Chapter 5160-13 Ambulatory Health Care Clinic Services

5160-13-01 Fee-for-service ambulatory health care clinics (AHCCs): general provisions.

Requirements outlined in this rule apply to all fee-for-service AHCCs identified in paragraph (B) of this rule.

(A) Definitions.

(1) "Ambulatory health care clinic (AHCC)" is a free-standing ambulatory healthcare facility that furnishes outpatient (non-institutional) health care by or under the direction of a physician or dentist, without regard to whether the clinic itself is administered by a physician or dentist.

(2) "Ambulatory health care facility" is a facility or distinct part of a facility that:

(a) Provides services on an outpatient basis in a fixed location or specifically designed mobile unit; and

(b) Does not provide overnight accommodations.

(3) "Cost-based ambulatory health care clinic" is an AHCC that is eligible for reimbursement on an encounter basis (in accordance with Chapter 5101:3-16, 5101:3-28, or 5101:3-29 of the Administrative Code) rather than on a service code basis.

(4) "Department," for the purposes of this chapter, is the Ohio department of job and family services (ODJFS).

(5) "Fee-for-service ambulatory health care clinic" is an AHCC that is eligible for reimbursement on a service code basis (in accordance with Chapter 5101:3-13 of the Administrative Code) rather than an encounter basis.

(6) "Free-standing" means having no administrative, organizational, financial or other connection with a hospital or long-term care facility. A free-standing clinic may be physically located in a hospital or long-term care facility as long as the clinic remains independent, as evidenced by cost reports and separate employer identification number (EIN).

(7) "Medical services" are, for the purposes of this chapter, defined in accordance with rule 5101:3-1-01 of the Administrative Code.

(8) "Non-specialty clinic" is an AHCC that provides a broad range of health care services.

(9) "Specialty clinic" is an AHCC that provides a limited or focused scope of healthcare services (e.g., dental, vision, dialysis).

(B) Medicaid providers eligible to be reimbursed by the department for AHCC services are either non-specialty or specialty clinics.

(1) Non-specialty clinics are:

(a) Primary care clinics, in accordance with rule 5101:3-13-01.1 of the Administrative Code; and

(b) Public health department clinics, in accordance with rule 5101:3-13-01.3 of the Administrative Code.

(2) Specialty clinics are:

(a) Community mental health services clinics, in accordance with rule 5101:3-13-01.2 of the Administrative Code;

(b) Outpatient rehabilitation clinics, in accordance with rule 5101:3-13-01.4 of the Administrative Code;

(c) Family planning clinics, in accordance with rule 5101:3-13-01.5 of the Administrative Code;

(d) Professional optometry school clinics, in accordance with rule 5101:3-13-01.6 of the Administrative Code;

(e) Professional dental school clinics, in accordance with rule 5101:3-13-01.7 of the Administrative Code;

(f) Speech-language/audiology clinics and diagnostic imaging clinics, in accordance with rule 5101:3-13-01.8 of the Administrative Code; and

(g) End-stage renal disease (ESRD) dialysis clinics, in accordance with rule 5101:3-13-01.9 of the Administrative Code.

(C) Any organization applying to be a fee-for-service AHCC medicaid provider on or after January 1, 2008 must:

(1) Meet the definition of an AHCC in accordance with paragraph (A)(1) of this rule;

(2) Not be eligible as a medicaid provider as a professional association of physicians, dentists, optometrists, opticians, podiatrists, or limited practitioners such as physical therapists, psychologists, or chiropractors in accordance with division (B)(5)(c)(i) of section 2317.02 of the Revised Code;

(3) Be enrolled as a medicare provider;

(4) Bill medicare as the primary insurer for services provided to patients eligible for 5101:3-13-01 2 both medicare and medicaid;

(5) Meet all specific requirements of at least one medicaid provider type listed under paragraph (B) of this rule;

(6) Submit to the department appropriate documentation of compliance with the requirements set forth in paragraphs (C)(1) to (C)(5) of this rule, in accordance with Chapter 5101:3-1 of the Administrative Code and the Ohio medicaid provider application/agreement for organizations, job and family services (JFS) 0651 (rev. 5/2006).

(D) Covered services include services identified per specific AHCC provider type set forth in rules 5101:3-13-01.1 to 5101:3-13-01.9 of the Administrative Code and the executed Ohio medicaid provider application/agreement for organizations, JFS 0651 (rev. 5/2006). AHCCs may be eligible providers of:

(1) Physician services in accordance with paragraph (D)(1) of rule 5101:3-4-01 of the Administrative Code;

(2) Dental services in accordance with rule 5101:3-5-01 of the Administrative Code;

(3) Vision services in accordance with paragraph (A)(5)(a) of rule 5101:3-6-01 of the Administrative Code;

(4) Podiatry services in accordance with Chapter 5101:3-7 of the Administrative Code;

(5) Advance practice nurse services in accordance with rules 5101:3-8-20 to 5101:3-8-23 of the Administrative Code;

(6) Laboratory services in accordance with rule paragraph (A)(2) of rule 5101:3-11-02 of the Administrative Code, if certified to perform laboratory procedures under Clinical Laboratory Improvement Act(CLIA);

(7) Psychology services in accordance with paragraph (E)(1) of rule 5101:3-8-01 of the Administrative Code;

(8) EPSDT services in accordance with Chapter 5101:3-14 of the Administrative Code;

(9) Transportation services in accordance with Chapter 5101:3-15 of the Administrative Code;

(10) Disability medical assistance in accordance with Chapter 5101:3-23 of the Administrative Code; and

(11) Therapy services in accordance with Chapter 5101:3-34 of the Administrative Code.

