TO: Health and Human Services Commission Council DATE: February 22, 2012 FROM: Andy Vasquez, Deputy Director, Vendor Drug Medicaid and CHIP Division SUBJECT: Vitamins and Minerals BACKGROUND: Federal Requirement Legislative Requirement Other The Health and Human Services Commission (HHSC) proposes to amend Title 1, Part 15, Chapter 354, Subchapter F, Division 2, §354.1831(b), Covered Drugs. This amendment removes the language in §354.1831(b), which states that, with a few exceptions, the Medicaid Vendor Drug Program (VDP) does not reimburse for vitamins and minerals. Currently, medically necessary vitamins and minerals are available for Medicaid clients under age 21 only through pharmacies that are specifically enrolled in the Medicaid Comprehensive Care Program (CCP). The 2012-13 General Appropriations Act, H.B. 1, 82nd Legislature, Regular Session, 2011 (Article II, Health and Human Services Commission, Rider 72), requires vitamins and minerals to be added to the VDP formulary so that all VDP-enrolled pharmacies can be reimbursed for this CCP benefit for Medicaid clients under age 21. HHSC identified 26 vitamins and minerals that will be available to CCP children through VDPenrolled pharmacies. This list was compiled by medical experts at Texas Southern University and The University of Texas College of Pharmacy at San Antonio and analyzed by a scientific / medical workgroup made up of HHSC staff and external nutritional experts. The following vitamins and minerals will be added to the VDP formulary: Beta-carotene; Vitamin A (retinol); Biotin; Boric acid; Copper; Iodine; Phosphorus; Zinc; Calcium; Chloride; Iron; Magnesium; Vitamin B1 (thiamin); Vitamin B2 (riboflavin); Vitamin B3 (niacin); Vitamin B5 (pantothenic acid); Vitamin B6 (pyridoxine, pyridoxal 5-phosphate); Vitamin B9 (folic acid); Vitamin B12 (cyanocobalamin); Vitamin C (ascorbic acid); Vitamin D (ergocalciferol); Vitamin E (tocopherols); Vitamin K (phytonadione); Multiminerals; Multivitamins; and Trace elements. Removing subsection (b) from §354.1831 will allow HHSC to add vitamins and minerals to the VDP formulary and reimburse all VDP-enrolled pharmacies for this Medicaid CCP benefit. ISSUES AND ALTERNATIVES: There are no alternatives because this rule is required by the 2012-13 General Appropriations Act, H.B. 1, 82nd Legislature, Regular Session, 2011 (Article II, Health and Human Services Commission, Rider 72). There are no significant issues. STAKEHOLDER INVOLVEMENT: A draft of the proposed rule was sent to external stakeholders for review. HHSC received no comments. External stakeholders included: Vitamins and Minerals - 1 Texas Osteopathic Medical Association Texas Association of Health Plans Texas Pharmacy Association National Association of Chain Drug Stores Texas Pharmacy Business Council Texas Retailers Association (includes the Texas Federation of Drug Stores) Texas Association of Community Health Centers Texas Academy of Family Physicians Children’s Hospital Association of Texas Texas Medical Association Texas Pediatric Society Walgreens Texas Organization of Rural and Community Hospitals FISCAL IMPACT: None Yes State FY 2012 $17,738 FY 2013 $332,798 FY 2014 $474,792 FY 2015 $508,027 FY 2016 $543,589 Federal 24,717 484,887 691,773 740,197 792,010 Total $42,455 $817,685 $1,166,565 $1,248,224 $1,335,599 SERVICES IMPACT STATEMENT: As a result of the proposed rule, Medicaid enrollees under age 21 will have increased access to certain vitamins and minerals. RULE DEVELOPMENT SCHEDULE: February 9, 2012 February 22, 2012 May 2012 August 2012 August 2012 Present to Medical Care Advisory Committee Present to HHSC Council Publish proposed rule in the Texas Register Publish adopted rule in the Texas Register Effective date REQUESTED ACTION: The Council recommends to the Executive Commissioner that the proposed rule be published in the Texas Register and later adopted should there be no substantive comment. Vitamins and Minerals - 2 TITLE 1 PART 15 CHAPTER 354 SUBCHAPTER F DIVISION 2 RULE §354.1831 ADMINISTRATION TEXAS HEALTH AND HUMAN SERVICES COMMISSION MEDICAID HEALTH SERVICES PHARMACY ADMINISTRATION Covered Drugs PROPOSED PREAMBLE The Texas Health and Human Services Commission (HHSC) proposes to amend §354.1831 concerning Medicaid covered drugs. Background and Justification This proposed amendment removes the language in §354.1831(b), which states that, with a few exceptions, the Medicaid Vendor Drug Program (VDP) does not reimburse for vitamins and minerals. Currently, medically necessary vitamins and minerals are available for Medicaid clients under age 21 only through pharmacies that are specifically enrolled in the Medicaid Comprehensive Care Program (CCP). The 2012-13 General Appropriations Act, H.B. 1, 82nd Legislature, Regular Session, 2011 (Article II, Health and Human Services Commission, Rider 72), requires vitamins and minerals to be added to the VDP formulary so that all VDP-enrolled pharmacies can be reimbursed for this CCP benefit. Removing subparagraph (b) will allow HHSC to add vitamins and minerals to the VDP formulary and reimburse all VDP-enrolled pharmacies for this benefit for Medicaid clients under age 21. Section-by-Section Summary The proposed amendment deletes