Skip to Main Content

insightsarticles

The seven elements at the bedside: A clinician's view of compliance effectiveness

11.02.26 /

Who this applies to: Read this if you are a healthcare compliance officer, clinical director/leader, medical director, Chief Medical Officer, or quality improvement professional.

The HHS Office of Inspector General (OIG) identifies seven foundational elements of an effective healthcare compliance program organized around written policies, compliance leadership, training, communication, enforcement, auditing, and corrective action. Compliance professionals tend to focus on regulatory requirements and organizational risk, while clinicians focus on patient care and real-time decisions. Effective programs connect both perspectives by turning the seven elements into practical tools for patient safety, sound clinical judgment, and organizational integrity.

1. Written policies: Reflecting clinical reality

A policy is useful only if it works where care is delivered. Guidance that overlooks workflow, staffing, resources, or real-time decisions is likely to be misunderstood, bypassed, or applied inconsistently. Organizations should:

  • Involve clinicians in translating regulatory expectations into practical steps.
  • Identify workflow barriers before implementation.
  • Measure whether staff understand and follow relevant policies and whether individual policies achieve their intended results.

2. Compliance leadership and oversight: Establishing shared ownership

Clinicians take cues from what leaders discuss, measure, and model. Compliance becomes part of professional practice when executive leadership sets expectations, compliance leaders identify risk, and clinical leaders translate requirements into daily operations. Shared reporting, clear escalation, and joint accountability connect these roles.

3. Training and education: Making it relevant

Completion rates show attendance, not whether training changes decisions or behavior. Clinicians are more likely to retain education built around case examples, familiar workflows, and specialty-specific risks.

4. Effective lines of communication: Creating psychological safety

Organizations cannot address concerns they never hear. Reporting channels should be accessible, trusted, responsive, and protected by a clear prohibition against retaliation.

5. Enforcement and accountability: Applying standards fairly

Clinicians expect accountability and fairness. Trust erodes when similar conduct produces different consequences based on position, influence, or professional status.

Effective accountability distinguishes misconduct from knowledge gaps, process failures, and reasonable clinical judgment. Consistent standards, paired with recognition for those who raise concerns and support improvement, show that compliance is both fair and constructive.

6. Monitoring and auditing: Learning whether controls work

Auditing becomes a constructive learning tool when the compliance team explains the risk, partners with clinical leadership and seeks clinical expertise to interpret findings, and connects results to practical improvement.

The Plan-Do-Study-Act cycle allows compliance, quality, and clinical leaders to test changes on a small scale, evaluate results, and refine the approach before broader implementation.

7. Response and corrective action: Preventing recurrence

Identifying a problem is only the beginning. Corrective action should address why it occurred and make the right course easier, more reliable, and more sustainable.

Retraining can address a knowledge gap, but it cannot fix a poor workflow, ambiguous policy, technology limitation, or staffing constraint. Leaders should match the intervention to the root cause, assign responsibility, set a timeline, and confirm that the action reduces risk.

From structure to sustainable performance

The seven elements provide the structure; collaboration makes them effective. The clinician’s test is simple: Does the program help people make the right decisions while caring for patients? When compliance, quality, and clinical leaders share responsibility for that result, the organization can demonstrate not merely that its program exists, but that it works.

BerryDunn can help

Questions about enhancing your organization’s compliance program? Our healthcare compliance team can help. We incorporate deep, hands-on knowledge with industry best practices to help your organization manage compliance and revenue integrity risks. Learn more about our healthcare compliance consulting team and services.

Related Industries

Related Services

Consulting

Business Advisory

Related Professionals

Leaders

BerryDunn experts and consultants

What Medicaid agencies and Medicaid-participating managed care organizations need to know about new mandatory federal requirements for reporting on the core sets of quality measures.

Read this if you administer a Medicaid agency, a CHIP program, or a Medicaid-participating managed care organization. 

On August 31, 2023, the Centers for Medicare & Medicaid Services (CMS) issued its Final Rule, which establishes requirements for mandatory annual state reporting of the following Core Sets of Medicaid quality measures:

  • The Core Set of Children’s Health Care Quality Measures for Medicaid and the Children’s Health Insurance Program (CHIP)
  • The behavioral health measures on the Core Set of Adult Health Care Quality Measures for Medicaid
  • The Core Sets of Health Home Quality Measures for Medicaid  
  • The regulations associated with the Final Rule are effective January 1, 2024. The initial (2024) round of reporting must be submitted and certified by states by December 31, 2024


