and there remains a gap in knowledge regarding potential health care disparities in genomic medicine and precision health approaches.
2/2021, Advamed Dx Priorities, Google Cache
https://webcache.googleusercontent.com/search?q=cache:69iQWHkmNy0J:https://dx.advamed.org/sites/dx.advamed.org/files/resource/advameddx-2021-priorities-summary.pdf+&cd=1&hl=en&ct=clnk&gl=us
https://dx.advamed.org/sites/dx.advamed.org/files/resource/advameddx-2021-priorities-summary.pdf+&cd=1&hl=en&ct=clnk&gl=us
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Friday, June 18, 2021
Early Comments on SEP1 at NQF (June 2021)
From:
https://www.qualityforum.org/comments_By_Project.aspx?projectID=253&MeasureID=2041&ActivityID=2473
(requires login with email)
Comment By
Name:
Mr. Joseph Kennedy
Organization:
American College of Emergency Physicians
On Behalf Of
Name:
Joseph Kennedy
Organization:
American College of Emergency Physicians
Date - Time:
Jun 04, 2021 - 10:56 AM
Comment Type:
Measure Specific
Comment:
Dear Members of the NQF Patient Safety Committee,
Since 2015, NQF measure #500 "Severe Sepsis and Septic Shock: Management Bundle" serves as the basis for the Centerss for Medicare and Medicaid Services Core Quality Measure, "SEP-1" which is currently a part of Hospital Compare.
We write to express and offer our expert insight, representing over 50,000 physicians delivering care to acutely ill patients with sepsis and with other conditions in the key early phases of care. We believe the measure should be markedly revised if it is to be continued, and we support a sepsis measure that embraces evidence-based expert clinical input. Our view is shared by other expert groups including the infectious Diseases Society of America (IDSA).
NQF #500 and CMS SEP-1 sought to improve sepsis care; something needed at the original endorsement time and still needed today despite improvements. Currently, however, we believe that neither the NQF #500 measure nor the CMS SEP-1 quality measure reflect the best available evidence. Specifically, current evidence published in high impact scientific journals show that NQF #500 and CMS SEP-1 are neither necessary nor sufficient in achieving better outcomes, especially when appropriate risk-adjustment is performed (JAMA Internal Medicine, Critical Care Medicine). 1,2 In addition to not creating a better care path as measured by outcomes, they do not save the healthcare system money. In the current form, both measures impose a high burden to healthcare systems and clinicians (Critical Care Medicine, Journal of Infectious Diseases). 3,4 This constellation of results was clearly not intended but nevertheless realized and run against the stated intent of using quality measures to improve care and decrease cost in the United States healthcare sector.
ACEP supports the receommended revisions to NQF #500/CMS SEP-1 proposed by the IDSA, as outlined earlier this year by Rhee et al (Clinical Infectious Diseases). 5 Specifically, we support the removal of all sepsis without shock from NQF #500/CMS SEP-1 (as currently defined by the CMS SEP-1 Data Dictionary). As Rhee et al state:
"Removing sepsis without shock from SEP-1 will mitigate the risk of unnecessary antibiotic prescribing for noninfectious syndromes, simplify data abstraction, increase measure reliability, and focus attention on the population most likely to benefit from immediate empiric broad-spectrum antibiotics."
ACEP believes that this change would make NQF #500/CMS SEP-1 more targeted and aligned with the data supporting key aspects of the measure; the evidence supporting the bundle largely arose from this subset of septic patients, yet the measure is applied more broadly. This risks harm and wastes effort, and our clinicians and experts agree that harm exists now with the current measures.
We are aware some believe change of this measure is thwarted because NQF #500 and CMS SEP-1 are process measures. However, even process measures require ongoing evaluation and honing based on evidence and feedback. One challenge was that the specific aspects of these measures were not directly tested prior to approval, noted by the Joint Commission public comment prior to rule's enacting in 2015 and by the measure stewards themselves in public comments at that time. Since enactment by CMS, the resulting measures' lack of evidence-basis and testing has been highlighted by others, including researchers at the National Institutes of Health (Annals of Internal Medicine). 6 In addition, the measure stewards have routinely altered the CMS SEP-1 in response to public comments made each year. While many of the changes have been welcome improvements (for example, excluding patients with ventricular assist devices form the fluid requirements of the bundle), none of them were tested and core concerns remain, especially surrounding the target populations.
