Ebola Preparedness Guidelines May Have Come Too Late

In an urgent effort to warn hospital health care personnel about recognizing symptoms and patterns of the Ebola virus, CMS issued a survey and certification memorandum articulating the Centers for Disease Prevention and Control’s (CDC) health advisory alert to state survey agency directors. The CDC’s October 2, 2014, alert came days after a Liberian man died from the virus in Dallas, Texas, exposing health care workers and family members to the deadly disease.

The CDC outlined the following evaluative and preventive guidelines for hospitals and critical access hospitals (CAHs):

  • Increased awareness of those traveling from West Africa within a 21-day period for anyone with a fever or other Ebola symptoms;
  • Patient isolation into a private room with bathroom for anyone who has traveled to or from West Africa and exhibits Ebola symptoms;
  • Immediate notification to local and state health departments;
  • Use of appropriate personal protective equipment (PPE), including gowns, face mask, eye protection, and gloves;
  • Vigilant monitoring for Ebola infection symptoms such as fever greater than 100.4°F (38°C), severe headache, muscle pain, vomiting, diarrhea, abdominal pain, or unexplained hemorrhaging;
  • Knowledge of Ebola’s incubation period (typically 8 to 10 days, but can range from 2 to 21 days); and
  • Knowledge of patterns of exposure that are either high-risk (needle sticks, mucous membrane contact with blood or body fluids, and direct skin contact with, or exposure to blood or body fluids of, an infected patient) or low-risk (brief direct contact such as hand shaking or being around infected patients who have been in the care area for a prolonged period of time without wearing proper PPE).

CMS has been urging hospitals and CAHs to immediately adopt these procedures, particularly in their emergency and other outpatient departments. Following protocol is key, since two hospital care givers who treated the Liberian man, Thomas Eric Duncan, have contracted Ebola. One of the health care workers was a 26-year-old nurse who provided care that included invasive dialysis procedures and use of a ventilator during Duncan’s hospital stay.

The protocols, however, may not be enough. CNN reported that Texas Health Presbyterian Hospital Dallas nurses have complained that guidance continually changed, and there were no up-to-date protocols available when Duncan was at the hospital. The nurses claim that Duncan was left in an open area, that their PPE exposed their necks, and there was no mandate for them to attend training. Further, the second 29-year-old nurse flew the next day between Cleveland and Texas after treating Duncan.

Regarding the infected nurse, the Washington Post reported on October 14, 2014, that CDC director Tom Frieden affirmed that a “breach in protocol resulted in this infection.”

The CMS memorandum provided a link to an Ebola detection checklist, but it is not mandatory or federally regulated. The checklist covers review of triage procedures, post-screening criteria, adequate training, and preparation of isolation, quarantine, and exposure reports. CMS also cited the CDC’s website for updates to affected countries, but again, the memorandum was issued days after Duncan’s visit.

The CDC and CMS will need to move faster as any changes in guidance arise. Whether current protocols will contain the Ebola virus remains to be seen, as it is likely more health care workers at the Dallas hospital will contract the disease.



Kusserow’s Corner: Extendicare Health DOJ Settlement of $38 Million and Five-Year Quality of Care CIA with the OIG

The Department of Justice (DOJ) announced the largest “failure of care” settlement with a chain-wide skilled nursing facility (SNF) in the Department’s history. Extendicare Health Services, Inc. (Extendicare) and its subsidiary ProStep entered into a settlement with the DOJ and agreed to pay $38 million to resolve allegations that they billed Medicare and Medicaid for materially substandard nursing services that were so deficient that they were effectively worthless, and billed Medicare for medically unreasonable and unnecessary rehabilitation therapy services in 33 of its skilled nursing homes in eight states (Indiana, Kentucky, Michigan, Minnesota, Ohio, Pennsylvania, Washington, and Wisconsin). Overall, the chain provides services at 146 facilities in 11 states.

Two Relators brought separate cases against Extendicare; they will receive more than $2 million as their share of the recovery. [See United States ex rel. Lovvorn v. EHSI, et. al. C.A. 10-1580 (E.D. Pa) and United States ex rel. Gallick et al., v. EHSI et al., C.A. 2:13cv-092 (S.D. Ohio)].

