Regulatory Solutions

Health care regulations are always changing, and ensuring that your organization both understands and complies with requirements is an ongoing task. From CHNA reports to long-term care regulations, the INCompliance team can help walk you through the details.

OVERVIEW

Keeping track of heath care regulations is a daunting task. However, INCompliance can help your organization plan and prepare for future demands for health care services. We offer practical options to identify your health service areas and address health needs in your community. Our areas of expertise include:

Community Health Needs Assessment (CHNA)

  • Data collection
  • Community input
  • CHNA report and implementation strategy preparation
  • Alignment with community assessments and state health improvement plan

Health Care Planning

  • Regulatory matters
  • Long-term care service requirements
  • Assisted living service requirements
  • Acute health care service regulations

Long-Term Care and Assisted Living

  • Certificate of Need
  • Licensure
  • Bed and facility sales and acquisitions
  • Franchise permit fee
  • Space requirements and conversion of space
  • Assisted living waiver

Acute Care

  • Cardiac catheterization
  • Open heart surgery
  • Radiation therapy
  • Pediatric intensive care unit
  • Hospital registration

All of our services consider the timing of each component to ensure your goals are met according to internal and external deadlines.

CHNA

The 2010 Affordable Care Act requires that all 501(c)(3) hospitals conduct a community health needs assessment (CHNA) to maintain tax-exempt status. INCompliance provides the support you need to develop a CHNA report and implementation strategy that complies with this requirement. Specifically, we can help address the following frequently asked questions.

What is meant by “describing the community served by the hospital facility”?

The IRS rules allow some flexibility. In most cases, it should be defined geographically (zip codes, counties, MSAs, etc.), but in special circumstances (e.g., children’s hospitals, cancer hospitals, specialty units) may also be described by patient populations. Should include not only those the hospital would like to serve, but those available to serve (including through emergency department). Often, this will be the hospital’s service area which is generally a geographic area comprising 75 percent of the admissions.

What kinds of data are required?

Data for the CHNA should include federal, state and local sources and identify the following:

  • Current and projected service area population and demographic information
  • Existing hospital services
  • Other health care providers and resources in the service area
  • Health Professional Shortage Areas within the service area
  • Health conditions of the area population
Where do we go for data?

Data can be obtained from a variety of sources, including the following:

  • State Health Department
  • Community Health Rankings and Roadmaps
  • Community Commons
  • HRSA Data Warehouse
  • Kids Count Data Center
How should organizational or individual resources for “community input” be identified?

The following organizations or groups may be considered for community input:

  • Associations – Ohio Hospital Association, Children’s Hospital Association, regional hospital associations
  • Consumers and individuals residing in the community
  • Local business owners
  • Physicians – both those on the medical staff and perhaps those who are not
  • Local Departments and organizations – Job and Family Services, ADMHS Board, FQHCs, County Health Department, Aging, school districts, United Way
How can community input be assessed or used?

One way to gather, assess and use community input is to form a group of interested stakeholders from both within and outside of the hospital (could be called an “Advisory Council”) to assist with considering the data and input and identifying and prioritizing needs.

What should be considered in prioritizing needs and identifying which needs are not going to be addressed by the hospital?

The hospital should review each significant need and consider the following:

  • The burden, scope, severity or urgency of the need
  • Estimated feasibility and effectiveness of possible interventions
  • Health disparities associated with the need
  • The importance the community places on the need
  • Whether the need can be addressed alone or does it require partnering with another organization
  • Whether the hospital has the capabilities and resources (e.g., skills, funding, knowledge) to address the need
  • Services the hospital has that can help address the need
  • Whether the hospital can change current business practices to help address the need
What should be included in the implementation strategy?

For each significant need addressed in a CHNA, the implementation strategy should include the following:

  • Action steps
  • Anticipated impact
  • Programs and resources to commit to addressing the need
  • Planned collaborations
We have done community benefit reports and community needs assessments in the past – can we just update these?

While those may be a resource considered as a part of the CHNA, it is extremely unlikely that those activities followed the steps and included the level of external input required for CHNAs.

What happens if a need is identified and not addressed?