(E) Limitations.

(1) AHCCs must follow all applicable general medicaid provisions of Chapter 5101:3-1 of the Administrative Code, including, but not limited to:

(a) The co-payment program set forth in rule 5101:3-1-09 of the Administrative Code; and

(b) Co-payments in managed care settings set forth in Chapter 5101:3-26 of the Administrative Code.

(2) AHCCs are limited to specific types of services and/or reimbursement codes as specified by provider type in rules 5101:3-13-01.1 to 5101:3-13-01.9 of the Administrative Code.

(3) Coverage limitations set forth in Chapter 5101:3-4 of the Administrative Code apply to AHCC services provided by physicians.

(4) Coverage limitations set forth in Chapter 5101:3-5 of the Administrative Code apply to AHCC services provided by dentists.

(5) Coverage limitations set forth in Chapter 5101:3-6 of the Administrative Code apply to AHCC services provided by opticians and optometrists.

(6) Coverage limitations set forth in Chapter 5101:3-7 of the Administrative Code apply to AHCC services provided by podiatrists.

(7) Coverage limitations set forth in rule 5101:3-8-23 of the Administrative Code also apply to advanced practice nurse services provided under the auspices of an AHCC.

(8) Take-home drugs must be billed through the pharmacy program as described in Chapter 5101:3-9 of the Administrative Code.

(9) Durable medical equipment (DME) for take-home use must be billed through the DME program as described in Chapter 5101:3-10 of the Administrative Code.

(10) Coverage limitations set forth in Chapter 5101:3-11 of the Administrative Code also apply to laboratory services provided by AHCCs.

(11) Coverage limitations set forth in rule 5101:3-8-05 of the Administrative Code apply to AHCCs providing psychology services.

(12) Coverage limitations set forth in Chapter 5101:3-14 of the Administrative Code apply to AHCCs providing services to individuals age birth to twenty-one years of age.

(13) Coverage limitations set forth in rules 5101:3-8-05 and 5101:3-4-29 of the Administrative Code also apply to mental health services provided under the auspices of an AHCC.

(14) Coverage limitations set forth in Chapters and 5101:3-15 of the Administrative Code apply to AHCCs providing transportation services.

(15) Coverage limitations set forth in Chapters 5101:3-17 and 5101:3-21 of the Administrative Code, regarding abortion and sterilization procedures, apply to AHCCs.

(16) Coverage limitations set forth in Chapter 5101:3-23 of the Administrative Code apply to AHCCs providing disability medical assistance medical program services.

(17) Coverage limitations set forth in Chapter 5101:3-26 of the Administrative Code apply to AHCCs with medicaid managed care program contracts. For consumers in the medicaid managed care program, claims submission requirements, including prior authorization requests for AHCC services, are specified in rules 5101:3-26-03.1 and 5101:3-26-05.1 of the Administrative Code.

(18) Coverage limitations set forth in Chapter 5101:3-34 of the Administrative Code also apply to therapy services provided under the auspices of an AHCC.

(F) The department reimburses fee-for-service AHCCs in accordance with rule 5101:3-1-60 of the Administrative Code.

Replaces: 5101:3-13-01, Part of 5101:3-13-03, Part of 5101:3-13-04, Part of 5101:3-13-05, Part of

Effective: 01/01/2008
R.C. 119.032 review dates: 01/01/2013
Promulgated Under: 119.03
Statutory Authority: 5111.02
Rule Amplifies: 5111.01 , 5111.02 , 5111.021
Prior Effective Dates: 4/7/77, 12/21/77, 12/30/77, 1/8/79, 1/14/83, 4/2/83, 6/3/83, 10/1/87, 4/1/88, 9/1/89, 7/1/93, 7/12/93 (Emer.), 10/1/93; 5/17/01, 3/1/05

5160-13-01.1 Fee-for-service ambulatory health care clinics (AHCCs): primary care clinics.

Requirements outlined in rule 5101:3-13-01 of the Administrative Code apply to all fee-for-service AHCCs.

(A) Definitions.

(1) "Primary care clinic" is an AHCC that provides primary care services in one location. This type of clinic may be administered by a number of different types of agencies/organizations, including community action agencies, or independent and un-affiliated local agencies/foundations.

