[Installment 2 of a two-part blog series addressing proposed changes in hospital accreditation and regulatory compliance by the Centers for Medicare & Medicaid Services [CMS]. In Installment 1, we framed up the current situation, including top-line concerns and recommendations made by the American Hospital Association [AHA] to CMS. In Installment 2, we look more closely at these concerns and recommendations, and why they matter.]
By JEFF LITTLE
Partner
In a letter penned earlier this year to the Centers for Medicare & Medicaid Services [CMS] by Ashley B. Thompson, Senior Vice President-Public Policy Analysis and Development with the powerful American Hospital Association [AHA], numerous concerns were raised about a proposed plan by the Federal government to tighten oversight of accreditation standards and processes for hospitals and other healthcare facilities.
The proposed plan calls for upping penalties for issues of regulatory non-compliance at a time when most hospital systems are scrambling to increase efficiencies, operationally and cost-wise.
In its present form, AHA said the plan presents numerous potential headaches for hospital staff who, on one hand, appreciate and acknowledge the importance of stringent accreditation and regulatory compliance but, on the other hand, must achieve that delicate balance of complying without negatively impacting the flow of normal, day-to-day hospital operations.
Let’s take a look at AHA’s six suggestions to CMS and why they matter:
1. Permit Accrediting Organizations [AO] to retain a limited number of “black-out” dates for accreditation surveys to protect time for emergency preparedness and other key activities drawing heavily on hospital staff and resources.
Patient flow in hospitals is, of course, less-than-scientifically predictable so administrators and staff never quite know when the “slam periods” will hit. In an ideal world, hospitals and other healthcare facilities would be 100% compliant 100% of the time. We do not live in an ideal world, unfortunately.
Typically, some AOs have permitted hospitals and other providers to identify a limited number of black-out dates during which they could request AOs not conduct onsite surveys for full accreditation or reaccreditation. Also, some AOs have provided hospitals with a “heads-up” a few hours ahead of time.
In the proposed plan, CMS wants to prohibit use of black-out dates and make all AO surveys entirely unannounced to more effectively assess whether healthcare organizations are in consistent compliance.
Hospitals and health systems say black-out dates are used to ensure an onsite survey does not interfere with other important activity drawing heavily on staffers’ and administrators’ time and resources [i.e., hospitals have used black-out dates to limit the likelihood of an onsite survey during a local or regional emergency preparedness exercise, to avoid conflicts with hospitals’ key leadership that may be offsite for industry-related events, etc.].
AHA also contends black-out dates are not used to predict when a survey may take place. Rather, they’re used to ensure hospitals have enough staff available to ensure AOs can fully and fairly evaluate compliance. Black-out dates are especially important for small and rural hospitals with far less personnel available to assist surveyors when they do knock on the door.
CMS accurately believes compliance should be a continual process, not a single “snapshot in time” of a facility’s compliance status. AO surveys are intended to assess the totality of a hospital’s policies and procedures to ensure documentation supports what AO observed in the moment; in addition to assessing staff preparedness, and policy & procedure competency.
A meet-in-the-middle solution would be for CMS to ask AOs to delineate criteria for when hospitals and other providers can request specific blackout dates notifications.
2. Pre-Arrival Notification
AHA urges CMS to permit AOs to provide advance notifications within 60 minutes of arrival of surveyors. One reason [on the extreme] involves hospitals experiencing incidents in which individuals claiming to be members of an AO survey team show sophisticated but bogus credentials, and demand access to sensitive facility and patient medical info.
Bureau of Labor Statistics data indicate healthcare workers are 5X more likely as other workers to experience physical attacks on the job. While these incidents are mostly rare, AHA believes patient and workforce safety benefits trump any potential risk without hindering CMS’ stated goals of rigorous, consistent and unbiased AO surveys. AHA believes a friendly 60-minute “heads-up” would be helpful.
3. Transition to a direct observation approach for validation surveys to reduce the rework and disruption of “look-back” surveys.
CMS’ current policy allows validation surveys on a representative sample of hospitals and other providers each year. During validation surveys, state agency staff and sometimes CMS surveyors conduct a full review of the organization approximately 60 days after an organization completes accreditation. This survey is conducted “cold” — that is, the validation team does not actually see the AO survey report before it re-surveys the organization. In theory, the goal is to evaluate performance of the AO.
In 2018, CMS also began a direct-observation survey model in which state agencies accompany AOs on their surveys to observe and evaluate the AO’s work and processes. CMS believes there is value to both types of validation surveys and proposes to make permanent a two-pronged validation survey process [“look-back” surveys and direct observation surveys].
AHA believes the direct observation model is better aligned with the agency’s goal of gaining meaningful, timely and actionable insights on whether AOs are conducting their work appropriately. It recommends CMS phase out use of look-back surveys altogether and says its assumption that a facility’s state of compliance in these two time periods is identical is flawed since hospitals and health systems operate in a highly dynamic environment.
AHA goes on to question whether look-back surveys are actually meaningful when compared to how resource- and time-intensive it is for hospitals to undergo a full re-survey. If CMS’ goal is to ensure AO surveyors “get it right the first time,” AHA believes the direct observation approach is a more effective way of giving AOs timely, direct and usable feedback on whether their survey approach is consistent with CMS standards.
CMS should also ensure it implements the direct observation model such that it does not add undue burden or confusion for providers. For example, CMS could instruct state surveyors to perform their work in an “observation mode” that ensures AO surveyors fully lead the survey.
In the event a state surveyor interprets a standard or an organization’s compliance with a standard differently from an AO, CMS should encourage state surveyors to discuss those interpretations with the AO rather than with the hospital, leaving staff free to do their jobs without unnecessary interruption.