Accordingly, we believe that the working standards for making substantial changes to NQF #500/CMS SEP-1 allow for the changes that the IDSA recommends and that we support. The current stewards of the measure may suggest that absent evidence of harm or no tangible benefits, the measure should continue. If failure to adapt and revise occurs because lack of evidence refuting impact, we believe this would become a capricious standard for ongoing changes in federal regulation. This would expose NQF #500/CMS SEP-1 to substantial legal vulnerability.
ACEP also has a new, multidisciplinary, and multi-organizational consensus paper being published in the coming days that outlines this and other opportunities to improve sepsis care starting at the earliest phases. We think this and input form other expert stakeholders can truly elevate the measures and ultimately improve outcomes for those with septic shock.
We thank the NQF for the opportunity to comment. The three-year cycle that NQF adhers to is wise in creating these natural reassessment and revision or removal opportunities. We hope to join you and others to achieve our mutual goals.
References
- Rhee C, Filbin MR, Massaro AF, et al. Compliance With the National SEP-1 Quality Measure and Association with Sepsis Outcomes: A Multicenter Retrospective Cohort Study*. Crit Care Med. 2018;46(10):1585-1591. doi:10.1097/CCM.0000000000003261
- Baghdadi JD, Brook RH, Uslan DZ, et al. Association of a Care Bundle for Early Sepsis Management with Mortality Among Patients with Hospital-Onset or Community-Onset Sepsis. JAMA Inern Med. 2020;180(5):707-716. doi:10.1001/jamaintermed.2020.0183
- Buchman TG, Simpson, SQ, Sciarretta KL, et al. Sepsis Among Medicare Beneficiaries: 1. The Burdens of Sepsis, 2012-2018:. Crit Care Med. 2020;48(3):276-288. doi:10.1097/CCM.0000000000004224
- Swenson, KE, Winslow DL. Impact of Sepsis Mandates on Sepsis Care: Unintended Consequences. JInfect Dis. 2020;222(Supplement_2):S166-S173. doi10.1093/infdis/jiaa133
- Rhee C, Chiotos K, Cosgrove SE, et al. Infectious Diseases Society of America Position Paper: Recommended Revisions to the National Severe Sepsis and Shock Early Management Bundle (SEP-1) Sepsis Quality Measure. Clin Infect Dis. 2021;72(4):541-552. doi:10.1093/cid/ciaa059
- Pepper DJ, Jaswal D, Sun J, Welsh J, Natanson C, Eichacker PQ. Evidence Underpinning the Centers for Medicare & Medicaid Services' Sever Sepsis and Septic Shock Management Bundle (SEP-1): A Systematic Review. Ann Intern Med. 2018;168(8):558-568. doi:10.7326/M17-2947
Comment By
Name:
Mr. Paul Epner, MBA
Organization:
Society to Improve Diagnosis in Medicine
Date - Time:
Jun 03, 2021 - 09:21 PM
Comment Type:
Measure Specific
Comment:
On behalf of the Society to Improve Diagnosis in Medicine (SIDM), we support the continued endorsement of Measure 0500. Inaccurate or delayed diagnosis is the most common, the most catastrophic and the most costly of all medical errors leading to the premature deaths of 300,000 per year and costing the US economy in excess of $100 billion annually. When considering high-severity harm (NAIC 6 to 9), 34% of all such malpractice claims involved diagnostic error (#1) and of those, 74% were concentrated in three categories, vascular events, infection and cancer. In the area of infection, Sepsis was number one (Newman-Toker, 2019).
We recognize that the current sepsis measure, 0500, is imperfect and needs to be updated based on the improving evidence base. We strongly urge that the mesasure steward and NQF work aggressively to update this measure based on the latest evidence. We also urge consideration by hospital administrators and others for the limitations of the current measure amid competing priorities so clearly visible during the COVID pandemic.
