PURPOSE: This rule implements federal regulatory requirements promulgated by the United States Department of Health and Human Services, Centers for Medicare and Medicaid Services at 76 Fed. Reg. 5862 (February 2, 2011), 42 CFR Parts 455 and 457, establishing the basis on which providers under the MO HealthNet Program may be approved or denied as a new provider and/or as a revalidating provider, establishing the basis on which a new practice location may be approved or denied, establishing a revalidation requirement for all providers and establishing application and periodic screening requirements.

PUBLISHER’S NOTE: The secretary of state has determined that the publication of the entire text of the material which is incorporated by reference as a portion of this rule would be unduly cumbersome or expensive. This material as incorporated by reference in this rule shall be maintained by the agency at its headquarters and shall be made available to the public for inspection and copying at no more than the actual cost of reproduction. This note applies only to the reference material. The entire text of the rule is printed here.

1. (1) Enrollment.

   1. (A) All persons are required to enroll with MMAC as a billing or performing provider in the MO HealthNet Program if the services or items they provide will be billed to the MO HealthNet Program.
   2. (B) For any person to receive payment from the MO HealthNet Program for items or services other than out-of-state emergency services, the billing providers and the performing providers of such items or services must be enrolled providers in the MO HealthNet Program on the date the items or services are provided unless applicable rules or manuals permit enrollment as of an earlier date, up to a maximum of three hundred sixty-five (365) days prior to the actual enrollment date.
   3. (C) As required by 42 CFR Section 455.440, all claims for payment for items and services that were ordered or referred must contain the National Provider Identifier (NPI) of the provider who ordered or referred such items or services.
   4. (D) All persons enrolled as MO HealthNet providers shall abide by the policies and procedures set forth in the MO HealthNet provider manual(s) applicable to the provider’s provider type(s). The MO HealthNet provider manuals are incorporated by reference and made a part of this rule as published by the Department of Social Services, MO HealthNet Division, 615 Howerton Court, Jefferson City, MO 65109, at the website dss.mo.gov/mhd, January 15, 2014. This rule does not incorporate any subsequent amendments or additions. A MO HealthNet provider’s breach of any MO HealthNet provider manual may result in imposition of sanctions, including but not limited to, termination.

2. (2) Application.

   1. (A) All applying providers shall have a valid e-mail address and shall submit an MMAC- approved application and any supplemental forms, information and documentation required by MMAC for the appropriate provider type for which the person is applying.
   2. (B) All information and documentation requested in the application and supplemental forms must be provided to MMAC prior to the application being considered and screening being conducted pursuant to this rule.
   3. (C) Specific application instructions are modified as necessary for efficient and effective administration of the MO HealthNet Program as required by federal or state laws and regulations. Providers applying on or after the promulgation of this rule should refer to the appropriate MMAC provider bulletins and application filing instructions for specific application filing instructions and information, which are incorporated by reference and made a part of this rule as published by the Department of Social Services, Missouri Medicaid Audit and Compliance Unit, 205 Jefferson Street, Second Floor, Jefferson City, MO 65109, at its website mmac.mo.gov, January 15, 2014. This rule does not incorporate any subsequent amendments or additions.
   4. (D) The application shall include all information required in the mandatory disclosures pursuant to section (3). Upon submission of any application(s), supplemental form(s), information and documentation requested in the application(s) and supplemental form(s), MMAC may, at its discretion, request additional or supplemental information and documentation from the applying provider prior to considering the application and/or conducting screening pursuant to this rule in order to clarify any information previously submitted and to verify that the provider meets all applicable requirements of state or federal laws and regulations.

