News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel

News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
Sign In

New Federal Rules on Sepsis Treatment Could Cost Hospitals Millions of Dollars in Medicare Reimbursements

Some hospital organizations are pushing back, stating that the new regulations are ‘too rigid’ and interfere with doctors’ treatment of patients

In August, the Biden administration finalized provisions for hospitals to meet specific treatment metrics for all patients with suspected sepsis. Hospitals that fail to meet these requirements risk the potential loss of millions of dollars in Medicare reimbursements annually. This new federal rule did not go over well with some in the hospital industry.

Sepsis kills about 350,000 people every year. One in three people who contract the deadly blood infection in hospitals die, according to the Centers for Disease Control and Prevention (CDC). Thus, the federal government has once again implemented a final rule that requires hospitals, clinical laboratories, and medical providers to take immediate actions to diagnose and treat sepsis patients.

The effort has elicited pushback from several healthcare organizations that say the measure is “too rigid” and “does not allow clinicians flexibility to determine how recommendations should apply to their specific patients,” according to Becker’s Hospital Review.

The quality measures are known as the Severe Sepsis/Septic Shock Early Management Bundle (SEP-1). The regulation compels doctors and clinical laboratories to:

  • Perform blood tests within a specific period of time to look for biomarkers in patients that may indicate sepsis, and to
  • Administer antibiotics within three hours after a possible case is identified.

It also mandates that certain other tests are performed, and intravenous fluids administered, to prevent blood pressure from dipping to dangerously low levels. 

“These are core things that everyone should do every time they see a septic patient,” said Steven Simpson, MD, Professor of medicine at the University of Kansas told Fierce Healthcare. Simpson is also the chairman of the Sepsis Alliance, an advocacy group that works to battle sepsis. 

Simpson believes there is enough evidence to prove that the SEP-1 guidelines result in improved patient care and outcomes and should be enforced.

“It is quite clear that this works better than what was present before, which was nothing,” he said. “If the current sepsis mortality rate could be cut by even 5%, we could save a lot of lives. Before, even if you were reporting 0% compliance, you didn’t lose your money. Now you actually have to do it,” Simpson noted.

Chanu Rhee, MD

“We are encouraged by the increased attention to sepsis and support CMS’ creation of a sepsis mortality measure that will encourage hospitals to pay more attention to the full breadth of sepsis care,” Chanu Rhee, MD (above), Infectious Disease/Critical Care Physician and Associate Hospital Epidemiologist at Brigham and Women’s Hospital told Healthcare Finance. The new rule, however, requires doctors and medical laboratories to conduct tests and administer antibiotic treatment sooner than many healthcare providers deem wise. (Photo copyright: Brigham and Women’s Hospital.)

Healthcare Organizations Pushback against Final Rule

The recent final rule builds on previous federal efforts to combat sepsis. In 2015, the Centers for Medicare and Medicaid Services (CMS) first began attempting to reduce sepsis deaths with the implementation of SEP-1. That final rule updated the Medicare payment policies and rates under the Inpatient Prospective Payment System (IPPS) and Long-Term Care Hospitals Prospective Payment System (LTCH PPS).

Even then the rule elicited a response from the American Hospital Association (AHA), the Infectious Disease Society of America (IDSA), American College of Emergency Physicians (ACEP), the Society of Critical Care Medicine (SCCM), and the Society of Hospital Medicine (SHM). The organizations were concerned that the measure “encourages the overuse of broad-spectrum antibiotics,” according to a letter the AHA sent to then Acting Administrator of CMS Andrew Slavitt.

“By encouraging the use of broad spectrum antibiotics when more targeted ones will suffice, this measure promotes the overuse of the antibiotics that are our last line of defense against drug-resistant bacteria,” the AHA’s letter states.

In its recent coverage of the healthcare organizations’ pushback to CMS’ final rule, Healthcare Finance News explained, “The SEP-1 measure requires clinicians to provide a bundle of care to all patients with possible sepsis within three hours of recognition. … But the SEP-1 measure doesn’t take into account that many serious conditions present in a similar fashion to sepsis … Pushing clinicians to treat all these patients as if they have sepsis … leads to overuse of broad-spectrum antibiotics, which can be harmful to patients who are not infected, those who are infected with viruses rather than bacteria, and those who could safely be treated with narrower-spectrum antibiotics.”

CMS’ latest rule follows the same evolutionary path as previous federal guidelines. In August 2007, CMS announced that Medicare would no longer pay for additional costs associated with preventable errors, including situations known as Never Events. These are “adverse events that are serious, largely preventable, and of concern to both the public and healthcare providers for the purpose of public accountability,” according to the Leapfrog Group.

In 2014, the CDC suggested that all US hospitals have an antibiotic stewardship program (ASP) to measure and improve how antibiotics are prescribed by clinicians and utilized by patients.