However, despite its limitations, we believe that abandoning this measure at this time would be the wrong decision. Morbidity and mortality of sepsis will only improve with more timely diagnosis leading to earlier adminstration of antibiotics and fluids (Rhea, 2019). While measures alone cannot guarantee improved diagnostic outcomes, they do bring attention and increased awareness to the diagnostic process in general and, in this case, to the potential diagnosis of sepsis in particular. To abandon the current measure would invite a lessening of attention to and consideration of this important diagnosis at the very moment when increased attention and data gathering is needed.
Comment By
Name:
Mrs. Theresa Edelstein, MPH, LNHA
Organization:
New Jersey Hospital Association
On Behalf Of
Name:
Cathleen Bennett
Organization:
New Jersey Hospital Association
Date - Time:
Jun 03, 2021 - 04:14 PM
Comment Type:
Measure Specific
Comment:
On behalf of the New Jersey Hospital Association’s more than 400 members, we are writing to express strong support of the Severe Sepsis and Septic Shock Management Bundle (NQF # 0500, or SEP-1). NJHA appreciates the opportunity to offer context for our support of this measure.
The SEP-1 measure is grounded in the clinical judgment and expertise of the nation’s foremost experts in sepsis prevention and care, including two from New Jersey -- R. Philip Dellinger, MD, FCCM, FCCP, Director, Cooper Research Institute, Cooper University Health Care andDavid V. Condoluci, DO, immediate-past Chief Patient Safety & Quality Officer, Jefferson Health in New Jersey. In addition, NJHA’s multi-year track record of working with hospitals, physicians and nursing homes in sepsis prevention, identification and care, have also informed our position. Below is a summary of additional key components that have informed our position.
- In a letter to the editor of JAMA (July 26, 2016 Volume 316, Number 4 ) CMS voiced its rationale to continue with the existing sepsis definition. CMS’ view was “The existing sepsis definition, including the use of SIRS criteria, have been instrumental in training clinicians and nurses on how best to identify the earliest stages of sepsis. The widespread teaching of these sepsis criteria and the adoption of screening and protocolized care processes have resulted in an unprecedented reduction in sepsis mortality. As such, the existing sepsis definitions have helped clinicians to identify, diagnose, and treat sepsis early, before a patient’s condition worsens. As opposed to early identification, the proposed task force definitions may delay the diagnosis of sepsis until patients are much sicker. Although the task force’s definition structure may identify patients with the highest likelihood of poor outcomes, it does not clearly identify patient in the early stages of sepsis when rapid resuscitation provides the greatest patient benefit and improves survival. A change to the existing definition could disrupt the 15-year trend toward further reduction in sepsis mortality.”
- The Sepsis 1 definition, in partnership with the standard bundle of care, has reduced mortality and hospital readmissions for all sepsis cases. The effectiveness and widespread approval of SEP-1 led to its incorporation into the CMS Hospital IQR program in 2015, which has brought every community hospital to the same level as academic facilities. This is based on many years of data, study and evaluation. In the absence of agreement by CMS and other national leadership groups such as the American College of
Emergency Physicians, American College of Chest Physicians, American Thoracic Society, Infectious Disease Society of America, Society of Critical Care Medicine and ICD-10-CM, a new measure that uses other definitions opens the door for conflicting protocols and confusion.
- Early recognition, diagnosis and immediate medical treatment are critical to saving lives of people like Rory Staunton, a young and healthy boy who died from sepsis in April 2012. The Rory Staunton Foundation continues to champion the cause of early identification of sepsis by healthcare practitioners in all settings.
- Our entire health care system is shifting toward value-based care and population health. Both of these concepts center on keeping people healthy and intervening before a medical issue requires intensive resources.
