10 Colo. Code Regs. § 2505-10-8.076

Current through Register Vol. 47, No. 20, October 25, 2024

Section 10 CCR 2505-10-8.076 - PROGRAM INTEGRITY

8.076.1DEFINITIONS

1. Abuse means Provider practices that are inconsistent with sound fiscal, business, or medical practices, and result in an unnecessary cost to the Medical Assistance program, an Overpayment by the Medical Assistance program, in reimbursement for goods or services that are not medically necessary, as defined at Section 8.076.1.8 ., or that fail to meet professionally recognized standards for health care. These practices may include, but are not limited to:

a. Billing for goods or services without valid documentation to support the claims submitted for reimbursement.

b. Unbundling charges on claims for goods or services by separating components of a group of procedures that are required to be billed together (or bundled), and billing each component separately.

c. Submitting a fee-for-service claim or claims for goods or services before they have been provided.

d. Signing prior authorizations or physician's orders for goods or services that are inappropriate or not medically necessary for the client.

e. Presenting or causing to be presented for payment any false or fraudulent claim for goods or services.

f. Submitting or causing to be submitted false information for the purpose of obtaining greater compensation than that to which the provider is legally entitled.

g. Submitting or causing to be submitted false information for the purpose of meeting prior authorization requirements.

h. Failing to retain or disclose or make available to the Department or its authorized agent(s) records of goods or services provided to eligible clients and related records of payments when requested.

i. Engaging in a course of conduct or performing an act deemed improper or continuing such conduct following notification that said conduct should cease.

j. Visiting a facility, such as a nursing home, and billing for individual visits without rendering any specific service to individual clients.

k. Overutilizing by inducing, furnishing, or otherwise causing a client to receive goods or services not otherwise required or requested by the client or prescribing Provider.

l. Violating any applicable regulation listed at Section 8.000, et seq. or failing to comply with any guidance provided by the Department, including but not limited to provider bulletins and billing manuals.

m. Submitting a false or fraudulent application for provider enrollment.

n. Violating any laws or regulations pertaining to federal or state health care programs or failing to meet professionally recognized standards for health care.

o. Conviction of a criminal offense relating to:

i) Performance of the Provider Agreement with the State;

ii) Negligent practice resulting in the death or injury to patients;

iii) Patient abuse;

iv) Fraudulent billing practices;

v) Misuse or misapplication of program funds;

vi) The unlawful manufacture, distribution, prescription or dispensing of controlled substances; or

vii) Actions that indicates a Provider may pose a risk to the health, safety, or well-being of a client.

p. Failure to meet standards required by state or federal law for participation such as licensure or certification requirements.

q. Failure to correct deficiencies in provider operations in accordance with an accepted plan of correction or written response after receiving written notice of these deficiencies from the Department, its designees, or other state agencies.

r. Formal reprimand or censure by an association of the Provider's peers or the appropriate state or federal regulatory or licensing body for unethical, illegal, or improper practices.

s. Suspension, exclusion, or termination from participation in another governmental medical program for fraudulent or abusive practices.

t. Failure to repay or make arrangements to repay Overpayments or payments made in error.

u. Use of another Provider's provider identification number for the purpose of obtaining reimbursement.

v. Use of client identification numbers to submit claims for reimbursement for goods or services that were not rendered or delivered.

w. Alteration of any source documentation performed to support claims billed or creation of new source documentation to support claims billed when the alteration or creation occurs after a request for documentation is received by the Provider from the Department or its agent. Alteration does not include a late entry that is signed and dated when documented or transcriptions made to facilitate a Department review.

x. Upcoding services by submitting claims for a higher level of goods or services than what was provided or medically necessary.

2. Conviction or Convicted means that:

a. A judgment of conviction has been entered against an individual or an entity by a federal, state, or local court, regardless of whether there is a post-trial motion or an appeal pending;

b. A federal, state, or local court has made a finding of guilt against an individual or entity;

c. A federal, state, or local court has accepted a plea of guilty or nolo contendere by an individual or entity; or

d. An individual or entity has entered into participation in a first offender, deferred adjudication, or other program or arrangement where judgment of conviction has been withheld.

3. Excluded means a Provider that has been barred from participating in any health care program by the Office of Inspector General for the United States Department of Health and Human Services (OIG).