FAQs: Medicaid Core Sets reporting requirements  

  • Do these reporting requirements apply exclusively to the 50 states? 
    No. These requirements include the 50 states, the District of Columbia, Puerto Rico, the Virgin Islands, and Guam. American Samoa and the Mariana Islands could, but would not be required to, report Child Core Set and Adult Core Set measures. 
  • Do all Medicaid agencies operate health home programs?
    No. “Health homes” refers to two optional Medicaid benefits that states may elect to implement through their CMS State Plan Amendment (SPA). The Section 1945 health home benefit is for Medicaid-eligible individuals who have: a) two or more chronic conditions; b) at least one chronic condition and who are at risk of developing a second; or c) at least one serious and persistent mental health condition. The Section 1945A health home benefit is for Medicaid-eligible children with medically complex conditions. 
  • If a state’s CHIP is separate from the Medicaid program, do these reporting requirements also apply to CHIP? 
    Yes. The Medicaid agency must report on the measures for standalone CHIP-enrolled beneficiaries in addition to Medicaid-enrolled beneficiaries, according to each measure’s age range specifications. 
  • Are Medicaid agencies required to report on all Medicaid and CHIP beneficiaries, including those enrolled in fee-for-service and managed care?
    Yes. However, the Secretary of HHS could specify in CMS’ annual reporting guidance that a population is not required to be included. Also, the Secretary could grant a Medicaid agency an exemption from reporting on one or more measures for a specific population.
  • Is there a filing deadline for a Medicaid agency to request a reporting exemption?
    Yes. A request for an exemption must be submitted by September 1 of the applicable reporting year. A Medicaid agency may request a one-year exemption from reporting for a specific population. This request must demonstrate that the Medicaid agency is unable to obtain access to data required to report the measures for a population despite making reasonable efforts to do so. The request must also document a reasonable timeline of actions underway to resolve data access problems.
  • Will these requirements require a Medicaid agency to submit a change in its state plan? 
    Yes. The Medicaid agency must submit a state plan amendment, specifying that it will report on the Child Core Sets and Adult Core Sets in accordance with 42 CFR § 437.15.

    If the Medicaid agency offers either or both of the optional health home services, then the state plan will need to also address the health home reporting requirements in accordance with 42 CFR § 437.15. The Medicaid agency must also require health home service providers to report to the agency on all populations served by the health home provider and on the measures in the applicable Health Home Core Set as a condition of receiving payment for these services.
  • Can CMS withhold federal Medicaid payments, in whole or part, from a state that is non-compliant with these reporting requirements? 
    Yes. CMS has stated that graduated enforcement mechanisms for compliance with Core Sets reporting requirements due to issues with state data systems will align with existing CMS policy regarding state corrective action plans.
  • Will CMS modify the Core Sets measures on an annual basis?
    Yes. The Secretary of HHS will identify and annually update the quality measures beginning no later than January 1, 2024, and annually no later than January 1 thereafter. In issuing the annual guidance, the Secretary may consider the level of difficulty in accessing the data required for reporting and may provide that reporting will be voluntary for a specific year. 
  • Will CMS establish data stratification rules for these measures? 
    Yes. In considering which measures, and by which factors (such as race, ethnicity, sex, age, rural/urban status, disability, language, or other factors) states must report stratified measures, the Secretary of HHS will consider whether stratification can be accomplished based on valid statistical methods. Other considerations include whether stratification will not risk a violation of beneficiaries’ privacy and whether the original survey instrument collects the variables necessary to stratify the measures. The rollout of stratification requirements will begin by the second year of annual reporting after the effective date of these regulations and increase yearly. By the fifth year of annual reporting after the effective date of these regulations, 100% of measures will be stratified.      
  • Will CMS make the reporting information publicly available? 
    Yes. CMS will make the Core Sets information publicly available not later than September 30, 2025, and annually by September 30 thereafter. 

Centers for Medicare & Medicaid Services Core Set resources

If you have questions about the Core Measure Sets for Medicaid or need guidance in complying with these reporting requirements, please contact Robyn Hoffmann or Ethan Wiley.

Article
CMS: Requirements for mandatory annual state reporting of Medicaid Core Sets of Quality Measures

Highlights from the Compliance + Ethics = Integrity Podcast

In this recent podcast, BerryDunn’s Robyn Hoffmann, Senior Compliance and Credentialing Manager in BerryDunn’s Healthcare Practice Group, Denny Roberge, Senior Manager in BerryDunn’s Healthcare and Not-for-Profit Practice Groups, and Roger Rego, Revenue Cycle Manager in BerryDunn’s Healthcare Practice Group, discuss the revenue cycle implications for the end of the Public Health Emergency.

Highlights from this episode:

  • Collecting patient information at the time of scheduling
  • How EHRs (Electronic Health Records) can help with your workflows and decrease denials
  • The importance of proactively educating patients
  • Working collaboratively as a revenue cycle team

Below is an edited transcript of the podcast. Listen to the full episode here. 