3. (3) All providers, fiscal agents, and managed care entities are required to disclose as follows:

   1. (A) The following disclosures are mandatory:

      1. 1. The name and address of any person

with an ownership or control interest in the applying provider. The address for corporate entities must include as applicable primary business address, every business location, and PO Box address;

1. 2. Date of birth and Social Security

number (in the case of a corporeal person);

1. 3. Other tax identification number of

any person with an ownership or control interest in the applying provider or in any subcontractor in which the applying provider has a five percent (5%) or more interest;

1. 4. Whether any person with an owner-

ship or control interest in the applying provider is related to another person with ownership or control interest in the applying provider as a spouse, parent, child, or sibling;

1. 5. Whether any person with an owner-

ship or control interest in any subcontractor in which the applying provider has a five percent (5%) or more interest is related to another person with ownership or control interest in the applying provider as a spouse, parent, child, or sibling;

1. 6. The name of any other provider or

applying provider in which an owner of the applying provider has an ownership or control interest; and

1. 7. The name, address, date of birth, and

Social Security number of any managing employee of the applying provider;

1. (B) Disclosures from any provider or applying provider are due at the following times, and must be updated within thirty-five (35) days of any changes in information required to be disclosed:

   1. 1. Upon the provider or applying

provider submitting an application; and

1. 2. Upon request of MMAC;

2. (C) Disclosures from fiscal agents are due at the following times:

   1. 1. Upon the fiscal agent submitting the

proposal;

1. 2. Upon request of MMAC;
2. 3. Ninety (90) days prior to renewal or

extension of the contract; and

1. 4. Within thirty-five (35) days after any

change in ownership of the fiscal agent;

1. (D) Disclosures from managed care entities (managed care organizations, prepaid inpatient health plans, prepaid ambulatory health plans, and health insuring organizations), except primary care case management programs, are due at the following times:

   1. 1. Upon the managed care entity submit-

ting the proposal;

1. 2. Upon request of MMAC; and
2. 3. Ninety (90) days prior to renewal or

extension of the contract;

1. (E) Disclosures from Primary Care Case Management Programs (PCCM). PCCMs will comply with disclosure requirements under subsection (B) of this section;
2. (F) All Disclosures Must be Provided to MMAC. Disclosures not made to MMAC will be deemed non-disclosed and not in compliance with this section; and

3. (G) Consequences for Failure to Provide Required Disclosures.

   1. 1. Any person’s failure to provide, or

timely provide, disclosures pursuant to this section may result in deactivation, denial, rejection, suspension, or termination. If the failure is inadvertent or merely technical, MMAC may choose not to impose consequences if, after notice, the person promptly corrects the failure.

1. (4) Provider Revalidation.

   1. (A) All enrolled MO HealthNet Program providers as of the effective date of this rule who are not on a closed-end provider agreement shall revalidate their enrollment as a MO HealthNet Program provider, on or before March 24, 2019, according to schedule as determined by MMAC, by submitting an MMAC-approved revalidation application, supplemental forms, information, and documentation requested by MMAC, along with any required application fee, hardship waiver request, or documentation showing that the provider has revalidated with Medicare or another state’s Medicaid Program or CHIP within the previous twelve (12) months, if applicable.
   2. (B) All MO HealthNet Program providers shall revalidate their enrollment as MO HealthNet providers every five (5) calendar years from the effective date of the provider’s most recently executed provider agreement, in order to remain a MO HealthNet provider. For example, a provider whose initial or revalidated provider agreement is effective on March 1, 2014, is required to revalidate his/her/its enrollment no later than March 1, 2019.
   3. (C) The MMAC approved revalidation application, supplemental forms, information, and documentation requested by MMAC, along with the application fee and/or hardship waiver request, if applicable, shall be submitted no later than one-hundred twenty (120) days prior to the expiration of the effective provider agreement.
   4. (D) Revalidating providers must comply with the requirements of this rule and will be subject to the screening process noted in this rule upon revalidation in order to have their applications for revalidation approved.
   5. (E) MMAC may request that the provider revalidate on an off-cycle revalidation period as a result of information obtained by MMAC indicating documented patterns of local health care fraud, national initiatives, complaints, or other reasons that cause MMAC to question the compliance of the provider with MO HealthNet Program.
   6. (F) All MO HealthNet provider agreements with effective dates on or before the effective date of this rule shall be terminated by MMAC pursuant to the terms of the provider agreement, effective March 25, 2016, if the provider has not revalidated or begun the process of revalidation.

2. (5) Application Fee.

