Wyo. Code R. 048-0037-10
Medicaid
Chapter 10: Medical Pharmaceutical Services
Effective Date: 07/01/1992 to 09/08/1995
Rule Type: Superceded Rules & Regulations
Reference Number: 048.0037.10.07011992
Date Filed 07/01/92 Expr Date
Supr Date Repeal Date
Document Type RULES
This rule is promulgated by the Department of Health pursuant to the Medical Assistance and Services Act at W. S. 42-4-101 et seq. and the Wyoming Administrative Procedures Act at w. S. 16-3-101 et seq.
This chapter establishes the standards and procedures for the provision of and payment for pharmaceutical services under Medicaid. it shall apply to all pharmaceutical services provided on or after March 1, 1992.
(a) 'Average wholesale price' or 'AWP.' The average wholesale price as computed by the most recent edition of the American Druggist Blue Book, First Data Bank, which is hereby incorporated by reference.
(b) 'Brand name.' The proprietary or trade name selected by the manufacturer and placed upon a drug, its container, label or wrapping at the time of packaging.
(c) 'Claim.' A request by a provider for Medicaid payment for services provided to a recipient.
(d) 'Compound drug.' A mixture of two or more ingredients to form a drug.
(e) 'Copayment.' The charge to a recipient seeking pharmaceutical services.
(f) 'Covered services.' Services which are Medicaid reimbursable as specified in this rule.
(g) 'Department.' The Wyoming Department of Health, the single state agency appointed pursuant to 42 U.S.C 1396a(a)(5), its designee or successor.
(h) 'Dispensing fee.' The amount of Medicaid reimbursement allowed by the Department as payment for the service of dispensing a prescribed drug.
(i) 'Drug.' (i) Substances recognized as drugs in official United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them, all of which are hereby incorporated by reference;
(ii) Substances intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in a person;
(iii) Substances (other than food) intended to affect the structure or any function of a person's body; or
(iv) Substances intended for use as a component of any article specified in (i) through (iii).
(j) 'Drug Efficacy Study implementation (DESi) drugs.' Drugs determined by the United States Food and Drug Administration to be less than effective.
(k) 'Emergency.' A condition, including labor and delivery, that could cause serious physical or mental disability, continuation of severe pain or death if not immediately diagnosed and treated.
(l) 'Estimated acquisition cost' or 'EAC.' AWP minus eleven percent.
(m) 'Excess payment.' Medicaid funds received by a provider in excess of those permitted by these rules.
(n) 'Fixed component of the fee.' The cost to dispense as determined pursuant to subsection 9(e). Until redetermined pursuant to that subsection, the fixed fee is $4.70.
(o) 'Formulary.' A compilation, by the Department, of therapeutically effective drugs and medical supplies deemed appropriate by the Department for inclusion in the formulary. The formulary may be changed from time to time.
(p) 'HCFA.' The Health Care Financing Administration of the United States Department of Health and Human Services.
(q) 'Life threatening illness.' A medical condition that will ultimately lead to death in the absence of medical treatment or intervention.
(r) 'Local trade area.' The geographic area surrounding the recipient's residence, including portions of states other than Wyoming, commonly used by other persons in the same area to obtain pharmaceutical services.
(s) 'Maintenance drug.' The drugs specified in (i) through (viii):
(i) Anti-diabetic preparations;
(ii) Anticonvulsant;
(iii) Antihypertensives;
(iv) Anti-arthritics;
(V) Cardiovascular preparations;
(vi) Diuretics;
(vii) Hormones, including thyroid preparations; and
(viii) Any other drug used on a chronic basis.
(t) 'Medicaid.' Medical assistance and services provided pursuant to Title XIX of the Social Security Act and the Wyoming Medical Assistance and Services Act.
(u) 'Medically necessary.' A pharmaceutical service that is consistent with the recipient's diagnosis or condition, and:
(i) is recognized as the prevailing standard or current practice among the provider's peer group; and
(ii) is rendered in response to a life-threatening condition or pain; to treat an injury, illness or infection; to treat a condition that could result in physical or mental disability; to care for a mother and child through the maternity period; or to achieve a level of physical or mental function which is consistent with prevailing community standards; or
(iii) is a preventive pharmaceutical service.
