The SIA allows hospitals to continue receiving CMS funding while a third-party monitors its policies, facilities, and patient care until the serious problems that caused them to fall out of compliance are fixed. The agreement grants the hospital additional time to make sustainable improvements in complex quality, cultural, policy, and procedural deficiencies.

The alternative to an SIA—Medicare Decertification—is to cut off CMS funding completely in as few as 23 days if the problem is not corrected.  For most hospitals, Medicare Decertification can close the hospital, as CMS funding may account for 40-70% of their revenue.

Termination can have serious detrimental effects on hospitals and the communities they serve. In the interest of ensuring the availability of health care services, such a heavy weapon is used reluctantly.

READ MORE: Systems Improvement Agreement

For immediate assistance with an Immediate Jeopardy situation or a Systems Improvement Agreement (SIA), contact Dr. Kate Fenner at 513-241-0142

This is an excerpt from the Compass Clinical Profile in Healthcare Leadership “A Fine Choice,” featuring Peter S. Fine, FACHE, Chief Executive Officer of Banner Health.

When Mr. Fine was hired to lead Banner Health in 2000, the newly-merged system was struggling with the chaos of clashing cultures and the complexities generated by the joined businesses. But, under his leadership, Banner – headquartered in Phoenix, Arizona – is now one of the largest not-for-profit, secular, multi-state systems in the country, generated $4.86 billion in revenue in 2009.

Dr. Kate Fenner: What’s ahead for Banner, your biggest challenge?

Peter Fine: Our main issues revolve around government structural regulations, reimbursement and the change in the business that’s going to occur in the next ten years because of healthcare reform. We’re going to have to adapt to those changes.

So we are doing a lot of talking around here about things like:

• Can we live with the new Medicare rates across all payor categories?
• How could we do that?
• How could or would we restructure our cost base to do that?
• Can we develop models in conjunction with physicians that can take on risk?
• And, most importantly, would we be prepared to do that?

A lot of activity, thinking and planning that is going on now is about structural changes—to respond to what we believe will be a highly tricky and dynamic business.

That does cause me to wake up at night.

For example, I think about the potential of getting penalized for something we had no intention of doing, but that we know happened—the potential of something going wrong.

Think about it. In this business, you basically have to be right every time, get a hit at every bat and score a touchdown on every drive. And, if you don’t, the regulators or auditors attack you for something that someone three levels down didn’t manage correctly.

For example, someone misses a contract being signed within two days. The penalty is to wipe out all of the revenues that doctor brought to your organization for the last two years?

Does that make sense?

But things like that are bound to happen. Not because someone was trying to do something devious or inappropriate, but simply because they just missed it.

The penalties and potential for mistakes are worrisome.

RELATED LINKS:

• Profile in Healthcare Leadership, “Building a Will to Quality,” featuring  Maureen Bisognano, CEO of The Institute for Healthcare Improvement (IHI).
• Profiles in Healthcare Leadership: An Interview with Jim Anderson

Our clinical experts are in the field every day at hospitals large and small. We’ve noticed an increase in regulatory scrutiny – especially among psychiatric hospitals. Frequent Immediate Jeopardy findings from CMS through contracted surveyors as well as evaluators from state agencies have been occurring. The survey process and outcomes demonstrate an increasing commitment by CMS to rigorously enforce compliance with the Conditions of Participation, particularly the special psychiatric conditions.

IMPLICATIONS

Regulatory scrutiny has the potential to be financially ruinious, and for many care providers, preparing for and responding to this scrutiny is a complicated and stressful process.

ASSISTANCE

Compass Clinical Consulting has assisted a range of clients—from freestanding psychiatric hospitals to state-sponsored institutions to general, acute-care hospitals—in successfully addressing clinical compliance challenges. We have supported our clients through all stages of CMS sanction: reinstatement after revocation, completion of Systems Improvement Agreements, Immediate Jeopardy responses, and preparation for survey.

100% RECOVERY RATE

As a result of our partnerships, our clients have experienced a 100% record of success in addressing the complex and sometimes confusing requirements of Medicare and Medicaid clinical compliance.

For more information or to discuss your organization’s concerns about clinical compliance, please contact Kate Fenner, RN, PhD, or Cary Gutbezahl, MD, at (513) 241.0142. We are here to help.