   1. (A) An application fee, hardship waiver request, and/or an exemption reason must accompany every institutional provider’s application.
   2. (B) The application fee must be in the form of a cashier’s check, money order, or an electronic payment acceptable to MMAC and for the correct application fee amount in effect as of the date of receipt by MMAC.
   3. (C) Failure to submit the application fee in the form of a cashier’s check, money order, or electronic payment acceptable to MMAC for the correct amount will result in the return of the fee to the provider and rejection of the application.

   4. (D) Applying providers and MO HealthNet providers that are revalidating with the Missouri Medicaid Audit and Compliance Unit (MMAC) must submit an application fee subject to the requirements of 13 CSR 65-2.020. The application fee is determined as follows:

      1. 1. As of the effective date of this rule for

calendar year 2015, five hundred fifty-three dollars ($553); and

1. 2. For calendar year 2016 and subse-

quent years— A.The amount of the application fee shall be the amount for the preceding year adjusted by the percentage change in the consumer price index for all urban consumers for the twelve- (12-) month period ending with June of the previous year as published by the Bureau of Labor Statistics of the United States Department of Labor. If the adjustment sets the fee at an uneven dollar amount, MMAC will round the fee to the nearest whole dollar amount; and

1. B. The application fee will be effec-

tive from January 1 to December 31 of a calendar year.

1. (E) An institutional provider shall submit an application and application fee for each provider type for which the institutional provider is applying. If an application is denied and the institutional provider submits another application, an additional application fee shall be included with each, all, and every subsequent application.
2. (F) If a person as defined herein is considered to be an institutional provider as defined herein, that person is required to pay the fee.
3. (G) Exemptions from Application Fee. Providers who are enrolled in, and paid the application fee required by CMS for Medicare or another state’s Title XIX or Title XXI program within two (2) years of the date the application to enroll as a MO HealthNet Provider shall be exempt from paying an application fee. Providers seeking an exemption from the application fee are responsible for notifying MMAC, in writing, that they qualify for exemption and for providing proof of such qualification.

1. (6) Hardship Waiver Request.

   1. (A) Institutional providers may submit application fee hardship waiver requests when submitting their initial enrollment applications, their revalidation applications, and their applications to establish new practice locations.

   2. (B) A hardship waiver request may be granted if any of the following exists:

      1. 1. The provider demonstrates, via

authenticated financial and legal records, hardship and MMAC, at its discretion, determines that imposition of the application fee would result in a hardship for the provider subject to the following requirements:

1. A. All records submitted in support of

a hardship waiver must be authenticated by an affidavit signed under oath by the applying provider’s or provider’s owner(s) and chief financial officer or chief executive officer. Records not meeting this requirement shall not be considered as evidence of hardship;

1. B. Providers applying for hardship

waivers must permit, upon request, MMAC to 13 CSR 65-2

inspect the provider’s financial records and other records MMAC deems relevant to MMAC’s determination of whether hardship exists, including, but not limited to, historical cost reports, recent financial reports such as balance sheets and income statements, cash flow statements, and tax returns. Any provider who does not permit MMAC to inspect such records upon MMAC’s request shall be denied a hardship waiver. Any provider who is denied a hardship waiver request based upon the provider’s failure to permit MMAC to inspect the provider’s financial records and any other records MMAC deems relevant to MMAC’s determination of whether a hardship exists, shall not be eligible for a waiver under paragraph (6)(B)1. for a period of five (5) years from the date of MMAC’s letter notifying the provider that its hardship waiver request was denied due to the provider’s failure to permit MMAC to inspect the provider’s records; and

1. C. A provider who is granted a hard-

ship waiver pursuant to paragraph (6)(B)1. shall not be granted a second waiver based upon paragraph (6)(B)1. for a period of five (5) years from the date of MMAC’s letter notifying the provider that its most recent paragraph (6)(B)1. waiver request was granted;

1. 2. MMAC, in consultation with other

state of Missouri departments, divisions and units, determines that imposition of the application fee would impede Missouri Medicaid participants’ access to care;

1. 3. A provider is submitting a provider

application as a result of a national or state public health emergency situation as lawfully declared by a federal or state authority; and

1. 4. The provider is owned and operated

by the state of Missouri or an agency of the state of Missouri.