(2) "Primary care" is health care rendered by licensed health care providers delivering services within their scope of practice, who are specifically trained for and skilled in comprehensive first contact and continuing care for persons with any sign, symptom, or health concern not limited by problem origin, organ system, or diagnosis. Primary care includes health promotion, disease prevention, health maintenance, counseling, patient education, diagnosis and treatment of acute and chronic illnesses, appropriate medication management in a variety of health care settings and in coordination/collaboration with other health care professionals and systems (e.g., office, inpatient, critical care, long-term care, home care, day care, etc.).

(3) "Primary care physician" is a generalist physician who provides definitive care to the undifferentiated patient at the point of first contact and takes continuing responsibility for providing the patient's care. Such a physician must be specifically trained to provide primary care services. Primary care physicians devote the majority of their practice to providing primary care services to a defined population of patients. The style of primary care practice is such that the personal primary care physician serves as the entry point for substantially all of the patient's medical and health care needs - not limited by problem origin, organ system, or diagnosis. Primary care physicians are advocates for the patient in coordinating the use of the entire health care system to benefit the patient.

(4) "Primary health care" is a method of health care delivery in which teams of providers are accountable for providing comprehensive services to their patients.

(B) Any organization applying to be a medicaid fee-for-service ambulatory health care primary care clinic provider on and after January 1, 2008 must:

(1) Meet the criteria for fee-for-service AHCC providers in accordance with paragraph (C) of rule 5101:3-13-01 of the Administrative Code;

(2) Meet the definition of a primary care clinic, in accordance with paragraph (A) of this rule; and

(3) Be certified or accredited by:

(a) The joint commission;

(b) The accreditation association for ambulatory health care (AAAHC);

(c) The healthcare facilities accreditation program of the American osteopathic association;

(d) The community health accreditation program (CHAP); or

(4) Receive state or federal grant funds for the provision of health services.

(C) A primary care clinic may provide all or some of the covered services identified in and provided in accordance with paragraph (D) of rule 5101:3-13-01 of the Administrative Code.

(1) If a primary care clinic does not provide a service, it must have a formal working arrangement with other medical providers for the services needed by the individual beyond the capability of the clinic.

(2) Primary care clinic services must be provided in accordance with the limitations identified in paragraph (E) of rule 5101:3-13-01 of the Administrative Code.

(D) Federally qualified health centers (FQHCs), rural health clinics (RHCs), and outpatient health facilities (OHFs) may submit claims as a primary care clinic only when billing for services that are not covered under the prospective payment system (PPS) base rate, in accordance with Chapters 5101:3-28, 5101:3-16, and 5101:3-29 of the Administrative Code. These services include:

(1) Inpatient hospital surgery;

(2) Inpatient hospital visits or consultations;

(3) Services provided to dual-eligibles when medicare cross-over claims for services are not paid through the automatic medicare crossover process in accordance with rule 5101:3-1-05 of the Administrative Code; and

(4) Services submitted as disability medical assistance claims.

Replaces: Part of 5101:3-13-01, Part of 5101:3-13-03

Effective: 01/01/2008
R.C. 119.032 review dates: 01/01/2013
Promulgated Under: 119.03
Statutory Authority: 5111.02
Rule Amplifies: 5111.01 , 5111.02 , 5111.021
Prior Effective Dates: 4/7/77, 12/21/77, 12/30/77, 1/8/79, 4/1/88

5160-13-01.3 Fee-for-service ambulatory health care clinics (AHCCs): public health department clinics.

Requirements outlined in rule 5101:3-13-01 of the Administrative Code apply to all fee-for-service AHCCs.

(A) Definitions.

(1) "Local health department" means a health department operated by the board of health of a city or general health district or the authority having the duties of a board of health under Chapter 3709. of the Revised Code.

(2) "Public health department," for the purposes of this chapter, has the same meaning as "local health department."

(B) Any organization applying to be a medicaid fee-for-service ambulatory health care public health department clinic provider on and after January 1, 2008 must:

(1) Meet the criteria for fee-for-service AHCC providers in accordance with paragraph (C) of rule 5101:3-13-01 of the Administrative Code;

(2) Have legal status as a county, city, or combined health district; and

(3) Meet the standards for boards of health and local health departments in accordance with Chapter 3709. and section 3701.342 of the Revised Code.

Replaces: Part of 5101:3-13-01, Part of 5101:3-13-03, Part of 5101:3-13-04

Effective: 01/01/2008
R.C. 119.032 review dates: 01/01/2013
Promulgated Under: 119.03
Statutory Authority: 5111.02
Rule Amplifies: 5111.01 , 5111.02 , 5111.021
Prior Effective Dates: 4/7/77, 12/21/77, 12/30/77, 1/8/79, 1/14/83, 4/2/83, 4/1/88

5160-13-01.4 Fee-for-service ambulatory health care clinics (AHCCs): outpatient rehabilitation clinics.

Requirements outlined in rule 5101:3-13-01 of the Administrative Code apply to all fee-for-service AHCCs.

