Category Archives: C. diff. for Healthcare Providers

SYN-004 (ribaxamase) For C. difficile Prevention Advances; U.S. Food and Drug Administration (FDA) Has Granted A Breakthrough Therapy Designation

On May 11, 2017 Synthetic Biologics, Inc. a late-stage clinical company developing therapeutics that preserve the microbiome to protect and restore the health of patients, announced that the U.S. Food and Drug Administration (FDA) has granted a Breakthrough Therapy Designation for SYN-004 (ribaxamase) for the prevention of Clostridium difficile infection.

SYN-004 (ribaxamase) is the Company’s first-in-class oral enzyme designed to protect the gut microbiome from disruption caused by certain intravenous (IV) beta-lactam antibiotics.

The Breakthrough Therapy Designation is based on data from the successful Phase 2b clinical trial of ribaxamase, which met its primary endpoint of significantly reducing CDI. FDA Breakthrough Therapy Designation is intended to expedite development and review timelines when preliminary clinical evidence indicates that a drug may demonstrate substantial improvement on one or more clinically significant endpoints over available therapies for serious or life threatening diseases. If approved by the FDA, SYN-004 (ribaxamase) would be the first available drug designed to prevent Clostridium difficile infection by protecting the gut microbiome from antibiotic-mediated dysbiosis.

“We are delighted by the FDA’s recognition of ribaxamase’s potential to prevent CDI, and the dire need to fill the current void of an approved intervention,” said Jeffrey Riley, President and Chief Executive Officer. “Following this announcement, we have been asked and anticipate requesting a Type-B multidisciplinary meeting with the Agency for a comprehensive discussion on the overarching, high-level drug development plan and pathway to licensure for ribaxamase. We look forward to working closely with the FDA throughout the development and review process and remain dedicated to bringing this potentially paradigm-shifting approach to antibiotic therapy to patients in critical need.”

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C. diff. Spores and More Global Broadcasting Network 

www.cdiffradio.com

Protecting the Gut Microbiome: A Paradigm Shift in Managing GI Disorders

Live Broadcast On Tuesday, May 16th Join us with our guest, Dr. Joseph Sliman, MD, MPH, Chief Medical Officer of Synthetic Biologics.  Dr. Sliman will be discussing  the protection of the natural gut microbiome from the unintended consequences of intravenous (IV) antibiotics which are excreted into the gut is expected to protect against opportunistic enteric infections. Synthetic Biologics is developing two microbiome-focused drug candidates in Phase 3 development including, SYN-004 (ribaxamase) which is designed to protect the gut microbiome by degrading certain IV beta-lactam antibiotics for the prevention of Clostridium difficile infection (CDI), pathogenic
overgrowth and the emergence of antimicrobial resistance, and SYN-010 which is intended to reduce the impact of methane producing organisms in the gut microbiome to treat an underlying cause of irritable bowel syndrome with constipation (IBS-C).

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To learn more about Synthetic Biologics, please click on the link provided below

.http://www.syntheticbiologics.com/about/overview

Source:  Synthetic Biologics

Synthetic Biologics – Protecting the Gut Microbiome: A Paradigm Shift in Managing GI Disorders

Two UK Researchers, Prof.Alistair Leanord and Dr. David Enoch, Present CDI Data At the 27th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID)

Repeated infection with the bacterium Clostridium difficile (C. difficile, C.diff.), which causes abdominal pain, fever, diarrhea is linked to higher death rates, as well as having a significant impact on health services in terms of cost and hospital beds occupied.

In the first of two presentations at the 27th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) (tomorrow (Saturday), Professor Alistair Leanord, from Glasgow University, UK, will say that in Scotland the extra impact on the health service from C. difficile infections amounted to 10,600 bed days a year. “This is the equivalent to a 30-bed hospital ward being fully occupied all year,” he will say.

He will tell the congress that the (median) average cost of a patient with C. difficile infection was £7,500 (€8,600 approximately) compared to £2,800 (€3,200 approx) for patients with other medical conditions. In Scotland over a one year period, from October 2015 to October 2016, there were 1,150 cases of C. difficile infection in patients aged 15 and over. This cost the National Health Service (NHS) in Scotland a total of £8,650,000. Out of this amount, the additional costs of treating C. difficile infection, over and above the basic cost of a hospital bed and normal medical care, was £1,955,000. The calculations were carried out at Strathclyde University, which is part of the Scottish Healthcare Associated Infection Prevention Institute (SHAIPI) research consortium.