Robyn Hoffmann: It’s my distinct pleasure to introduce my colleagues. I'll start with Denny Roberge, who is a recognized subject matter expert on revenue cycle and patient access transformation, revenue integrity program management, and back-end revenue cycle redesign. Denny, you've been called upon to share your revenue cycle expertise with various chapters of the Healthcare Financial Management Association, and also with the mid-Atlantic region of the National Association of Healthcare Revenue Integrity. And it's my pleasure to also introduce my colleague, Roger Rego. Roger, you bring to BerryDunn over 30 years of experience from the not-for-profit healthcare sector. You've worked as a Chief Financial Officer at a Federally Qualified Health Center (FQHC). You've worked in hospital settings and you've also worked for Medicare and for TRICARE.

Denny, I saw you were the author of what was a really wonderful article for BerryDunn, which was published back in March 2020. The title of that article was “Preparing Your Revenue Cycle for the Pandemic – COVID-19.” Now the pandemic has finally ended. With the end of the Public Health Emergency and the unwinding of Medicaid continuous eligibility, can you give our listeners some examples of the impacts on what we at BerryDunn refer to as the “schedistration” segments of revenue cycle?

Denny Roberge: Certainly, a lot has changed in terms of the healthcare landscape from the payer side, provider side, all throughout it. It’s been a really challenging time. But when it comes back down to it, we think about our revenue cycle and the challenges that we had pre-, post-, and during the pandemic, we've always had issues in and continue to have the issues around making sure that we're getting the right demographic and insurance information so that we can:

  • Bill correctly
  • Eliminate the denials
  • Eliminate patient frustration from getting bills that they don't deserve

When we talk about “schedistration,” that's really combining two processes that are often disjointed: the scheduling event and the registration event. There are plenty of different ways you can structure a revenue cycle on intake, but ideally, you really can't start a good financial clearance process unless you have the basic information you need, and the best time to do that is when you have the patient in need of a service and on the phone. So, when we talk about “schedistration” and those types of things, it's really combining that scheduled event or the earliest event possible in your revenue cycle to start getting the information you need to start processing that patient.

And by processing, I mean verifying that, in fact, the information they gave you from the insurance company is correct. From there, if there is a patient balance, making sure that they're aware of it, having those discussions, or if they qualify for charity care or other programs, assisting them in finding that. If the service requires authorization, the time to do it is as soon as you can start really working on that patient, which is the scheduling event most of the time. And again, sometimes even at an ordering event, you can start the same process.

But to your point, you know now that we're in this post-pandemic era where we've got a new challenge, right, the Medicaid eligibility criteria are rolled back now. So, it comes back to:

  • You're not going to get paid if you bill the wrong insurance
  • If a patient doesn't have the means to pay, you're also not going to get paid

Looking forward—or backwards, I should say, in the revenue cycle continuum to really make sure we understand that patient’s financial obligations, what they have for insurance. If they just lost their Medicaid or what is available to them, and the only thing that's available to them is charity care, then enroll them in the charity care program. That's what they're there for, right? Or in the FQHC space, the sliding fee schedule. That's what's best for the patient and it's also what's best for your revenue cycle, so you're not spending time and effort trying to find dollars that aren't there. And so again, this is where getting it right up front really makes a difference. And so, “schedistration,” as soon as you can start getting that information and clearing that patient, is essential. Right now, we've got that new challenge because a lot of insurances are changing for a really vulnerable population.

Robyn Hoffmann: I'd like to turn to Roger now, who has worked as a CFO in an FQHC. And I'm wondering, should there be any changes in the design of a healthcare organization’s internal reports due to the unwinding of the Medicaid continuous eligibility? Would there be a need to increase the frequency of generating internal reports to identify whether your organization might be heading toward some losses in reimbursement?

Roger Rego: With the unwinding of this emergency, and the Medicaid coming out, now, it's even that much more important because we've had the last two-and-a-half, three years where Medicaid was much more available to people. With that rolled back, it's going to really make a demand on the whole revenue cycle, especially in the back end. Like you said, it's very important to get all that information upfront, but we know that there are times when that doesn't happen.

Then the responsibility comes to the back end who is seeing it. Unfortunately, by the time they see it, it’s too late and, especially in the Medicaid world, if a person lost Medicaid, maybe that patient doesn't even realize it. It's important that not just one person or that your billers are the ones watching for denials, you want a team to be meeting on a regular basis. Bring a team together that has the whole revenue cycle: your patient access coding, your departments, your IT, your business office, and work through those reports as a team and take a look at what's causing your denials. There's going to possibly be more opportunity to see denials increasing on the Medicaid side, which, if you're not being proactive or not getting your patient signed up for charity care or sliding fee scales, it's going to be hard for collections and it's just going to be hard for the organization.

Robyn Hoffmann: Denny, because you are so knowledgeable about EHR systems, is there any way that the EHR can be used to help to inform patients about these imminent changes?