1. (C) Application fee hardship waiver requests shall be considered by MMAC on a case-by-case basis.
2. (D) Application fee hardship waiver requests are subject to approval by CMS.

1. (7) MMAC shall use the application fee to offset the costs associated with the provider screening program in its entirety. This includes, but is not limited to, the following:

   1. (A) Implementation and augmentation of MMAC’s provider enrollment system; and
   2. (B) Any other administrative costs related to the provider screening program, which include costs associated with processing fingerprints and conducting criminal background checks. The application fee does not cover the cost associated with capturing fingerprints and a provider may be charged additional costs for this purpose in addition to the application fee.

2. (8) Refund of the Application Fee.

   1. (A) If an institutional provider is granted a hardship exception pursuant to this rule or if the application is rejected because it was not properly signed or is missing other information required to be provided on the application itself, and an application fee was included with the application and the hardship waiver request, the application fee shall be returned to the applying provider.
   2. (B) Once the screening process has begun, regardless whether the application goes through part or all of the screening process, the application fee is non-refundable.

3. (9) Screening.

   1. (A) The screening requirements contained in this section apply to all applying providers and to all persons disclosed, or required to be disclosed, in the application.

   2. (B) MMAC shall conduct pre-enrollment screening and post-enrollment monthly screenings. Screenings shall include the following:

      1. 1. Screening pursuant to 42 CFR sec-

tions 455.410(a), (b); 42 CFR 455.412; 42 CFR 455.432; 42 CFR 455.436; and 42 CFR 455.452;

1. 2. Screening to ensure that the providers

meet all enrollment criteria for their provider type;

1. 3. Unannounced preand post-approval

site visits; and

1. 4. For screening purposes, utilization of

databases and other sources of information to prevent enrollment of non-existent providers, to ensure that spurious applications are not processed, and to prevent fraud, waste, and abuse in the MO HealthNet Program.

1. (C) The screening procedures and requirements in this rule shall be implemented as of the effective date of this rule.
2. (D) The new screening procedures and requirements will be applicable to all enrolled MO HealthNet Program providers and applying providers as of the effective date of this rule. All enrolled MO HealthNet providers are required to revalidate according to the schedule of revalidation. After being screened pursuant to this rule, MO HealthNet Program providers will be required to revalidate every five (5) years from the date of their most recent revalidation.
3. (E) Upon the effective date of this rule, no provider shall be allowed to enroll or revalidate in the MO HealthNet Program without being screened pursuant to this rule. On or before March 25, 2016, all providers in, and applying providers to, the MO HealthNet Program shall be screened pursuant to this section. By operation of law, any provider who has not been screened pursuant to this section on or before March 25, 2016, shall have his/her/its provider number deactivated at 5:00 p.m. on March 25, 2016. Such deactivation shall remain in effect until the provider or applying provider has been screened pursuant to this rule.
4. (F) The following screening categories are established for MO HealthNet providers, as required by federal law and regulation for Medicare and Medicaid providers under 42 CFR section 424.518 and section 1902(kk)

1. (1) of the Social Security Act. There are three

2. (3) levels of screening: limited, moderate, and high. Each provider type is assigned to one (1) of these screening levels. If a provider could fit within more than one (1) screening level described in this section, the highest risk category of screening is applicable.

   1. 1. Limited Risk Category.

      1. A. The following providers pose a lim-

ited risk of fraud, waste, and abuse to the MO HealthNet Program and are subjected to limited category screening:

1. (I) Physicians, dentists, or non-

physician practitioners (except as otherwise listed in another risk category) and medical groups or clinics with the exception of physical therapists and physical therapy(ist) groups;

1. (II) Ambulatory surgical centers

(ASCs);

1. (III) Competitive acquisition pro-

gram/Part B vendors;

1. (IV) End-stage renal disease

(ESRD) facilities;

1. (V) Federally qualified health cen-

ters (FQHCs);

1. (VI) Histocompatibility laborato-

ries;

1. (VII) Hospitals, including critical

access hospitals (CAHs); (VIII) Health programs operated by an Indian Health Program (as defined in section 4(12) of the Indian Health Care Improvement Act) or an urban Indian organization (as defined in section 4(29) of the Indian Health Care Improvement Act) that receives funding from the Indian Health Service pursuant to Title V of the Indian Health Care Improvement Act (IHS);

