Wyo. Code R. 048-0037-10
Medicaid
Chapter 10: Medical Pharmaceutical Services
Effective Date: 09/08/1995 to 12/16/1998
Rule Type: Superceded Rules & Regulations
Reference Number: 048.0037.10.09081995
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.
(a) 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 April 1, 1995.
(b) The Department may issue Provider Manuals, Provider Bulletins, or both, to interpret the provisions of this Chapter. Such Provider Manuals and Provider Bulletins shall be consistent with and reflect the policies contained in this Chapter. The provisions contained in Provider Manuals or Provider bulletins shall be subordinate to the provisions of this Chapter.
Except as otherwise specified, the terminology used in this Chapter is the standard terminology and has the standard meaning used in health care, Medicaid, and Medicare.
(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) 'Board of Pharmacy.' The Wyoming State Board of Pharmacy, its agent, designee or successor.
(c) 'Board of Pharmacy Chapter 9.' Chapter 9, Patient Counseling and Drug Use Review Regulations, of the Board of Pharmacy Rules.
(d) '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.
(e) 'Chapter I.' Chapter I, Medicaid Administrative Hearings, of the Wyoming Medicaid Rules.
(iv) Substances intended for use as a component of any article specified in (i) through (iii).
(t) "Drug Efficacy Study Implementation (DESI) drugs." Drugs determined by the United States Food and Drug Administration to be less than effective. This definition applies to all drugs which are similar, related, or identical to DESI drugs pursuant to FDA designation. Compound formulations which contain a DESI drug are considered to be DESI drugs.
(u) "Emergency." The sudden onset of a medical condition, including labor and delivery, manifesting itself by acute symptoms of sufficient severity (including severe pain) that the absence of immediate medical attention could reasonably be expected to result in:
(v) "Estimated acquisition cost" or "EAC." AWP minus eleven percent.
(w) "Excess payment." Medicaid funds received by a provider which exceed the Medicaid allowable payment established by the Department.
(x) "FDA." The Food and Drug Administration of the United States of America.
(y) "Fixed component of the fee." The cost to dispense as determined pursuant to Section 15. Until redetermined pursuant to that Section, the fixed fee is $4.70.
(z) "Formulary." A compilation, by the Division, 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. The formulary shall be distributed to providers through Provider Manuals and/or Provider Bulletins.
(aa) "HCBS services." Home or community based services as defined by 42 C.F.R. § 440.180, which definition is incorporated by this reference.
(bb) "HCFA." The Health Care Financing Administration of the United States Department of Health and Human Services.
(cc) "Hospital." "Hospital" as defined by Chapter 9, which definition is incorporated by this reference.
(dd) "Legend drug." A drug that is required by Federal law to be dispensed pursuant to a prescription.
(ee) "Life threatening illness." A medical condition that will ultimately lead to death in the absence of medical treatment or intervention.
(ff) "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.
(gg) "Maintenance drug." The drugs specified in (i) through (ix):
(hh) "Medicaid." Medical assistance and services provided pursuant to Title XIX of the Social Security Act and the Wyoming Medical Assistance and Services Act.
(ii) "Medicaid allowable payment." The maximum Medicaid reimbursement for covered services as specified by this Chapter.
(jj) "Medically necessary." A pharmaceutical service that is:
(iii) 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 is a preventive pharmaceutical service.
(kk) "Medical supplies." Disposable, semi-disposable or expendable medical supplies. "Medical supplies" does not include durable medical equipment, oxygen or oxygen supplies.
(ll) 'Medicare.' The health insurance program for the aged and disabled under Title XVIII of the Social Security Act.
(mm) 'Medicare cross-over claim.' A claim seeking reimbursement for a pharmaceutical service provided to a person who is eligible for Medicaid and Medicare.
(nn) '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.
(oo) 'National drug code' or 'NDC.' The code number determined for and assigned to a drug by the FDA.
(pp) 'Nursing facility.' A nursing facility as defined by 42 U.S.C. § 1396r(a), which is incorporated by this reference. 'Nursing facility' includes an intermediate care facility for the mentally retarded (ICF/MR), or a distinct part of a hospital which is designated to provide nursing facility services.
(qq) 'Nursing facility services.' 'Nursing facility services' as defined by 42 U.S.C. § 1396d(f), which is incorporated by this reference.
(rr) 'Over-the counter (OTC) drugs.' Drugs which are legally available without a prescription.
(ss) 'Pharmaceutical service.' Drugs, devices or medical supplies that are covered services.
(tt) 'Pharmacist.' A person licensed to practice pharmacy by the Wyoming State Board of Pharmacy or a similar board or agency in another state.
(uu) 'Pharmacy.' An entity licensed to operate a pharmacy by the Wyoming State Board of Pharmacy or a similar board or agency in another state.
(vv) 'Physician.' A person licensed to practice medicine or osteopathy by the Wyoming State Board of Medical Examiners or a similar board or agency in another state.
