No. 27023 (Amendment): R414-1A. Medicaid Policy for Experimental, Investigational or Unproven Medical Practices

DAR File No.: 27023
Filed: 03/31/2004, 01:03
Received by: NL

 

RULE ANALYSIS

Purpose of the rule or reason for the change:

This rulemaking is necessary to comply with H.B. 126, which eliminated the ability to implement the Medicaid program by policy and required that Medicaid policies be put into rule. As with experimental or unproven medical practices, investigational medical practices are not proven to be medically efficacious or widely utilized as standard medical practices. Therefore, investigational medical practices are not covered Medicaid services. (DAR NOTE: H.B. 126 is found at UT L 2003 Ch 324, and was effective May 5, 2003.)

 

Summary of the rule or change:

The term "investigational" is added to the title of the rule and is included in Sections R414-1A-1, R414-1A-2, and R414-1A-3. In addition, this rule updates an outdated reference to the definition of medical necessity found in Subsection R414-1-2(17).

 

State statutory or constitutional authorization for this rule:

Sections 26-18-3 and 26-1-5

 

Anticipated cost or savings to:

the state budget:

There is no impact to the state budget associated with this rulemaking because the existing policy on coverage of investigational medical practices is simply being implemented in rule pursuant to recent amendments to the state Medicaid statute.

 

local governments:

There is no impact to local governments as a result of this rulemaking because the existing policy on coverage of investigational medical practices is simply being implemented in rule pursuant to recent amendments to the state Medicaid statute.

 

other persons:

There is no impact to other persons as a result of this rulemaking because the existing policy on coverage of investigational medical practices is simply being implemented in rule pursuant to recent amendments to the state Medicaid statute.

 

Compliance costs for affected persons:

There are no compliance costs for affected persons because the existing policy on coverage of investigational medical practices is simply being implemented in rule pursuant to recent amendments to the state Medicaid statute.

 

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

This proposed rule updates a citation and clarifies that Medicaid does not cover investigational medical practices. This is consistent with current Medicaid policy and will not change reimbursement for any provider. Scott D. Williams, MD

 

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 [e-mail]

 

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:

05/17/2004

 

This rule may become effective on:

05/18/2004

 

Authorized by:

Scott D. Williams, Executive Director

 

 

RULE TEXT

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

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

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 [R414-13x-1(5)(a)]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: M[m]edicaid

[September 4, 1997]2004

Notice of Continuation June 25, 2002

26-1-5

26-18-3(2)