1. (IX) Mammography screening cen-

ters;

1. (X) Mass immunization roster

billers;

1. (XI) Organ procurement organiza-

tions (OPOs);

1. (XII) Pharmacies; (XIII) Religious nonmedical health

care institutions (RNHCIs);

1. (XIV) Rural health clinics (RHCs);
2. (XV) Radiation therapy centers;
3. (XVI) Skilled nursing facilities

(SNFs); (XVII) Occupational therapists; (XVIII) Speech language pathologists;

1. (XIX) Rehabilitation agencies; and
2. (XX) Community mental health

centers (CMHCs).

1. B. The providers in the limited cate-

gory are subject to the following screening requirements:

1. (I) Verification that the applying

provider, and all persons disclosed or required to be disclosed, meet all applicable federal regulations and MO HealthNet Program requirements for the provider type;

1. (II) Verification that the applying

provider, and all persons disclosed, have a valid license, operating certificate, or certification if required for the provider type, and that there are no current limitations on such licensure, operating certificate, or certification which would preclude enrollment;

1. (III) Verification that the applying

provider’s, and that of all persons disclosed, license(s) held in any other state has/have not expired and that there is/are no current limitations on such license(s) which would preclude enrollment;

1. (IV) Confirmation of the identity of

the applying provider and determination of the exclusion status of the applying provider and any person with an ownership or control interest or who is an agent or managing employee of the provider through routine checks of the following federal databases:

1. (a) Social Security Administra-

tion’s Death Master File;

1. (b) National Plan and Provider

Enumeration System;

1. (c) List of Excluded Individ-

uals/Entities;

1. (d) The Excluded Parties List

System;

1. (e) Medicare Exclusion Database;
2. (f) Department of the Treasury’s

Debt Check Database; and

1. (g) Department of Housing and

Urban Development’s (DHUD) Credit Alert System or Credit Interactive Voice Response System;

1. (V) Database checks of the Missouri

Department of Revenue;

1. (VI) Database check of the National

Sex Offender Public Website;

1. (VII) The information from these

databases shall be used to determine eligibility of the MO HealthNet provider and for verification of: the identity of the applying person; the Social Security number; the National Provider Identifier (NPI); the National Practitioner Data Bank (NPDB) licensure; any exclusion by the Department of Health and Human Services, Office of Inspector General; the taxpayer identification number; any Missouri tax delinquencies and death of the applying provider and all other persons disclosed in the applications and supplemental forms; and (VIII) MMAC may conduct preapproval site visits prior to acceptance of an applying provider’s application.

1. 2. Moderate Risk Category:

   1. A. The following providers pose a

moderate risk of fraud, waste, and abuse to the MO HealthNet Program and are subject to moderate screening requirements:

1. (I) Comprehensive outpatient reha-

bilitation facilities (CORFs);

1. (II) Hospice organizations;
2. (III) Independent diagnostic testing

facilities (IDTFs);

1. (IV) Independent clinical laborato-

ries;

1. (V) Ambulance service suppliers;
2. (VI) Physical therapists including

physical therapy groups;

1. (VII) Portable x-ray suppliers; (VIII) Revalidating home health

agencies;

1. (IX) Revalidating durable medical

equipment providers;

1. (X) Adult day care waiver providers;
2. (XI) Personal care providers,

including providers billing under the Consumer Directed Services program;

1. (XII) Entities established under

sections 205.968-205.973, RSMo; (XIII) Prosthetics, orthotics, and supplies suppliers (DMEPOS) (this includes an existing pharmacy durable medical equipment supplier that seeks to add a new DME- POS supplier store, new practice locations, and those that are owned by occupational or physical therapists); or

1. (XIV) Non-emergency transporta-

tion providers; and

1. B. In addition to the screening require-

ments for the limited risk category in paragraph (9)(F)1., the providers in the moderate risk category shall be subject to pre-approval site visits prior to acceptance of an applying provider’s application and are additionally subject to unannounced preand post-enrollment site visits—

1. (I) To determine and ensure that the

provider is operational at the practice location found on the enrollment application. For these purposes, “operational” means the provider has a qualified physical practice location, is open to the public for the purpose of providing health care related services, is prepared to submit valid Medicaid claims, and is properly staffed, equipped, and stocked (as applicable, based on the type of facility or organization, provider specialty, or the services or items being rendered), to furnish these items or services; and

1. (II) To verify established provider

standards or performance standards other than conditions of participation subject to survey and certification by MMAC, where applicable, to ensure that the provider remains in compliance with program requirements.