subsection (b) to allow for all VDP-enrolled pharmacies to receive reimbursement for vitamins and minerals, a current CCP benefit. Fiscal Note Greta Rymal, Deputy Executive Commissioner for Financial Services, has determined that during the first five-year period the proposed rule is in effect, there is an estimated cost to general revenue of $17,738 for state fiscal year (SFY) 2012; $332,798 for SFY 2013; $474,792 for SFY 2014; $508,027 for SFY 2015; $543,589 for SFY 2016; and $581,640 for SFY 2017. The proposed rule will not result in any fiscal implications for local health and human services agencies. Local governments will not incur additional costs. Small and Micro-business Impact Analysis Ms. Rymal has also determined that there will be no effect on small businesses or microbusinesses to comply with the proposed rule, as they will not be required to alter their business practices as a result of the amended rule. There are no anticipated economic costs to persons who are required to comply with the proposed rule. There is no anticipated negative impact on local employment. Vitamins and Minerals - 3 Public Benefit Billy Millwee, Deputy Executive Commissioner for Health Services, has determined that for each year of the first five years the section is in effect, the public will benefit from the adoption of the rule. The anticipated public benefit of enforcing the proposed rule will be increased access to vitamins and minerals for Medicaid clients under age 21. Regulatory Analysis HHSC has determined that this proposal is not a “major environmental rule” as defined by §2001.0225 of the Texas Government Code. A “major environmental rule” is defined to mean a rule the specific intent of which is to protect the environment or reduce risk to human health from environmental exposure and that may adversely affect, in a material way, the economy, a sector of the economy, productivity, competition, jobs, the environment, or the public health and safety of a state or a sector of the state. This proposal is not specifically intended to protect the environment or reduce risks to human health from environmental exposure. Takings Impact Assessment HHSC has determined that this proposal does not restrict or limit an owner’s right to his or her property that would otherwise exist in the absence of government action and, therefore, does not constitute a taking under §2007.043 of the Government Code. Public Comment Written comments on the proposal may be submitted to Stacey Johnston, Policy Analyst, Medicaid/CHIP Division, Texas Health and Human Services Commission, P.O. Box 85200, Austin, TX 78708-5200, Mail Code H310; by fax to (512) 491-1953; or by e-mail to Stacey.Johnston@hhsc.state.tx.us within 30 days of publication of this proposal in the Texas Register. Public Hearing A public hearing is scheduled for DATE, 2011, at TIME a.m./p.m. at the John H. Winters Building, Public Hearing Room, 125-E, located at 701 W. 51st Street, Austin, Texas. Persons requiring further information, special assistance, or accommodations should contact Leigh Van Kirk at (512) 491-2813. Statutory Authority The amendment is proposed under Texas Government Code §531.033, which provides the Executive Commissioner of HHSC with broad rulemaking authority; Texas Human Resources Code §32.021 and Texas Government Code §531.021(a), which provide HHSC with the authority to administer the federal medical assistance (Medicaid) program in Texas. Vitamins and Minerals - 4 The amendment affects Texas Human Resources Code Chapter 32, and Texas Government Code Chapters 531 and 533. No other statutes, articles, or codes are affected by this proposal. This agency hereby certifies that the proposal has been reviewed by legal counsel and found to be within the agency’s legal authority to adopt. Vitamins and Minerals - 5 Legend: [begin addition] Single Underline [end addition] = Proposed new language [begin deletion] Strikethrough and Brackets [end deletion] = Current language proposed for deletion Regular Print = Current language (No change.) = No changes are being considered for the designated subdivision TITLE 1 PART 15 CHAPTER 354 SUBCHAPTER F DIVISION 2 RULE §354.1831 ADMINISTRATION TEXAS HEALTH AND HUMAN SERVICES COMMISSION MEDICAID HEALTH SERVICES PHARMACY ADMINISTRATION Covered Drugs (a) Only those drugs listed in the latest edition of the Texas Drug Code Index (TDCI) are covered by the program and are payable. Venosets, catheters, and other medical accessories are not covered and are not included when claiming for intravenous and irrigating solutions. [begin deletion] (b) Except for vitamins K and D3, prenatal vitamins, fluoride preparations, and products containing iron in its various salts, the Commission does not reimburse for vitamins and legend and nonlegend multiple ingredient antianemia products. [end deletion] [begin addition] (b) [end addition] [begin deletion] c) [end deletion] The Commission may limit coverage of drugs listed in the TDCI. Procedures used to limit utilization may include prior approval, cost containment caps, or adherence to specific dosage limitations recommended by manufacturers. Limitations placed on the specific drugs are indicated in the TDCI. Vitamins and Minerals - 6