Research Does Not Show Federal Sepsis Programs Work

In a paper published in the Journal of the American Medical Association (JAMA) titled, “The Importance of Shifting Sepsis Quality Measures from Processes to Outcomes,” Chanu Rhee, MD, Infectious Disease/Critical Care Physician and Associate Hospital Epidemiologist at Brigham and Women’s Hospital and Associate Professor of Population Medicine at Harvard Medical School, stressed his concerns about the new regulations.

He points to analysis which showed that though use of broad-spectrum antibiotics increased after the original 2015 SEP-1 regulations were introduced, there has been little change to patient outcomes.  

“Unfortunately, we do not have good evidence that implementation of the sepsis policy has led to an improvement in sepsis mortality rates,” Rhee told Fierce Healthcare.

Rhee believes that the latest regulations are a step in the right direction, but that more needs to be done for sepsis care. “Retiring past measures and refining future ones will help stimulate new innovations in diagnosis and treatment and ultimately improve outcomes for the many patients affected by sepsis,” he told Healthcare Finance.

Sepsis is very difficult to diagnose quickly and accurately. Delaying treatment could result in serious consequences. But clinical laboratory blood tests for blood infections can take up to three days to produce a result. During that time, a patient could be receiving the wrong antibiotic for the infection, which could lead to worse problems.

The new federal regulation is designed to ensure that patients receive the best care possible when dealing with sepsis and to lower mortality rates in those patients. It remains to be seen if it will have the desired effect.  

Jillia Schlingman

Related Information:

Feds Hope to Cut Sepsis Deaths by Hitching Medicare Payments to Treatment Stats

Healthcare Associations Push Back on CMS’ Sepsis Rule, Advocate Tweaks

Value-Based Purchasing (VBP) and SEP-1: What You Should Know

NIGMS: Sepsis Fact Sheet

CDC: What is Sepsis?

CDC: Core Elements of Antibiotic Stewardship

The Importance of Shifting Sepsis Quality Measures from Processes to Outcomes

Association Between Implementation of the Severe Sepsis and Septic Shock Early Management Bundle Performance Measure and Outcomes in Patients with Suspected Sepsis in US Hospitals

Infectious Diseases Society of America Position Paper: Recommended Revisions to the National Severe Sepsis and Septic Shock Early Management Bundle (SEP-1) Sepsis Quality Measure

CMS to Improve Quality of Care during Hospital Inpatient Stays – 2014

Medical Residency ‘Match Day’ Yields Rare Mother and Son Placements with Mother Matched to Pathology Program at the University of Wisconsin-Madison

It was a special and unusual moment for this mother and son duo as they applied for acceptance into residency programs and were both matched on the same day

Pathologists and other clinical laboratory scientists who underwent the matching process will be interested to learn how a mother and son were matched on the same day as part of the National Resident Matching Program (NRMP) 2023 Match Day.

Match Day is the next step for medical and medical technology students to be placed into desired training programs in chosen specialties. According to the NRMP website, pairings are determined by a mathematical algorithm to match applicants with residency positions.

Wenjing Cao, MD, PhD, and her son Hefei Liu, MD, didn’t plan to apply for residency together, but when Cao wanted to return to medicine, the pair realized they could be matched to programs at the same time, Good Morning America reported.

Cao, 54, is currently a research scientist/professor at the University of Kansas. She graduated from medical school in China and spent 10 years practicing internal medicine there before immigrating with her family to the US in 2006. Liu, 26, is finishing his oncology studies at the Medical College of Wisconsin where he expects to graduate in May.

Hefei Liu, MD and Wenjing Cao, MD, PhD

Hefei Liu, MD (left), a radiation oncology student at Medical College of Wisconsin, and his mom hematologist Wenjing Cao, MD, PhD (right), a research scientist and professor at the University of Kansas, matched residencies on the same day during the annual National Resident Matching Program 2023 Match Day. Pathologists and clinical laboratory scientists know how exciting this day can be for residency applicants. (Photo copyright: Good Morning America.)

Pair Express Their Excitement, Awe

The matching program will take the pair to different locations for their training. Cao will be headed to the clinical pathology residency program at the University of Wisconsin-Madison and Liu to the University of Pennsylvania for the radiation oncology residency program, Good Morning America noted.

“When she told me she was going to reapply this year and it was the same year I was applying, I thought, this could actually happen. Somehow it did and it’s still incredible to me,” Liu said.

Cao is also thrilled. “This is incredible and amazing, something I feel very excited about. I never thought I would go through this process with my son together,” she told Good Morning America.

National Resident Matching Program

Though this is a special and rare moment, it’s not the first time the NRMP matched a parent/child in the Main Residency Match. However, Stephanie Bartek, Senior Communications Analyst for the NRMP, told Dark Daily that the NRMP does not track whether applicants are related, so there is no way to provide odds of it occurring.

The NRMP has matched physicians to residency training programs since 1952, but in 1984 it formalized the Medical Specialties Matching Program (MSMP) which matches physicians into fellowships and subspecialty training programs.

The first fellowship match was for Colon and Rectal Surgery. Since then, the NRMP has grown the MSMP to 73 subspecialties in 20 separate fellowship Matches, according to an NRMP press release.