(A) Definitions.

(1) "Outpatient rehabilitation clinic" is defined in accordance with 42 C.F.R. 485.703 (10/01/2006). An outpatient rehabilitation clinic provides "basic rehabilitation services," including any or all of the following services: physical therapy, occupational therapy, speech-language pathology services, audiology services.

(2) "Comprehensive outpatient rehabilitation facility (CORF)" is defined in accordance with 42 C.F.R. 485.51 (10/01/2006). A CORF provides more rehabilitation services than physical therapy, occupational therapy, speech-language pathology (SLP) services, audiology services. A CORF might also provide services such as cardio/pulmonary rehab

(B) Any organization applying to be a medicaid fee-for-service ambulatory health care outpatient rehabilitation clinic provider on and after January 1, 2008 must:

(1) Meet the criteria for fee-for-service AHCC providers in accordance with paragraph (C) of rule 5101:3-13-01 of the Administrative Code; and

(2) Be certified by medicare:

(a) As either an outpatient rehabilitation clinic; or

(b) A CORF.

(3) Provide services in accordance with division level 5101:3 of the Administrative Code, including, but not limited to physical therapy, occupational therapy, and speech language pathology (SLP)/audiology services in accordance with Chapter 5101:3-34 of the Administrative Code.

(C) Coverage limitations set forth in Chapter 5101:3-33 of the Administrative Code also apply to therapy services provided under the auspices of an AHCC.

Replaces: Part of 5101:3-13-01, Part of 5101:3-13-03, Part of 5101:3-13-04

Effective: 01/01/2008
R.C. 119.032 review dates: 01/01/2013
Promulgated Under: 119.03
Statutory Authority: 5111.02
Rule Amplifies: 5111.01 , 5111.02 , 5111.021
Prior Effective Dates: 4/7/77, 12/21/77, 12/30/77, 1/8/79, 1/14/83, 4/2/83, 4/1/88

5160-13-01.5 Fee-for-service ambulatory health care clinics (AHCCs): family planning clinics.

Requirements outlined in rule 5101:3-13-01 of the Administrative Code apply to all fee-for-service AHCCs.

(A) Definitions.

(1) "Family planning," means, in accordance with rule 5101:3-21-02 of the Administrative Code, preventing or delaying pregnancy.

(2) "Family planning clinics" are ambulatory health care clinics (AHCCs) whose primary function is to provide family planning services.

(3) "Family planning services" means, in accordance with rule 5101:3-21-02 of the Administrative Code, pregnancy prevention/contraceptive management services.

(4) "Qualified family planning provider (QFPP)" is defined in accordance with rule 5101:3-26-01 of the Administrative Code.

(B) Any organization applying to be a medicaid fee-for-service ambulatory health care family planning clinic provider on and after January 1, 2008 must:

(1) Meet the criteria for fee-for-service AHCC providers in accordance with paragraph (C) of rule 5101:3-13-01 of the Administrative Code; and

(2) Meet one or more of the following qualifications:

(a) Affiliation with the planned parenthood federation of America (PPFA);

(b) Receive a grant award for the provision of family planning services under Title X of the Public Health Services Act; or

(c) Receive a grant award through the Ohio department of health for family planning services under the child and family health services program; and/or

(d) Receive a grant award through the Ohio department of health's women's health services, in accordance with rule 3701-68-01 of the Administrative Code.

(C) Covered services are family planning services, including medical, consultative, and educational services as specified in accordance with rule 5101:3-21-02 of the Administrative Code.

(D) Coverage limitations set forth in Chapter 5101:3-26 of the Administrative Code apply to AHCCs.

Effective: 07/01/2009
R.C. 119.032 review dates: 04/14/2009 and 07/01/2014
Promulgated Under: 119.03
Statutory Authority: 5111.02
Rule Amplifies: 5111.01 , 5111.02 , 5111.021
Prior Effective Dates: 4/7/77, 12/21/77, 12/30/77, 1/8/79, 1/14/83, 4/2/83, 10/1/87, 4/1/88, 9/1/89, 1/1/08

5160-13-01.6 Fee-for-service ambulatory health care clinics (AHCCs): professional optometry school clinics.

Requirements outlined in rule 5101:3-13-01 of the Administrative Code apply to all fee-for-service AHCCs.

(A) Any organization applying to be a medicaid fee-for-service ambulatory health care professional optometry school clinic provider on and after January 1, 2008 must:

(1) Meet the criteria for fee-for-service AHCC providers in accordance with paragraph (C) of rule 5101:3-13-01 of the Administrative Code; and

(2) Be a professional optometry school clinic accredited by the accreditation council on optometry education (ACOE) of the American optometric association.

(B) Covered services are optometry services specified in accordance with Chapter 5101:3-6 of the Administrative Code.

(C) In accordance with paragraph (A)(5)(a) of rule 5101:3-6-01 of the Administrative Code, AHCCs are eligible providers of vision services. Coverage limitations set forth in Chapter 5101:3-6 of the Administrative Code apply to AHCC services provided by opticians and optometrists.