4. False Representation means an inaccurate statement that is relevant to a claim for reimbursement or Prior Authorization Request and is made by a Provider who has actual knowledge of the truth or false nature of the statement, or by a Provider acting in deliberate ignorance of or with reckless disregard for the truth of the statement. A Provider acts with deliberate ignorance of or with reckless disregard for the truth if the Provider fails to maintain records required by the Department or if the Provider fails to become familiar with rules, manuals, and bulletins issued by the Department, board or the Department's fiscal agent.

5. Fraud means an intentional deception or misrepresentation made by a person with the knowledge that the deception could result in some unauthorized benefit to her/himself or some other person. It includes any act that constitutes fraud under any federal or state law.

6. Furnished means goods or services provided directly by, or under the direct supervision of, or ordered by, a practitioner or other individual (either as an employee or in his or her own capacity), a Provider, or other supplier of goods or services.

7. Good cause, for the purpose of withholding payments to a provider or denying, terminating, or not renewing a Provider agreement means:

a. The Provider has failed to comply substantially with rules, manuals, and bulletins issued by the Department, board, or the Department's fiscal agent.

b. The Provider has not complied with applicable federal and state statutes and regulations.

c. The Provider, either by omission or commission, is endangering or has endangered the health, safety, or well-being of a program services client or cients.

d. The owner, operator, partner, or other participating employee of the Provider has previously owned, operated, or otherwise participated in and received direct or indirect payment from the Medical Assistance Program and has a documented pattern of program abuse, substandard care, endangerment of the health or well-being of clients, or non-compliance with program requirements.

e. The Provider's license or certification has expired, been revoked, suspended, surrendered while a formal disciplinary proceeding was pending before a state licensing authority, or for any other reason is invalid at the time goods are provided or services are rendered for which claims are submitted for reimbursement.

f. The Provider has been excluded, suspended, or terminated from any Medical Assistance program of another state or has been excluded, suspended, terminated or had had its billing privileges revoked under the Medicare program, or has been excluded by the OIG unless a waiver is granted by the OIG.

g. The Provider has failed to fully and accurately make any disclosures required by federal and state statutes or regulations.

h. Any Provider, or person with an ownership or controlling interest in the Provider, or who is a Provider's agent or managing employee, has been convicted of a criminal offense outlined in Section 8.076.1.1.o.

i. The Provider has demonstrated a pattern of Abuse.

j. The Provider has engaged in False Representation and/or Fraud in submitting Medical Assistance program claims.

k. The Provider has billed or sought collection through a third party from a client or the estate of a client, his or her family, friend, or other representative, for any amount for covered goods or services, excluding any required copayment, coinsurance, or other client cost-sharing amounts, and failed, once notified by the Department, to correct the billing or collection action.

l. The Provider has failed to return money paid by clients for covered goods or services rendered during any period of client eligibility. This includes failing to pay back clients for goods or services for which they were charged when their eligibility was determined retroactively and there is evidence of notification of retroactive eligibility for the client, regardless of whether payment for the covered goods or services were received.

m. The Provider owes the Department an outstanding balance and has failed to enter into a payment plan with the Department or the provider has failed to comply with a payment plan it had previously entered into.

n. The Provider has failed to provide a written response within thirty (30) days of the Department's request or the Provider has provided a written response but failed to meet the requirements set out in the Department's request as described in Section 8.076.6.

o. The Provider has failed to provide information related to the False Claims Act and whistleblower protections described in Section 8.076.7, within thirty (30) days of the Department's request.

8. Medical necessity means a Medical Assistance program good or service:

a. Will, or is reasonably expected to prevent, diagnose, cure, correct, reduce, or ameliorate the pain and suffering, or the physical, mental, cognitive, or developmental effects of an illness, condition, injury, or disability. This may include a course of treatment that includes mere observation or no treatment at all;

b. Is provided in accordance with generally accepted professional standards for health care in the United States;

c. Is clinically appropriate in terms of type, frequency, extent, site, and duration;

d. Is not primarily for the economic benefit of the provider or primarily for the convenience of the client, caretaker, or provider;

e. Is delivered in the most appropriate setting(s) required by the client's condition;

f. Is not experimental or investigational; and

g. Is not more costly than other equally effective treatment options.

9. Overpayment means the amount paid to a Provider which is in excess of the amount that is allowable for goods or services furnished and which is required by Title XIX of the Social Security Act to be refunded. An Overpayment may include, but is not limited to, improper payments made as the result of fraud, waste, and abuse.

