You just laid the last brick and turned on the lights at your new dialysis clinic. Before you start hiring staff and having an open house, there is one more thing to do: have your clinic surveyed and approved by the Centers for Medicare & Medicaid Services to treat Medicare patients.

Easier said than done. CMS has struggled to keep up with requests for initial certifications and approving expansions on dialysis units and other health care facilities for years, and states that have ESRD licensure also require their own review before the doors can open.

The process

Surveyors are employed by state agencies with funding from CMS, which has set up 10 regional offices to handle survey requests. Those offices follow a Mission Priority Document, which outlines a tier system that determines the priority ranking of different types of surveys. According to a 2015 memo from CMS to the State Agency Survey Directors, the tier system for outpatient dialysis facilities is as follows:

Tier 1: This includes surveys mandated by law to be in this priority tier, such as nursing homes. Dialysis facilities are not included for surveying in Tier 1 with the exception of complaint investigations categorized as a potential immediate jeopardy.

Tier 2: States survey a 10% targeted sample of dialysis facilities, selected from a list provided by CMS that identifies those facilities most at risk of providing poor care. Some of these surveys may be moved to Tier 3 and Tier 4 categories. Complaints not categorized as a potential immediate jeopardy are in Tier 2.

Tier 3: Initial surveys of new dialysis facilities, resurveys of existing dialysis facilities, relocations, and expansion of number of stations or services (such as home dialysis training) are in Tier 3. This tier also includes surveys of facilities that have more than 3.5 years since their last one.

Getting priority status

There are ways for a dialysis provider to get surveys done sooner. In a 2010 memo to state agency (SA) survey directors, CMS wrote, “Due to the unique reliance of dialysis patients on Medicare and the fact that there are no deemed accreditation options for ESRD facilities, we accord such facilities a higher Tier 3 priority than most other provider or supplier types. We encourage initial surveys of ESRD facilities to occur as early as possible on the survey schedule because of a combination of unique characteristics of ESRD facilities.”

The memo also addressed priority exception requests, stating, “Providers or suppliers may apply to CMS via the SA requesting consideration for an exception to the priority assignment of the initial survey if lack of Medicare certification would cause significant access-to-care problems for beneficiaries served by the provider or supplier.

The SA may choose whether to make a recommendation to CMS before forwarding the request to the RO (regional office). There is no special form required to make a priority exception request. However, the burden is on the applicant to provide data and other evidence that effectively establishes the probability of serious, adverse beneficiary healthcare access consequences if the provider is not enrolled to participate in Medicare.

CMS will not endorse any request that fails to provide such evidence and fails to establish the special circumstances surrounding the provider’s request. We expect that such exceptions will be infrequent.”

Tier 4: Additional surveys are done beyond those in Tiers 2 and 3 to ensure that dialysis facilities are surveyed with an average frequency of three years or less.

In the same 2010 memo to state survey directors, CMS acknowledged the challenge of providing timely surveys, citing multiple issues:

States may have difficulty staying fully staffed with surveyors. Some states have implemented hiring freezes due to state budget issues, even though the funding for the surveys comes from federal and not state funds.

An increase in health care providers has caused survey delays. Of particular mention were home health agencies, ambulatory surgical centers, and dialysis facilities. This increase in providers has delayed not only surveys of new facilities but re-certification of existing dialysis facilities.

An increase in patient complaints has contributed to the delay. As an example, the Ebola crisis resulted in a significant number of complaints requiring surveys of hospitals in some states.

Congress has not always fully funded the CMS budget request for surveys. The 2% decrease due to sequestration is applied to the survey and certification budget. Some years, the CMS has approved catch-up funds for surveys in some areas.

Not all parts of the country are experiencing survey delays—they seem to occur more along the southern border and the west coast. Some new dialysis facilities in New Mexico have had to wait over two years for their Medicare certification survey.

In Oklahoma, an existing facility wanting to expand services to offer home dialysis training had to wait five years for a survey. Long waits are taxing on both the dialysis facility providers and the patients who are waiting for in-center and home dialysis services.

State surveyors fall behind, too

Several states have recently indicated that one reason they are falling behind is the length of time it takes to train a surveyor for dialysis facility surveys, including the issue of only being allowed several spots for their surveyors to attend the CMS ESRD Core Surveyor training.

California passed legislation this year mandating that state licensing surveys be conducted within three months of a completed application and that the Medicare certification survey be conducted within three months of CMS providing permission to conduct the survey. However, the state legislation could not mandate how long the facility may have to wait between the state licensing and Medicare certification survey.

Although the bill was vetoed by Governor Jerry Brown, the legislation did highlight the concern of delayed surveys. In his veto message, Governor Brown stated that the state is working to make progress on closing the time gap for survey delays. Some states have increased their state budgets in order to hire more surveyors.

As stated earlier, dialysis providers are able to make their case to their CMS regional offices to be moved to a higher priority level if access to care issues exist due to the new facility not being surveyed in a timely manner. Patients are encouraged to contact their CMS regional office and state legislators if they have concerns.

Be patient

There is no identified solution at this time for delayed surveys. CMS remains committed to the Tier system. Some of the CMS regional offices and state survey agencies are able to manage their workload better than others, and some states will have ongoing staffing and budget issues. The best advice is to build relationships and remain in communication with local state survey offices and the CMS regional offices.

Sources

  1. FY2011 Mission & Priority Document memo from the Centers for Medicare and Medicaid Services to State Survey Agency Directors, September 3, 2010
  2. FY2015 Mission & Priority Document, Survey and Certification, Centers for Clinical Standards and Quality, Survey and Certification Group, Centers for Medicare and Medicaid Services, April 10, 2015