Replaces: Part of 5101:3-13-01, Part of 5101:3-13-04

Effective: 01/01/2008
R.C. 119.032 review dates: 01/01/2013
Promulgated Under: 119.03
Statutory Authority: 5111.02
Rule Amplifies: 5111.01 , 5111.02 , 5111.021
Prior Effective Dates: 4/7/77, 12/30/77, 1/14/83, 4/2/83

5160-13-01.7 Fee-for-service ambulatory health care clinics (AHCCs): professional dental school clinics.

Requirements outlined in this rule 5101:3-13-01 of the Administrative Code apply to all fee-for-service AHCCs.

(A) Any organization applying to be a medicaid fee-for-service ambulatory health care professional dental school clinic provider on and after January 1, 2008 must:

(1) Meet the criteria for fee-for-service AHCC providers in accordance with paragraph (C) of rule 5101:3-13-01 of the Administrative Code; and

(2) Function as a training facility for a professional dental school clinic accredited by the commission on dental accreditation (CODA) of the American dental association (ADA).

(B) Covered services are covered dental services in accordance with Chapter 5101:3-5 of the Administrative Code.

(C) Limits.

(1) In accordance with rule 5101:3-5-01 of the Administrative Code, AHCCs are eligible providers of dental services. Coverage limitations set forth in Chapter 5101:3-5 of the Administrative Code apply to AHCC services provided by dentists.

(2) Individual dentists working within an ambulatory health care professional dental school clinic are not required to have provider numbers. The clinic must retain proof of legal authorization for each dentist without medicaid provider number to provide services.

Replaces: Part of 5101:3-13-01, Part of 5101:3-13-04

Effective: 01/01/2008
R.C. 119.032 review dates: 01/01/2013
Promulgated Under: 119.03
Statutory Authority: 5111.02
Rule Amplifies: 5111.01 , 5111.02 , 5111.021
Prior Effective Dates: 4/7/77, 12/30/77, 1/14/83, 4/2/83

5160-13-01.8 Fee-for-service ambulatory health care clinics (AHCCs): speech-language/audiology clinics and diagnostic imaging clinics.

Requirements outlined in rule 5101:3-13-01 of the Administrative Code apply to all fee-for-service AHCCs.

(A) Definitions.

(1) "Diagnostic imaging," in accordance with rule 3701-83-51 of the Administrative Code, means the production of images used for medical diagnosis using magnetic resonance imaging(MRI), positron emission tomography (PET), computed tomography (CT), nuclear medicine. Diagnostic imaging does not mean the production of images used for medical diagnosis using diagnostic x-ray, mammography, or ultrasound.

(2) "Freestanding diagnostic imaging center," in accordance with rule 3701-83-51 of the Administrative Code, means a facility, or part of a facility, at which diagnostic imaging services are provided. A freestanding diagnostic imaging center does not include hospitals registered under section 3701.07 of the Revised Code

(3) "Mobile diagnostic imaging center," in accordance with paragraph (J) of rule 3701-83-51 of the Administrative Code, means any arrangement in which diagnostic imaging services are transported to various sites. A mobile diagnostic imaging center does not include movement within a hospital or movement to a site where the equipment will be located permanently and does not include the provision of diagnostic imaging by an entity that is reviewed as part of a hospital accreditation program.

(4) "Speech and hearing clinic" is an AHCC that provides speech, language, and audiology services designed to improve and restore the functioning of an individual.

(B) Any organization applying to be a medicaid fee-for-service ambulatory health care speech-language/audiology clinic or diagnostic imaging clinic on and after January 1, 2008 must:

(1) Meet the criteria for fee-for-service AHCC providers in accordance with paragraph (C) of rule 5101:3-13-01 of the Administrative Code;

(2) Specialize in either speech-language/audiology services or diagnostic imaging services;

(3) Not meet the requirements of any other AHCC type identified in Chapter 5101:3-13 of the Administrative Code;

(4) Provide services in accordance with division 5101:3 of the Administrative Code; and

(5) If providing diagnostic imaging services, be:

(a) A freestanding diagnostic imaging center; or

(b) A mobile diagnostic imaging center; and

(c) Licensed, registered, and credentialed in accordance with applicable, federal, state, and local laws.

(6) If providing speech and hearing services, deliver such services:

(a) In accordance with rule 5101:3-4-17 of the Administrative Code; and

(b) By professionals holding a certificate of clinical competence in speech-language pathology (CCC-SLP) and/or a certificate of clinical competence in audiology (CCC-A), issued by the American speech-language hearing association (ASHA).

Replaces: Part of 5101:3-13-01, Part of 5101:3-13-04

Effective: 01/01/2008
R.C. 119.032 review dates: 01/01/2013
Promulgated Under: 119.03
Statutory Authority: 5111.02
Rule Amplifies: 5111.01 , 5111.02 , 5111.021
Prior Effective Dates: 4/7/77, 12/30/77, 1/14/83, 4/2/83

5160-13-01.9 Fee-for-service ambulatory health care clinics (AHCCs): end-stage renal disease (ESRD) dialysis clinics.