Denny Roberge: The good thing with the EHR technology is most of them integrate to and from the payers, you know, the 27X responses. It can bring you a lot of information about their eligibility, term dates, and so forth. Again, for me, the best practice has always been to start financially clearing the patient ahead of time, and this is where the EHR can become a tool of real value.

If you select your EHR correctly—if your EHR doesn't have the functionality, there are plenty of bolt-on companies that can assist, and the value of it is well worth any cost. You can create a workflow where, as soon as the patient is scheduled, you start verifying their benefits, and at that point you'll know if they'll be eligible or not for their upcoming visit.

You can use that response to reach back out to the patient and engage them in the charity care process, sliding fee process, and/or enroll them in an alternative plan. There are a lot of different ways you can reach out to a patient with these tools, technologies, and workflows and be assured that if you follow the right workflow, that the patient has coverage and that you're not going to have any issues on the back end. These processes can be heavily automated so that your team is only looking at the exceptions. So, if I register and I'm good, I'm green, you don't have to worry about me. And if you come back red, it tells you that no matter what you do on the back end, you're not going to pay—you're not going to get paid because that patient’s registration is incorrect, and those are the ones you should focus all your effort on. I’m a big advocate of setting up the workflows within your EHR and, to me, that is the only way you can officially and effectively create a best practice front end.

Robyn Hoffmann: Roger, do you have any thoughts about this in terms of ways that healthcare organizations can inform either their established patients or new, and are shopping for a new primary care provider, about the unwinding of Medicaid? Are there ways that you would recommend organizations take action in addition to all of the EHR opportunities that Denny has offered?

Roger Rego: Within your EHR, you can run a report that lists all your Medicaid patients. So, you could go through that report and do an eligibility check on all the people who are established patients. If you identify people who have lost Medicaid, instead of waiting for them to come in, you can actually start reaching out to them now. That way you're going to be able to change what's in their demographics and they're going to be pretty happy that you're contacting them to walk them through the process.

You want staff to be educated on Medicaid, what this all means, and the changes that are happening and be able to explain that to the people ahead of time. It’s really critical to be doing that for new patients. What if they're out there looking for a new provider? You can let them know about the end of the COVID emergency and changes in Medicaid enrollment using your website, using Facebook, using Twitter, and any other means that you have to reach out to patients. I would recommend that for any changes within your organization that impact patients. Even your established patients are going to look at your website. Sometimes they're going to make an appointment there. Sometimes they're looking to see what specialists there are, so I mean, it's a great way to educate patients on the different changes.

Denny Roberge: That's great, Roger. And I know Robyn was asking for our final thoughts about the end of the pandemic and what we think organizations should be looking at and doing. There's been a lot of change since the pandemic began, and those changes are things that we learned to adapt to quickly. We learn to respond to things. And those skills we learned, I think we have to make sure we keep them sharp and continue to focus on the commercial and the government regulations because the commercial payers are probably going to start pulling back on a lot of different things that they allowed around telehealth and coverage.

You really want to make sure you're monitoring your commercial payers, monitoring Medicare, because we're in a new period. I think rapid change and the kind of change we've seen in the past is here to stay. It's going to be on us, as providers, to stay on top of things and we have to be proactive and not reactive if we really want to make sure that our revenue cycles are healthy. Those would be my parting words: just keep up the nimbleness and willingness to change. Those are going to be the guiding strengths that help you and your organization succeed and remain strong in the future months.

Roger Rego: That's great information, Denny and to follow up on that, the important thing is to be really working as a team. Because if one department identifies something, and they're not talking to anybody else, it's just not going to work. It's really important that you're working together as a revenue cycle team: front end, middle, back end, it's all the same. The key piece is to just keep working together, stay on top of it, and watch for changes. When you identify changes, get it out to everybody in the organization and make sure they're aware of it.

Robyn Hoffmann: Denny and Roger, thanks again for sharing your insights. We've reached the conclusion of our discussion about the impacts of the close of the COVID-19 Public Health Emergency on revenue cycle operations and the unwinding of the Medicaid continuous eligibility provision. We welcome your questions and feedback about the ideas we discussed, as well as suggestions for topics that we should consider developing for future episodes.

Disclaimer: The content we discussed is based on our professional experience advising healthcare providers, facilities, and other organizations that engage BerryDunn for compliance and other services. While we may reference specific government programs, Medicare and Medicaid policies, and regulatory guidance, we do not speak for any government agency or contractor, nor do we have the authority to do so. Nothing in this podcast should be considered legal advice. Anyone seeking legal advice on the subjects we discuss should consult their own attorney.

Article
Implications for revenue cycle operations as the COVID-19 Public Health Emergency ends

What every free-standing Skilled Nursing Facility (SNF) and chains with five or more facilities needs to know to avoid civil money penalties and regulatory compliance survey F895, F867, and F946 findings. 