(v) 'Medical supplies.' Disposable, semi-disposable or expendable medical supplies. 'Medical supplies' does not include durable medical equipment, oxygen or oxygen supplies.
(w) 'Medicare.' The health insurance program for the aged and disabled under Title XVIII of the Social Security Act.
(x) 'Medicare cross-over claim.' A claim seeking reimbursement for a pharmaceutical service provided to a person who is eligible for Medicaid and Medicare.
(y) 'Multiple source drug.' A drug marketed or sold by two or more manufacturers or labelers or a drug marketed or sold by the same manufacturer or labeler under two or more different proprietary names or both under a proprietary name and without such a name.
(z) 'National drug code' or 'NDC.' The code number determined for and assigned to a drug by the United States Food and Drug Administration.
(aa) 'Nursing facility.' an intermediate care facility includes an intermediate care (ICF/MR). 'Nursing facility' hospital or institution which or nursing facility services. A skilled nursing facility (SNF), (ICF) or a nursing facility. ICF facility for the mentally retarded may include a distinct part of a is designated to provide SNF, ICF
(bb) 'Over-the counter (OTC) drugs.' Drugs which are legally available without a prescription.
(cc) 'Pharmaceutical service.' The dispensing of drugs or medical supplies by a provider.
(dd) 'Pharmacist.' A person licensed to practice pharmacy by the Wyoming State Board of Pharmacy or a similar board or agency in another state.
(ee) 'Pharmacy.' An entity licensed to operate a pharmacy by the Wyoming State Board of Pharmacy or a similar board or agency in another state.
(ff) 'Physician.' A person licensed to practice medicine by the Wyoming State Board of Medical Examiners or a similar board or agency in another state.
(gg) 'Practitioner.' A physician or other licensed practitioner of the healing arts authorized to prescribe drugs and practicing within the scope of professional practice as defined under Wyoming Statutes or the laws of another state.
(hh) 'Prescription.' A written order from a practitioner that a certain drug is medically necessary.
(ii) 'Prescription drug.' A drug or medical supply that is:
(i) Prescribed by a practitioner acting within the scope of his practice; and
(ii) Dispensed by a provider pursuant to a written prescription that is recorded and maintained in the provider's records.
(jj) 'Primary provider.' The provider selected by a recipient as his or her primary provider of pharmaceutical services in any given month.
(kk) 'Provider.' A pharmacy, pharmacist or physician that:
(i) Is located in the State of Wyoming and has signed a provider agreement; or
(ii) Is located outside the State of Wyoming, and
(A) Is within the local trade area and has signed a provider agreement;
(B) Is providing pharmaceutical services to a recipient as the result of an emergency which occurs while the recipient is outside the State of Wyoming; or
(C) The recipient is less than 19 years of age; and:
(I) Is a foster child not covered by Title IV-E of the Social Security Act and resides with a foster family outside the State of Wyoming; or
(II) Has been placed in an out-of-state institution.
(ll) 'Provider Agreement.' A formal written agreement between the Department and a provider to provide pharmaceutical services.
(mm) 'Recipient.' A person who has been determined eligible for Medicaid.
(nn) 'Recipient under age twenty-one.' A recipient before or during the month in which he or she turns twenty-one years of age.
(oo) 'Residence.' The place a recipient uses as his or her primary dwelling place, and intends to continue to use indefinitely for that purpose.
(pp) 'Terminal illness.' An individual with a medical prognosis that his or her life expectancy is six months or less.
(qq) 'Usual and customary.' When used to refer to a claim submitted by a provider, the average charge of the provider to non-recipients, other than persons eligible for payment on a reduced or sliding fee schedule.
(rr) 'Usual and customary prescription drug survey.' A survey of the selling prices charged by pharmacists for non-Medicaid prescriptions filled on a specific date. The survey is used to determine average cost plus profit (or fee) for all participating pharmacy providers. In conducting the survey, the Department may use such methods and request such information as it deems necessary.