Extendicare also will enter into a five-year chain-wide Quality of Care Corporate Integrity Agreement with the HHS Office of Inspector General (OIG) under which they must have a comprehensive compliance program with systems to address the quality of resident care. The compliance program must include, among other things, corporate-level committees to address compliance and quality, including a committee to assess staffing, and an internal audit program to assess the quality of care provided to residents. Extendicare must retain an independent monitor, selected by the OIG, who will regularly visit Extendicare’s facilities and report to the OIG, along with an Independent Review Organization (IRO) that will perform annual reviews of claims to Medicare.

This case is particularly significant in the fact that the fraud charges resolved by the settlement were for billing for sub-standard care. It helps set precedents for taking actions against other providers who provide services that did not measure up to quality of care standards. The DOJ allegations focused on the fact that Medicare and Medicaid were billed for materially substandard nursing services. They alleged that the services were so deficient that they were effectively worthless, and that Extendicare billed Medicare for medically unreasonable and unnecessary rehabilitation therapy services, meaning the claims were in fact false and fraudulent.

Richard P. Kusserow served as DHHS Inspector General for 11 years. He currently is CEO of Strategic Management Services, LLC (SM), a firm that has assisted more than 3,000 organizations and entities with compliance related matters. The SM sister company, CRC, provides a wide range of compliance tools including sanction-screening.

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Copyright © 2014 Strategic Management Services, LLC. Published with permission.

SNFs to Report More Data to Nursing Home Compare

A number of enhancements and additional reporting requirements to the Five-Star Quality Rating System for skilled nursing facilities (SNFs) have been announced by CMS. The enhancements have to do with better collection of data regarding: (1) SNF staffing; (2) the use of antipsychotic medications; (3) state maintenance of quality reporting websites; and (4) a new scoring methodology for determining the number of stars a SNF receives on the Five-Star Quality Rating System. The majority of the enhancements are in response to requirements in the Patient Protection and Affordable Care Act (ACA) (P.L. 111-148) or the recently enacted Improving Medicare Post-Acute Care Transformation Act (IMPACT) of 2014, which was signed into law on October 6, 2014 (see New law to make an ‘IMPACT’ on quality of post-acute care, October 6, 2014). These changes were announced in conjunction with the release of a Proposed rule making changes to the conditions of participation for home health agencies (HHAs).

CMS launched the Nursing Home Compare Website in 2002 and the Five-Star Quality Rating System was added in 2008. These tools were designed to provide information to individuals and family members about the quality of care provided at SNFs. In 2011, section 6103 of the ACA required additional information to be added to the Nursing Home Compare Website and the Five-Star Quality Rating System.

Staffing Measurements

The ACA required CMS to collect more data on staffing at SNFs. To meet this requirement, CMS is announcing that it will implement a quarterly electronic reporting system that is connected to payroll systems to verify staffing information. This new system, which was funded by IMPACT, will increase accuracy and timeliness of staffing data, said CMS. New quality measures based on staff turnover, retention, types of staffing and levels of different types of staffing will be able to be developed from this data. In addition, beginning in 2015, focused surveys will be administered to randomly selected SNFs to verify the staffing information and reported quality measures that are contained in the Five-Star Quality Rating System.

Antipsychotic Quality Measure

Beginning in January 2015, SNFs will have to report on the extent to which antipsychotic medications are being administered to residents. This is an enhancement to the posting of the use of antipsychotic medications in two instances as required in a July of 2012 enhancement. In addition, CMS plans to add quality measures that are derived from claims data that document rehospitalization and community discharge rates.

Revised Scoring Method

The methodology used to calculate each SNF’s quality measure rating, which is used to calculate the Five-Star Quality Rating on the Nursing Home Compare Website, will be revised during 2015. CMS is also strengthening an ACA requirement that requires states to maintain a user-friendly website for SNF quality data and survey results. In addition CMS plans on developing ways to help states complete inspections of nursing homes in a more timely and accurate manner so more of that data is used in the Five-Star Quality Rating System.