Until now, little has been known about the impact on health service resources from C. difficile infections, and on patients in terms of recurrence of infection, readmission to hospital, length of stay and death rates.

Prof. Leanord and his colleagues in Scotland identified 3,304 patients with C. difficile in Scottish hospitals between 2010 and 2013 and matched them with 9,516 patients who did not have the infection (the control group). Approximately two-thirds of the C. difficile patients acquired the infection in hospital.

They found that patients with C. difficile infection had more than double the risk of dying from any cause within two months of being admitted to hospital; nearly a third of all C. difficile cases (29%) died within two months compared to 14% of patients in the control group. Patients with C. difficile stayed in hospital a (median) average 9.7 days longer than the patients without the infection. Of the 1,712 C. difficile patients who were discharged from hospital within 30 days of the first episode of infection, 59% were readmitted within six months; of the 626 cases discharged more than 30 days after the first episode 53% were readmitted within six months. Few of these re-admissions were directly related to C. difficile infection.

“However, nearly a sixth of patients (14%) who were cured of the initial infection recurred within three months, and nearly one third of them (29%) had a second recurrence within a year,” says Prof. Leanord.

Older people were more vulnerable to a recurrence. Among the patients with C. difficile infection, 22% were aged 85 or over, and patients aged 75 and over had approximately double the risk of a recurrence of the infection compared to those aged under 65. Patients aged between 65-74 had 1.5 times the risk of recurrence compared to younger patients.

Prof. Leanord will conclude: “Having a clear understanding of the nature of C. difficile infections in Scotland will allow the Scottish government to target resources at the most appropriate patients to try to reduce the overall burden of the disease on the health service. Our findings are very likely to be applicable to the rest of the UK and other countries as well.”

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In a second presentation on Saturday, Dr David Enoch, a consultant microbiologist and infection control doctor at the National Infection Service, Public Health England, Cambridge (UK), will report the outcomes of 6,874 patients who had acquired C. difficile infection in hospital between 2002 and 2013 in England. Of these, 1,141 (16.6%) had recurrences of the infection.

“We found that 49% of hospital patients who suffer a recurrent episode of C. difficile infection die within a year, compared to 38% of those who suffer an initial infection only,” he will say. “In addition, 21% of patients with a recurrence suffered other complications as well, such as dehydration, malnourished and sometimes even perforation of the bowel, compared to 18% of patients who did not have a recurrence.”

Dr Enoch estimates that there are approximately 125,000 cases of C. difficile infection in Europe each year, and between 15-30% of these recur. “Cases in the UK have been coming down since 2008, which is most probably due to improvements in antibiotic prescribing and cleaning regimens in hospitals. This is encouraging but more still needs to be done.”

The average age of the patients was 77 and the average length of stay in hospital was 38 days.

“The main risk factor for developing C. difficile infection is prior antibiotic use. These patients are often already ill from some other underlying illness, which explains why they needed antibiotics in the first place. Older people are at greater risk of C. difficile infection as they are often sicker, have other illnesses or conditions, and so need more antibiotics,” he will say.

Dr Enoch continues: “Although much has been done, particularly in the UK, to try to prevent C. difficile infection, strict adherence to antibiotic guidelines by clinicians and thorough cleaning of the hospital environment are crucial in ensuring that patients don’t develop C. difficile infection in the first place. Treatment with a new drug called fidaxomicin has also been shown to reduce the risk of recurrence in patients who are unfortunate enough to develop an infection. However, we still have a lot to learn, particularly about how C. difficile infection occurs in the community, and how best to treat it.”

Treatments for recurrences of C. difficile infection  —–  include stopping the antibiotic that made the patient susceptible to the infection and starting a different antibiotic that is effective against C. difficile infection. These antibiotics include metronidazole, vancomycin and fidaxomicin. Supportive therapy, such as extra fluids, and surgery in serious or life-threatening cases may also be necessary. Faecal transplantation is emerging as a promising option; this is a process in which the good bacteria that the gut needs but which has been killed off by antibiotics is transplanted into the patient from a healthy donor.

(CDF:  Consider contacting an organization conducting Clinical Trials to Treat and Prevent.  Click on the following link for more information :  https://cdifffoundation.org/clinical-trials-2/

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Abstract no: #1672, presented by Prof. Alistair Leanord in the “Clostridium difficile infections: epidemiology and outcome” oral session, 16.30-18.30 hrs, Saturday 22 April, Hall A.