(ss) 'Variable component of the fee.' The portion of the dispensing fee based on the cost of a drug's ingredients as determined pursuant to subsection 10(e). Until redetermined pursuant to that subsection, the variable fee is .07 times EAC, except that the variable fee for multiple source drugs shall be .07 times the cost of the drug as determined pursuant to subsection 10(b).
(a) Pharmacies or pharmacists that have completed a provider agreement and have been assigned a provider number by the Department.
(b) Physicians that have completed a provider agreement. A physician who practices in a local trade area where pharmacy services are not available from a pharmacy or pharmacist may enroll as a Medicaid pharmacy services provider. Except as otherwise specified in this chapter, such a physician must meet the standards and follow the procedures established for a pharmacist provider.
(a) Prescription drugs. Prescription drugs included in the formulary are covered in the quantity prescribed by a practitioner, subject to the dispensing limitations of Section 6, the service limitations of Section 7, and the exclusions of Section 8.
(b) Refill of prescription. In addition to the criteria specified in subsection (a), a refill of a prescription must:
(i) Be authorized by the practitioner who originally prescribed the drug; and
(ii) Such authorization must be given within one year after the date the prescription was originally dispensed, except that authorization to refill a prescription for insulin may be given within two years after the date the prescription was originally dispensed.
(c) Brand name drugs certified in writing as medically necessary by the prescribing practitioner.
(d) Compound drugs if the main active ingredient is a prescription drug covered pursuant to subsection (a).
(e) OTC drugs and medical supplies. The OTC drugs specified in subsection (f) and the medical supplies specified in subsection (g) are covered services if:
(i) Furnished to a recipient who is not a resident of a nursing facility;
(ii) Prescribed by a practitioner;
(iii) Dispensed in the original trade package; and (iv) The drug has been assigned an NDC number.
(f) Covered OTC drugs.
(i) Acetaminophen; (ii) Antacids; (iii) Antihistamines; (iv) Antitussives; (v) Aspirin; (vi) Calcium supplements; (vi) Class five or exempt narcotics; (vii) Contraceptive condoms, creams, foams, tablets and sponges; (viii) Cough and cold preparations; (ix) Expectorants; (x) Ibuprofen; (xi) Insulin; (xii) Iron supplements; (xiii) Laxatives and Anti-Diarreals; (xiv) Pediatric and prenatal vitamins; (xv) Sodium chloride for diluting bronchodilator solutions; (xvi) Vaginal antifungals; (xvii) Topical antibiotics; and (xviii) Topical antifungals.
(g) OTC drugs not listed in subsection (f) are covered services if:
(i) Medically necessary; and (ii) Alternatives to more expensive drugs or therapy; or (iii) Unavailable by prescription order.
(iv) Procedure for requesting coverage of OTC drugs not listed in subsection (f). A physician or a pharmacist on behalf of a physician may request that an OTC drug not listed in subsection (f) be covered. Such request shall be directed to the Department and shall be in the form and contain the information specified by the Department. The Department may limit coverage to specified recipients for a specified period of time, or the Department may add the OTC drug to the formulary.
(h) Medical supplies as approved by the Department for inclusion in the formulary, including:
(i) Adhesives;
(ii) Diabetic supplies;
(iii) Gloves;
(iv) Humidifiers;
(v) Incontinence pads;
(vi) Inhalation therapy supplies;
(vii) Irrigation equipment;
(viii) Miscellaneous bandages and protectives;
(ix) Ostomy supplies; and
(x) Urologic supplies.
(a) Generic drugs. Physicians are encouraged to prescribe generic drugs except when name brand drugs are medically necessary.
(b) Quantities dispensed.
(i) Maintenance drugs.
(A) Minimum quantities. Except as provided in (C) maintenance drugs shall be dispensed in a quantity sufficient for at least one month.
(B) Maximum quantities. Maintenance drugs shall not be dispensed in an amount which exceeds a three month supply or one hundred and twenty tablets, capsules, etc, whichever is less.
(C) Less than a one month supply of a maintenance drug may be dispensed to allow a recipient to be stabilized on a new or adjusted maintenance drug.
(iii) Oral contraceptives. The maximum quantity of oral contraceptive which may be dispensed is a three month supply.
