Medicare Home Health Agencies:

Weaknesses in Federal and State Oversight Mask Potential Quality Issues

GAO-02-382: Published: Jul 19, 2002. Publicly Released: Jul 19, 2002.

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The 6,900 Home Health Agencies (HHAs) that serve Medicare beneficiaries must meet federal requirements, known as conditions of participation (COP), to ensure that they have the appropriate staff, are following the plan of care specified by a physician, maintain medical records to document the care provided, and periodically reassess each patient's condition. Although nationwide surveys done at HHAs since 1998 have identified a small proportion of agencies with serious deficiencies, the extent of the problem may be understated, and dangerous situations affecting home health patients may occur more often than documented. Shortcomings in the survey process and inconsistencies in state surveys make it difficult to assess the quality of care delivered and may mask potential problems. The ability to lodge complaints about an HHA and have them resolved promptly is important to protecting patient health and safety. HHA oversight by the Centers for Medicare and Medicaid Services (CMS) has been too limited to identify the problems GAO found in the survey process. CMS does not review state compliance with requirements for conducting HHA surveys, such as whether HHAs with COP-level deficiencies are surveyed annually rather than every 3 years or whether minimum patient visit and medical record review samples are adhered to.

Matters for Congressional Consideration

  1. Status:

    Comments: Congress has not taken action on this issue. GAO will continue to monitor Congressional activity on this issue. 2006 Update: We are closing this recommendation because we do not believe that Congress will act on our suggestion. However, according to the Director of CMS's Survey and Certification Division, CMS may issue an NPR for intermediate sanctions before the end of 2006.

    Matter: Given the significant delay in implementing intermediate sanctions for HHAs, Congress may wish to consider giving CMS a new deadline for issuing the necessary implementing regulations.

  2. Status: Closed - Not Implemented

    Comments: Congress has not taken action on this issue. GAO will continue to monitor Congressional activity on this issue. 2006 Update: We closed this recommendation because it had become apparent that Congress would not act on our suggestion.

    Matter: To better ensure that state surveys comply with statutory, regulatory, and other CMS requirements, Congress may wish to consider requiring CMS to conduct federal monitoring surveys of HHAs, with priority given to comparative surveys.

Recommendations for Executive Action

  1. Status: Closed - Implemented

    Comments: As of January 1, 2004, CMS assigned a branch identification number to every home health agency branch and entered the number into its OSCAR and ASPEN survey and certification data systems. In addition, CMS is developing branch outcome reports using OASIS data. The reports will allow surveyors to target their investigations of care practices on those branches with poor clinical outcomes. Before the reports can be used, CMS needs to (1) collect at least 12 months of patient assessment data to generate the branch outcome reports, (2) overcome potential data validity issues involving branches serving a small number of patients and branches serving the same patient, and (3) determine how to effectively integrate the outcome reports into the home health survey protocol.

    Recommendation: To strengthen the ability of the HHA survey process to identify and address problems that affect the quality of care, the Administrator of CMS should develop more specific branch oversight criteria and procedures for states and assign unique identification numbers for each HHA branch office to enable CMS to track survey results and facilitate its own branch oversight.

    Agency Affected: Department of Health and Human Services: Centers for Medicare and Medicaid Services

  2. Status: Closed - Implemented

    Comments: CMS conducted several training sessions for state home health agency surveyors in fiscal year 2003 and the training for home health surveyors has been enhanced to focus surveyors' attention on consistently identifying and documenting standard and condition-level deficiencies. In addition, CMS is in the process of convening a panel of home health agency survey experts to develop surveyor guidelines to improve the consistency of citing both standard and condition-level deficiencies. The panel is currently evaluating possible formats for such guidelines, e.g., a worksheet for guiding and documenting decision processes. The guidelines will be pilot tested during 2005 and CMS hopes to implement them sometime during 2006. August 2007 Update: the guidelines are still being evaluated and have not yet been issued to surveyors. We will check back with CMS in 2008. On Sept. 16, 2008, we were informed that the staff person who was going to work on this project was sick this year and she now anticipates that it will not be done until 2009. We will keep this recommendation open and check back next year. 2009 Update: Jan Tarnantino provided the following update on Sept. 14, 2009--CMS has a draft of the policy to accompany the revised guidance and will be finalizing drafts of both documents when the HHA team returns from providing training on the new version of OASIS. CMS plans to share the draft with CMS regional office HHA leads and then the regional office managers this fall, targeting December for finalizing and releasing the guidance and policy memo. We will keep the recommendation open and check back next year. 2010 Update: In 2006, a contract was established to further these protocols & revise the survey process. This contract developed the concept of priority tags for surveyor attention and a systematic priority plan for surveyors to address HHAs issues. Guidance was also developed for surveyors on how to address citations of standard versus condition level deficiencies. During 2007 through 2009, these protocols were tested, developed and refined by CMS Central Office and Regional Office staff, State Agency volunteers, industry leaders and consultants. Based on the recommendations of the contract, new surveyor protocols were developed. The protocols are now going through the clearance process and final revisions are being made. These new protocols will be incorporated into the State Operations Manual and HHA CoP Interpretive Guidance. Surveyor training is currently being revised to include the new protocol and will be presented to surveyors (both new and experienced) nationwide in April 2011.