The US Department of Health and Human Services, Office of the Inspector General (OIG) released its Compliance Program Guidance for Nursing Facilities in 2000. Additional Program Guidance was introduced in 2008, to reflect the OIG’s continued focus on quality of care and address specific risk areas related to quality of care, claims submissions, the federal anti-kickback statute, and other emerging areas.

Section 11281(b) of the Patient Protection and Affordable Care Act (PPACA, also known as Obamacare) amended regulations pertaining to the Medicare and Medicaid programs, requiring long-term care facilities to implement a compliance and ethics program to effectively prevent and detect criminal, civil, and administrative violations, and to promote quality of care as of November 28, 2019.

As defined in the 42 CFR §483.85, a facility’s compliance and ethics program, at a minimum, must have eight required components: 

  1. Written compliance and ethics standards, policies, and procedures
  2. Assigned specific high-level personnel within the organization (such as the chief executive officer, members of the board of directors, or directors of major divisions) to oversee the compliance program
  3. Sufficient resources and authority to the specific individuals, designated above in Item 2, to assure compliance with such standards, policies, and procedures
  4. Due care to not delegate substantial authority to individuals who had a propensity to engage in criminal, civil, and administrative violations under the Social Security Act.
  5. Procedures for effective communication of the compliance and ethics program elements to the entire staff, contractors, and volunteers
  6. Reasonable steps to achieve compliance with the program's elements, such as:
    •    Monitoring and auditing systems designed to detect violations 
    •    A reporting system to report violations anonymously
    •    A process in place for ensuring the integrity of any reported data
  7. Consistent enforcement of the program through appropriate disciplinary mechanisms, including discipline for the failure to detect and report a violation
  8. Steps to respond to the reported violations and to prevent further violations, such as modification to the organization's program to prevent and detect criminal, civil, and administrative violations under the Act

Additional compliance and ethics program requirements for skilled nursing facility (SNF) chains with five or more facilities

Organizations operating five or more nursing facilities must also include, at a minimum, the following components in their compliance and ethics program:

  1. A designated compliance officer for whom the organization’s compliance and ethics program is a major responsibility. This individual must report directly to the operating organization’s governing body and not be subordinate to the general counsel, chief financial officer, or chief operating officer.
  2. Designated compliance liaisons located at each of the organization’s facilities        
  3. A mandatory annual training on the organization’s compliance and ethics program, meeting the requirements of 42 CFR §483.95: 
  • Effective communications—mandatory training for direct care staff 
  • The rights of the facility’s residents and the responsibilities of the facility to properly care for its residents, per 42 CFR §483.10
  • Freedom from abuse, neglect, and exploitation, per 42 CFR §483.12
  • The elements and goals of the facility’s quality assurance and performance improvement (QAPI) program, per 42 CFR §483.75
  • The written standards, policies, and procedures for the facility’s infection prevention and control program, per 42 CFR §483.80(a)(2)
  • Explanation of the compliance and ethics program standards, policies, and procedures
  • Minimum annual 12-hour in-service training for nurse aides, including dementia management and resident abuse prevention training, as well as training in any areas of weakness as determined by the nurse aides’ performance reviews and assessments of the facility, per 42 CFR §483.70
  • Completion of a state-approved paid feeding assistant training program, per 42 CFR §483.160
  • Behavioral health training consistent with 42 CFR §483.40 and as determined by the facility’s assessment based on 42 CFR Section 483.70(e)

Evaluation of a corporate compliance program

Each facility must review its compliance and ethics program annually and revise its program as needed to reflect changes in all applicable laws or regulations. If you are not sure how to approach your review, the US Department of Justice sets forth three fundamental questions to ask when assessing the effectiveness of a corporate compliance program:  

  1. Is the corporation’s program well-designed?
  2. Is the program being applied earnestly and in good faith?
  3. Does the corporation’s compliance program work in practice?

Need help assessing your compliance program? BerryDunn can help. 

BerryDunn’s SNF operations and compliance experts can answer your questions regarding compliance and ethics program requirements and provide an external review. Please contact Robyn Hoffmann or Olga Gross-Balzano.

Resource
US Department of Health and Human Services, Center for Clinical Standards and Quality/Quality, Safety & Oversight Group. Ref: QSO-22-19-NH (June 29, 2022). Revised Long-Term Care Surveyor Guidance | CMS

Article
SNF rules of participation with Medicare and Medicaid  services: A deeper dive into compliance and ethics program requirements 

Read this if you work for a healthcare organization that serves uninsured or self-pay patients.