(ww) '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.
(xx) 'Prescription.' A written order or oral order from a practitioner that a certain drug, medical supply, device or service is medically necessary.
(yy) 'Prescription drug.' A drug, including a legend 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.
(zz) 'Primary provider.' The provider selected by a recipient as his or her primary provider of pharmaceutical services in any given month.
(aaa) 'Provider.' A pharmacy, pharmacist or physician that is:
(i) Located in the State of Wyoming and has signed a provider agreement; or
(ii) Located outside the State of Wyoming, and
(A) Within the local trade area and has signed a provider agreement;
(B) Providing pharmaceutical services to a recipient:
(I) As the result of an emergency which occurs while the recipient is outside the State of Wyoming; or
(II) That 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.
(bbb) 'Provider Agreement.' A provider agreement as defined by Chapter 3, which definition is incorporated by this reference.
(ccc) 'Recipient.' A person who has been determined eligible for Medicaid.
(ddd) 'Recipient under age twenty-one.' A recipient before or during the month in which he or she turns twenty-one years of age.
(eee) 'Residence.' The place a recipient uses as his or her primary dwelling place, and intends to continue to use indefinitely for that purpose.
(fff) 'Service limitations.' 'Service limitations' as defined by Chapter 26, which definition is incorporated by this reference.
(ggg) 'Services.' Drugs, medical supplies and devices that are reimbursable pursuant to this Chapter.
(hhh) 'Swingbed.' A bed in a hospital which is certified for either inpatient hospital services or nursing facility services.
(iii) 'Terminal illness.' An individual with a medical prognosis that his or her life expectancy is six months or less.
(jjj) 'TPL waiver.' A waiver granted by HCFA of the third party liability requirements of Chapter 4.
(kkk) 'Usual and customary.' The provider's charge to the general public for the same or similar services.
(lll) '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.
(mmm) 'Variable component of the fee.' The portion of the dispensing fee based on the cost of a drug's ingredients as determined pursuant to Section 15. Until redetermined pursuant to that Section, the variable fee is .07 times AWP, except that the variable fee for multiple source drugs shall be .07 times the cost of the drug as determined pursuant to Section 15.
(a) Compliance with Chapter 3. An individual or entity that wishes to receive Medicaid funds for pharmaceutical services furnished to a recipient must meet the requirements of Chapter 3, which requirements are incorporated by this reference.
(b) Eligible pharmaceutical services providers.
(i) Pharmacies;
(ii) Pharmacists; and
(iii) Physicians 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) Compliance with Chapter 3. A provider of pharmaceutical services must comply with the record-keeping requirements of Chapter 3, which are incorporated by this reference.
(b) Additional requirements. In addition to the requirements of Chapter 3, providers of pharmaceutical services must retain records that include:
(i) Invoices for drugs;
(ii) Prescriptions. All prescriptions must be reduced to writing. 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.
Section 7. Verification of recipient data. A provider of pharmaceutical services must comply with the verification of recipient data requirements of Chapter 3, which are incorporated by this reference.
Section 8. DUR requirements. A provider of pharmaceutical services must comply with the DUR requirements as set forth in Board of Pharmacy Chapter 9.
(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 10, the service limitations of Section 11, and the exclusions of Section 12.
(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 conform to State and Federal laws governing prescription refills.
(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), and no ingredient of the compound is classified by the FDA as a DESI drug.
(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 or occupying a swunged;
(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 products.
(i) Analgesics;
(ii) Antacids;
(iii) Antidiarrheals;
(iv) Antihistamines;
(v) Antitussives;
(vi) Artificial tears;
(vii) Calcium supplements;
(viii) Class 5 (schedule 5) exempt narcotic cough syrups;
(ix) Contraceptive products;
(x) Cough and cold symptom products;
(xi) Ibuprofen;
(xii) Insulin;
(xiii) Iron supplements;
(xiv) Laxatives;
(xv) Nutritional products when medically necessary;
(xvi) Pediatric and prenatal vitamins;
(xvii) Sodium chloride for nebulizer use;
(xviii) Topical antifungals; (xix) Topical antiparasitics; and (xx) Vaginal anti-infectives.
(g) OTC drugs not listed in subsection (f) are covered services if:
(i) Medically necessary; and (ii) Alternatives to more expensive drugs or therapy.
(iii) Procedure for requesting coverage of OTC drugs not listed in subsection (f). A practitioner, or a pharmacist on behalf of a practitioner, may request that an OTC drug not listed in subsection (f) be covered. Such request shall be directed to the Division and shall be in the form and contain the information specified by the Division. The Division may limit coverage to specified recipients for a specified period of time, or the Division may add the OTC drug to the formulary.