All significant needs are not required to be addressed. The implementation strategy must address each significant health need, indicating whether the need is one the hospital will address or not. If the need is not being addressed by the hospital, indicate the reason (e.g., limited resources, lacking expertise, etc.).

LONG-TERM CARE/ASSISTED LIVING

With changes in reimbursement and more stringent regulations, providing long-term care and assisted living services is more challenging than ever. Our consultants can help you meet those challenges. We provide expert assistance to long-term care and assisted living providers in many areas including those described below.

Space Requirements and Conversion of Space

We assist in the conversion of space for nursing home and assisted living use. We can advise on space requirements, timing of notifications and notice requirements, and survey process.

Assisted Living Licensure and Waiver

We assist you in meeting licensure requirements and waiver regulations for participation in an assisted living waiver program. We can help with conversion of space and prepare notification filings to initiate licensure, certification under a waiver program and, if necessary, survey processes.

Certificate of Need

Our Certificate of Need expert was director of Ohio’s Certificate of Need program before joining our team. She will prepare and submit your Certificate of Need application and support you throughout the process, including support for administrative hearings.

Nursing Home Licensure, Certification and Survey Process

We assist you in meeting licensure and certification requirements throughout the planning and implementation of bed sales and acquisitions, ensuring that the beds remain “valid” throughout the process. Serving as your liaison with Ohio Department of Health (ODH), we will prepare notification filings to initiate licensure, certification and survey processes.

Bed/Home Sales and Acquisitions

Do you need additional long-term care beds? Are you struggling with low occupancy rates? We bring providers together to relocate beds to areas where they can be better utilized to enhance operations. We assist you by negotiating terms for bed transaction agreements and ensuring your interests are met throughout the process. Specifically, we provide:

  • Preparation of Certificate of Need application
  • A plan review to address licensure requirements
  • Consultation on staffing requirements
  • Preparation of variance requests
  • Preparation of requests for a change in licensed capacity
  • Interaction with the ODH throughout the licensure process
  • Nursing Home Certification
  • Franchise Permit Fee (Bed Tax) information
  • Identify market value for bed operating rights
Franchise Permit Fee

Our nursing home consultant will ensure that your interests are met during negotiations for allocation of the franchise permit fee associated with bed sales and acquisitions. We also advise on the optimal time for de-licensure of beds being relocated and the licensure of beds at the receiving facility to minimize your franchise permit fee liability.

ACUTE CARE

State regulations for acute care services can change without providers having any knowledge of, or input on, the change. We can monitor regulations, advise you on proposed changes and provide public comment where appropriate. We can help ensure that your interests are addressed and that your service is in compliance. In addition, we can prepare your request for a waiver or variance and work with the Ohio Department of Health (ODH) to address specific concerns, such as:

Health Care Services/Quality Rules

Our director of regulatory services has worked with experts to develop rules for the Health Care Services (HCS) program, covering cardiac catheterization, open heart surgery, radiation therapy and pediatric intensive care unit services.

She developed and implemented the HCS program for the ODH and was the program’s administrator from its inception in 1997 through 2009. We can assist with the following:

  • Initiating a new health care service
  • Discontinuing an existing health care service
  • Interpreting regulations and evaluating compliance
  • Changing the scope of service or service level designation
  • Preparing waiver and variance request for requirements not met or met in an alternative manner
  • Conducting service review to evaluate compliance
Hospital Registration

Our director of regulatory services has 28 years of involvement with hospital registration as a program administrator with the ODH. Additionally, our director has provided consultation to the ODH regarding registration policy and rules and can help ensure that your registration is accurate. If you are having registration issues, we can work with the ODH to resolve problems and correct mistakes.

INSIGHTS
August 21, 2019 - Ohio Budget Bill changes Ambulatory Surgical Facility definition: Now captures facilities operating within a hospital

On July 18, 2019, Governor Mike DeWine signed Ohio’s general operating budget for fiscal years 2020–2021. Provisions in this bill change the definition of an Ambulatory Surgical Facility (ASF) and, accordingly, change the types of facilities that are required to be licensed as an ASF. This provision takes effect on October 17, 2019.