In the past, the only remedy for failure to cure an IJ within prescribed timelines was revocation of Medicare participation status—a devastating blow to a hospital’s financial and operational integrity. Recently, however, CMS has begun using a new method to gain compliance from hospitals with repeat or multiple IJ findings on complaint or validation surveys:  the Systems Improvement Agreement (SIA).

The SIA is a contract between the hospital and CMS that binds the hospital to engage in a series of improvement activities to address multiple deficiencies in compliance with the CoPs. The agreement grants the hospital additional time to make sustainable improvements in complex quality, cultural, policy, and procedural deficiencies.

Typically, the SIA has several additional features beyond curing an IJ finding, including the requirement for an outside monitor or agent to assess ongoing progress and the selection of a CMS-approved consultant to 1) assist the hospital in assessing compliance with all relevant CoPs; 2) develop a plan to address required improvements; 3) provide support for plan implementation; and 4) prepare the organization for survey of all CoPs by the designated agency using the Survey Operations Manual.

The SIA approach represents an intermediate step between full revocation of participation in Medicare/Medicaid and ongoing repeated surveys and corrective actions. As such, it gives CMS a mechanism for prompting large-scale organizational change in the face of noncompliance without the drastic move of revocation. Nevertheless, an SIA requires a significant commitment of organizational resources to making sustainable behavioral changes and maintaining a leadership focus to ensure compliance with the CoPs.

With a new weapon in the arsenal, CMS expectations for correcting deficiencies may quickly become more difficult to fulfill. As a result, expect to see more hospitals agreeing to SIAs.

For more information on Systems Improvement Agreements and how Compass Clinical Consulting is prepared to help your organization respond to this new tool, contact Cary D. Gutbezahl, MD at (513) 241.0142 or visit the Compass Clinical Consulting website.

The CoPs are black and white statements that define clinical and environmental minimum expectations that must be maintained at all times. Compliance with the CoPs is necessary to participate in Medicare and Medicaid. The focus of the CoPs—to ensure that care is provided in a consistently safe environment—is nothing fancy or particularly sophisticated. Nevertheless, dozens of hospitals fail to demonstrate compliance each month and, as a result, are confronted with the task of response and recovery, having to rapidly determine corrective actions to fix gaps in addressing the CoPs.

How does this happen? How can you prevent this crisis and resultant organizational disruption?

In our experience, threats of CMS termination often begin with what seems to be an insignificant occurrence—a perceived patient care error occurs, and an unhappy patient or family member or even a disgruntled staff member alerts CMS, either through a complaint to The Joint Commission or, more frequently, a grievance lodged with the state agency that contracts with CMS to provide CoP compliance oversight. Adverse coverage in local or regional news can also initiate scrutiny. Regardless, a regulatory agency inquiry results as a response to assure CMS that continued participation is merited.

And then the institutional scramble begins.

A CMS investigation of a complaint is a stressful and distracting process. Once in-house for an investigation, surveyors are expected to follow their findings and examine any or all potential CoP-related deficiencies. Consequently, a patient complaint about rough or rude treatment by a clinician might lead to an examination of restraint usage, emergency room management, or provision of behavioral health services.

Once the door to further examination has been opened, the surveyor will investigate any deviation that pops into view. Several institutions have found themselves responding to a series of inquiries and even Immediate Jeopardy (IJ) findings even though an initial investigation found little merit related to the original complaint because surveyors uncovered other condition-level findings.

The rule to follow:  because a survey is a potential show-stopper, there is no such thing as a minor clinical compliance issue.

Senior executives will not be able to personally and continuously monitor CoP compliance—this is why hospitals have Compliance and/or Performance Improvement functions. However, senior executives must establish the expectation that clinical compliance issues will be reported when discovered and that vigilance on patient grievances, unexpected clinical outcomes, and sentinel events (and near misses) will result in preparation for regulatory evaluation, as well as addressing systemic root causes.

Just as a financial auditor alerts the senior team of indications of divergence from accepted financial practices, compliance “auditors” should be sending alerts about clinical vulnerabilities. The organizational rule should be one of “no surprises” because when this is true, the organization is prepared to demonstrate its management of trigger events if  CMS scrutiny occurs.

A good practice for ensuring that senior executives are informed about clinical compliance is a monthly briefing of key indicators. An even better practice is conducting periodic CoP compliance audits and using key performance measures and reported incidents to uncover vulnerabilities.