(iv) All other drugs. The maximum quantity dispensed for all other conditions shall be a one-month supply.
(a) The Medicaid program shall not reimburse providers for pharmaceutical services furnished in excess of the limitations specified in subsection (b).
(b) Ambulatory recipients. Medicaid reimbursement shall be limited to three prescriptions per calendar month.
(c) Exceptions.
(i) The limitations specified in subsection (b) shall not apply to the following pharmaceutical services:
(A) Clozaril;
(B) Family planning products;
(C) Insulin;
(E) Medical supplies specified in subsection 5(g); and
(F) Parenteral drugs.
(ii) The limitations specified in subsection (b) shall not apply to the recipients with the following diagnoses:
(A) Cancer requiring chemotherapy or radiation therapy;
(B) End stage renal disease;
(C) Hemophilia;
(D) Unstable diabetes;
(E) Terminal illness; or
(F) Life threatening illness.
(iii) The limitations specified in subsection (b) shall not apply to:
(A) Recipients under age twenty one;
(B) Pregnant women; and (C) Recipients residing in a nursing facility for any part of a month.
(a) The following prescription drugs are excluded:
(i) Anorexicals, except Amphetamines and derivatives which are prescribed for narcolepsy and hyperkinetic conditions;
(ii) Fertility drugs;
(iii) Hair growth products;
(iv) Weight gain agents, including androgenic or anabolic steroid agents when used for weight gain;
(v) Retin-A when used for cosmetic purposes; and
(vi) Products containing nicotine and used for smoking cessation.
(b) OTC drugs and medical supplies, except as specified in Section 5.
(c) DESI drugs or compound drugs which contain a DESI drug.
(d) Drugs supplied by a manufacturer that has not entered into and does not have in effect a rebate agreement which meets the requirements of Pub. L. No. 101-508, Section 4401(a), except as otherwise specified by that Section. Pub. L. No. 101-508, Section 4401(a) is hereby incorporated by this reference.
(a) Recipient's responsibilities.
(i) Selection of primary provider. A recipient that wishes to obtain pharmaceutical services must select a primary provider each month; and
(ii) Prescription drug card. After selecting a primary provider, the recipient must furnish the provider with the recipient's prescription drug identification card. A provider is not required to furnish prescription drugs to a recipient that cannot furnish a prescription drug card.
(b) Primary provider.
(i) The primary provider must track the number of prescriptions dispensed to each recipient which selects the provider as a primary provider to ensure that the service limitations of Section 7 are not exceeded;
(ii) The primary provider is entitled to receive Medicaid reimbursement for prescription drugs furnished to a recipient subject to the service limitations of Section 7 and as otherwise specified in this Chapter.
(c) Non-primary provider.
(i) A non-primary provider may dispense and receive Medicaid reimbursement for prescription drugs furnished to a recipient:
(A) In an emergency and the recipient's primary provider is not open; or
(B) The recipient's primary provider does not stock or is unable to furnish the entire prescribed amount.
(C) If a non-primary provider furnishes a prescription drug pursuant to (A), that provider shall advise the primary provider that an emergency prescription has been filled.
(D) Medicaid reimbursement made to a non-primary provider may be recovered by the Department if the non-primary provider fails to notify the primary provider that a prescription has been filled and the primary provider subsequently seeks Medicaid reimbursement and the service limitations of Section 7 have been exceeded.
(a) Recipients must pay a $1.00 per prescription copayment for pharmaceutical services, except as specified in subsection (b).
(b) Exemptions. The following recipients and pharmaceutical services are exempt from the copayment requirement:
(i) Residents of a nursing facility;
(ii) Family planning products;
(iii) Pharmaceutical services related to pregnancy; and (iv) Pharmaceutical services provided to a recipient under age twenty-one.
(c) Collection of copayment. Providers are responsible for collecting the copayment. The amount of the copayment shall be automatically deducted by the Department from the allowable Medicaid payment, regardless of whether the copayment is actually paid.
(i) Prohibition or denial of services. A provider may not deny pharmaceutical services to a recipient because of the recipient's inability to make the copayment.
(ii) Regular refusal to make copayment. A provider may refuse pharmaceutical services to a recipient who regularly refuses to make copayments.