Under the previous definition, facilities located within a building where inpatient care is provided were exempt from the licensure requirement for an ASF. Under the new definition, facilities located within a building where inpatient care is provided are required to be licensed as an ASF if the entity that operates the ASF is not the entity that operates the remainder of the building or if the facility is held out as an ASF.

Facilities previously exempt from ASF licensure should review and be prepared to apply for licensure as necessary.

August 9, 2019 - Ohio budget bill provides significant changes to Certificate of Need laws

On July 18, 2019, Governor Mike DeWine signed Ohio’s general operating budget for state fiscal years 2020-21. Provisions within this bill make a number of substantive changes to the Certificate of Need (CON) laws. Most of these CON provisions take effect on October 17, 2019. These substantive changes are outlined below.

Moratorium on CON applications: The provisions place a moratorium on the acceptance of many, but not all, CON applications beginning with the effective date of the bill and ending July 1, 2021 (the end of the budget biennium; note that the next budget bill could extend this moratorium). The Ohio Department of Health (ODH) may only accept CON applications for (1) the comparative review process, (2) contiguous county bed relocations, (3) replacement of an existing long-term care facility if the new facility will have the same owner and operator and the county in which the facility is being replaced has a bed need under the 2016 bed need determination, or (4) renovation of or addition to an existing long-term care facility if the facility is in a county with a bed need under the 2016 bed need determination.  Accordingly, for a county without a bed need under the 2016 bed need determination, this will prohibit ODH from accepting a CON application for an intra-county bed relocation (either the addition of beds to an existing facility or development of a new facility with intra-county beds) or a replacement or renovation of an existing long-term care facility. An application for a contiguous county bed relocation to a county without a bed need may still be accepted.

Completeness process: The provisions provide for the director to declare an application complete within 180 days after the date the CON application is filed. This change does NOT take effect on October 17, 2019. Rather, ODH is required to develop rules to implement this change; until final rules are effective, the current process and time frame for completeness remain in place. When finalized, this change will likely cause ODH to shorten the 90-day time frame that the applicant currently has to respond to a request for additional information.

Appeal of CON decisions: Perhaps the most significant change is that interested third parties have lost the right to appeal CON and reviewability ruling decisions. The budget bill provisions provide that only the applicant for a CON may appeal the director’s decision. An affected person may still submit written comments on CON applications during the review process, but that is their only recourse or remedy.

Comparative review process: The provisions move the next comparative review period sooner to January 1, 2020, through December 31, 2023, and every four years thereafter. The next review period was previously scheduled to begin on July 1, 2020. This change requires ODH to perform a new determination of each county’s bed supply and bed need or excess and publish the results on the web site by October 1 beginning in 2023 (and every four years thereafter). For the comparative review process beginning January 1, 2020, the director will use the 2016 bed supply and bed need for each county, and ODH will publish by October 1, 2019, and accept applications in January 2020. Comparative review applications will be accepted in January, and applications will be reviewed through September 30. The previously-provided second phase (or redistribution of surrendered beds) of the comparative review process is eliminated.

County-Specific Exceptions to the 2020 comparative review process: For Delaware, Greene, Lake, Licking and Median Counties, the director (1) will not apply the county’s average occupancy information to determine bed need, (2) will refuse to accept an application, except for Green County, unless the applicant is already an owner or operator of a skilled nursing facility in the receiving county, (3) will refuse to accept an application if the source facility has a 4- or 5-star rating, unless the facility is voluntarily closing, (4) will not require that the number of beds remaining in the source facility’s service area after relocation be at least equal to the state bed need rate and (5) will not apply the criteria that require comparative review of two or more applications if the applications request beds from the same service area, and the number of beds that would remain in the source service area will be less than the state bed need rate. The five exception counties are limited to the following increase in beds:

Delaware County – 200 beds
Greene County – 99 beds
Lake County – 200 beds
Licking County – 185 beds
Medina County – 200 beds

January 10, 2019 - ODH alignment recommendations for 2019 CHNA process

Ohio Department of Health (ODH) alignment recommendations apply to each tax-exempt hospital, defined as a nonprofit or government-owned hospital, that is exempt from income tax under section 501(c)(3) of the Internal Revenue Code and that under federal law is a hospital organization required to meet Community Health Needs Assessment (CHNA) requirements. No later than October 1, 2020, each tax-exempt hospital must submit a CHNA and related implementation strategy covering years 2020 through 2022 to the ODH. This means that all tax-exempt hospitals must complete a CHNA in 2019 and adopt an implementation strategy covering 2020 through 2022.