10. Provider means any person, public or private institution, agency, or business concern enrolled under the state Medical Assistance program to provide medical care, services, or goods and holding, where applicable, a current valid license or certificate to provide such services or to dispense such goods.

8.076.2COMPLIANCE MONITORING

8.076.2.A. All Providers shall comply with the efforts of the Department, the U.S. Department of Health and Human Services (HHS), any investigative entity, the Medicaid Fraud Control Unit (MFCU), or their designees to monitor Provider compliance with federal and state Medical Assistance program statutes, regulations and guidance in order to detect and correct noncompliance and prevent fraud, waste and abuse.

8.076.2.B. Compliance monitoring includes, but is not limited to:

1. Conducting prospective, concurrent, and/or post-payment reviews of claims.

2. Verifying Provider adherence to professional licensing and certification requirements.

3. Reviewing goods provided and services rendered for fraud, waste and abuse.

4. Reviewing compliance with rules, manuals, and bulletins issued by the Department, board, or the Department's fiscal agent.

5. Reviewing compliance with nationally recognized billing standards and those established by professional organizations including, but not limited to, Current Procedural Terminology (CPT), Current Dental Terminology (CDT), and Healthcare Common Procedure Coding System (HCPCS).

6. Reviewing adherence to the terms of the Provider Participation Agreement. 8.076.2.C. Compliance monitoring activities may include, but are not limited to:

1. Site reviews.

2. Desk audits.

3. Medical records reviews.

4. Claims reviews.

5. Data mining.

8.076.2.D. The Department, HHS, investigative entities, the MFCU, or their designees has the right to audit and confirm any information submitted by the Provider to the Medical Assistance program. The Provider shall furnish information about submitted claims, claim documentation records, and original source documentation including, but not limited to, provider and patient signatures; medical, accounting, or financial records; or any other relevant information upon request.

8.076.2.E. A written request to review records shall be provided to the Provider. This request shall include clearly defined due dates for submitting requested records, and the procedures for requesting an extension of time to submit the requested records. This request shall include the option of providing paper copies of records, electronic copies of records in a format that is compatible with the Department's or its designee's systems, or an inspection or reproduction of the records by the Department or its designees at the Provider's site. Medical records requested for review shall be provided to the Department at the expense of the Provider. The Provider shall submit or produce the requested materials within forty-five (45) calendar days unless:

1. The review is based on quality of care concerns, in which case the materials shall be submitted within fourteen (14) calendar days of the request;

2. The request is made during the course of a civil or criminal investigation, in which case the records shall be submitted immediately upon request; or

3. The request is made during the course of an external audit with the state or federal government, in which case the records shall be submitted within the timeframe the external auditors request.

8.076.2.F. Records received by the Department after the forty-five (45) calendar day deadline may be considered in the review at the Department's discretion. The written request for an extension to submit records must be received by the Department within fifteen (15) calendar days from the date of the Department's request. Telephone requests shall not be accepted. The request shall specify the additional time requested and the circumstances present that require an extension of time.

8.076.2.G. Any claims submitted for which documentation is not received within the time limits specified in this section shall be considered an Overpayment subject to recovery regardless of whether goods or services have been provided.

8.076.2.H. A Provider subject to a review or audit may request an interview in person or by telephone with the Department or its designees before the final written post-review correspondence is released. The request for an interview must be in writing, specify whether an in person or telephone interview is being requested, and must be received by the Department within ten (10) calendar days from the date of the Department's request for records. During this interview, the Provider may discuss the preliminary findings of the review or audit, what documentation the Provider may use to refute the findings, and the next steps in the review or audit process.

8.076.2.I. For all post-payment reviews, the Provider shall receive a letter identifying the Overpayment demand or notice of no repayments. This notice shall include the procedures for requesting an informal reconsideration or an appeal.

8.076.2.J. The staff of the Department, HHS, investigative entities, the MFCU, or their designees may photocopy or otherwise duplicate any paper or electronic document, chart, policy, or other record relating to medical care or services provided, charges to or payments made by clients, or goods or services provided for which a claim is submitted. The use of duplicating equipment on the Provider's premises shall be allowed to the extent that such use results in minimal disruption of the Provider's business. If such use of duplicating equipment will cause more than minimal disruption of business, the Provider shall notify the Department in writing or by telephone, and the Department shall attempt to resolve the issue with the Provider or make other arrangements.