Requirements outlined in rule 5101:3-13-01 of the Administrative Code apply to all fee-for-service AHCCs.

(A) Definitions.

(1) "Ambulatory health care ESRF dialysis clinic" is a renal dialysis facility that meets the requirements outlined in paragraph (C) of this rule and provides chronic maintenance dialysis for end-stage renal disease (ESRD).

(2) "Chronic maintenance dialysis," in accordance with rule 3701-83-23 of the Administrative Code, means the regular provision of dialysis for an end stage renal disease patient with any level of patient involvement.

(3) "Composite payment rate" is a prospective system for the comprehensive payment of all modes of outpatient (in-facility and method I home) maintenance dialysis services. The composite payment rate covers most items and services related to the treatment of a patient's ESRD. The composite rate covers the complete dialysis treatment, specific laboratory tests, diagnostic services, laboratory services, and drugs (including injections and immunizations) in specific quantities and frequencies, as described in appendix A to this rule. The composite rate does not cover physician professional services, separately billable laboratory services, or separately billable drugs. Dialysis composite rates are listed in rule 5101:3-1-60 of the Administrative Code.

(4) "Continuous ambulatory peritoneal dialysis" (CAPD) is a type of peritoneal dialysis in which the patient's peritoneal membrane is used as a dializer. CAPD is usually performed three to five times a day in four to six hour cycles.

(5) "Continuous cycling peritoneal dialysis" (CCPD) is a type of peritoneal dialysis in which the patient's peritoneal membrane is used as a dializer. CAPD is usually accomplished three times a night in approximately three hours cycles, using an automatic peritoneal dialysis cycler.

(6) "Dialysis" is a process by which waste products are removed from the body by diffusion from one fluid compartment to another across a semi-permeable membrane. The two types of dialysis procedures currently in common use are hemodialysis and peritoneal dialysis.

(7) "Dual-eligible," for the purposes of this rule, means a patient who is eligible for both medicare and medicaid coverage of ESRD services.

(8) "End-stage renal disease" (ESRD) occurs from the destruction of normal kidney tissues over a long period of time. The loss of kidney function in ESRD is usually irreversible and permanent.

(9) "End-stage renal disease patient," in accordance with rule 3701-83-23 of the Administrative Code, means an individual who is at a stage of renal impairment that appears irreversible and permanent and who requires a regular course of dialysis or renal transplantation to ameliorate uremic symptoms and maintain life.

(10) "ESRD services" are diagnostic, therapeutic, rehabilitative, or palliative services, including:

(a) Services furnished at an ambulatory health care ESRD dialysis clinic by or under the general or direct supervision of a physician.

(b) Services furnished outside an ambulatory health care ESRD dialysis clinic by clinic personnel under the general or direct supervision of a physician to a patient who does not reside in a permanent dwelling or does not have a fixed home or mailing address.

(c) Services specified by revenue center codes delineated in appendix A to this rule.

(11) "Free-standing" is defined in accordance with rule 5101:3-13-01 of the Administrative Code.

(12) "Freestanding dialysis center" or "dialysis center," in accordance with rule 3701-83-23 of the Administrative Code, means a facility that provides chronic maintenance dialysis to ESRD patients on an outpatient basis, including the provision of dialysis services in the patient's place of residence. A freestanding dialysis center does not include a hospital or other entity that performs dialysis services that are reviewed and accredited or certified as part of the hospital's accreditation or certification as required by section 3727.02 of the Revised Code.

(13) "Home dialysis" is dialysis performed by an appropriately trained patient and patient caregiver at home. Home dialysis, in accordance with rule 3701-83-23 of the Administrative Code, means dialysis performed by an appropriately trained patient, with or without minimal assistance, at the patient's place of residence.

(14) "Home dialysis training" is a program that trains ESRD patients to perform home dialysis with little or no professional assistance, and trains other individuals to assist patients in performing home dialysis.

(15) "Hospital-based ESRD facilities" are an integral and subordinate part of a hospital, as evidenced by the cost report, in accordance with Chapter 5101:3-2 of the Administrative Code.

(16) "Hemodialysis" is a renal dialysis procedure in which blood passes through an artificial kidney machine and the waste products diffuse across a manmade membrane into a bath solution known as dialysate after which the cleansed blood is returned to the patient's body. Hemodialysis is usually accomplished in three to four hours sessions, three times a week.

(17) "In-facility dialysis" is dialysis furnished on an outpatient basis at an approved renal dialysis facility.

(18) "Intermittent peritoneal dialysis" (IPD) is a type of peritoneal dialysis in which waste products pass from the patient's body through the peritoneal membrane into the peritoneal cavity where the dialysate is introduced and removed periodically by machine. IPD is usually conducted for approximately thirty hours per week in three or fewer sessions of ten or more hours.

