5160-4-12. Immunizations, injections and infusions (including trigger-point injections), skin substitutes, and provider-administered pharmaceuticals

(A) General provisions.

(1) "Current procedural terminology (CPT)" is a comprehensive listing of medical terms and codes published by the American medical association, www.ama-assn.org, for the uniform designation of diagnostic and therapeutic procedures in surgery, medicine, and the medical specialties. "Healthcare common procedure coding system (HCPCS)" is a numeric and alphanumeric code set maintained and distributed by the centers for medicare and medicaid services (CMS), http://www.cms.gov, for the uniform designation of certain medical procedures and services.

(2) A "not otherwise specified," "unlisted," or "miscellaneous" procedure code should be reported on a claim only if no procedure code is available that identifies the particular service or item provided.

(3) No separate payment is made for an immunization, injection, infusion, vaccine, toxoid, or provider-administered pharmaceutical as a medical service if it is provided in a hospital setting (inpatient hospital, outpatient hospital, or hospital emergency department).

(4) A provider-administered pharmaceutical reported on a claim submitted in accordance with Chapter 5160-9 of the Administrative Code is regarded as a pharmacy service rather than a physician service, and payment of the claim is governed by the provisions of that chapter. For example, a vaccine, toxoid, or other provider-administered pharmaceutical prescribed for a resident of a long-term care facility (LTCF) and subsequently administered by a LTCF staff member is a pharmacy service.

(5) Payment for an immunization, injection, or infusion includes payment for related supplies (e.g., alcohol wipes, needles, syringes, and tubing).

(B) Coverage of immunizations. An immunization has two components: the administration of the vaccine or toxoid and the vaccine or toxoid itself.

(1) Payment for administration may take one of two forms:

(a) Payment for the most appropriate administration procedure; or

(b) Payment for the least complex evaluation and management service rendered to an established patient.

(2) Separate payment may be made for the vaccine or toxoid. No payment, however, will be made for vaccines that can be obtained at no cost through the federal vaccines for children (VFC) program, which is administered by the Ohio department of health (ODH).

(3) Limitations apply to certain vaccines.

(a) Regardless of the formulation, payment for hepatitis B vaccine (HBV) administered to individuals younger than nineteen years of age may be made only under the VFC program. Different procedure codes must be reported on claims to distinguish HBV administered to individuals younger than nineteen from HBV administered to individuals older than eighteen.

(b) Vaccines for the human papilloma virus (HPV) are covered in accordance with the schedule regarding the appropriate periodicity, dosage, and contraindications applicable to vaccines established by the advisory committee on immunization practices of the centers for disease control and prevention, found athttp://www.cdc.gov/vaccines/hcp/acip-recs/index.html.

(C) Coverage of therapeutic, prophylactic, or diagnostic injections or infusions (excluding chemotherapy and other complex procedures).

(1) An injection or infusion has two components: the administration of a fluid medium and, except in the case of hydration, the pharmaceutical itself. No separate payment is made for the administration service if an injection or infusion is given during the course of an office visit or in conjunction with another medical service that includes an evaluation and management element.

(2) Payment may be made for an injection or infusion or a provider-administered pharmaceutical only if at least one of the following criteria is met:

(a) Its use for a particular indication has been approved by the U.S. food and drug administration; or

(b) According to accepted standards of medical practice, it is a specific or effective treatment for the particular condition for which it is given.

(3) No separate payment is made for an injection or infusion or a provider administered pharmaceutical that meets either of the following criteria:

(a) The frequency or duration of its administration exceeds accepted standards of medical practice for the particular condition; or

(b) It is provided for or in association with non-covered medicaid services, which are defined in rule 5160-1-61 of the Administrative Code.

(4) Immune globulin is covered when it is used to provide passive immunity to an individual who is immunosuppressed; has an acquired or congenital immunodeficiency; is at risk of Rho(D) isoimmunization; or is in immediate danger of contracting a communicable disease through direct contact with blood, saliva, or other body fluids through an open wound, bite, puncture, or mucous membrane.

(5) Epoetin alfa (EPO) for the treatment of anemia, either associated with or not related to chronic renal failure, is covered as a medical service when a provider incurs the cost of the drug and the service is provided in a clinic (e.g., a renal dialysis facility) or office setting.

(6) Certain procedure codes represent a specific number of dosage units. On a claim, the fewest number of procedure codes must be reported together to represent the administered dosage.

(D) Coverage of trigger-point injections.

(1) A trigger point is a hyperexcitable area of the body, where the application of a stimulus will provoke pain to a greater degree than in the surrounding area. The purpose of a trigger-point injection is to treat not only the symptom but also the cause through the injection of a single substance (e.g., a local anesthetic) or a mixture of substances (e.g., a corticosteroid with a local anesthetic) directly into the affected body part in order to alleviate inflammation and pain. Payment may be made for a trigger-point injection only if the following criteria are met:

(a) The patient must have a diagnosis for which the trigger-point injection is an appropriate treatment; and

(b) The following information must be documented in the patient's medical record:

(i) A proper evaluation including a patient history and physical examination leading to diagnosis of the trigger point;

(ii) The reason or reasons for selecting this therapeutic option;

(iii) The affected muscle or muscles;

(iv) The muscle or muscles injected and the number of injections;

(v) The frequency of injections required;

(vi) The name of the medication used in the injection;

(vii) The results of any prior treatment; and

(viii) Corroborating evidence that the injection is medically necessary.