    Recommendation: To strengthen the ability of the HHA survey process to identify and address problems that affect the quality of care, the Administrator of CMS should develop more specific guidance and training for distinguishing between COP-level and lesser deficiencies and for improving the consistency across states in documenting deficiencies.

    Agency Affected: Department of Health and Human Services: Centers for Medicare and Medicaid Services

  3. Status: Closed - Implemented

    Comments: Effective May 1, 2003, CMS instructed home health surveyors to begin using enhanced protocols to identify specific records and "at risk" patients for review during surveys. A scoring metric for identifying home health agencies with problematic outcomes is under development and will be tested in early 2005. August 2007 Update: CMS still plans to include guidance to surveyors on increasing the sample size in guidelines developed by a contractor. However, the guidelines are still under review and have not yet been issued. We need to check back with CMS next year. August 2007 Update: Guidance to surveyors that includes sampling has been developed by a contractor but has still not been released to surveyors. We will check back with CMS in 2008. On Sept. 16, 2008, we were informed that the guidance had not been released to surveyors because the staff member working on the guidance had been sick this year. She anticipates it will be implemented in 2009 and we will check back. 2009 Update: Jan Tarantino provided the following update on Sept. 14, 2009: CMS has a draft of the policy to accompany the revised guidance and will be finalizing drafts of both documents. CMS plans to share these drafts with its regional office HHA leads and managers this fall with a goal of finalizing and releasing the guidance and policy memo in December. We will keep this recommendation open and check back next year. 2010 Update: CMS plans to release the final guidance on sample size in Oct. 2010. We will then close the recommendation.

    Recommendation: To strengthen the ability of the HHA survey process to identify and address problems that affect the quality of care, the Administrator of CMS should improve the adequacy of the sampling process, such as increasing the size of the sample medical records and patient visits, to better determine the prevalence of quality-of-care problems.

    Agency Affected: Department of Health and Human Services: Centers for Medicare and Medicaid Services

  4. Status: Closed - Not Implemented

    Comments: August 2007 update: CMS revised and simplified its policy on HHA survey frequency. For example, it eliminated the requirement to survey new home health agencies within a year of their initial certification. These changes rendered our recommendation moot and the recommendation is being closed as not implemented. CMS restructured its fiscal year 2004 budget call letter to highlight that states must perform all statutorily required surveys, including home health surveys at least once every 36 months. CMS's fiscal year 2005 budget call letter reiterates this legal requirement. As the agency enhances the home health survey process, it intends to request the necessary resources to ensure adequate funding levels.

    Recommendation: To strengthen the ability of the HHA survey process to identify and address problems that affect the quality of care, the Administrator of CMS should ensure that resources are adequate for states to fully comply with the requirement to survey all HHAs at least once every 36 months and certain HHAs more frequently.

    Agency Affected: Department of Health and Human Services: Centers for Medicare and Medicaid Services

  5. Status: Closed - Implemented

    Comments: Effective June 1, 2004, CMS published a new chapter of its State Operations Manual that consolidates procedures for reporting and investigating complaints, including those filed against home health agencies. This new guidance specifies that complaints do not have to be in writing.

    Recommendation: To ensure that the complaint process adequately addresses quality-of-care problems, the Administrator of CMS should ensure that states eliminate barriers to filing complaints by improving the accessibility and effectiveness of hotlines and by not requiring complaints to be filed in writing.