8.076.2.K. Providers who maintain records to substantiate their claims for reimbursement in another entity's records including, but not limited to, a nursing facility, adult day care center, or hospital, are still subject to the requirements set forth at Section 8.076.2.E.

8.076.2.L. The Department may delegate compliance monitoring activities to its designees.

8.076.2.M. Nothing in Section 8.076 shall be construed as limiting the right of the Department to conduct quality improvement activities in accordance with the provisions of Section 8.079.

8.076.2.N. Nothing in Section 8.076 shall be construed as limiting the right of the Department to conduct emergency site visits when the Department has concerns about client safety, quality of care, fraud, abuse, or Provider financial failure.

8.076.3RECOVERY OF OVERPAYMENTS

8.076.3.A. Overpayments are subject to recovery by the Department or its designees.

8.076.3.B. Any identified Overpayment shall be recoverable from the Provider following exhaustion of any informal reconsideration and appeal pursuant to 8.050 .

1. Overpayments and/or other indebtedness to the state are recoverable through a repayment agreement with the Provider, by offsetting the amount owed against current and future claims of the Provider, through litigation, or by any other appropriate action within the Department's legal authority.

2. The offset rate shall be 100% of the total amount owed to be withheld from subsequent payments until the entire amount owed is recovered. The Overpayment offset rate may be reduced if the Provider shows good cause that withholding payment at the established rate will result in undue hardship.

3 In cases where sufficient records are not available to the reviewer or auditor, the recovery may be determined through a sampling of records so long as the sampling and any extrapolation are reasonably valid from a statistical standpoint and is in accordance with generally accepted auditing standards.

8.076.3.C. Self-Disclosure of Provider Identified Overpayments

1. If a Provider has received an Overpayment, the Provider is required to report and return the Overpayment within sixty (60) days of identification.

2. Identification of an Overpayment occurs when the Provider has determined that it has received an Overpayment and quantified the amount of the Overpayment.

3. Reporting an Overpayment must be made in writing and at a minimum contain the following information:

a) Provider National Provider Identification (NPI);

b) Provider Medicaid Identification Number;

c) Provider contact information (name, phone number, address and email address);

d) Claims affected for each service location; and

e) Basis for the Overpayment determination.

4. Failure to report and return the Overpayment within sixty (60) days of identification shall result in the Department recovering the Overpayment plus statutory interest in accordance with Section 8.076.3.C.

5. Self-disclosure of Provider-identified Overpayments are not an Adverse Action as defined in Section 8.050, and are not subject to an appeal.

8.076.4SUSPENSION OF PAYMENTS IN CASES OF A CREDIBLE ALLEGATION OF FRAUD

8.076.4.A. Payments to a Provider will be suspended, in whole or in part, upon a determination of a credible allegation of fraud for which an investigation is pending unless there is good cause to not suspend payments or to suspend payment only in part.

1. An allegation of fraud is considered credible if the allegation has evidence of reliability after a review of the allegation, facts and evidence.

2. A determination that there is good cause to not suspend payments or to suspend payment only in part will be made in accordance with the provisions in 42 C.F.R. § 455.23(e)-(f).

8.076.4.B. A Provider shall be notified of a suspension of payments, in whole or in part, by a notice of Adverse Action.

8.076.4.C. A Provider shall be granted appeal rights in accordance with Section 8.050.

8.076.4.D. Payments may be suspended without first notifying the Provider of the intention to withhold such payments. Notice of suspension of payments shall be sent to the Provider within the following timeframes:

1. Within five (5) calendar days of taking such action.

2. Within thirty (30) days if requested by law enforcement in writing to delay sending the notice. Requests for delay notice may be renewed in writing twice, not to exceed ninety (90) days.

8.076.4.E. The notice shall include:

1. A statement that payments are being suspended in accordance with this provision and 42 C.F.R. § 455.23;

2. The general allegations as to the nature of the suspension of payments action;

3. A statement that the suspension of payments is for a temporary period, and the circumstances under which suspension of payments will be terminated;

4. Which type or types of claims are subject to the suspension of payments, when appropriate;

5. A statement that the Provider may submit written evidence showing why the suspension of payments should not be implemented for consideration by the Department; and

6. The right to appeal as described in Section 8.050.

8.076.4.F. A suspension of payment action under Section 8.076.4 shall cease if the Department or prosecuting authorities determine that there is insufficient evidence of fraud or false representation by the Provider or if legal proceedings related to the alleged fraud are complete.