It is said that the best defense is a good offense—staying vigilant to the potential triggers for survey, monitoring overall compliance, and ensuring smooth and efficient communication throughout leadership best prepares hospital for CMS, state agency, and accreditation scrutiny.

The IG also stated that state survey agencies and CMS must do a better job of alerting accrediting agencies to serious errors for the agency’s additional review. Dr. Donald Berwick, CMS Administrator, concurred with the IG’s recommendations and stated that improvements in oversight are being made.

What does this mean for hospitals?
Normally, one might question whether an IG report is going to result in substantive changes. But this time, the report made front-page news in USA Today. So don’t expect the story to go away without some CMS response.

Expect CMS to begin to pressure state survey authorities to conduct more hospital inspections. The Chicago Tribune story on Illinois’ failure to investigate most complaints will only add fuel to the fire. As a result, hospitals will receive additional state investigations for reported errors and patient complaints.

Although different states exhibit great variance in survey rigor—from the fairly rigorous and frequent oversight provided in California, Texas,  and North Carolina, to the less frequent or almost absent oversight reflected in other states—all state agencies will receive increased pressure from CMS to provide additional oversight and relay errors and concerns to the hospital’s appropriate accrediting agency:  the Joint Commission (TJC), the Healthcare Facility Accrediting Program (HFAP), and DNV.

How can hospitals prepare for this increase in oversight?
Identify your vulnerabilities by objectively assessing your compliance with the Conditions of Participation; monitor occurrences, complaints, and grievances; and rigorously track corrective actions and to ensure that they were implemented and effective. Every hospital can and should improve CMS compliance. Soon company may be coming, and failing to be diligent in assuring continuous compliance can be painful.

For additional information on improving CMS compliance, call Kate M. Fenner, RN, PhD, or Cary D. Gutbezahl, MD, at (513) 241.0142.

On September 10, 2010, the Institute for Safe Medication Practices (ISMP) published results of a survey of nurses in which they self-reported unsafe practices and work-arounds resulting from the 30-minute standard. In response to this survey, an interdisciplinary advisory group was formed, which published the Acute Care Guidelines for Timely Administration of Medication on May 19, 2011.

Based on these guidelines, CMS is updating the hospital interpretive guidance concerning the timing of medication administration, stating:

“Recognizing that it is no longer the standard of practice in the current hospital environment, we are removing reference to the so-called ‘30-minute rule’ in the survey procedures portion of the guidance, which had established a uniform 30-minute window before or after the scheduled time for all scheduled medication administration.”

Based on this statement, hospitals are expected to develop medication administration policies and procedures that take into account the nature of the prescribed medication, specific clinical application, and patient needs. At the least, the policies and procedures must address the following:

• Medications not eligible for scheduled dosing times— those medications that require exact or precise timing of administration, including but not limited to:
• Stat doses
• First time or loading doses
• One-time doses specifically timed for procedures
• Time-sequenced doses; doses timed for serum drug levels
• Investigational drugs
• Drugs prescribed on an as needed basis (prn doses)
• Medication eligible for scheduled dosing times—those medications prescribed on a repeated cycle of frequency.
  • Time-critical scheduled medications—those medications for which an early or late administration of greater than 30 minutes might cause harm or have a significant, negative impact on the intended therapeutic or pharmacological effect, including but not limited to:
    • Antibiotics
    • Anticoagulants
    • Insulin
    • Anticonvulsants
    • Immunosuppressive agents
    • Pain medication
    • Medications prescribed for administration within a specified period of time of the medication order
    • Medications that must be administered apart from other medications for optimal therapeutic effect
    • Medication prescribed more frequently than every four hours
• Non-time-critical scheduled medications—those medications for which a longer or shorter interval of time since the prior dose does not significantly change the medication’s therapeutic effect or otherwise cause harm.
  • Medications prescribed for daily, weekly, or monthly administration may be within two hours before or after the scheduled dosing time, for a total window that does not exceed four hours.
  • Medications prescribed more frequently than daily but no more frequently than every four hours may be administered within one hour before or after the scheduled dosing time, for a total window that does not exceed two hours.
  • Administration of eligible medication outside of their scheduled dosing times and windows. The policies and procedures must also identify the parameters within which nursing staff are allowed to use their own judgment regarding the rescheduling of missed or late doses, and when notification of the physician or other practitioner responsible for the care of the patient is required prior to rescheduling the medication.
  • Evaluation of medication administration timing policies, including adherence to these policies. Medication timing policies must periodically be evaluated to determine staff adherence to policies and whether they ensure safe and effective administration.  Medication errors related to the timing of medication administration must be tracked and analyzed to determine their causes. Based on medication errors and evaluation of the policies, the medical staff must consider whether there is a need to revise the policies.

