DAR File No. 39985

Health, Health Care Financing, Coverage and Reimbursement Policy

Rule R414-1A

Medicaid Policy for Experimental, Investigational or Unproven Medical Practices

Notice of Proposed Rule

(Amendment)

DAR File No.: 39985
Filed: 12/09/2015 08:50:30 AM

RULE ANALYSIS

Purpose of the rule or reason for the change:

The purpose of this change is to consolidate the scope of Medicaid policy for experimental, investigational or unproven medical practices to the Medicaid provider manual.

Summary of the rule or change:

This amendment removes all provisions in the rule text and defers to the scope of policy for experimental, investigational or unproven medical practices found in Section I: General Information Utah Medicaid Provider Manual and in the Medicaid State Plan.

State statutory or constitutional authorization for this rule:

• Section 26-1-5
• 42 CFR 405.201
• Subsection 26-18-3(2)

Anticipated cost or savings to:

the state budget:

There is no impact to the state budget because services provided to Medicaid recipients remain unaffected by this change.

local governments:

There is no impact to local governments because services provided to Medicaid recipients remain unaffected by this change.

small businesses:

There is no impact to small businesses because services provided to Medicaid recipients remain unaffected by this change.

persons other than small businesses, businesses, or local governmental entities:

There is no impact to Medicaid providers and to Medicaid recipients because services provided to Medicaid recipients remain unaffected by this change.

Compliance costs for affected persons:

There are no compliance costs to a single Medicaid provider or to a Medicaid recipient because services provided remain unaffected by this change.

Comments by the department head on the fiscal impact the rule may have on businesses:

There is no fiscal impact to business because the rule does not change any requirements for Medicaid providers nor does it change any payment or funding to those providers.

Joseph K. Miner, MD, Executive Director

The full text of this rule may be inspected, during regular business hours, at the Division of Administrative Rules, or at:

Health
Health Care Financing, Coverage and Reimbursement Policy
CANNON HEALTH BLDG
288 N 1460 W
SALT LAKE CITY, UT 84116-3231

Direct questions regarding this rule to:

• Craig Devashrayee at the above address, by phone at 801-538-6641, by FAX at 801-538-6099, or by Internet E-mail at [email protected]
• Nina Baker at the above address, by phone at 801-538-9127, by FAX at 801-538-6412, or by Internet E-mail at [email protected]

Interested persons may present their views on this rule by submitting written comments to the address above no later than 5:00 p.m. on:

02/01/2016

This rule may become effective on:

02/08/2016

Authorized by:

Joseph Miner, Executive Director

R414. Health, Health Care Financing, Coverage and Reimbursement Policy.

R414-1A. Medicaid Policy for Experimental, Investigational or Unproven Medical Practices.

R414-1A-1. Introduction.

The policy for experimental, investigational or unproven medical practices is found in Section 1: General Information Utah Medicaid Provider Manual as incorporated into Section R414-1-5.

[R414-1A-1. Introduction and Authority.

(1) This rule establishes Medicaid payment policy for experimental, investigational or unproven medical practices.

(2) This rule is authorized by Sections 26-1-5, 26-1-15, and 26-18-6, and by Subsections 26-18-3(2) and 26-18-5(4).

 

R414-1A-2. Definitions.

(1) The definitions in R414-1 apply to this rule.

(2) In addition:

(a) "Experimental, investigational or unproven medical practice" means any procedure, medication product, or service that is:

(i) not proven to be medically efficacious for a given procedure; or

(ii) performed for or in support of purposes of research, experimentation, or testing of new processes or products; or

(iii) both;

(b) "Medically efficacious" means a medical practice that:

(i) has been determined effective and is widely utilized as a standard medical practice for specific conditions; and

(ii) has been approved as a covered Medicaid service by division staff and physician consultants on the basis of medical necessity, as defined in R414-1-2(17);

(c) "Supporting services" means supplies or laboratory, X-ray, physician, pharmacy, therapy, or transportation services.

 

R414-1A-3. Medicaid Policy.

(1) Experimental, investigational or unproven medical practices are not covered Medicaid services.

(2) Procedures or services proven to be medically efficacious for specific medical conditions may be provided as covered Medicaid services only for the conditions specified. Procedures or services are not covered Medicaid services for any other conditions or for investigational or experimental trials.

(3) Inpatient or outpatient hospitalization for the purpose of receiving services or procedures that are experimental, investigational or medically unproven, or in support of such services or procedures, is not a covered Medicaid service. If services or procedures are provided during hospitalization for an otherwise medically necessary and appropriate service, experimental, investigational or unproven medical procedures are excluded from reimbursement.]

 

KEY: Medicaid

Date of Enactment or Last Substantive Amendment: [May 25, 2004]2016

Notice of Continuation: April 30, 2012

Authorizing, and Implemented or Interpreted Law: 26-1-5; 26-18-3(2)