Abstract no: #883, presented by Dr Enoch in the “Clostridium difficile: guts and glory” e-poster mini-oral session, 15.30-16.30 hrs, Saturday 22 April, ePoster Arena 4.

 

To read the article in its entirety – please click on the following link:

https://www.eurekalert.org/pub_releases/2017-04/esoc-cdi041917.php

Clostridium difficile Infection More Prevalent In Patients Undergoing Allogeneic Stem Cell Transplantation

Clostridium difficile infection was more prevalent in patients undergoing allogeneic stem cell transplantation compared with patients undergoing autologous stem cell transplantation, according to findings published in Infection Control & Hospital Epidemiology.

 

C. difficile infection is the most common cause of infectious diarrhea in hospitalized patients,” Nishi N. Shah, MD, MPH, resident at the University of Arkansas for Medical Sciences, Little Rock, Arkansas and colleagues wrote. “Epidemiological studies evaluating the incidence of and morbidity and mortality due to C. difficile infection in hematopoietic stem cell transplant recipients are limited.”

To read the article in its entirety, please click on the following link:

http://www.healio.com/infectious-disease/nosocomial-infections/news/in-the-journals/%7B889c4781-fda5-43e5-84ce-629cf3692f57%7D/cdi-more-prevalent-in-allogeneic-stem-cell-recipients

The researchers reviewed patient data from the NIS database, analyzing records on adults admitted for allogeneic stem cell transplantation (n = 33,189) and autologous stem cell transplantation (n = 53,072) between January 2001, and December 2010.

Most patients had received autologous stem cell transplantation (61.5%). Of patients in the allogeneic group, 8.5% had C. difficile infection, compared with 5.8% in the autologous group, the researchers reported. Shah and colleagues wrote that univariate analyses identified a number of risk factors for C. difficile infection, including: age, gender, indication for stem cell transplantation, radiation as part of the conditioning regimen, respiratory failure, septicemia and lengthy hospital stay.

Multivariate analyses for autologous transplantation showed significant correlation between age and indication for transplant, but this indication was not associated with C. difficile infection in either group upon multivariate analysis.

Through multivariate analysis, the researchers found multiple factors associated with C. difficile infection: septicemia (autologous OR = 1.64; 95% CI, 1.35-2; allogeneic OR = 1.69; 95% CI, 1.36-2.1), male gender (autologous OR = 1.29; 95% CI, 1.09-1.53; allogeneic OR = 1.36; 95% CI, 1.18-1.57), lengthy hospital stay (autologous OR = 2.81; 95% CI, 2.29-3.45; allogeneic OR = 2.63; 95% CI, 2.15-3.22) and presence of multiple comorbidities (autologous OR = 1.32; 95% CI, 1.11-1.57; allogeneic OR = 1.18; 95% CI, 1-1.4).

“The current study helps identify higher risk groups for such clinical interventions. Among allogeneic stem cell transplantation recipients, interventions to reduce or treat gut GVHD could also impact C. difficile infection rates,” the researchers wrote. “Many topics of study remain to be explored in the prevention of C. difficile infection among stem cell transplantation patients. Certainly, further interventions to improve outcomes, such as reducing the rate of C. difficile infection, are needed.” – by Andy Polhamus

Rebiotix Reports Topline Results From a Controlled Open-label Phase 2 Trial of RBX2660 (PUNCH™ Open Label) For the Prevention of Recurrent Clostridium difficile (C. diff.) Infection (rCDI)

In The News

April 2017

 

 

Rebiotix Inc., a clinical-stage microbiome company focused on harnessing the power of the human microbiome to treat challenging diseases, today announced topline results from a controlled open-label Phase 2 trial of RBX2660 (PUNCH™ Open Label) for the prevention of recurrent Clostridium difficile (C. diff.) infection.

Data indicated that RBX2660 was well-tolerated and achieved the primary efficacy endpoint of preventing C. diff. recurrence; patients treated with RBX2660 exhibited a treatment success rate of 78.8% compared with a historical control of 51.8% (p<0.0001). RBX2660 is a broad-spectrum microbiota suspension that is designed to rehabilitate the human microbiome by delivering live microbes into a patient’s intestinal tract to treat disease.

Lee Jones, president and CEO of Rebiotix, stated, “The 78.8% treatment success achieved in this open label Phase 2 trial demonstrates the potential of RBX2660, a broad spectrum microbiota drug product, to rehabilitate the gut microbiome and break the cycle of C. diff. recurrence. These results, coupled with the safety and efficacy data observed in our prior Phase 2b and Phase 2 clinical trials, position Rebiotix to advance RBX2660 into Phase 3 clinical development, solidifying our standing as the most clinically advanced microbiome company in the industry.”

