DAR File No. 44173

Health, Health Care Financing, Coverage and Reimbursement Policy

Rule R414-60

Medicaid Policy for Pharmacy Program

Notice of Proposed Rule

(Amendment)

DAR File No.: 44173
Filed: 10/31/2019 05:21:21 PM

RULE ANALYSIS

Purpose of the rule or reason for the change:

The purpose of this change is to implement, by rule, the Support for Patients and Communities Act passed by the United States Congress to promote opioid recovery and treatment, and to make other clarifications.

Summary of the rule or change:

This amendment implements safeguards for opioid use that include quantity restrictions, restrictions on morphine, restrictions on opioids used in combination with higher-risk medications, and strategies to manage antipsychotic medications prescribed to Medicaid members who are 19 years of age or younger. This amendment also clarifies the time limit for claims for covered outpatient drugs, clarifies coverage for cough and cold preparations, removes provisions for the Primary Care Network, clarifies the length of coverage for long-acting injectable antipsychotic drugs, and clarifies prescription drugs not covered by Medicaid.

Statutory or constitutional authorization for this rule:

• Section 26-18-3
• Section 26-1-5

Anticipated cost or savings to:

the state budget:

There is no impact to the state budget because there are no additional program costs to implement opioid-use safeguards, and the other clarifications do not affect current or future appropriations.

local governments:

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

small businesses:

There is no impact to small businesses because there are no additional program costs to implement opioid-use safeguards, and the other clarifications do not affect current or future appropriations.

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

There is no impact to Medicaid providers and to Medicaid members because there are no additional program costs to implement opioid-use safeguards, and the other clarifications do not affect current or future appropriations.

Compliance costs for affected persons:

There is no impact to a single Medicaid provider or to a Medicaid member because there are no additional program costs to implement opioid-use safeguards, and the other clarifications do not affect current or future appropriations.

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

After conducting a thorough analysis, it was determined that this proposed rule amendment will not result in a fiscal impact to businesses.

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 801-237-0750, or by Internet E-mail at cdevashrayee@utah.gov

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:

12/16/2019

This rule may become effective on:

01/01/2020

Authorized by:

Joseph Miner, Executive Director

Appendix 1: Regulatory Impact Summary Table*

Fiscal Costs	FY 2020	FY 2021	FY 2022
State Government	$0	$0	$0
Local Government	$0	$0	$0
Small Businesses	$0	$0	$0
Non-Small Businesses	$0	$0	$0
Other Person	$0	$0	$0
Total Fiscal Costs:	$0	$0	$0
Fiscal Benefits
State Government	$0	$0	$0
Local Government	$0	$0	$0
Small Businesses	$0	$0	$0
Non-Small Businesses	$0	$0	$0
Other Persons	$0	$0	$0
Total Fiscal Benefits:	$0	$0	$0
Net Fiscal Benefits:	$0	$0	$0

 

*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

None of the three non-small business providers of pharmacy services will see a fiscal impact, as there are no additional program costs to implement opioid-use safeguards, and the other clarifications in the rule do not affect current or future appropriations.

 

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.

R414-60-4. Program Coverage.

(1) Covered outpatient drugs eligible for Federal Medical Assistance Percentages funds are included in the pharmacy benefit; however, covered outpatient drugs may be subject to limitations and restrictions.

(2) In accordance with Subsection 58-17b-606(4), when a multi-source A-rated legend drug is available in the generic form, Medicaid will only reimburse for the generic form of the drug unless:

(a) reimbursing for the non-generic brand-name legend drug will result in a financial benefit to the State; or

(b) the treating physician demonstrates a medical necessity for dispensing the non-generic, brand-name legend drug.

(3) Prescriptions that are not executed electronically must be written on tamper-resistant prescription forms. Tamper-resistant prescription forms must include all of the following:

(a) One or more industry-recognized features designed to prevent unauthorized copying of a completed or blank prescription form;

(b) One or more industry-recognized features designed to prevent the erasure or modification of information written on the prescription by the prescriber; and

(c) One or more industry-recognized features designed to prevent the use of counterfeit prescription forms.

(d) Documentation by the pharmacy of verbal confirmation of a prescription not written on a tamper resistant prescription form by the prescriber or the prescriber's agent satisfies the tamper-resistant requirement. Documentation of the verbal confirmation must include the date, time, and name of the individual who verified the validity of the prescription.

(e) Pharmacies must maintain documentation of receipt of a prescription by a Medicaid client or the client's authorized representative. The documentation must clearly identify the covered outpatient drug received by the client, the date the covered outpatient drug was received, and who received the covered outpatient drug.

(f) Claims for covered outpatient drugs not dispensed to a Medicaid client or the client's authorized representative within 1[0]4 days must be reversed and any payment from Medicaid must be returned.

 

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 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]three-month 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]three-month 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]a) Drugs for[anorexia, ]weight loss ;[or weight gain;]

([c]b) Drugs to promote fertility;

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

([e]d) Drugs for cosmetic purposes ;[or hair growth;]

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

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

([h]g) 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]h) Drugs given by a hospital to a patient at discharge;

([j]i) Breast milk, breast milk substitutes, baby food, or medical foods .[, except for p]Prescription metabolic products for congenital errors of metabolism are covered through the Durable Medical Equipment benefit;

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

(12) Opioid claims used for the treatment of non-cancer pain are subject to limitations or restrictions set forth by the department such as:

(a) Initial fill limits;

(b) Monthly limits;

(c) Quantity limits;

(d) Additional limits in children and pregnant women;

(e) Morphine Milligram Equivalents (MME) and cumulative Morphine Equivalents Daily (MED) limits; or

(f) Concurrent use of opioids with high-risk drugs as defined by the Division of Medicaid and Health Financing.

(13) Antipsychotic medications prescribed to Medicaid members who are 19 years of age or younger are limited as follows:

(a) No use of multiple antipsychotic drugs;

(b) No off-label use;

(c) No use outside established age guidelines; and

(d) No doses higher than FDA recommendations.

(14) Exceptions may be granted as appropriate through the prior authorization process.

 

KEY: Medicaid

Date of Enactment or Last Substantive Amendment: [May 1, 2018]2019

Notice of Continuation: April 28, 2017

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