Download the letter from CMS, the consolidation of Tag A-404 into Tag A-405, and the new wording of  Standard §482.23(c) Preparation and Administration of Drugs here.

For more information on regulatory standards, contact Shawna O’Neill, RN, MHA, at (513) 241.0142.

• The IM is a standard notice that must delivered to all Medicare inpatients on admission and before discharge.
• The IM form is an Office of Management and Budget (OMB) approved form and cannot be altered from its original form.
• The timeframe for the delivery of the form is clearly spelled out in the Condition of Participation (CoP) §482.13(a)(1), as illustrated in this table.
• The designee response for delivering the form is determined by the hospital and is usually performed by Registration, Case Management, Social Work, or Nursing.

It is important to remember that CMS requires 100% compliance, so organizations should hardwire the process.

The first step in hardwiring the process is to create and implement policies and procedures that define how the notification process will occur during every hospital day. Click here to download a sample policy that details the admission and discharge procedures and the discharge appeal process.

To ensure compliance, you must audit your performance. Most hospitals audit for compliance in their monthly closed medical record review, which enables the organization to monitor the timeliness of delivery of both the IM admission and IM discharge forms.

While most hospitals have achieved compliance with delivery of the form on or before admission, many struggle with compliance in delivering the form at discharge. The America Case Management Association (ACMA) met with CMS officials to discuss results of the ACMA Public Policy Committee’s survey about the delivery of the second IM. The results of the survey include the following findings:

• The majority of respondents (84%) report that case management is responsible for issuing the second IM.
• More than half the respondents (59%) report that issuing the IM requires 10 minutes or less.
• More than 77% of respondents report that they track IM compliance.
  • Of those who track IM compliance, 40% report a compliance rate between 76% and 100%.
  • Only 38% of respondents report increased numbers of patient appeals.
  • The majority report that less than 25% of patient appeals are successful.
  • Respondents generally feel the second IM process adds little value to patient care but contributes to patient confusion and frustration.

According to the ACMA, CMS was “receptive to the feedback.”

The latest versions of the IM, Form CMS-R-193, and the “Detailed Notice of Discharge”, Form CMS-10066— updated as of July 20, 2010—along with instructions, are posted on the CMS website. This latest version of the IM requires hospitals to note the time of delivery. After April 1, 2011, the forms with approval dates of 05/07 are not valid.

For more information on compliance with the Important Message from Medicare or for an editable version of the sample policy, contact Shawna O’Neill, RN, MHA, or Cary Gutbezahl, MD, at (513) 241.0142.

By Kate Fenner, RN, PhD

Because there are many requirements within the Conditions of Participation, it is beyond the scope of this article to explain the far-reaching topics that must be affirmatively managed to assure compliance.

However, there are Board Member “symptoms” of regulatory vulnerability that can be observed in “at risk” organizations.

1. The Board spends most of its time on finance and business development, and dedicates little attention to clinical operations, outcomes, or patient and physician satisfaction.

It is not surprising that Boards like to focus on the financials and business development. Most Board members are familiar with financial and business issues, but have little familiarity with clinical operations or the indicators of clinical performance. People, especially successful people like Board members, tend to spend time on things that they understand and have mastered. When talking about familiar issues, one feels comfortable asking questions and making a contribution to the discussion. But talking about finances isn’t going to ensure that the organization complies with the CoPs. While every business needs to be financially successful, the business of the hospital is, at its core, clinical. Patients, like business customers, aren’t attracted to a hospital because it has a great balance sheet. They come because the hospital can care for them and their medical problems. Finances are important, but a Board that focuses on finances to the exclusion of the primary business is acting like a Finance Committee, rather than a true Governing Body. Managing a hospital by just watching the finances is like managing a baseball team by watching the scoreboard. The scoreboard doesn’t help you win the game; it only shows that you are winning or losing.