2023’s Matches Speak to Healthcare Growth

“The 2023 Main Residency Match proved once again to be a highly successful Match with outstanding results for participants. We were excited to see the record number of primary care positions offered in this year’s Match and how the number of positions has consistently increased over the past five years, and most importantly, the fill rate for primary care has remained steady,” said Donna L. Lamb, PhD, NRMP President and CEO, in a press release announcing the release of “Results and Data Specialties Matching Service, 2023 Appointment Year for Fellowship Matches Conducted by the NRMP’s Specialties Matching Service (SMS)” in April.

The report shows 13,919 active applicants competed for 13,365 fellowship positions offered by 5,734 programs, according to the press release.

“For the past 70 years, the NRMP has been proud to play a part in helping physicians transition into residency training and begin careers serving their patients and community,” she added.

Age is Only a Number

Cao hopes her match will impact individuals who are holding back from following their desires.

“I hope my story can inspire so many others like me, at my age, [in their] 50s, and as a mother, as a woman, as an immigrant, [anyone] can pursue their dream, as long as you want it,” she said. “It’s your dream, put hard work on it. Keep positive. Stay motivated. You can get it.”

Her son Liu mirrored her sentiment. “If you see your parents or any of your family members who are interested in pursuing medicine and they have an interest, but they clearly have some sort of obstacles in their life, you should … be supportive of them and encourage them to pursue that dream because I think with dedication, hard work, and sometimes just even luck, that you can truly achieve your success.”

With the demand for pathologists in the United States outstripping the supply, Wenjing Cao, MD, PhD, may have her pick of positions when she finishes her pathology residency program and any pathology fellowship programs she may undertake.

—Kristin Althea O’Connor

Related Information:

Mom and Son Celebrate Matching Residency Programs Together: ‘Still incredible to me’

NRMP Publishes Comprehensive Data Book for Fellowship Matches

Medical Specialties Matching Program

Results and Data Specialties Matching Service, 2023 Appointment Year for Fellowship Matches Conducted by the NRMP’s Specialties Matching Service

Pathologist and Radiologists Head toward a Collision… or Will It Be a Collaboration!

How much longer will anatomic pathologists spend the majority of their time in a quiet office, viewing glass slides through a microscope? Will radiologists and pathologists soon collaborate on diagnosing the patient and jointly releasing an integrated patient report to the referring physician?

Should you think these scenarios are several years into the future, you may be surprised to learn that first-mover pathology groups and radiology groups are in the earliest stages of fully-digital (non-glass) pathology and collaborative diagnosis/patient reporting. These pathologists and radiologists will tell you that this is an exciting time and they are advancing patient care because of these innovations.

At University of Kansas, an extraordinary collaboration was launched last summer involving Ossama W. Tawfik, M.D., Ph.D., Director of Anatomic and Surgical Pathology and his colleague; Mark L. Redick, M.D., Assistant Professor of Radiology, University of Kansas. Tawfik and Redick began meeting regularly to jointly review selected breast cancer cases. “It was quickly obvious to us both that, by reviewing each other’s primary clinical data together, there were immediate benefits to the referring physician and the patient,” noted Tawfik. “We’ve learned two things from this collaboration. First, there have been few changes in the diagnostic aspect of the cases we review. Second, on the treatment side, our pathology/radiology integration is driving significant changes in how the patient receives treatment and what therapies are recommended.”

Tawfik and Redick are speaking about their in vivo/in vitro collaboration at the upcoming Molecular Summit on the Integration of In Vivo and In Vitro Diagnostics in Philadelphia on February 10-11, 2009. Location is the Sheraton Society Hill Hotel in Philadelphia, Pennsylvania.

At Molecular Summit 2009, the future of the glass slide versus an all-digital pathology service will be discussed by CEOs from industry-leading firms such as Aperio Technologies, Inc., BioImagene, Inc., and DMetrix, Inc.. One sure sign that pathologists are adopting slide scanning and digital pathology systems is the accelerating rate of sales of digital systems reported by these three companies during the past 24 months.

Pathologists and radiologists wanting to stay at the top of their game and profit from the opportunities unfolding in personalized medicine and vivo/in vitro integration should register to attend Molecular Summit 2009. This year’s top-flight event has a distinguished faculty of 27 international experts and covers the spectrum of advanced molecular diagnostics, imaging, and informatics. Unique case studies provide attendees with everything they need to know to advance their molecular skills and tap new sources of patient referrals and income.

Register today and guarantee your place at this important event for pathology and radiology! The full agenda and speaker line-up for Molecular Summit 2009 on February 10-11 can be viewed here (or paste this URL into your browser: http://www.molecular-summit.com/program.htm )

Visit http://www.molecular-summit.com

Download Full Program Brochure

Four Easy Ways to Register:
1. Register ONLINE
2. Call 800-560-6363. Our friendly staff can register you quickly and easily, as well as answer any questions you may have.
3. Fax this complete registration form to 512-264-0969
4. Mail the one page register form with payment to:

THE DARK REPORT
21806 Briarcliff Dr.
Spicewood, TX 78669

;