PUNCH™ Open Label was designed as a prospective, multicenter, open-label, controlled Phase 2 study to assess the efficacy and safety of RBX2660 for the prevention of recurrent C. diff.

The primary efficacy endpoint involved a comparison of patients treated with RBX2660 to a closely matched set of antibiotic only treated historical controls through 56 days. There were 31 active treatment sites and four control sites in the US and Canada. 132 RBX2660 and 110 historical control subjects were included in this topline analysis.

Actively treated patients, after determining eligibility, were administered two doses of RBX2660; the first at day one and the second at day seven. Patients were then monitored for eight weeks to determine whether there was a recurrence of C. diff.

Top line results from the trial, which examined responses from 132 patients versus a historical control of 110 patients, indicated a treatment success rate of 78.8% as compared to a historical control of 51.8% (p<0.0001). Overall, RBX2660 was generally well-tolerated with the most commonly reported adverse events being gastrointestinal, including diarrhea, abdominal pain, flatulence, constipation and distension.


About Rebiotix Inc.

Rebiotix Inc. is a clinical-stage microbiome company focused on harnessing the power of the human microbiome to revolutionize the treatment of challenging diseases. Rebiotix is the most clinically advanced microbiome company in the industry, with its lead drug candidate, RBX2660, expected to enter Phase 3 clinical development for the prevention of recurrent Clostridium difficile (C. diff.) infection. Previously, RBX2660 was the subject of three Phase 2 trials in recurrent C. diff, including a Phase 2b randomized, double-blind, placebo-controlled trial (PUNCH™ CD2), with data indicating the drug was well-tolerated and demonstrated statistically significant treatment efficacy. RBX2660 has been granted Orphan Drug status, Fast Track status and Breakthrough Therapy Designation from the FDA for its potential to prevent recurrent C. diff. infection.

Rebiotix’s development pipeline includes multiple formulations targeting several disease indications and is built around its pioneering Microbiota Restoration Therapy (MRT) platform. MRT is a standardized, stabilized drug technology that is designed to rehabilitate the human microbiome by delivering a broad spectrum of live microbes into a patient’s intestinal tract via a ready-to-use and easy-to-administer format.

For More Information About C. difficile Clinical Trials In Progress : 

https://cdifffoundation.org/clinical-trials-2/

 

For more information on Rebiotix and its pipeline of human microbiome-directed therapies, visit www.rebiotix.com

 

Source:  Rebiotix 4/17

Clostidium difficile Most Recent Research Discussed By ASM and Dr. Alice Guh, MD, MPH of the CDC

Clostridium difficile is an increasingly important problem being faced by clinical microbiologists. From 1993 to 2009, incidence of C. difficile increased fourfold (85,700 cases increased to 336,600 cases) in the United States. Because of this, it has become a significant area of research, as researchers search for better antimicrobial therapies, diagnostic assays, and prevention tactics.   ASM recently invited Alice Guh, MD, MPH, of the Centers for Disease Control and Prevention, to present the most recent C. difficile research as part of the Hot Topics in Clinical Microbiology series*. In her presentation, ‘Update on Clostridium difficile Infection’, Guh first describes the changing epidemiology of C. difficile infections (CDI), updating the data from the CDC’s Emerging Infections Program (EIP) and their long-term surveillance of CDI within the United States.

Guh further reviews current CDI diagnostic testing and its associated challenges. She highlights the benefits and downfalls of traditional enzyme immunoassay to detect C. difficile toxins compared to the nucleic acid amplification tests (NAAT) first put to widespread use in 2009.

Finally, Guh describes the role of asymptomatic carriers in C. difficile transmission. Her review of the literature presents best practices to trace transmission from asymptomatic carriers as well as suggested strategies to stop this transmission.

To read the article in its entirety please click on the following link:

https://www.asm.org/index.php/clinmicro-blog/item/6264-hot-topics-in-clinical-microbiology-clostridium-difficile

 

Clostridium difficile Diagnostic Testing Ranging From Most Sensitive to Lower End Sensitivity

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Clostridium difficile Diagnostic Testing and C.diff. Background Information

 

 

Background:

According to the CDC statistic reporting 2015, there are 453,000 CDI cases diagnosed each year. 2/3 of the cases are Inpatient HAI only 24% have hospital onset, 23% Long-term care, 18% post discharge.