8.076.5DENIAL, TERMINATION AND/OR NONRENEWAL OF PROVIDER AGREEMENTS

8.076.5.A. The Department may deny an application for a Provider agreement, terminate or not renew a Provider agreement for Good Cause, as defined at Section 8.076.1.7.

8.076.5.B. A potential Provider shall be notified of the Department's decision to deny an application for a Provider agreement by a notice of Adverse Action.

8.076.5.C. A Provider shall be notified of the Department's decision to terminate or not renew a Provider agreement by a notice of Adverse Action. Termination and/or nonrenewal shall not be effective sooner than thirty (30) calendar days from the date of the notice except as provided at Section 8.076.5.D, where notice will be provided within five (5) calendar days of taking such action.

8.076.5.D. Provider agreements may be terminated without prior notice if:

1. The Provider has been convicted of fraud or convicted of a crime related to the Provider's involvement in Medicare, Medicaid, or any other federally funded program;

2. The Provider has been found to have made a false representation;

3. The termination is imperatively necessary for the preservation of the public health, safety, or welfare and observance of the requirements of notice would be contrary to the public interest. Within five (5) business days of the emergency termination, the Provider shall receive a notice of Adverse Action;

4. The Provider has been excluded by the OIG, or Medicare has terminated its Provider agreement or revoked the Provider's billing privileges.

8.076.5.E. Providers who had their Provider agreement terminated for Good Cause under this Section must apply for reinstatement in the Medical Assistance program prior to filing an application for enrollment. In order to apply for reinstatement, the Provider-applicant must send a written request to the Department that includes information that provides reasonable assurances that the actions that were the basis for termination have not reoccurred and will not recur in the future. After reviewing the written request, the Department will notify the provider of whether the provider is eligible for reinstatement or if the reinstatement has been denied, If the reinstatement has been denied the provider has the right to appeal in accordance with Section 8.050.

8.076.6REQUEST FOR WRITTEN RESPONSE

8.076.6.A. The Department may request a written response from any Provider who fails to comply with the rules, manuals, bulletins, other guidance issued by the Department, state board or the Department's fiscal agent, or from any Provider whose activities endanger the health, safety, or welfare of clients.

1 The request by the Department will be made in writing and contain specific information on the Provider's failed compliance.

2 The Provider must provide a written response within thirty (30) calendar days of the request addressing each identified area of failed compliance and either describe how the Provider will come into and ensure future compliance, or provide an explanation and specific reason why the Provider disagrees with the Department's finding of failed compliance.

3. The Department will review the written response to determine if it addresses the identified areas of failed compliance or provides an acceptable explanation of why the Department's findings were incorrect. The Department will notify the Provider of its determination within thirty (30) calendar days of the receipt of the response.

8.076.6.B Once the Department has requested a written response, the Department may take the following actions until it determines that the Provider has come into compliance:

1. Conduct a prospective review to ensure compliance with rules in accordance with Section 8.076.2.

2. Prohibit the provider from accepting new referrals or receiving reimbursement for services provided under new referrals for Medicaid services.

8.076.7FALSE CLAIMS ACT AND WHISTLEBLOWER PROTECTIONS COMPLIANCE

8.076.7.A. If an entity is reimbursed at least $5,000,000 per year, as a condition of reimbursement the entity must maintain documentation:

1. Establishing written policies for all employees of the entity (including management), and of any contractor or agent of the entity, that provide detailed information about the False Claims Act established 31 U.S.C. §§ 3729-3733; administrative remedies for false claims and statements as provided in 31 U.S.C. §§ 3801-3812; state laws pertaining to civil or criminal penalties for false claims and statements; and whistleblower protections under such laws, with respect to the role of such laws in preventing and detecting fraud, waste, and abuse;

2. Detailing provisions reagarding the entity's policies and procedures for detecting and preventing fraud, waste, and abuse; and

3. Of the employee handbook for the entity, including a specific discussion of the laws described in subparagraph (1), the rights of employees to be protected as whistleblowers, and the entity's policies and procedures for detecting and preventing fraud, waste and abuse.

8.076.7.B. In order to ensure compliance with the provisions of Section 8.076.7.A, the entity must comply with written requests for this information within thirty (30) calendar days.

10 CCR 2505-10-8.076