1. 3. High Risk Category.

   1. A. The following providers pose a

high risk of fraud, waste, and abuse to the MO HealthNet Program and are subject to high screening requirements:

1. (I) Prospective (newly enrolling)

home health agencies; and

1. (II) Prospective (newly enrolling)

DMEPOS suppliers; and

1. B. In addition to the screening require-

ments for the limited risk category in paragraph (9)(F)1. of this rule, and for the moderate risk category in paragraph (9)(F)2. of this rule, the providers in the high risk category must submit to, or subject individuals with ownership or control interests to, a fingerprint-based criminal history report check of the Federal Bureau of Investigations (FBI) Integrated Automated Fingerprint Identification System—

1. (I) A revalidating provider who has

already submitted fingerprints once will not be required to submit fingerprints a second time unless required by FBI protocols;

1. (II) Pursuant to 42 CFR section

455.434(b), the provider is responsible for the cost of taking the fingerprints and supplying the fingerprints, and the state and federal government will share the cost of the processing of the fingerprints and the background check; and

1. (III) This fingerprint-based crimi-

nal history report check applies to all persons in this risk category applying to be a provider (whether as a billing or performing provider), or an individual with a five percent (5%) or greater direct or indirect ownership interest in such provider, or a managing employee;

1. (G) MMAC must adjust the categorical risk level from “limited” or “moderate” to “high” when any of the following occurs:

   1. 1. MMAC imposes a payment suspension

on a provider based on a credible allegation of fraud, waste, or abuse by the provider; the provider has an existing Medicaid overpayment; or the provider has been excluded by the Department of Health and Human Services, Office of Inspector General or another state’s Medicaid program within the previous ten (10) years. The upward adjustment of the provider’s categorical risk level for a payment suspension or overpayment shall continue only so long as the payment suspension or overpayment continues; or 13 CSR 65-2

1. 2. MMAC or CMS in the previous six

1. (6) months lifted a temporary moratorium for the particular provider type and a provider that was prevented from enrolling based on the moratorium applies for enrollment as a provider at any time within six (6) months from the date the moratorium was lifted.

   1. (H) If a person has been screened by Medicare or by another state Medicaid agency and paid Medicare or another state Medicaid agency’s application fee, within two

2. (2) years of the date of the application to MMAC, such person will not be subject to the screening requirements or application fee provided for by this rule except those screening requirements and application fee imposed pursuant to subsection (G) of this section.

   1. (I) Any MO HealthNet Program provider not categorized by this regulation as within the limited, moderate or high risk category shall be a considered moderate risk and screened as a moderate risk.
   2. (J) MMAC may request and consider additional information or documentation related to the eligibility criteria, if at any time during the application process it appears that: the enrollment application or supporting documentation is inaccurate, incomplete, or misleading; or it appears the applying person may be ineligible to become a MO HealthNet provider.
3. (10) The provisions of this rule are declared severable. If any provision of this rule is held invalid by a court of competent jurisdiction, the remaining provisions of this rule shall remain in full force and effect, unless otherwise determined by a court of competent jurisdiction to be invalid.
4. (11) Except to the extent inconsistent with this rule, the requirements of 13 CSR 70- 3.020 and 13 CSR 70-3.030 remain in force, including any provisions regarding denial of applications and termination, until those provisions are rescinded.

AUTHORITY: sections 208.159 and 660.017, RSMo 2000.* Original rule filed Dec. 12, 2013, effective July 30, 2014. Amended: Filed May 26, 2015, effective Nov. 30, 2015. *Original authority: 208.159, RSMo 1979 and 660.017, RSMo 1993, amended 1995.