(a) Reimbursement Limits. Except as otherwise specified in this section, Medicaid payments for pharmacy services shall be the lower of:
(i) The estimated acquisition cost of the ingredient plus the dispensing fee specified in subsection (d);
(ii) The provider's usual and customary charge.
(b) Multiple source drugs. Medicaid payments for multiple source drugs shall be the lower of:
(i) The cost of the drug as determined pursuant to 42 c.F.R. 447.331-332, which regulations are hereby incorporated by reference, plus the dispensing fee specified in subsection (d); or
(ii) The provider's usual and customary charge.
(c) OTC drugs and medical supplies. Medicaid payments for prescribed OTC drugs and medical supplies shall be the lower of:
(i) 150% of the average wholesale price; or
(ii) The provider's usual and customary charge.
(d) Dispensing fee. Except as specified below, the dispensing fee shall be the lower of the provider's usual and customary dispensing fee or the sum of the fixed component of the fee plus the variable component of the fee. The dispensing fee shall be adjusted as specified in subsection (e).
(i) Physicians. The dispensing fee for physicians who dispense pharmacy services shall be $2.00 per prescription.
(e) Adjustment of dispensing fee. The dispensing fee shall be adjusted effective January 1, 1994, and effective January 1 every third year thereafter as follows:
(i) The Department shall conduct a usual and customary survey;
(ii) Using the data collected pursuant to paragraph (i), the Department shall redetermine the fee. The redetermination shall take into consideration prior survey results to discover any possible bias or trends; or
(iii) The Department may use an appropriate indicator of pharmacy costs to adjust the dispensing fee.
(iv) The Department shall notify providers of any adjustment in the dispensing fee through a provider bulletin.
(f) Prescription splitting. If a provider does not have sufficient supplies of a drug to fill a prescription completely, the provider may fill the prescription to the extent possible and claim a dispensing fee. When the balance of the prescription is dispensed, the provider may not seek an additional dispensing fee.
(g) Proof of delivery. A provider must maintain a signature log, in the form specified by the Department, to act as proof of delivery of prescription drugs. Each recipient, or an individual acting on behalf of the recipient, must sign the log each time a prescription drug is delivered. For prescription drugs delivered to a nursing facility, the individual charged with ensuring the security of pharmaceutical supplies may sign the log after verifying delivery of all prescription drugs.
(h) Submission of claims.
(i) Claims must be submitted to the Department in the manner and on the forms specified by the Department.
(ii) Claims must be submitted to the Department on or before twelve months after the date of service, except that Medicare cross-over claims must be submitted to the Department on or before six months after the date on which Medicare acts on the claim. The date of submission is the date the claim is received by the Department. Claims not timely submitted shall be rejected.
(iii) A provider shall not bill the Department in excess of the provider's usual and customary charge for the service.
(iv) A provider may seek Medicaid payment through a business agent for services provided to a recipient if the business agent's compensation is related to the actual cost of processing the billing and is not related on a percentage or other basis to the amount of the claim and is not dependent upon payment of the claim.
(i) Payer of last resort. Medicaid is the payer of last resort. A provider may not seek Medicaid payment for services provided to a recipient until payment from third parties has been sought pursuant to Chapter IV of these rules.
(j) Medicaid payment as payment in full.
(i) Covered services. A provider must accept as payment in full the amount paid by the Department for any covered service provided to a recipient. A provider may not seek any payment from a recipient except the copayment described in Section 10.
(ii) Noncovered services. Except as otherwise provided in this paragraph, a provider may seek reimbursement from a recipient for noncovered services only if the provider notifies the recipient before the services are provided that such services are not covered by Medicaid and that the provider will seek reimbursement from the recipient, and the recipient agrees, in writing, to pay for such services before they are provided@ This provision does not apply to pharmaceutical services furnished to a recipient in excess of the service limitations specified in Section 7.
(a) Denial or reduction of payments. The Department may deny or reduce payment for any claim not submitted in accordance with this rule or as otherwise specified in applicable federal or state statutes or rules.
(b) Recovery of excess payments. The Department may recover any excess payments.