(2) A trigger-point injection is normally considered to be a stand-alone service. No additional payment will be made for an office visit on the same date of service unless there is an indication on the claim (e.g., in the form of a modifier appended to the evaluation and management procedure code) that a separate evaluation and management service was performed.

(3) Certain trigger-point injection procedure codes specify the number of injection sites. For these codes, the unit of service is different from the number of injections given. Payment may be made for one unit of service of the appropriate procedure code reported on a claim for service rendered to a particular patient on a particular date.

(4) Trigger-point injections should be repeated only if doing so is reasonable and medically necessary. For trigger-point injections of a local anesthetic or a steroid, payment will be made for no more than eight dates of service per calendar year per patient.

(E) Coverage of skin substitutes.

(1) Skin substitutes may be used on burns or ulcers when grafting with actual skin is not an appropriate option. Skin substitutes are expected to function as a permanent replacement for lost or damaged skin. They may be used for temporary wound coverage or wound closure as appropriate and medically necessary. Payment may be made for a skin substitute if a practitioner determines that the skin substitute will be of benefit for the particular type of wound.

(a) When a skin substitute is applied in an office setting, payment may be made to a practitioner for both the skin substitute and an appropriate skin application procedure.

(b) When a skin substitute is applied in a hospital setting (inpatient hospital, outpatient hospital, or hospital emergency department), payment may be made to a practitioner only for the skin application procedure. Payment for the skin substitute is included in the hospital's facility payment.

(c) When a skin substitute is applied in a long-term care facility (LTCF), payment may be made to a practitioner for the skin application procedure. Payment for the skin substitute may be made to the practitioner only if the practitioner supplies the skin substitute; otherwise, payment for the skin substitute is included in the LTCF's facility payment.

(2) The results of treatment must be documented in the individual's medical record. Payment will not be made for additional applications or re-applications if the wound volume has not decreased by at least fifty per cent after three separate treatments over twelve weeks.

(F) Claim payment.

(1) On the department's web site, http://medicaid.ohio.gov, is a list of vaccines, toxoids, skin substitutes, and other provider-administered pharmaceuticals each of which is covered by medicaid either as a medical service or as a VFC-designated vaccine. Payment for a covered non-VFC vaccine, toxoid, skin substitute, or other provider-administered pharmaceutical is the lesser of two figures:

(a) The provider's submitted charge; or

(b) The maximum allowable amount, which is the first applicable item from the following ordered list:

(i) An amount specified in or determined in accordance with the Administrative Code;

(ii) The state maximum allowable cost (SMAC), which is defined in rule 5160-9-05 of the Administrative Code;

(iii) The payment limit shown in the current medicare part B drug pricing file, which is available at http://www.cms.gov;

(iv) One hundred seven per cent of the wholesale acquisition cost (WAC); or

(v) Eighty-five and six-tenths per cent of the average wholesale price (AWP).

(2) The payment amount for any other covered administration service or evaluation and management service is the lesser of the provider's submitted charge or the maximum amount listed in appendix DD to rule 5160-1-60 of the Administrative Code.

Replaces: 5160-4-12, 5160-4-35

Effective: 11/1/2017
Five Year Review (FYR) Dates: 5/24/2017 and 11/01/2022
Promulgated Under: 119.03
Statutory Authority: 5164.02
Rule Amplifies: 5164.02
Prior Effective Dates: 04/01/1977, 12/21/1977, 12/30/1977, 01/08/1979, 02/01/1980, 09/20/1984 (Emer), 12/17/1984, 05/19/1986, 07/01/1987, 04/01/1988, 09/01/1989, 05/25/1991, 03/19/1992, 12/01/1992, 12/30/1992 (Emer), 12/31/1992 (Emer), 04/01/1993, 12/30/1993 (Emer), 03/31/1994, 09/30/1994 (Emer), 12/30/1994 (Emer), 12/30/1994, 03/30/1995, 08/01/1995, 12/29/1995 (Emer), 03/21/1996, 12/31/1996 (Emer), 03/22/1997, 08/01/1997, 12/31/1997 (Emer), 03/19/1998, 12/31/1998 (Emer), 03/31/1999, 03/20/2000, 12/29/2000 (Emer), 01/01/2001, 03/30/2001, 01/01/2003, 04/14/2003, 01/02/2004 (Emer), 04/01/2004, 10/01/2004, 11/15/2004, 09/01/2005, 12/30/2005 (Emer), 03/27/2006, 07/01/2006, 07/15/2006, 01/01/2007, 07/25/2007, 12/31/2007 (Emer), 03/30/2008, 07/01/2008, 11/13/2008, 12/31/2008 (Emer), 03/31/2009, 07/01/2009, 10/01/2009 (Emer), 12/29/2009, 03/31/2010, 04/28/2010 (Emer), 07/26/2010, 12/30/2010 (Emer), 03/30/2011, 08/02/2011, 09/01/2011, 12/30/2011 (Emer), 03/29/2012, 12/31/2012 (Emer), 03/28/2013, 09/01/2013, 11/01/2015