DAR File No. 42626

This rule was published in the March 15, 2018, issue (Vol. 2018, No. 6) of the Utah State Bulletin.


Health, Health Care Financing, Coverage and Reimbursement Policy

Rule R414-60

Medicaid Policy for Pharmacy Program

Notice of Proposed Rule

(Amendment)

DAR File No.: 42626
Filed: 02/27/2018 10:41:36 AM

RULE ANALYSIS

Purpose of the rule or reason for the change:

The purpose of this rule change is to implement an exception that allows Medicaid to cover long-acting injectable psychotic medications for up to a 90-day supply per dispensing.

Summary of the rule or change:

This amendment allows Medicaid to cover long-acting injectable psychotic medications for up to a 90-day supply per dispensing. This coverage also extends to the treatment of opioid use disorders.

Statutory or constitutional authorization for this rule:

  • Section 26-1-5
  • Section 26-18-3

Anticipated cost or savings to:

the state budget:

There is an annual savings of about $2,200,000 in supplemental rebates that will become available to the Department of Health.

local governments:

There is no impact to local governments because they do not fund pharmacy services under the Medicaid program.

small businesses:

Improved access to these medications will result in increased revenue to small businesses. Nevertheless, there are not sufficient nor cost effective data available to determine what those increases may be.

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

Drug companies will pay about $2,200,000 in supplemental rebates to the state. Nevertheless, these companies will see net revenue over time to offset this cost. Improved access to these medications will also result in increased revenue to pharmacies and providers, but there is no data available to know what those increases may be. Medicaid members will likewise see an increased, yet undetermined, amount of out-of-pocket savings through improved access.

Compliance costs for affected persons:

A single drug company, required to pay supplemental rebates to the state, may see a portion of $2,200,000 in annual cost. Nevertheless, this cost will be offset over time by net revenue.

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

Drug companies will pay about $2,200,000 in supplemental rebates to the State. Nevertheless, these companies will see net revenue over time to offset this cost.

Joseph K. Miner, MD, Executive Director

The full text of this rule may be inspected, during regular business hours, at the Office 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]

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:

04/16/2018

This rule may become effective on:

04/23/2018

Authorized by:

Joseph Miner, Executive Director

RULE TEXT

Appendix 1: Regulatory Impact Summary Table*

Fiscal Costs

FY 2018

FY 2019

FY 2020

State Government

$0

$0

$0

Local Government

$0

$0

$0

Small Businesses

$0

$0

$0

Non-Small Businesses

$2,200,000

$2,200,000

$2,200,000

Other Persons

$0

$0

$0

Total Fiscal Costs:

$2,200,000

$2,200,000

$2,200,000





Fiscal Benefits




State Government

$2,200,000annual savings

$2,200,000 annual savings

$2,200,000 annual savings

Local Government

$0

$0

$0

Small Businesses

Undetermined revenue

Undetermined revenue

Undetermined revenue

Non-Small Businesses

Net revenue over time

Net revenue over time

Net revenue over time

Other Persons

Undetermined savings and revenue

Undetermined savings and revenue

Undetermined savings and revenue

Total Fiscal Benefits:

Undetermined savings and revenue

Undetermined savings and revenue

Undetermined savings and revenue





Net Fiscal Benefits:

Net savings and revenue

Net savings and revenue

Net savings and revenue

 

*This table only includes fiscal impacts that could be measured. If there are inestimable fiscal impacts, they will not be included in this table. Inestimable impacts for State Government, Local Government, Small Businesses and Other Persons are described above. Inestimable impacts for Non - Small Businesses are described below.

 

Appendix 2: Regulatory Impact to Non - Small Businesses

Two drug companies will pay about $2,200,000 in supplemental rebates to the State. Nevertheless, these companies will see net revenue over time to offset this cost.

 

The Executive Director of the Department of Health, Joseph K. Miner, MD, has reviewed and approved this fiscal analysis.

 

 

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

R414-60. Medicaid Policy for Pharmacy Program.

R414-60-5. Limitations.

(1) Limitations may be placed on drugs in accordance with 42 U.S.C. 1396r-8 or in consultation with the Drug Utilization Review (DUR) Board. Limitations are included in the Pharmacy Services Provider Manual and attachments, incorporated by reference in Section R414-1-5, and may include:

(a) Quantity limits or cumulative limits for a drug or drug class for a specified period of time;

(b) Therapeutic duplication limits may be placed on drugs within the same or similar therapeutic categories;

(c) Step therapy, including documentation of therapeutic failure with one drug before another drug may be used; or

(d) Prior authorization.

(2) A covered outpatient drug that requires prior authorization may be dispensed for up to a 72-hour supply without obtaining prior authorization during a medical emergency.