- Hospitals’ clinical quality improvement teams have focused on recognizing symptoms and acting appropriately in a patient-centric manner before sepsis leads to severe complications or even death. This is complicated by the fact that sepsis can rapidly develop from an issue as innocuous as a scratch. Health care providers studied and implemented bundled interventions to standardize response every time sepsis is suspected. Time is of the utmost importance when identifying and treating sepsis, so much so that the Sepsis Alliance promotes the acronym TIME (Temperature, Infection, Mental Decline, Extremely Ill) to educate the public on early symptoms of sepsis. Health care professionals prioritize the needs of their patients in alignment with compelling clinical evidence that clearly support early reaction to warning signs. The risk of not taking potential sepsis cases seriously is death.
- Disruption in data capture that would be caused by the elimination of the SEP-1 measure will significantly impact the healthcare community’s ability to understand the severity of sepsis and whether quality interventions work because our data will not be as specific or complete.
- Efforts to modify the SEP-1 measure in response to updated evidence and provider feedback are ongoing. The elimination of the SEP-1 measure would mean that many institutions, including those serving the most underserved populations, may divert their attention away from the number one cause of death in U.S. hospitals, and may no longer push the education, screening, early recognition, and management of sepsis that improves care and saves lives. This is not a prudent approach.
- Significant decisions about quality measurement could have the unintended effect of delaying what is most beneficial for patients and that put their lives at risk. This contradicts best practices and a culture of health and would be a step in the wrong direction. Promoting good preventive strategies and public education is beneficial to patients, providers and payers in achieving the common goal of saving lives.
It is true that clinical evidence will continue to evolve, but until CMS and the leading clinical organizations dedicated to the science of sepsis come to agreement on what best practice is, NJHA believes SEP-1 should remain in place. In the meantime, the collective health care community should focus on the public health issue sepsis presents to the all. By coming together in a collaborative manner, we can find solutions that encourage the most effective care – from a cost and quality perspective -- without sacrificing value to all of the stakeholders.
Thank you again for the opportunity to provide the context and basis for our position. Please feel free to contact me at 609-275-4241 or cbennett@njha.comwith any questions you may have.
Sincerely,
Cathleen D. Bennett
President & CEO
C
Comment By
Name:
Thomas Heymann
Date - Time:
Jun 02, 2021 - 04:06 PM
Comment Type:
Measure Specific
Comment:
To whom it may concern,
On behalf of Sepsis Alliance, the nation’s first and leading sepsis organization, and on behalf of the many millions of sepsis patients and survivors we represent, I write to express strong support of the continued measure of hospitals' compliance with the Severe Sepsis and Septic Shock Management Bundle (NQF # 0500, or SEP-1), with modifications as research continues to advance in the field.
Sepsis Alliance’s mission is simple: to save lives and reduce the suffering caused by sepsis. Sepsis is the leading cause of death in U.S. hospitals[i] and claims over 270,000 American lives each year[ii]. Another 1.4 million American survive sepsis every year[iii], many of them with lingering costs and complications—including approximately 14,000 amputations annually[iv].
SEP-1 focuses on timely recognition of sepsis and early intervention with life-saving therapies. We know that saving lives and limbs from sepsis is about time: 12% of septic emergency department patients develop shock within 48 hours of presentation[v] and each hour of delay until initial antimicrobials are administered is associated with an 8.0% increase in progression to septic shock[vi]. By emphasizing the screening of every patient in an effort to catch sepsis early, SEP-1 helps prevent the progression of sepsis to septic shock and ultimately saves lives.
Moreover, studies have shown the association between performance metrics and patient outcomes[vii] and that decreased risk-adjusted sepsis mortality is associated with increased hospital-level compliance with mandated public reporting[viii]. The mandate that hospitals gather and report sepsis-relevant performance data is part of what makes SEP-1 a life-saving measure.
The effectiveness and widespread approval of the SEP-1 measure led to its incorporation into the CMS Hospital IQR program in 2015. Today, there are sepsis screening programs at every hospital in the U.S., which has brought every community hospital in America up to the level of an academic facility on diagnosing and treating this challenging syndrome.
We respectfully disagree with those who urge removal of this measure. We understand that care is nuanced and that no single test can (yet) accurately or reliably establish a diagnosis of sepsis. In fact, this lack of a precise test is exactly why we should maintain a measure meant to focus on improving the quality of care for the sepsis patient. Based on continued insights from analysis of the SEP-1 measure and associated outcomes, we support its continued improvement—there are, in fact, ongoing efforts to modify the measure in response to updated evidence and provider feedback.