(h) Medical supplies as approved by the Division for inclusion in the formulary, including:
(i) Adhesives; (ii) Diabetic supplies; (iii) Gloves; (iv) Humidifiers; (v) Incontinence products; (vi) Inhalation therapy supplies; (vii) Irrigation equipment; (viii) Ostomy supplies; and (ix) Urologic supplies.
Section 10. Dispensing limitations
(a) Generic drugs. Practitioners 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 subparagraph (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 ninety (90) day supply.
(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.
(ii) Oral contraceptives. The maximum quantity of oral contraceptive which may be dispensed is a three month supply.
(iii) 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) Non-institutionalized recipients. Medicaid reimbursement for recipients that are not inpatients of a hospital or residents of a nursing facility shall be limited to three prescriptions per calendar month.
(c) Exceptions.
(i) The service limitations specified in subsection (b) shall not apply to prescriptions for the following pharmaceutical services:
(A) Clozaril;
(B) Family planning drugs or products;
(C) Insulin;
(D) Medical supplies and diabetes supplies; and
(E) Enteral and parenteral drugs.
(ii) The limitations specified in subsection (b) shall not apply to recipients with the following diagnoses:
(A) Cancer requiring chemotherapy or radiation therapy;
(B) End stage renal disease;
(C) Hemophilia;
(D) Life threatening illness; or
(E) Terminal illness.
(iii) The limitations specified in subsection (b) shall not apply to:
(A) Recipients under age twenty one;
(B) Pregnant women;
(C) Recipients residing in a nursing facility for any part of a month, recipients occupying a swingbed for any part of a month, or recipients of HCBS services.
(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 9.
(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 11 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 11 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 for business; 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 11 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; (iv) Pharmaceutical services provided to a recipient under age twenty-one;
and
(v) Recipients of HCBS services.
(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 Medicaid allowable 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.
Section 15. Medicaid allowable payment.
(a) Reimbursement Limits. Except as otherwise specified in this section, the Medicaid allowable payment for pharmaceutical services shall be the lower of:
(i) The estimated acquisition cost of the ingredient plus the dispensing fee specified in subsection (d); or
(ii) The provider's usual and customary charge.
(b) Multiple source drugs. The Medicaid allowable payment 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. The Medicaid allowable payment 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 pursuant to (f) when necessary to:
(i) Enlist enough providers so that pharmaceutical services are available to recipients to the extent that those services are available to the general population; and
(ii) Ensure that payments are consistent with efficiency, economy and quality of care.
(f) Method of adjusting dispensing fee. The dispensing fee shall be adjusted as follows:
(i) The Division shall conduct a usual and customary survey;
(ii) Using the data collected pursuant to paragraph (i), the Division shall redetermine the fee.
(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 Manual or Provider Bulletin.
(g) 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.
(h) 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.
Section 16. Submission and Payment of claims.
(a) Except as otherwise specified in this Chapter, submission and payment of claims shall be pursuant to the provisions of Chapter 3, which are incorporated by this reference.
(b) Medicaid is no longer the payer of last resort to the extent specified in a HCFA TPL waiver for pharmaceutical services.
Section 17. Recovery of excess payments. The Department may recover excess payments pursuant to the provisions of Chapter 3, which are incorporated by this reference.
(a) Request for reconsideration. A provider may request that the Department reconsider a decision to recover excess payments. Such request must be mailed to the Department by certified mail, return receipt requested within twenty days of the date the facility receives notice pursuant to Section 17. The request must state with specificity the reasons for the request. Failure to provide such a statement shall result in the dismissal of the request with prejudice.
(b) Reconsideration. The Department shall review the decision and send written notice by certified mail, return receipt requested, to the provider of its final decision within forty-five days after receipt of the request for reconsideration or the receipt of any additional information requested pursuant to (c), whichever is later.
(c) Request for additional information. The Department may request additional information from the provider as part of the reconsideration process. Such a request shall be made in writing by certified mail, return receipt requested. The provider must provide the requested information within thirty days after the date of the request. Failure to provide the requested information shall result in the dismissal of the request with prejudice.
(d) Reconsideration shall be limited to whether the Department has complied with the provisions of this Chapter.
(e) Informal resolution. The provider or the Department may request an informal meeting before the final decision on reconsideration to determine whether the matter may be resolved. The substance of the discussions and/or settlement offers made pursuant to an attempt at informal resolution shall not be admissible as part a subsequent administrative hearing or judicial proceeding.
(f) 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, return receipt requested or personally delivering a request for hearing to the Department within twenty days of the date the provider receives notice of the final decision.
(g) Failure to request reconsideration. A provider which fails to request reconsideration pursuant to this section may not subsequently request an administrative hearing regarding the decision to recover excess payments pursuant to Chapter I.
Section 19. Superseding effect. This Chapter supersedes all prior rules or policy statements issued by the Department, including Provider Manuals and Provider Bulletins, which are inconsistent with this Chapter.
Section 20. Severability. If any portion of these rules is found to be invalid or unenforceable, the remainder shall continue in effect.