(3) Drugs listed as non-preferred on the Preferred Drug List may require prior authorization as authorized by Section 26-18-2.4.

(4) Drugs may be restricted and are reimbursable only when dispensed by an individual pharmacy or pharmacies.

(5) Medicaid does not cover drugs not eligible for Federal Medical Assistance Percentages funds.

(6) Medicaid does not cover outpatient drugs included in the Medicare Prescription Drug Benefit-Part D for full-benefit dual eligible beneficiaries.

(7) Drugs provided to clients during inpatient hospital stays are not covered as an outpatient pharmacy benefit nor separately payable from the Medicaid payment for the inpatient hospital services.

(8) Medicaid covers only the following prescription cough and cold preparations meeting the definition of a covered outpatient drug:

(a) Guaifenesin with Dextromethorphan (DM) 600mg/30mg tablets;

(b) Guaifenesin with Hydrocodone 100mg/5mL liquid;

(c) Promethazine with Codeine liquid;

(d) Guaifenesin with Codeine 100mg/10mg/5mL liquid;

(e) Carbinoxamine with Pseudoephedrine 1mg/15mg/5mL liquid; and

(f) Carbinoxamine/Pseudoephedrine/DM 15mg/1mg/4mg/5mL liquid.

(9) Medicaid will pay for no more than a one-month supply of a covered outpatient drug per dispensing, except for the following:

(a) Medications included on the Utah Medicaid [Generic Medication ]Three-Month Supply Medication List attachment to the Pharmacy Services Provider Manual may be covered for up to a three-month supply per dispensing. Medicaid clients eligible for Primary Care Network services under Rule R414-100 are not eligible to receive more than a one-month supply per dispensing.

(b) Prenatal vitamins for pregnant women, multiple vitamins with or without fluoride for children through five years of age, and fluoride supplements may be covered for up to a 90-day supply per dispensing.

(c) Medicaid may cover contraceptives for up to a three-month supply per dispensing.

(d) Medicaid may cover long-acting injectable antipsychotic drugs in accordance with Section R414-60-12 for up to a 90-day supply per dispensing.

(10) Medicaid will pay for a prescription refill only when 80% of the previous prescription has been exhausted, with the exception of narcotic analgesics. Medicaid will pay for a prescription refill for narcotic analgesics after 100% of the previous prescription has been exhausted.

(11) Medicaid does not cover the following drugs:

(a) Drugs not eligible for Federal Medical Assistance Percentages funds;

(b) Drugs for anorexia, weight loss or weight gain;

(c) Drugs to promote fertility;

(d) Drugs for the treatment of sexual or erectile dysfunction;

(e) Drugs for cosmetic purposes or hair growth;

(f) Vitamins; except for prenatal vitamins for pregnant women, vitamin drops for children through five years of age, and fluoride supplements;

(g) Over-the-counter drugs not included in the Utah Medicaid Over-the-Counter Drug List attachment to the Pharmacy Services Provider Manual;

(h) Drugs for which the manufacturer requires, as a condition of sale, that associated tests and monitoring services are purchased exclusively from the manufacturer or its designee;

(i) Drugs given by a hospital to a patient at discharge;

(j) Breast milk, breast milk substitutes, baby food, or medical foods, except for prescription metabolic products for congenital errors of metabolism;

(k) Drugs available only through single-source distribution programs, unless the distributor is enrolled with Medicaid as a pharmacy provider.

(12) Medicaid may only cover hemophilia clotting factor when it is dispensed by a single-contracted provider in accordance with the Utah Medicaid State Plan.

 

R414-60-12. Provider-Administered Long-Acting Injectable Antipsychotic Drugs and Drugs for the Treatment of Opioid Use Disorders.

A pharmacy may bill Medicaid for any covered, provider-administered drug not directly dispensed to a patient for a long-acting injectable antipsychotic drug or for the treatment of an opioid use disorder. The pharmacy may only release the drug to the administering provider or the provider's staff for treatment.

 

KEY: Medicaid

Date of Enactment or Last Substantive Amendment: [January 1], 2018

Notice of Continuation: April 28, 2017

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


Additional Information

More information about a Notice of Proposed Rule is available online.

The Portable Document Format (PDF) version of the Bulletin is the official version. The PDF version of this issue is available at https://rules.utah.gov/publicat/bull_pdf/2018/b20180315.pdf. The HTML edition of the Bulletin is a convenience copy. Any discrepancy between the PDF version and HTML version is resolved in favor of the PDF version.

Text to be deleted is struck through and surrounded by brackets ([example]). Text to be added is underlined (example).  Older browsers may not depict some or any of these attributes on the screen or when the document is printed.

For questions regarding the content or application of this rule, please contact 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].  For questions about the rulemaking process, please contact the Office of Administrative Rules.