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.

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.

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

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.