(19) "Method I" is medicare terminology used to describe the provision of home dialysis services whereby a renal dialysis facility assumes responsibility for providing all home dialysis equipment, supplies and support services.

(20) "Peritoneal dialysis" is a renal dialysis procedure in which waste products pass from a patient's body through the peritoneal membrane into the peritoneal (abdominal) cavity where the dialysate is introduced and removed periodically. The three types of peritoneal dialysis are continuous ambulatory peritoneal dialysis (CAPD), continuous cycling peritoneal dialysis (CCPD), and intermittent peritoneal dialysis (IPD).

(21) "Physician professional services," in accordance with rule 5101:3-4-14 of the Administrative Code, are age-specific services performed in an outpatient setting that are related to a patient's ESRD.

(22) "Renal dialysis center" is a hospital unit approved by medicare to furnish the full spectrum of services required for the care of ESRD dialysis patients.

(23) "Renal dialysis facility" is a unit approved by medicare to furnish dialysis services directly to ESRD patients.

(24) "Self-dialysis" is dialysis performed by an appropriately trained ESRD patient with little or no professional assistance.

(25) "Self-dialysis training" is a program that trains ESRD patients to perform self-dialysis with little or no professional assistance, and trains other individuals to assist patients in performing self-dialysis.

(26) "Staff-assisted dialysis" is dialysis performed by the staff of a renal dialysis center or facility.

(B) Any organization applying to be a medicaid fee-for-service ambulatory health care dialysis clinic provider on and after January 1, 2008 must:

(1) Meet the criteria for fee-for-service AHCC providers in accordance with paragraph (C) of rule 5101:3-13-01 of the Administrative Code; and

(2) Be certified by medicare as a dialysis facility;

(3) Be licensed by the director of the Ohio department of health in accordance with Chapter 3701-83 of the Administrative Code and demonstrate to the director of health that it meets the requirements of section 3702.30 of the Revised Code and either meets the requirements of Chapter 3701-83 of the Administrative Code or has submitted an acceptable accreditation inspection report, in accordance with rule 3701-83-05 of the Administrative Code; and in accordance with rule 3701-83-02 of the Administrative Code, complies with rules 3701-83-23 to 3701-83-24 of the Administrative Code. Non-Ohio providers must be licensed by their respective state's authority if applicable.

(4) Provide services in accordance with division level 5101:3 of the Administrative Code.

(C) Dialysis clinic claims, billing, payment/reimbursement.

(1) Fee-for-service ambulatory health care dialysis clinic providers that have executed the standard medicaid provider agreement and meet all eligibility requirements specified in paragraph (C) of this rule may bill the department for ESRD dialysis services.

(2) All medicaid providers, including fee-for-service ambulatory health care dialysis clinics, must determine whether medicare or other third party insurers are responsible for the coverage of a medicaid patient's dialysis treatment for the date of treatment. Medicaid is the payer of last resort for ESRD services.

(a) Medicaid coverage of ESRD services for patients, including dual-eligibles, begins with the initial onset of dialysis treatment.

(i) If CMS determines that the patient is medicare eligible at the onset of the disease, medicaid coverage as the primary payer begins with the initial onset of dialysis and continues until medicare coverage begins (usually three months).

(ii) If CMS determines that the patient is not medicare eligible at the onset of the disease, medicaid coverage continues as long as the dialysis treatments are medically necessary and the patient is eligible for medicaid.

(b) The medicaid provider must pursue medicare eligibility for the patient through CMS within the first three months of a medicaid eligible patient's initial dialysis treatment.

(i) The provider must retain proof in the medical record that the patient has applied for medicare coverage and is ineligible.

(ii) The department may conduct a retrospective review to verify that the provider assisted the patient to apply for medicare coverage.

(iii) Fee-for-service ambulatory health care dialysis clinic providers shall bill medicare cross-over claims in accordance with rule 5101:3-1-05 of the Administrative Code.

(3) Dialysis clinic claims for "clinic facility dialysis services" are payable only if submitted in accordance with national uniform billing committee (NUBC) requirements, using revenue center code(s) and appropriate procedure code(s) as described in appendix A to this rule.

(4) Dialysis clinics must document in the patient's medical record the medical necessity, defined in accordance with rule 5101:3-1-01 of the Administrative Code, of each service provided and billed to the department. to verify that the services were rendered as billed on the claim.

(5) The department reimburses ambulatory health care dialysis clinics for dialysis treatment, dialysis support, and dialysis treatment with self-care training using composite rates, as described in appendix A to this rule. The composite rates include specific laboratory tests, diagnostic services, and drugs (including injections and immunizations) in specific quantities and frequencies, as described in appendix A to this rule. Items included in the composite rates may not be billed separately by the dialysis clinic or by any laboratory for the same date of dialysis treatment. Laboratory services may be performed in the clinic or by an outside laboratory if the clinic or laboratory is clinical laboratory improvement act (CLIA) certified. Laboratory tests are included in the composite rate regardless of where the tests are performed. Composite rates do not include a physician's professional supervision. Physician professional supervision may only be billed by physicians, in accordance with rule 5101:3-4-14 of the Administrative Code. Dialysis clinic composite rates are listed in rule 5101:3-1-60 of the Administrative Code.