Furthermore, we understand and wholeheartedly agree with the widespread concern about the immense problem of antimicrobial resistance (AMR). In fact, because AMR is a growing threat to sepsis prevention and treatment, and because sepsis patients are at the greatest risk if we lose access to a wide range of antimicrobials, we believe efforts to combat AMR are crucial,
Sepsis Alliance embraces the dual responsibility to diagnose and treat sepsis patients in a timely way, and to manage our antimicrobial medicine chest. At this time, the SEP-1 measure’s stewards have proposed modifications meant to promote both decreased time to sepsis treatment and appropriate antibiotic usage; we also recognize the judicious use of IV fluids in the resuscitation of the sepsis patient and continue to encourage better multidisciplinary clinician engagement in the care of septic patients throughout their illness and recovery. Importantly, that standard of care includes stewardship considerations.
Continuing the SEP-1 measure would assure that hospitals maintain their focus on the number one cause of death in U.S. hospitals: sepsis. With modification, the SEP-1 measure will support the continued necessary education, screening, early recognition, and management of sepsis that improves care and saves lives in every community. Sepsis Alliance joins its organizational voice with the many leaders in the field who strongly support the maintenance and continued development of the SEP-1 measure.
Sincerely,
Thomas Heymann
President & CEO
Sepsis Alliance
[i] Liu V, et al. JAMA. 2014;312(1):90-92. http://jama.jamanetwork.com/article.aspx?articleid=1873131&resultClick=3
[ii] Rhee C, et al. JAMA. 2017;318(13):1241-1249. http://jamanetwork.com/journals/jama/fullarticle/2654187
[iii] Rhee C, et al. JAMA. 2017;318(13):1241-1249. http://jamanetwork.com/journals/jama/fullarticle/2654187
[iv] Healthcare Cost and Utilization Project, Nationwide Inpatient Sample, 2012.
[v] Capp R, Horton CL, Takhar SS, Ginde AA, Peak DA, Zane R, Marill KA. Predictors of patients who present to the emergency department with sepsis and progress to septic shock between 4 and 48 hours of emergency department arrival. Crit Care Med. 2015 May;43(5):983-8. doi: 10.1097/CCM.0000000000000861. PMID: 25668750.
[vi] Whiles BB, Deis AS, Simpson SQ. Increased Time to Initial Antimicrobial Administration Is Associated With Progression to Septic Shock in Severe Sepsis Patients. Crit Care Med. 2017 Apr;45(4):623-629. doi: 10.1097/CCM.0000000000002262. PMID: 28169944; PMCID: PMC5374449.
[vii] Levy MM, Rhodes A, Phillips GS, Townsend SR, Schorr CA, Beale R, Osborn T, Lemeshow S, Chiche JD, Artigas A, Dellinger RP. Surviving Sepsis Campaign: association between performance metrics and outcomes in a 7.5-year study. Crit Care Med. 2015 Jan;43(1):3-12. doi: 10.1097/CCM.0000000000000723. PMID: 25275252.
[viii] Levy MM, Gesten FC, Phillips GS, Terry KM, Seymour CW, Prescott HC, Friedrich M, Iwashyna TJ, Osborn T, Lemeshow S. Mortality Changes Associated with Mandated Public Reporting for Sepsis. The Results of the New York State Initiative. Am J Respir Crit Care Med. 2018 Dec 1;198(11):1406-1412. doi: 10.1164/rccm.201712-2545OC. PMID: 30189749; PMCID: PMC6290949.