Collaboration                 

Local health departments and tax-exempt hospitals are strongly encouraged to collaborate with a broad range of community partners to identify local health priorities and implement strategies that will contribute to improving the health status of the community. Collaboration should occur at the county level, at a minimum, to conduct a community health assessment to be shared among all partners. Local health departments and tax-exempt hospitals should be the lead partners in the process with suggested participation from the following:

  • Federally qualified health centers (FQHC)
  • Rural health clinics
  • Healthcare providers
  • Alcohol Drug and Mental Health Boards (ADAMH)
  • Health plans
  • Schools
  • Employers
  • Governmental and nongovernmental agencies
  • Businesses

Alignment

The Ohio 2016 State Health Assessment (SHA) and Ohio 2017-2019 State Health Improvement Plan (SHIP) provide information on Ohio’s population health status, health need priorities and strategies to address health needs. The SHA can be used as a data source in assessing a local community’s health needs. The SHIP provides evidence-based strategies and outcome indicators that can be used as a foundation for implementation strategies.

Local health departments and tax-exempt hospitals are encouraged to select at least two priority topic areas from the SHIP to address in the community health improvement plan (CHIP) and hospital implementation strategy. The priority topics identified in the Ohio 2017-2019 SHIP are:

  • Mental health and addiction
  • Chronic disease
  • Maternal and infant health

For each priority topic selected, hospitals are encouraged to choose at least one priority outcome indicator, at least one strategy to implement and one related indicator to measure impact.

For a stronger plan, hospitals should consider selecting at least one strategy to implement and one related indicator to measure impact from each of the following cross-cutting factors:

  • Social determinants of health – conditions in the social, economic and physical environment that affect health and quality of life
  • Public health system, prevention and  health behaviors – organizations working to promote health and prevent disease and injury and actions that people take to stay healthy
  • Healthcare system and access – systems that pay for and deliver services and timely use of services for best health outcomes

Some SHIP strategies can be used to address all priority outcomes. Examples of these strategies include school-based health centers, healthy food initiatives, and screening and treatment services.

All SHIP strategies and outcome indicators are available here.

April 9, 2018 - Ohio cardiac catheterization program: Two-physician requirement

Cardiac catheterization programs are required to have at least two licensed physicians on staff who are knowledgeable about the laboratory’s protocols and equipment. These physicians must be credentialed to provide cardiac catheterization services, however, guidance from the Ohio Department of Health (ODH) suggests that these physicians do not have to be credentialed to perform all procedures within the program’s scope of service.

For example, a level 1 service may have one physician credentialed to perform all diagnostic cardiac catheterization procedures and one physician only credentialed to perform device implantation.

For a level II or level III service, individual physicians do not have to provide all therapeutic cardiac catheterization procedures within the service’s scope of service. However, because a level II and level III service must operate on a 24/7 basis to perform primary percutaneous coronary intervention (PCI), at least two physicians should be credentialed to perform primary PCI to ensure adequate coverage.

April 2, 2018 - Ohio cardiac catheterization program: Incident notification to ODH

Cardiac catheterization programs are required to have at least two licensed physicians on staff who have been credentialed to provide cardiac catheterization services by meeting all of the following criteria:

  • Completed training that includes at least one year dedicated to cardiac catheterization procedures
  • Designated as a fully-accredited member of the service’s staff
  • Participate in the cardiac catheterization laboratory’s quality assurance programs, including peer review

In addition, physicians performing percutaneous coronary intervention (PCI) who have not performed PCI prior to March 20, 1997, must have completed a fellowship training program in interventional cardiology.

It’s likely time to review your credentialing criteria to ensure that your physicians performing cardiac catheterization procedures meet these requirements.