Rate of Colectomies have increased as high as 6.2% in epidemic periods.

CDI extends inpatient hospital stays by 2.3 to 12 days increasing financial burden by $2,454 to $27,160 EACH CASE.

More than 82% or 8 in 10 individuals are diagnosed with Community-associated CDI and had a recent healthcare exposure such as a Doctor’s office or Dentist office visit within 12 weeks time.

Each Year – 29k patients newly diagnosed with a CDI die within 30 days of a CDI (mostly senior population) 14k patients die each year from a CDI involvement.

Each Year – 83k patients are being treated for Recurrent CDI within 8 weeks of initial onset.

The most prevalent Clostridium strain today is the B1/NAP1/027 – the Hypervirulent Strain vs the 078 strain which was the typical strain.

027 Ribotype is the largest recorded outbreak and fatalities .  Mode of transmission remains the same – Fecal to Oral route transmission and lives on inanimate objects and surfaces longer than 6 months.

According to researchers Merrigan and colleagues (https://www.ncbi.nlm.nih.gov/pubmed/20675495)

Examined the accumulation of spores over the bacterial growth cycle and demonstrated that hypervirulent strains sporulated earlier and accumulated significantly more spores per total volume of culture than non-hypervirulent strains (078).  This increased rate of sporulation may explain the observation of unusually high relapse rates associated with hyupervirulent strains because patients are more likely to contaminate their local environment and subsequently re-infect themselves.  More research needs to be done to confirm this theory and it remains contentious.

Diagnostic Testing – Clostridium difficile (C.diff.):

There are a number of diagnostics and studies continue to create debate and discussions about CDI testing and diagnosis and the connection between testing methods and clinical outcomes.

Per studies and research by Dr.’s Dale Gerding, MD, Dr. M. Thomas, Jr.MD, Dr. Clifford McDonald in January 2016 the Diagnosis and Treatment of Clostridium difficile Infection   Gerding, Dale N. MD*†; File, Thomas M. Jr MD, MSc‡§; McDonald, L. Clifford MD

Infectious Diseases in Clinical Practice: January 2016 – Volume 24 – Issue 1 – p 3–10 doi: 10.1097/IPC.0000000000000350 NFID Clinical Updates

A 2006 survey found that the most common lab test for CDI diagnosis was EIA (Enzyme Immunoassay) for toxins A and B.  48-96 Hours turn around time. 

Found to generate false positives and false negative results.

Today PCR is by far the most common test. It became available for laboratory diagnosis C.diff. associated diarrhea (CDAD) and colitis in 2010.

>PCR = Polymerase Chain Reaction with a 1 day turn around.

>Proven sensitivity of 100%,,  96.9% A/B specific accuracy and superior to A/B EIA testing.

  • The MOST Sensitive test in use today is Culture plus Toxin Confirmation, but it is too SLOW to be of practical use.
  • Nucleic Acid Amplification Test –This test may lead to over diagnosing by detecting colonized patient with diarrhea from another cause (viral or other ).
  • Glutamate dehydrogenase EIA is very sensitive but not specific and cell cytotoxin is also too slow for practical use today.
  • At the lower end of sensitivity are toxins A and B EIA, toxin A  EIA,  GDH latex test, and endoscopy, which is approximately 50% sensitive.

Summary:

If Labs have no clinical input and accept any unformed stool for testing, it may be most appropriate to use a test that better identifies CDI such as a relatively sensitive test for toxin in the stool (eg., cell cytotoxin or GDH = Glutamate dehydrogenase,  coupled with EIA for toxin).

If patients are screened carefully for clinical symptoms associated with a CDI (at least 3 unformed stools within 24 hours plus a history of antibiotic therapy) then a highly sensitive test such as the NAAT or a toxigenic culture, or GDH plus toxin detection may be best.

Neither approaches have been established today – appropriate testing strategy remains a dilemma.

Clinicians should be aware of the test being used in their laboratories. 

 >If a NAAT = Nucleic Acid Amplification Test  (PCR=Polymerase Chain Reaction or LAMP = Loop Mediated Isothermal Amplification) is being used, then they should recognize the potential for over diagnosis, especially if the specimens are sent from patients with minimal diarrhea.

>If EIA toxin testing is being used, it is more likely that a positive test represents CDI, but EIA testing yields FALSE negatives in patients with CDI due to the lack of sensitivity.