The No Surprises Act was passed in 2020 as part of a COVID relief package, with the goal of reducing surprise bills for patients who received medical or surgical services. One part of the act requires healthcare facilities and providers to give Good Faith Estimates (GFEs) to uninsured and self-pay patients starting on January 1, 2022. Read on for frequently asked questions about this topic, an update for 2023, and resources where you can find more information.

Frequently asked questions about good faith estimates for healthcare

What is a good faith estimate?

A Good Faith Estimate (GFE) is a document provided to a patient that details the expected charges for healthcare services provided. It is not a bill.

Who needs to provide GFEs, and to whom?

At this time, GFEs need to be provided to uninsured and self-pay patients. 

The following healthcare facilities must comply:

  • Federally Qualified Health Centers (FQHCs)
  • FQHC Look-Alikes
  • Tribal/Urban Indian Health Centers
  • Rural Health Clinics (RHCs)
  • Hospitals
  • Hospital outpatient departments
  • Critical access hospitals
  • Title X Family Planning Clinics
  • Health care providers who serve uninsured and self-pay patients

How should information about the GFE process be communicated to uninsured and self-pay individuals?

Information about the availability of GFEs for uninsured or self-pay individuals must be:

  • Written in a clear and understandable manner and prominently displayed:
  • On the facility’s website and easily searchable from a public search engine
  • In the office (such as in the patient waiting room), and
  • Onsite where scheduling or questions about the cost of items or services occur, such as at the registration or check-out areas
  • Explained verbally when scheduling an item or service or when questions about the cost of items or services occur
  • Made available in accessible formats, and in the languages spoken by individuals considering or scheduling items or services

How does the US Department of Health and Human Services (HHS) define uninsured and self-pay individuals?

HHS has a two-fold definition:

  • Individuals who have no health insurance coverage
  • Individuals who do have health insurance coverage, but do not want to have a claim submitted to their insurer

Both of these groups of individuals must receive a GFE.

What content is required in a GFE?

A GFE must include the following:

Patient information

  • The patient’s name and date of birth

Services estimated

  • A description of the primary item or service in clear and understandable language and, if applicable, the date the primary item or service is scheduled
  • A list of items or services reasonably expected to be furnished for the primary item or service

Information about services, providers, and estimated charges

  • Applicable diagnosis codes, expected service codes, and expected charges associated with each listed item or service
  • The name, National Provider Identifier, and Tax Identification Number of each provider or facility represented in the GFE, and the State and office of the facility’s location where the items are services are expected to be provided
  • Lists of items or services that the provider or facility anticipates will require separate scheduling and that are expected to occur before or following the expected period of care for the primary item or service. (A disclaimer should state that separate GFEs will be issued upon scheduling or upon request of the listed items or services.)

Disclaimers

  • A disclaimer that there may be additional items or services that the provider or facility recommends as part of the course of care that must be scheduled or requested separately and are not included in the GFE
  • A disclaimer that the information provided in the GFE is only an estimate and that actual items, services, or charges may differ from the GFE
  • A disclaimer that the individual has a right to initiate the patient-provider dispute resolution process if the actual billed charges are substantially in excess of the expected charges included in the GFE.
  • “Substantially in excess” is defined as at least $400 more than the total amount of expected charges.
  • This disclaimer must include instructions about where an uninsured or self-pay individual can find information about how to initiate the patient-provider dispute resolution process and state that the initiation of the patient-provider dispute resolution process will not adversely affect the quality of health care services that are furnished.
  • HHS strongly encourages providers and facilities to include an email address and telephone number for someone within the provider’s or facility’s office that has the authority to represent the provider or facility in a billing dispute.
  • A disclaimer that a GFE is not a contract and does not require the uninsured or self-pay individual to obtain the items or services identified in the GFE.

HHS encourages sliding fee discount providers and facilities to include information about the provider’s or facility’s sliding fee schedule and any other financial protections that it offers. Sliding fee discount providers and facilities have flexibility to determine how best to demonstrate the expected charges associated with each listed item or service, and to determine what additional information to include, if any.

What are the required methods for providing a GFE?

A GFE must be provided in written form either on paper or electronically, based on the individual’s requested method of delivery and within the required time frames. GFEs that are provided electronically must be provided in a manner that the individual can both save and print. A GFE must be written using clear and understandable language that can be understood by the average uninsured or self-pay individual.

If the individual requests a GFE in a method other than on paper or electronically (such as by telephone or verbally in person), the provider or facility may verbally inform the individual of the information contained in the GFE. However, the provider or facility must also issue the GFE in written form.

What is the timeline for providing a GFE?

When providing a GFE to an uninsured or self-pay patient, the following time frames must be followed.

When the service is scheduled: When the GFE must be provided:
If scheduled at least 3 business days prior to the date that the item or service will be furnished Not later than 1 business day after the date of scheduling
If scheduled at least 10 business days prior to the date that the item or service will be furnished Not later than 3 business days after the date of scheduling

Please note, when a GFE is requested by an uninsured or self-pay patient, a GFE must be provided not later than 3 business days after the date of the request.