March 26, 2018 - Ohio cardiac catheterization program: Incident notification to ODH

If a level I or level II cardiac catheterization service provides emergency care outside the designated scope of services, it must provide written notice to ODH within 48 hours of the incident. While maintaining patient confidentiality, the notification must include the following:

  • When the incident occurred
  • The nature of the emergency and actions taken
  • The patient’s outcome

Be sure to incorporate this notification requirement into your service’s policies and procedures and ensure that timely notification is provided.

March 19, 2018 - Ohio cardiac catheterization program: Informed consent

Cardiac catheterization services are required to obtain a signed informed consent form from each patient or patient designee prior to the procedure. For a level I or level II service, the informed consent must include an acknowledgment that the procedure is being performed in a cardiac catheterization service without on-site open heart surgery and that, if necessary as the result of an adverse event, the patient may be transferred to a receiving service for medical/surgical management.

While a general hospital informed consent may be used for a level III service, a level I or level II service must use an informed consent that includes this language.

January 9, 2018 - Ohio cardiac catheterization program: Quality assessment and review process

A cardiac catheterization service specific rule from the Ohio Department of Health (ODH) provides that major complications and emergency transfers should be reviewed at least once every 90 days by the quality assessment review process. However, the ODH general quality assessment and performance improvement rule requires the program to hold regular meetings, chaired by the medical director of the health care service or designee, at least within 60 days after a death or complication to review all deaths and complications and to report findings. To be compliant, providers must meet the 60-day requirement for review of any death or complication.

December 12, 2017 - Ohio open heart surgery program staffing requirements

The Ohio Department of Health requires an appropriate number of scrub nurses or technicians and a circulating nurse for each open heart surgery procedure. The number of staff present at each procedure should be based on the needs of the surgeons and the patient. At a minimum, there must be two staff present for each procedure, including a circulating nurse and one scrub nurse or technician.

Be sure to include these requirements in your open heart surgery service’s policies and procedures and document compliance.

December 5, 2017 - Ohio open heart surgery program multidisciplinary approach to patient care

Effective August 1, 2017, the Ohio Department of Health requires a provider of an adult open heart surgery service to utilize a multidisciplinary approach to patient care. This approach is to include meetings between cardiologists and cardiovascular surgeons as necessary to address the needs of patients with complex cardiovascular disease. In addition, as part of the service’s quality assessment and performance improvement process, there must be a periodic review and evaluation of the multidisciplinary meetings.

Be sure to include these requirements in your open heart surgery service policies and procedures. Also, document the meetings, reviews and evaluations.

November 28, 2017 - Surgeon review: Ohio open heart surgery programs

An Ohio Department of Health (ODH) rule requires that providers of adult open heart surgery services conduct a thorough internal review of any surgeon with a combination of high risk adjusted mortality and low individual surgeon volume. ODH also requires providers to have a written policy requiring the documentation of the internal review of surgeons with this combination. Rules further specify that a volume goal of at least 25 open heart procedures per surgeon per year is recommended.

Be sure to include this requirement in your open heart surgery service’s policies and procedures and also document the surgeon review process.

November 17, 2017 - Ohio health care service rules: New personnel and staffing requirements

The Ohio Department of Health recently added a new requirement for all Chapter 84 health care services listed below:

• Adult cardiac catheterization

• Adult open heart surgery

• Solid organ transplantation

• Bone marrow transplantation

• Pediatric intensive care unit

• Radiation therapy

• Pediatric cardiac catheterization

• Pediatric cardiovascular surgery

Beginning August 1, 2017, each service must have an ongoing process for ensuring the competence of “staff members,” defined as the administrator and individuals providing direct care to patients on a full-time, part-time, temporary, contract, or voluntary basis. This process must include a periodic assessment and re-determination of necessary skill levels for each staff position practicing within the health care service. Note that this requirement cannot be met by providing training – there must be an assessment of skill level for each staff member. At least every 36 months, a performance evaluation must be conducted stating whether each staff member has achieved the skill levels for the position.

Be sure to include this requirement in your policies and procedures and document the assessment in each individual’s personnel file, explicitly stating whether the staff member has achieved the skill levels for the position.

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