A less complicated breakdown of diagnostic testing:

Cultures:  Stool culture for C. diff.  most sensitive test available. 48-96 hours turn around.

Molecular tests:  FDA approved PCR assays, test for the gene encoding toxin B, are highly sensitive and specific for the presence of a toxin-producing Clostridium difficile organism.

Antigen detection:  rapid tests – less than 1 hour – detect presence of C. diff. antigen by latex agglutination or Immunochromatographic assays.  (used often in ER).

Toxin testing – tissue culture cytotoxicity assay detects toxin B only. Costly and requires 24-48 hours for final result. Historical gold standard for diagnosing clinical significant disease caused by C. diff. it is recognized as less sensitive than PCR or culture for detecting the organism in patients with CDI symptoms.

Enzyme immunoassay detects toxin A , toxin B  or both A and B.  Due to concerns overtoxin A-negative, B-positive strains causing disease, most laboratories employ a toxin B only or A and B assay.  Because these are same day assays that are relatively inexpensive and easy to perform, they are popular with clinical labs. There are increasing concerns about their relative insensitivity – less than tissue culture cytotoxicity and much less than the PCR or toxigenic culture.

C. diff. toxin is very unstable. The toxin degrades at room temperature and may be undetectable within 2 hours after collection of a specimen.

False-negative results occur when specimens are not properly tested or kept refrigerated until the testing can be done.

To learn more about how to collect and transport stool specimens to the laboratory click on the link below:

https://cdifffoundation.org/2015/06/17/c-difficile-laboratory-test-information-for-patients-and-healthcare-providers/

Home Health Care Information for Both Physicians and Patients

What is Home Health Care?

At its basic level, “home health care” means exactly what it sounds like – medical care provided in a patient’s home. Home health care can include a range of  care given by skilled medical professionals, including skilled nursing care, physical therapy, occupational therapy and speech therapy. Home health care can also include skilled, non-medical care, such as medical social services or assistance with daily personal activities provided by a highly qualified home health aide.

As the Medicare program describes, home health care is unique as a care setting not only because the care is provided in the home, but the care itself is “usually less expensive, more convenient, and just as effective” as care given in a hospital or skilled nursing facility.

When we say “home care” a common thought is senior care.  However; in  today’s society wellness draining diagnosis occur in every age group. Some of the more chronic, long-term illnesses greatly benefit from receiving home health care vs extended stays in acute care facilities and other health care in-patient services depending upon individual living situations and over-all health conditions.

Who qualifies for Home Health Care?

Each individual must contact their insurance provider to inquire about this skilled care provided within their home.  There may be co-pays per visit, limitations of the number of visits per episode and per calendar year, there may additional stipulations and should be understood by the patient and their families prior to discussing with a Medicare enrolled Physician.

To be eligible for Medicare home health services a patient must have Medicare Part A

and/or Part B.

To  be eligible for Home Health Care Services: (1)

  • Be confined to home.
  • Need Skilled Services.
  • Be Under the Care Of a Medicare -enrolled Physician.
  • Receive Services Under a Plan Of Care Established and Reviewed by a Physician and Have Had a Face-to-Face Encounter With a Physician or Allowed Non-Physician Practioner (NPP).  Care Must Be Furnished By or Under Arrangements Made by A Medicare-Participating Home  Home Health Agency (HHA).
  • Patient Eligibility—Confined to Home
    Section 1814(a) and Section 1835(a)
    of the Act specify that an

    individual is considered
    confined to the home” (homebound) if the following two criteria are met:
    First Criteria: One of the Following must be met:
    1. Because of illness or injury, the individual needs the aid of supportive devices such as crutches, canes, wheelchairs, and walkers; the use of special transportation; or the
    assistance of another person to leave their place of residence
    2.  Have a condition such that leaving his or her home is medically contraindicated.

    Second Criteria Both of the following must be met:
    1. There must exist a normal inability to leave home.
    2. Leaving home must require a considerable and taxing effort.

     

     

    Home Health Aids May Be Included In the Home Health Care Assessment and Assigned To Assist With Personal Care – Activities of Daily Living  (ADL’s), Bathing, Feeding, Dressing, and Walking.

    To learn more about Home Health Care Nursing and being treated in the home environment, listen to Linda Jablonski, MS, BSN, RN-BC – Director of Nursing Home Health.   Click on the C.diff. radio logo below to listen to the podcast.

    cdiffRadioLogoMarch2015

 

 

 

 

 

Sources:

(1) CMS  (article se1436)  https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/se1436.pdf