How long should a provider or facility retain a copy of GFEs?

A GFE is considered part of the patient’s medical record and must be maintained in the same manner. At the request of an uninsured or self-pay individual, the provider or facility must provide a copy of any previously issued GFE within the last six years.

Update for 2023

  • As of the start of 2023, all of the preceding requirements remain in place.
  • As of January 1, 2023, HHS has paused enforcement on the next phase of GFE implementation

The next phase of GFE implementation, which began on January 1, 2023, requires that GFEs for uninsured and self-pay patients include expected charges from co-providers or co-facilities that are part of an episode of care for a patient coordinated by a provider or facility. However, on December 2, 2022, HHS paused its enforcement of this requirement based on comments it received during the rulemaking process indicating that compliance with this provision was likely not possible by January 1, 2023.

HHS is extending enforcement discretion, pending future rulemaking, for situations where GFEs for uninsured or self-pay individuals do not include expected charges from co-providers or co-facilities. We will provide an update when HHS issues any communication about changes to GFE-related enforcement.

Helpful resources for FQHC, RHCs, and other healthcare facilities

If you have questions about the information provided in this article or are interested in an external review of your healthcare facility’s compliance with current GFE requirements, please contact Robyn Hoffmann or Mary Dowes.

Article
Healthcare Good Faith Estimates (GFEs): Updates for 2023

Read this if you are at a senior living organization or Skilled Nursing Facility (SNF).

On September 1, 2023, the Centers for Medicare and Medicaid (CMS) released a much-anticipated proposed minimum staffing rule. The proposed rule would require nursing homes participating in Medicare and Medicaid to meet specific nurse staffing levels that promote safe, high-quality care for residents. The proposed rule represents the first time the federal government has proposed comprehensive nationwide nursing home staffing requirements. Various states have already enacted their own staffing requirements.

There are three major requirements under the proposed rule:

  1. Nursing homes would need to provide residents with a minimum of 0.55 registered nurse (RN) hours per resident per day
  2. An RN is required to be on-site 24 hours per day, seven days per week
  3. Each resident must receive 2.45 hours of care from a nursing aide per day, exceeding existing standards in nearly all states

In addition, the proposed rule includes additional reporting requirements regarding Medicaid payments for institutional long-term care support services and $75 million for nurse aide training.

CMS proposed minimum staffing rule challenges

The proposed rule is extremely problematic and seems impossible to implement. Here are just some of the issues of the proposed rule.

Lack of clarity

There is a lack of clarity in the rule as to what positions can be included in the nurse aide count and the rule does not include Licensed Practical Nurses (LPNs), of which there are approximately 120,000 nationwide.

Current staffing levels are insufficient

Based on Payroll Based Journal (PBJ) data through the first quarter of 2023, the American Health Care Association (AHCA) estimates that approximately 37% of all nursing facilities are currently unable to meet any of the three staffing requirements mentioned above and less than 7% of facilities nationwide are currently meeting all three of the requirements. 

Nursing employment shortage

The rule would require the industry to employ an additional 85,000 nursing assistants and 28,000 registered nurses. Where will these additional nurses come from given the post-COVID-19 pandemic workforce shortages?

Lack of funding for providers to implement this proposed rule

CMS estimates the proposed rule will cost $4 billion annually to implement, while the AHCA estimates $6.8 billion annually. We believe that some of the discrepancy in estimated costs to implement is the increased utilization of contract nursing. The AHCA estimate of nurses needed and cost to implement include the contract nursing that existed in the Q1 2023 PBJ data. 

Impact to states’ Medicaid budgets

AHCA estimates annual costs to states range from $6 million in states such as Maine and North Dakota to as high as $700 million in Texas, Florida, and New York. States that are already strapped by Medicaid budgets will likely not be able to increase reimbursement rates enough to pay for this proposed rule, which may ultimately lead to nursing home closures and lack of access to care for seniors.  

The proposed rule has phased-in implementation and hardship exemptions that take into consideration rural and underserved communities. However, many believe the phased implementation is not enough to compensate for the workforce shortage and the onerous exemption process will not benefit the rural providers it is intended to benefit.

There is strong opposition to this proposed rule as it could have a devastating impact on nursing facilities. On September 28, 2023, the US House of Representatives majority introduced House Bill 5796, which would prevent the Secretary of Health and Human Services from implementing and enforcing this proposed rule. AHCA has a grass-roots outreach campaign in which it seeks to have 10,000 individual comments sent to CMS by November 6, 2023.

Read more about the proposed rule: HHS Proposes Minimum Staffing Standards to Enhance Safety and Quality in Nursing Homes | CMS.