(a) Composite rates for medicaid coverage of dialysis treatment.

(i) Dialysis treatment is available to patients in both clinic and home settings.

(ii) Limits.

(a) The department will reimburse dialysis clinics for in-facility and method I home dialysis at a maximum frequency of one treatment per recipient per day. These rates are to be used only by clinics providing care to patients who have elected medicare's method I payment system.

(b) Treatment sessions for hemodialysis and IPD are limited to three treatments per week. This limitation may be exceeded only if additional treatments are determined to be medically necessary, defined in accordance with rule 5101:3-1-01 of the Administrative Code, by the physician who is primarily responsible for dialysis services and the medical necessity for the services is documented in the medical record.

(c) Treatment sessions for CCPD and CAPD are limited to a daily composite rate. Treatments for CCPD and CAPD must be determined to be medically necessary by the physician who is primarily responsible for the dialysis services. The medical necessity for the services must be documented in the patient's medical record.

(b) Composite rates for medicaid coverage of dialysis support services.

(i) The patient may elect to make his/her own arrangements for securing necessary supplies and equipment in either the home or the clinic setting.

(ii) Only dialysis clinics using medicare's method II payment system may bill the department using the composite rate for support services.

(iii) The composite rate for support services does not include durable medical equipment (DME) or laboratory services. Payment for supplies will be made to the DME supplier at rates listed under rule 5101:3-10-03 of the Administrative Code entitled"medicaid supply list."

(iv) The department will reimburse a dialysis clinic for support services composite rates at a maximum frequency of once per month.

(c) Composite rates for medicaid coverage of dialysis treatment with self-care training.

(i) The composite rate for dialysis treatment with self-care training reflects training costs per session.

(ii) Limits.

(a) Hemodialysis treatment services with self-care training is limited to fifteen sessions or three months of training, whichever comes first.

(b) IPD treatment services with self-care training is performed in ten to twelve hour sessions and is limited to four weeks of training.

(c) CAPD treatment services with self-care training is performed five days a week and is limited to a maximum of fifteen training sessions.

(d) CCPD treatment services with self-care training is performed five to six days a week and is limited to a maximum of fifteen training sessions.

(6) The department reimburses dialysis clinics for medically necessary laboratory tests (as described in Chapter 5101:3-11 of the Administrative Code), diagnostic services, and prescribed drugs (including therapeutic injections as described in rule 5101:3-4-13 of the Administrative Code) and immunizations (as described in rule 5101:3-4-12 of the Administrative Code) not included in the composite rates or that exceed the frequency described in the composite rates as described in appendix A to this rule, if:

(a) The medical record documents the medical necessity for the laboratory test, diagnostic service, and/or drug; and

(b) The laboratory test, diagnostic service, and/or drug is a covered medicaid service.

(7) Laboratory tests, diagnostic services, and drugs provided in excess of the frequency described in the composite rates are subject to review and potential recovery.

(8) The department reimburses physician professional services associated with the medical management of ESRD patients in accordance with rule 5101:3-4-14 of the Administrative Code.

(9) The department reimburses durable medical equipment providers for supplies associated equipment and all related medical supplies necessary for the home dialysis patient who elects to receive such services under method II, in accordance with rule 5101:3-10-10 of the Administrative Code.

(10) The department reimburses for medical transportation to and/or from dialysis treatment in accordance with Chapter 5101:15 of the Administrative Code.

(11) The following services are non-covered:

(a) All blood products;

(b) All services exceeding the limitations defined in Chapters 5101:3-1, 5101:3-4, 5101:3-05, 5101:3-06, 5101:3-8, 5101:3-9, 5101:3-13, 5101:3-14, 5101:3-15, and 5101:3-24 of the Administrative Code;

(c) Services determined by the department as not medically necessary or that are duplicative of a service provided concurrently by another medicaid provider;

(d) Any service not provided in accordance with the criteria and protocols set forth by the Ohio law for advanced practice nurses, registered nurses, and physician assistants;

(e) All services itemized as non-covered in rule 5101:3-4-28 of the Administrative Code.

APPENDIX A

See Appendix at

http://www.registerofohio.state.oh.us/pdfs/5101/3/13/5101$3-13-01$9_PH_FF_N_APP1_20071221_1225.pdf

Replaces: Part of 5101:3-13-01, Part of 5101:3-13-07

Effective: 01/01/2008
R.C. 119.032 review dates: 01/01/2013
Promulgated Under: 119.03
Statutory Authority: 5111.02
Rule Amplifies: 5111.01 , 5111.02 , 5111.021
Prior Effective Dates: 4/2/83, 3/30/01, 10/01/03