4. Modify its overly punitive proposal to remove the deemed status of providers following certain validation surveys.
AHA believes removal of deemed status is overly punitive and unnecessary. More troubling is that the proposal seems inconsistent with adjudication processes currently in place for hospitals to respond to validation survey findings. Under its proposal, hospitals and other providers could lose their deemed status in the interim while issues are adjudicated, basically deeming the facility “guilty until proven innocent.”
CMS’ proposed plan calls for the possibility of hospitals or providers receiving one or more “condition-level citations” after any survey, losing their all-important deemed status. Additionally, the provider could be subject to “ongoing review by state survey agents”. Once compliance is back in place, organizations would regain deemed status.
Even a short-term loss of deemed status can have devastating impacts to providers and the communities they serve. The process of responding to validation survey findings can take months, raising real concerns about the ability for hospitals and other providers to provide quality care for their communities during CMS’ adjudication process.
AHA believes CMS should only remove deemed status in cases of providers either failing to provide CMS a formal Plan of Correction, or when they are found to be non-compliant after two or more Plans of Correction.
5. Clarify circumstances under which CMS would make AO survey reports public.
Currently, CMS collects only high-level data from AOs [i.e., survey date, overall findings, severity of issues, etc.] on surveys. CMS asserts collecting all reports from AOs would help it better understand AO performance and identify discrepancies with state agencies. CMS notes that Federal law does not permit it to make AO reports public unless it pertains to an enforcement action, such as terminating a provider agreement.
Meanwhile, AHA believes this raises significant concerns about confidentiality of provider information in a healthcare facility and urges CMS to provide greater clarity around circumstances in which AO survey reports would be made public. Further, the proposed rule currently lacks specificity as to what is meant by an “enforcement action”.
Providers are at risk of decertification by state survey agencies, which immediately terminates the relationship between provider and Medicare/Medicaid programs. As a result, if CMS were to finalize this rule, AHA believes the agency should clarify that it would disclose an AO survey report only when CMS has used it as part of its basis for terminating a provider agreement.
6. Eliminate duplicative complaint survey activity conducted by state survey agencies and AOs, which adds unnecessary administrative burden and confusion for hospitals and other providers.
The proposed plan includes several new requirements for AOs to detail their processes for responding to complaint surveys at healthcare facilities. AHA supports CMS’ efforts to ensure complaint surveys are handled in a consistent and expeditious manner across all AOs. It adds that the agency should also ensure AO complaint survey activity is not redundant with state agency complaint surveys as it relates to compliance with Medicare/Medicaid regulations.
Patients and families have the legal right to submit concerns about care received in health care facilities, including to CMS, state agencies and AOs. Complainants also have a right to avail themselves of all three reporting options for the specific patient care event in question. AHA is concerned that CMS may not be sufficiently coordinating investigative efforts of AOs and state survey agencies.
Indeed, many hospitals and health systems have experienced situations in which AOs and state agencies have provided hospitals with divergent survey findings, leaving hospital administrators confused about how to respond to both the AO and the state survey agency in a consistent and compliant manner [especially since hospitals are required to pay AOs for complaint surveys].
AHA writes, “When hospitals receive two surveys from two different parties on the same Medicare regulation, it leads to duplicative and wasteful spending of time and resources to respond. It also raises concerns about whether hospitals have the clarity they need to come into compliance with CMS regulations”.
AHA goes on to urge CMS to work with state survey agencies and AOs to “un-duplicate” complaint survey activity performed under the auspices of CMS, thereby ensuring hospitals aren’t unduly burdened by having to respond to two sets of surveys.
So, where are we?
Bottom line: Hospitals and other healthcare groups simply want to be able to do their jobs without unnecessary interference. Meanwhile, CMS wants to ensure healthcare systems and the AOs keeping watch are all playing by the rules. Both sides have valid concerns and well-intended priorities. It will be interesting to see how this all shakes out.
In the meantime, it might be a wise idea to take a fresh look at your current state of compliance and address any issues now before they become a citation [or worse] later. Exploring options for third-party service providers who can guide you through the morass of regulation and compliance could help you avoid headaches.
FileVision LLC, a Strategic Partner of Excelerant, is a cloud-based, marketing and process- centric solutions provider. ComplyVision is one of FileVision’s accreditation-agnostic, compliance solutions that can assist your organization in cultivating a culture of safety and compliance with Federal regulatory standards. You may want to check them out at www.complyvision.com.
ABOUT JEFF LITTLE
Jeff is a Partner at Excelerant Consulting and a widely recognized thought-leader in hospital supply chain, purchased services, hospital operations, facilities and construction, and medical capital equipment. He brings a deep insight and understanding of today’s healthcare environment and is well-connected throughout the industry, having worked in clinical settings within world-class hospitals, and multiple Integrated Delivery Networks [IDN] and Group Purchasing Organizations [GPO]. He is highly skilled at educating clients on subtleties and nuances of today’s complex healthcare ecosystem and excels at the development of commercial strategies.
Jeff is an active member of the Association for Health Care Resource & Materials Management [AHRMM], American College of Healthcare Executives [ACHE], Federation of American Hospitals [FAH], the IDN Summit, and serves on the board of the ACE Summit.
ABOUT EXCELERANT CONSULTING
Excelerant Consulting is the go-to organization for med-tech companies that need to position products and services successfully for Value Analysis Committees, contract acquisition, and sales modeling and execution to commercialize the launch of medical devices or services with Group Purchasing Organizations [GPO], Integrated Delivery Networks [IDN], or Regional Purchasing Coalitions [RPC]. Clients rely on Excelerant to identify their unique Value Proposition, enhance their product positioning, navigate corporate contracting opportunities, and provide sales support to accelerate growth and profits.