To submit a comment on CMS’ proposed minimum staffing, contact the AHCA: regulatory@ahca.org.

If you have any questions about the proposed rule, please contact our Senior Living team. We’re here to help.

Article
CMS' proposed minimum staffing rule: Requirements and challenges

What happens when you put a group of healthcare experts in a room and let them talk? A lot of information coming at you fast! At our recent Healthcare Leadership Event, BerryDunn’s experts and guests covered a wide range of challenges and solutions for healthcare leaders. Here are just a few of the takeaways. View all the session recordings.

Revenue cycle optimization: Manage and minimize denials from all angles

In the revenue cycle roundtable, our diverse group of experts each had a different perspective on how to decrease, manage, and prevent denials.

  • On the front end, patient access teams should focus on being proactive about the collection of patient guarantor and insurance information in order to qualify patients for services ahead of time.
  • On the back end, you need a dedicated person or team focused on tracking and managing denials, with regular meetings with your revenue cycle team.
  • Both the end of the PHE as well as the influx of Medicare Advantage plans are causing a major uptick in denials. Many patients who were covered by Medicaid during the PHE are no longer covered (and may not even realize it). The diversity of Medicare Advantage plans can cause confusion over what services are covered due to the differences between each plan.
  • On the Home Health side, optimize technology to meet regulatory and billing requirements for Medicaid and other insurers, which would include Electronic Visit Verification. The right technology can help agencies gain efficiencies and decrease denials.

Get your credentialing and enrollment house in order to minimize risks

Credentialing and enrollment are critical areas within the revenue cycle. When it’s not done correctly, it can cost an organization hundreds of thousands of dollars in denials, non-compliance, and provider dissatisfaction (think recruitment costs).

Healthcare organizations should recognize that credentialing and enrollment requirements are variable by state, payer, accrediting bodies, and organizational standards. Understanding these varying requirements is key in staying compliant and maximizing revenue, particularly for multi-state organizations.

Involving representatives from legal, compliance, and risk can help you manage these challenges, as can a periodic outside review of an organization’s credentials verification, enrollment, and onboarding processes, particularly for newly-onboarded physicians.

Navigate labor market shifts in healthcare finance

Like nearly all industries, the healthcare field is losing leaders and experienced staff due to higher-than-normal attrition, aging out, and consolidations. Here are some tips to focus on for improving the culture of finance teams to help retain finance leaders and staff members, as well as minimize the disruption from a leadership departure.

  • Create an environment that incentivizes leaders to stay.
  • Keep the lines of communication open. Frequent communication between staff and management will allow everyone in the department to stay connected and build trust amongst each other. Answer emails in a timely fashion. Walk through the department weekly to say hello. During departmental meetings, ask staff to share and actively lead the agenda. Management should welcome questions from the staff and intentionally solve problems together. Employees want to feel appreciated and integral to the department, and if they do, they will have more reason to stay.
  • Provide education and training on a regular basis. Meet with your team monthly to review operational results and how the various metrics such as patient bed volumes and payor reimbursement mix correlate to the financial results. Encourage high-performing employees to participate in industry-specific associations and community events. Share knowledge and build relationships through formal mentoring and meetings with a trusted advisor. Healthcare organizations that provide valuable training will better retain their high-achieving finance leaders.

For business planning, focus on what is in your control

For organizations that may be thinking of acquiring or selling their business, be aware that in the current economic climate with rising interest rates, there may be a significant impact on your organization’s value. Did you know that every 1% rise in interest rates can equal a 10% decrease in value? In turbulent economies, it’s important to focus on what is in your control to add and protect business value, including:

  • Assess the maturity of your business systems. Improving your technology systems, for example, can help you get information quicker, which helps you make better decisions and be more efficient. This can positively impact your bottom line.
  • Examine your financing models. If you’re relying on lines of credit, higher interest rates are costing you. You may want to tighten up your expenses and lessen your reliance on lines of credit or generate cash to pay off higher-rate loans.
  • Readjust your staffing models. Is there a way to readjust staffing to reduce high expenses, such as the cost of travelers?
  • Be aware of the impact of interest rates on all of your operations.

Be proactive about patient communication as the PHE unwinds

As the public health emergency comes to an end, there will be a large impact on patient coverage. With Medicaid redeterminations underway, as many as 15 million people may lose coverage. It’s more important than ever to have processes around obtaining patient information, as well as educating patients on alternative options. For example, do your patients realize that there is a special enrollment period available for marketplace health insurance? For Medicare Disproportionate Share Hospitals (DSH), be prepared for a potential drop in Medicaid days and reimbursement. Be sure to monitor this closely to stay in compliance.

Get more insights, presentations, and recordings from our Healthcare Leadership Event 2023. 

Article
Five key takeaways for Healthcare Leaders