Comment By
Name:
Ms. Lori Harmon, RRT, MBA
Organization:
Society of Critical Care Medicine
Date - Time:
Apr 30, 2021 - 01:03 PM
Comment Type:
Measure Specific
Comment:
To whom it may concern,
On behalf of the Society of Critical Care Medicine (SCCM), I write in support of continued endorsement of NQF #0500. The NQF #0500 Severe Sepsis and Septic Shock Management Bundle began with the work of Dr. Emanuel Rivers’ seminal trial in 2001 andexponentially grew based on the important contributions of the Surviving Sepsis Campaign (SSC), a joint international effort sponsored by SCCM and the European Society of Intensive Care Medicine. Between 2008 and 2014, the measures were comprehensively reviewed and vetted by multiple expert stakeholder groups leading to incorporation of NQF #0500 into the CMS Hospital IQR program in 2015.
Sepsis has been documented to be a major public health issue with an estimated 1.7 million adult cases annually in the United states and approximately 270,000 related deaths. Furthermore, the disability resulting from sepsis can have a profound and lasting impact on patients and their families. It is for these reasons that SCCM collaborates with dedicated experts from emergency medicine, infectious diseases, and intensive care medicine across multidisciplinary professions to publish continually updated guidance with an aim to refresh with the most recent, reliable scientific evidence.This evidence can then inform changes to the measures intended to have a meaningful impact on patient outcomes.These efforts reflect the ongoing evaluation of the measures and recognition by NQF of the important role that #0500 plays in improving care for patients with sepsis and septic shock .
Hospitals across the United States respond to Federal and now growing State mandates. Many have engaged in strategic innovations to support early detection and intervention models across care settings. A diverse and growing number of States have engaged involuntary state-wide initiatives funded by CMS to support implementation of the #0500 management bundle to improve care and facilitate compliance with the SEP-1 core measures. This ground-swell movement toward deeper adoption of the #0500 sepsis measures is stimulated in part by SEP-1 incorporation into the IQR program and as is the case with any initiative time, resources,and regular affirmation of accuracy is vital.
Therefore, SCCM endorses the ongoing process of NQF #0500 maintenance to bring measures into alignment with the latest published evidence as a stimulant to implement evidence-based practice. It is in this spirit of pursuing clinical excellence that SCCM supports NQF #0500 as the nation’s first, and evolving, sepsis quality measures.
Sincerely,
Greg S. Martin, MD, MSc, FCCM
President, Society of Critical Care Medicine
500 Midway Drive
Mount Prospect, IL 60056
president@sccm.org
Comment By
Name:
Ms. Koryn Y. Rubin, MHA
Organization:
American Medical Association
Date - Time:
May 27, 2021 - 08:42 PM
Comment Type:
Measure Specific
Comment:
The American Medical Association (AMA) supports the intent of #500, Severe Sepsis and Septic Shock: Management Bundle and believes that a measure on this topic that is evidence-based and precisely specified has great potential to improve the quality of care provided to patients and save lives. Regrettably, we do not agree that this composite measure meets this need and therefore, we urge this committee to recommend removal of endorsement due to ongoing concerns over the lack of alignment with current evidence and the potential for negative unintended consequences such as incentivizing antibiotic overuse. Specifically, the AMA strongly urges the Standing Committee to consider the concerns and recommended revisions outlined in recent position paper by the Infectious Diseases Society of America (IDSA) and endorsed by five medical specialty societies (Rhee, 2021).
Concerns on the measure as specified have been repeatedly raised regarding the potential for patient harm, including the recent position paper by IDSA, as well as the article by Pronovost and colleagues published in the American Journal of Medical Quality (Pronovost 2017) and researchers continue to examine the potential influence of this measure on patient care. For example, an analysis on the impact that this measure had on antibiotic utilization rates demonstrated that its implementation likely contributed to increases in broad-spectrum antibiotic use (Pakyz, 2021) and in comments that the AMA provided during the last endorsement review, we also identified a scenario where a physician may determine that treating a patient severe systolic dysfunction (LVSD) with the amount of fluids required under this composite would be harmful to the patient, possibly causing fluid overload. Research shows that this can be harmful to patients with septic shock and increase mortality and more than 60 percent of patients who present with septic shock have LVSD (Baciak 2015, Pulido 2012, Boyd 2011). If a physician provides the appropriate care to the patient in this circumstance (limiting the fluids), it would impact their ability to comply with the measure. This need to allow physicians to tailor treatment based on individual patient needs and clinical judgment continues to be reaffirmed (Pepper, 2019).