    Agency Affected: Department of Health and Human Services: Centers for Medicare and Medicaid Services

  6. Status: Closed - Implemented

    Comments: CMS has taken steps to improve states' ability to properly identify and prioritize home health complaints in need of investigation. For example, CMS issued guidance in November 2003, which covers (1) complaint intake and triage procedures and (2) priority definitions and investigation requirements. Effective June 1, 2004, CMS revised the complaint chapter of its State Operations Manual by consolidating procedures for investigating complaints into a single document. In addition, CMS implemented an annual state performance standard in which it determines whether states are investigating all home health complaints alleging immediate jeopardy to resident and/or patient health and safety within no more than two (2) working days of receipt, as required.

    Recommendation: To ensure that the complaint process adequately addresses quality-of-care problems, the Administrator of CMS should monitor states' responsiveness to complaints, including developing assurances that serious allegations are promptly investigated and resolved.

    Agency Affected: Department of Health and Human Services: Centers for Medicare and Medicaid Services

  7. Status: Closed - Implemented

    Comments: In January 2004, CMS implemented its new complaint tracking system nationwide. The new system, called the ASPEN Complaints/Incidents Tracking System (ACTS), is intended to improve the management and oversight of complaints by allowing states to create electronic intake records and update them as necessary. The system allows CMS and states to track complainants' allegations, investigations of complaints, referrals made to other investigating bodies, and how complaints are ultimately resolved. CMS has also taken steps to improve the consistency of how states track Medicare home health complaints. For example, during 2003, CMS conducted a web and satellite broadcast and issued guidelines on how to use the new ACTS system to effectively manage complaints. In addition, effective June 1, 2004, CMS revised the complaint chapter of its State Operations Manual by consolidating procedures for investigating complaints into a single document. One section of the revised complaint chapter discusses ACTS, including the fields states and CMS regional offices must complete and the definitions of those fields.

    Recommendation: To ensure that the complaint process adequately addresses quality-of-care problems, the Administrator of CMS should provide technical assistance to states as appropriate to develop consistently effective complaint tracking systems.

    Agency Affected: Department of Health and Human Services: Centers for Medicare and Medicaid Services

  8. Status: Closed - Implemented

    Comments: CMS has incorporated home health agency (HHA) criterion into its annual state performance standards. Thus, CMS now routinely evaluates states on the (1) timeliness of HHA surveys, (2) adequacy in which surveyors document survey findings, (3) timeliness of correcting condition-level deficiencies, and (4) timeliness and quality of complaint investigations.

    Recommendation: To ensure that states comply with home health statutory, regulatory, and other CMS requirements designed to protect health and safety, the Administrator of CMS should adopt comprehensive state performance standards for HHAs, such as holding states accountable for (1) performing HHA surveys based on CMS's variable 12- to 36-month survey schedule and (2) improving the timeliness and reliability of states' Online Survey, Certification, and Reporting System (OSCAR) data entry.

    Agency Affected: Department of Health and Human Services: Centers for Medicare and Medicaid Services

  9. Status: Closed - Implemented

    Comments: CMS has created a web-based data reporting system, known as PDQ (Providing Data Quickly), which accumulates and stores data related to a variety of home health agency survey activities. The home health agency reports available on PDQ for CMS and all 50 states and the District of Columbia include (1) detailed demographic information for active, new, and terminated providers, including those with branch locations; (2) provider-specific and summary data for home health agencies scheduled to be surveyed as prescribed by CMS's 4- to 36-month survey cycle, including those that are overdue; and (3) detailed deficiency information, including the number and percentage of recertification and complaint surveys resulting in serious citations. Unlike the OSCAR data system, PDQ does not require computer programming to extract survey data and does not purge old surveys from the system. Thus, CMS and states are now able to access historical data on home health agencies and surveys, using an online data system that is user-friendly and fast. PDQ also allows states and CMS to continually monitor home health agency survey activities and to make important adjustments as needed.

    Recommendation: To ensure that states comply with home health statutory, regulatory, and other CMS requirements designed to protect health and safety, the Administrator of CMS should use OSCAR and other means to monitor and assess state survey performance on an ongoing basis.

    Agency Affected: Department of Health and Human Services: Centers for Medicare and Medicaid Services

 

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