“Nursing homes are working to improve their quality, and we are improving how we measure that quality,” said Patrick Conway, M.D., deputy administrator for innovation and quality, and CMS’ chief medical officer. “We believe the improvements we are making to the Five Star system will add confidence that the reported improvements are genuine, are sustained, and are benefiting residents,” said Conway.

QIOs Helping to Prevent Readmissions and Improve Quality

When Quality Improvement Organizations (QIOs) and providers work together, the rate of hospital readmission is less than in areas where QIOs do not work with providers, according to the American Health Quality Association (AHQA). The data provided by the AHQA shows that this collaboration has prevented more than 95,000 hospitalization and 27,000 hospital readmissions among Medicare beneficiaries resulting in a cost savings of nearly $1 billion.  In addition, recent data shows that QIOs have helped improve care at nursing homes as well by reducing the uses of restraints and the rate at which pressure sores develop.

Readmission Reduction

From October 2010 to March 2013 readmission rates among Medicare beneficiaries declined by 13.22 percent when the provider worked with a QIO, reported the AHQA.  The readmission rate for Medicare beneficiaries for providers who did not work with a QIO declined by 12.55 percent.  Similarly the AHQA reported that overall hospital admissions for Medicare beneficiaries declined by 8.39 percent when the provider worked with a QIO as opposed to 8.12 percent reduction in hospital admissions for Medicare beneficiaries when the provider did not work with a QIO.

An earlier study in the Journal of the American Medical Association (JAMA) came to similar conclusions. That study found that rehospitalizations were cut in half when providers worked with QIOs. In these cases QIOs implemented strategies aimed at (1) developing effective community coalitions that work to help keep patients healthy; (2) develop standard transition process as patients move from one care setting to another; (3) transferring patient clinical information between providers in a timely fashion; and (4) helping patients and their family members become actively engaged in the transition from one care setting to another.   The study involved 6,800 hospitalizations and averted 1,800 rehospitalizations.


A QIO is usually a non-profit organization staffed by doctors trained in medical review;  ensures that services provided to Medicare beneficiaries are medically necessary, reasonable, effective, and economical; and that the services meet professionals accepted standards of care. QIOs have been around since the 1980’s and there is generally one QIO per state. QIOs, among other things, are required to establish Memoranda of Agreements with providers and health plans that are consistent with the goals of the Health Care Quality Improvement Program.  They are  also to implement quality improvement projects on a standardized set of quality indicators and initiate local projects to improve quality.

“QIOs work in close partnership with physicians, nurses, and other members of the interdisciplinary team across settings–forming a network that helps patients remain healthy long after they leave the hospital,” said Adrienne Mimms Vice President and Chief Medical Officer of Atlanta-based Alliant GMCF, the QIO for Georgia and president of the AHQA.

HAIs. A greater reduction in hospital acquired infections (HAIs) has been reported in areas where QIOs work with providers as well, according to the AHQA.  From February 2011 to August 2013, QIOs’ efforts resulted in a 53 percent reduction in central line associated blood stream infections.  In addition, hospitals that work with QIOs have reduced the total number of Medicare patient days in which a catheter was used by more that 85,000 days. A major source of HAIs is catheter associated urinary infections.

Improvements at Nursing Homes

In another QIO project the rate of pressure sore development in nursing homes has been dramatically reduced according to a report in McKnights. Nursing homes working with QIOs have achieved a 38 percent reduction in the rate of pressure sore development from 2011 to 2014.  The use of restraints in nursing homes working with QIOs has been reduced by 76 percent under a separate initiative involving 1,000 nursing facilities working with QIOs.

“As the rates of chronic disease increase and the baby boom generation ages, it’s essential that we improve the quality of health care provided to  America’s seniors,” said Todd Ketch, executive director of AHQA. “Quality Improvement Organizations have driven major improvements in the quality of care across the nation, and in the years ahead, our work with QIOs will focus on  coordinating patient care across settings, reducing health care associated infections, improving care for common conditions like diabetes and heart disease, and more,” said Patrick Conway, MD, MSc, Chief Medical Officer for CMS, and Deputy Administrator for Innovation and Quality.