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Clinical Laboratories and Pathology Groups

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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

Anthem Blue Cross Blue Shield of Georgia Drops Coverage for Non-Emergency ER Visits; Medical Laboratories Could See Drop in ER Clinical Lab Test Orders

Experts concerned people will be unable to judge a true emergency from a minor health concern; patients could be left with a big ER bill if they are wrong

Here’s a groundbreaking way payers are keeping healthcare costs down: Anthem Blue Cross and Blue Shield (BCBS) of Georgia sent letters to its members in May informing them that they will no longer be reimbursed by the insurer for “non-emergency” related services obtained in emergency rooms (ERs).

Pathology groups and medical laboratory leaders, will want to monitor and potentially respond to this important emergency coverage development. Hospital-based medical laboratories receive high volumes of test orders from the ER. Any decline in ER visits from a payer policy like this will have staffing and budget implications for hospital labs.

Medical Groups Warn of Dire Consequences

The new policy garnered national media coverage in addition to local exposure in Georgia, where it went into effect on July 1. BCBS affiliates in New York, Missouri, and Kentucky are considering similar policies as well, noted an article in The Fiscal Times.

“Anthem believes that primary care doctors are in the best position to have a comprehensive view of their patient’s health status and should be the first medical professionals patients see with any non-emergency medical concerns,” Anthem stated in the Fiscal Times article.

In its letter, BCBS of Georgia defines an emergency as a “medical or behavioral health condition of recent onset” that a “prudent layperson” deems health-threatening. However, many symptoms, such as chest pain, can lead to sudden death. How is the average person to know if what they are experiencing will turn out to be angina, a painful but often non-fatal condition, and not a life-threatening embolism?

“The prudent layperson standard requires that insurance coverage is based on a patient’s symptoms, not their final diagnosis,” the American College of Emergency Physicians (ACEP) in Georgia explained in its own statement.

“Anyone who seeks emergency care suffering from symptoms that appear to be an emergency, such as chest pain, should not be denied coverage if the final diagnosis does not turn out to be an emergency,” the ACEP concluded.

Are Patients Able to Judge Where They Should Go?

Some experts warn that many people might be unable to judge the true nature of their conditions when under stress.

The ACEP and its Missouri Chapter said in a statement that Anthem BCBS lists almost 2,000 diagnoses it considers to be “non-urgent” and not covered in the ER. The professional organization contends, however, that some of the diagnoses on the insurer’s list have the propensity to be medical emergency symptoms as well.

Two examples ACEP noted are:

However, cold symptoms, sore throat, physical exams, and minor injuries are among the complaints best addressed by walk-in clinics or urgent care centers, BCBS explained in a blog article.

Nevertheless, Debbie Diamond, Public Relations Director for BCBS of Georgia, told The Fiscal Times that a person who mistakes indigestion for chest pain is likely to be covered for ER care (in keeping with prudent layperson guidance).

Distinguishing Between Necessary and Unnecessary ER Visits

It’s not always simple to recognize an emergency from a non-emergency. Even emergency medicine professionals often have difficulty doing so.

In a Los Angeles Times article, Renee Hsia, MD, Professor and Director of Health Policy Studies, Department of Emergency Medicine at the University of California San Francisco School of Medicine, noted that, “People don’t come with a sticker on their forehead saying what the diagnosis is. We as physicians can’t always distinguish necessary from unnecessary visits.”

 

Renee Hsia, MD

Renee Hsia, MD (above), is Professor and Director of Health Policy Studies, Department of Emergency Medicine at the University of California School of Medicine, San Francisco (UCSF). She told the Los Angeles Times that the Blue Cross Blue Shield of Georgia emergency coverage policy is a “well-intentioned policy with dangerous consequences.” (Photo copyright: Angie’s List/Adm Golub.)

According to the Centers for Disease Control and Prevention, there are 130.4 million emergency department visits each year in the US. A study published in the Journal of the American Medical Association (JAMA) Journal of Internal Medicine found that six of the 10 top symptoms that send people to non-emergency care settings match those driving decisions to head to emergency departments as well. They include:

  1. Back symptoms;
  2. Abdominal pain;
  3. Sore throat;
  4. Headache;
  5. Chest pain; and
  6. Low back pain.

“Our findings indicate that either patients or healthcare professionals do entertain a degree of uncertainty that requires further evaluation before diagnosis,” the authors wrote in JAMA.

Where Next? Who’s Next?

Despite the discord over the reduction in non-emergency coverage, more BCBS affiliates may soon adopt the same policy. And what of other large insurers? Might they be watching and considering whether to alter their emergency coverage, as well, to save money?

Thus, clinical laboratories in Georgia hospitals will want to closely monitor their institution’s ER test volume. It could take a while for Blue Cross patients in Georgia to realize that some ER visits (and the clinical laboratory tests associated with them) might not be covered by their insurance. This will happen in instances where their insurer denies claims for services that, in Anthem’s opinion, were better suited for primary care doctors and urgent care centers rather than ERs.

—Donna Marie Pocius

 

Related Information:

Got Chess Pain? This Insurer May Not Cover Your Emergency Room Visit

Blue Cross in Georgia to Limit Emergency Room Coverage

Choosing Between ER and Urgent Care

Blue Cross Blue Shield of Georgia Launch Emergency Room Policy

Emergency Physicians: Anthem Blue Cross Blue Shield Policy Violates Federal Law

Emergency Physicians: Georgia Blue Cross Blue Shield Policy Violates Federal Law

A Big Health Insurer is Planning to Punish Patients for Unnecessary ER Visits

Urgent Care Needs Among Non-Urgent Visits to the Emergency Department

Medical Scribes Move Outside the ER to Help Clinicians in Other Healthcare Settings Make the Switch From Paper Charts to EHRs

Scribe-assisted physicians say their productivity is back to normal after plummeting with connection to an EHR and have time to spare

One unintended consequence of the federal program to encourage hospitals and physicians to adopt and use electronic health record (EHRS) systems is the creation of a new category of healthcare worker. Today, a growing number of hospitals and medical groups are hiring medical scribes.

Medical scribes are trained individuals who document physician-patient encounters in real-time while a physician is examining the patient. Dark Daily was one of the first to call attention to this new healthcare profession. Medical scribes got their start several years ago working in emergency rooms (ER) to help increase ER physician productivity [See Dark Daily: Adoption of EMRs Creates Demand for New Healthcare Job of ‘Scribes’].

Now, thanks in part to $15.5 billion in federal funding under the American Recovery and Reinvestment Act of 2009, medical scribes are assisting physicians outside the ER. They can be found with doctors making hospital rounds and in medical practices, entering patient medical data into EHRs while physicians are examining or interacting with patients, noted a report published in Modern Healthcare. (more…)

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