2. The Board does not hear what physicians and nurses think about the quality of care.

Physicians and nurses have first-hand knowledge of the quality of care on a daily basis. While their perspectives may contain biases, their concerns are worthy of Board investigation. We know of one hospital that ignored Medical Staff complaints about poor nursing care until CMS made a finding of Immediate Jeopardy related to medication administration. Not all complaint reports are valid, but consensus opinions and concerns should warrant Board attention. Yet, rarely are clinicians’ opinions, especially unfiltered opinions, shared with the Board. Designing a pathway for physician and nurse input need not be complex nor undermine the authority of the senior management. For example, satisfaction surveys, which are conducted in the vast majority of hospitals, are a good route for aggregated data on physician and nurse concerns to be presented to the Board. Additionally, compliance officers and patient advocate staff members receive information on individual issues, but also can compile trending information for an annual presentation to the Board. The Chief Medical Officer and President of the Medical Staff are also very important sources of information and should routinely address the Board on the subject of physician satisfaction.

3. The Board never receives any bad or concerning news about clinical care.

Hospital executives generally want to show the Board how well the institution is being managed. So, they bring information to the Board that shows that everything is under control, as if to say, “Don’t worry. We’ve got great scores; we’re winning awards.” In these organizations, management rarely presents evidence that suggests problems. Boards need to penetrate the filtering of information. Even though most Boards don’t necessarily know what information needs to be presented to them relative to the CoPs, one sure warning sign is not hearing about bad events. Every hospital has suboptimal performance, “never” events (a list of 28 things that should never happen to hospitalized patients) and “near misses” (when bad things almost happen to a patient). These problems represent potential risks to the hospital’s compliance and reputation. Frequently, they also represent tips of an iceberg. Yet, at some hospitals, Boards are presented with information about awards and rankings rather than hearing about the problems. We know of a hospital that was recognized as a clinical leader by a hospital ranking system mere days before it was decertified by Medicare. Hospital executives should be presenting information about operational problems that are being addressed. If the Board doesn’t hear about them, the Board should ask “what else should we be measuring that hasn’t been reported?”

4. Information flow is tightly controlled and discussion is choked off.

Boards need to find out how information is shared within the organization. Organizations where mid-level managers are discouraged from discussing issues across organizational boundaries promote secrets and defensiveness. Containment, rather than problem-solving, becomes a dominant management effort. While peer review data is confidential, other operational information is widely shared in a transparent organization. Transparency demonstrates that there are no secrets, and the organization is committed to improving performance and correcting shortcomings. In addition, transparency allows for the constructive sharing of perspectives and ideas. For example, people who are not directly involved with a particular problem may be able to suggest a solution that is not obvious to someone deeply immersed in that situation. Innovation often involves transferring an application from one setting into a new setting. Consequently, organizations that control the distribution of information limit innovation and resources available for problem-solving. An atmosphere of tight control can lead to a culture of mistrust, cloaking suboptimal performance until issues fester and eventually explode.

5. Top-down discussions dominate meetings.

Higher-level people (e.g., CEO, COO, Board Chair) are the only vocal participants in management and Board meetings. Discussion from others is discouraged and limited to superficial comments and clarifying questions. Conflicting opinions are not welcomed, nor are inquiries about assumptions or alternative approaches. Meetings should not be social events, where everyone is supposed to uphold social conventions and appear to agree. Rather meetings should be held to broaden the analysis of issues. If meetings exist to “rubber stamp” existing management plans and actions, then there is no reason to bother with management or Board meetings. Effective Boards encourage challenging and provocative questions from members and executives. Such robust discussion clarifies issues. In fact, challenging ideas and assumptions is the primary value of group discussion. Many committees and Boards try to avoid disagreement because they fear relationship conflict. However, effective groups differentiate between task conflict and relationship conflict. In dysfunctional boards, clinical leaders (CNOs, CMOs, Chiefs of Service) are invited to present information, especially when it showcases outstanding work. But, they are usually carefully restricted in what they can say and generally are not invited to participate fully in discussion at leadership meetings. In these situations, discussions are limited to answering factual or “softball” questions, and open discussion is strongly discouraged.

RELATED:

Medical Staff: Are You Doing Enough to Ensure Compliance with CMS’ Conditions of Participation (CoPs)?