The developers and implementers such as the Centers for Medicare & Medicaid Services (CMS) must ensure that the specifications are flexible enough to allow for individual patient differences to be factored, while also enabling hospitals to demonstrate the quality of care provided.
During the 2017 review, we also questioned whether the measure was based on strong evidence. Specifically, Kalil and colleagues examined more than thirty-five observational studies and randomized clinical trials to determine why results in more recent studies were not supportive of the original trials from 2001. On review, they found that patient survival rates were primarily driven by prompt and appropriate antibiotic administration rather than early goal-directed therapy (EGDT). In addition, EGDT was associated with higher mortality rates in patients that had higher disease severity (Kalil, 2017). A similar analysis by the PRISM investigators found no differences in outcomes for patients who received EGDT versus usual care and those same patients had higher costs associated with the hospitalization (PRISM, 2017). The IDSA position paper (Rhee, 2021) also raised concerns with the evidence used to support the inclusion of suspected sepsis without shock, yet, the measure continues to include these individuals. We do not believe that the developer has provided any new evidence in this latest submission to address these discrepancies.
The AMA strongly urges the Standing Committee to not recommend the measure for continued endorsement in light of the lack of alignment with clinical evidence and known potential for negative unintended consequences.
References:
Baciak K (2015). Sepsis care – what’s new? The CMS guidelines for sever sepsis and septic shock have arrived. Available at: http://www.emdocs.net/sepsis-care-whats-new-the-cms-guidelines-for-severe-sepsis-and-septic-shock-have-arrived/
Boyd et al (2011) Fluid resuscitation in septic shock: A positive fluid balance and elevated central venous pressure are associated with increased mortality. Critical Care Medicine (39)(2): 259-265.
Kelm et al (2015). Fluid overload in patients with severe sepsis and septic shock treated with early goal-directed therapy is associated with increased acute need for fluid-related medical interventions and hospital death. Shock 43(1): 68-73.
Kalil AC, Johnson DW, Lisco SJ, Sun J. Early goal-directed therapy for sepsis: a novel solution for discordant survival outcomes in clinical trials. Critical Care Medicine. 2017;45:607-614. DOI: 10.1097/CCM.0000000000002235
Pakyz AL, et al. Orndahl CM, Johns A, Harless DW, Morgan DJ, Bearman G, Hohmann SF, Stevens MP. Impact of the Centers for Medicare and Medicaid Services sepsis core measure on antibiotic use. Clinical Infectious Diseases 72(4):556–565. https://doi.org/10.1093/cid/ciaa456
Pepper DJ, Sun J, Cui X, Welsh J, Natanson C, Eichacker PQ. Antibiotic- and Fluid-Focused Bundles Potentially Improve Sepsis Management, but High-Quality Evidence Is Lacking for the Specificity Required in the Centers for Medicare and Medicaid Service's Sepsis Bundle (SEP-1). Crit Care Med. 2019 Oct;47(10):1290-1300. doi: 10.1097/CCM.0000000000003892. PMID: 31369426.
Pronovost PJ, Berry SA, Sutliffe KM. Finding balance: standardizing practice is corseting physician judgement. American Journal of Medical Quality. First published date: April-27-2017
The Prism Investigators. Early, goal-directed therapy for septic shock – a patient-level meta-analysis. New England Journal of Medicine. 2017. DOI: 10.1056/NEJMoa1701380
Pulido et all (2012). Clinical spectrum, frequency, and significance of myocardial dysfunction in severe sepsis and septic shock. Mayo Clinic Proceedings 87(7): 620-628.
Rhee C, Chiotos K, Cosgrove SE, et al. for the Infectious Diseases Society of America Sepsis Task Force. Infectious Diseases Society of America Position Paper: Recommended evisions to the National Severe Sepsis and Septic Shock Early Management Bundle (SEP-1) Sepsis Quality Measure. Clinical Infectious Diseases 72(4):541–552. https://doi.org/10.1093/cid/ciaa059
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