(c) Notice of denial, reduction or recovery of excess payments. After determining that a claim shall be denied or reduced, other than a reduction to the Medicaid allowable payment, the Department shall send notice as required by Chapter I, stating:
(i) That payment is being denied or reduced or that excess payments will be recovered;
(ii) The amount of the excess payments, if applicable;(iii) The reason for the denial or reduction of payments or the recovery of excess payments; and (iv) That the provider may request reconsideration pursuant to Section 13.
(d) Reimbursement of excess payments. A provider must reimburse the Department for excess payments within 30 days after the provider receives written notice from the Department of the excess payments, even if the provider has requested reconsideration or appealed the determination of excess payments.
(e) Methods of recovery of excess payments. If a provider does not timely reimburse the Department, the Department may recover the excess payments by:
(i) Withholding all or part of Medicaid payments until the excess payments are recovered; or
(ii) Any other method of collecting a debt permitted by law.
(a) Request for reconsideration. A provider may request that the Department reconsider a decision to reduce or deny payment for a claim or recover excess payments. Such request must be mailed to the Department by certified mail within twenty days of the date the Department sends notice to the provider pursuant to Section 12.
(b) Reconsideration. The Department shall review the decision and send written notice, by certified mail, to the provider of its final decision within forty-five days after receipt of the request for reconsideration.
(c) Administrative hearing. A provider may request an administrative hearing regarding the final decision pursuant to Chapter I of these rules by mailing by certified mail or personally delivering a request for hearing to the Department within twenty days after the date the notice of final decision is mailed to the provider. The request for hearing must comply with Chapter I.
(d) Failure to request reconsideration. A provider that fails to request reconsideration pursuant to this section may not subsequently request an administrative hearing regarding the decision to deny payment or recover excess funds pursuant to Chapter I.
(e) A provider may not appeal a denial or reduction of payment or recovery of excess payments caused by a change in the reimbursement methodology, a change in the formulary, or any change in state or federal law.
(a) Retention. Providers must maintain medical and financial records, including information regarding dates of services, diagnoses, services provided, and bills for services, for at least six years after the end of the federal fiscal year (September 30) in which the services were rendered. Such records must be maintained for three years in hard-copy, after which they may be maintained on micro-fiche or micro-film. Records must include:
(i) Invoices for drugs;
(ii) Prescriptions. All prescriptions must be reduced to writing. Oral prescriptions for brand name drugs must contain the certification 'medically necessary,' in the prescribing practitioner's hand-writing, and must be received and on file within thirty days after the oral prescription;
(iii) A signature log in the form specified by the Department;
(iv) Recipient account records; and
(v) Copies of claim forms.
(b) Confidentiality. All medical records and other information regarding a recipient is confidential. A provider may not disclose such information to any person or entity other than the recipient, the Department or the Department's designee, unless the recipient provides written consent to such disclosure.
(c) Right of Access. The Department and its designees shall have the right to inspect any records maintained by the provider pursuant to this Section.
Section 15. Severability. If any portion of these rules is found to be invalid or unenforceable, the remainder shall continue in effect.
The Wyoming Department of Health (the Department) is the single state agency appointed pursuant to the Social Security Act (the Act) to administer the Medicaid program in Wyoming. The Wyoming Medical Assistance and Services Act of 1967 (the Wyoming Act) requires the Department to administer the Medicaid program in conformance with federal standards.
The Wyoming Act authorizes the Department to promulgate necessary rules. The Wyoming Administrative Procedure Act requires all agency statements of general applicability that implement, interpret or prescribe law or policy be promulgated as rules.
The Health Care Financing Administration of the United States Department of Health and Human Services (HCFA) is the federal agency for administering the Medicaid program. HCFA regulations permit the Department to determine which pharmaceutical services to cover, and require the Department to establish policies and methods for reimbursing providers of such services to Medicaid recipients. Accordingly, the Department promulgated Chapter X, Pharmaceutical Services, to establish the scope of covered pharmaceutical services and policies and methods for reimbursing providers of such services.
The rule is now being amended to reflect service limitations which become effective March 1, 1992. It is being promulgated to replace the existing Chapter x, which was promulgated as an emergency rule.