In this chapter, the following terms have the meanings indicated. Terms Defined. “Acquisition cost” means actual cost of a product to a provider. “Board” means the State Board of Examiners in Optometry. “Department” means the Maryland Department of Health, the single State agency designated to administer the Maryland Medical Assistance Program pursuant to Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq. “Diagnostically certified optometrist” means a licensed optometrist who is certified by the Board to administer topical ocular diagnostic pharmaceutical agents to the extent permitted under Health Occupations Article, §11-404, Annotated Code of Maryland. “EPSDT partial screen” means less than the complete package of various screening procedures required by the State Periodicity Schedule that an EPSDT participant receives at a given age. “EPSDT screen” means EPSDT screen as defined in COMAR 10.09.23.01. “Invoice” means a form designated by the Department for use by providers in submitting bills for payment. “Medically necessary” means that the service or benefit is: Directly related to diagnostic, preventive, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition; Consistent with current accepted standards of good medical practice; The most cost efficient service that can be provided without sacrificing effectiveness or access to care; and Not primarily for the convenience of the consumer, family, or provider. “Ophthalmologist” means a physician skilled in diseases of the eye. “Ophthalmic lenses or optical aids” means a lens, contact lens, prism, or vision aid which has a therapeutic effect on a patient, or which will contribute to the visual welfare of a patient. “Optician” means an individual, partnership, or company which meets applicable licensing requirements as a qualified grinder or dispenser of ophthalmic lenses or optical aids, and which is capable of translating, filling, and adapting ophthalmic prescriptions, products, and accessories. “Optometric clinic or center” means a facility, which provides services for patients under the supervision of a licensed optometrist. Optometric Examination. “Optometric examination” means a series of tests and measurements used to determine the extent of visual impairment, or the correction required to improve visual acuity, performed by a licensed optometrist. “Optometric examination” includes as a minimum: Reviewing a patient's history, past prescriptions, and specifications when available; Visual analysis; Ophthalmoscopy of internal eye; Tonometry without anesthetic when indicated or for a patient 40 years old or older; Muscle balance examination; Gross visual field testing when indicated; Writing of lens formula and other prescription data when needed, as well as specific instructions for future care; Other tests when indicated by §B(12)(b)(i)—(vii) of this regulation; and Subsequent progress evaluations when indicated. “Optometrist” means an individual who is licensed by the Board to practice optometry or by the state in which the service is rendered. “Orthoptic treatment” means the use of instruments to measure and enhance the binocular coordination of the eyes (a category of “visual training”). Practice Optometry. “Practice optometry” means, subject to Health Occupations Article, §§11-404 and 11-404.2, Annotated Code of Maryland, to use any means known in the science of optics or eye care, except surgery, to: Detect, diagnose, and treat any optical or diseased condition in the human eye; Prescribe eyeglasses or lenses to correct any optical or visual condition in the human eye; Give advice or direction on the fitness or adaptation of eyeglasses or lenses to an individual for the correction or relief of a condition for which eyeglasses or lenses are worn; and Use, or permit the use of an instrument, test card, test type, test eyeglasses, test lenses, or other device to aid in choosing eyeglasses or lenses for an individual to wear. “Practice optometry” includes, subject to Health Occupations Article, §§11-404 and 11-404.2, Annotated Code of Maryland: The administration of topical ocular diagnostic pharmaceutical agents; The administration and prescription of therapeutic pharmaceutical agents; and The removal of superficial foreign bodies from the cornea and conjunctiva. “Preauthorization” means an approval required from the Department or its designee before providing services. “Prescriber” means a physician or optometrist licensed to prescribe optical aids, and authorized by the Department to participate in the Program. “Prescription” means a written order for treatment or optical aids, or both, signed by the prescriber. “Program” means the Maryland Medical Assistance Program. “Progress evaluation” means a follow-up visit, when indicated, to determine the effectiveness of an eye examination, prescription, or series of orthoptic treatments. “Provider” means a physician (when dispensing ophthalmic lenses or visual aids), optometrist, optometric clinic or center, or optician, recognized by the Department to participate in the Program. “Recipient” means a person who is certified as eligible for, and is receiving, Medical Assistance benefits. “Routine adjustment” means an adjustment made to an optical aid other than an adjustment required because of damage. “Screening” means tests or measurements, other than an eye examination, performed to discover the possibility of difficulty in vision. “Therapeutically certified optometrist” means a licensed optometrist who is certified by the Board to administer or prescribe therapeutic pharmaceutical agents or remove superficial foreign bodies from a human eye, adnexa, or lacrimal system to the extent permitted under Health Occupations Article, §11-404.2, Annotated Code of Maryland. “Visual training” means use of instruments or other means to measure and enhance the binocular coordination of the eyes and visual perceptual functions. An optometrist shall be licensed to practice optometry in the state in which service is provided. An optician shall meet the legal requirements of the state in which the service is provided. An ophthalmologist shall be licensed to practice medicine in the state in which the service is provided. To participate in the Program, the provider shall: Apply for participation in the Program using the application form designated by the Department; Be approved for participation by the Department; Verify the recipient's eligibility; Maintain adequate records for a minimum of 6 years and make them available, upon request, to the Department or its designee; Provide service without regard to race, creed, color, age, sex, national origin, marital status, or physical or mental handicap; Not knowingly employ an optometrist, optician, or physician to provide services to Medical Assistance patients after that optometrist, optician, or physician has been disqualified from the Program, unless prior approval has been received from the Department. Accept payment by the Department as payment in full for services rendered and make no additional charge to any person or covered services; Use first quality materials that meet the criteria established by the Department; Place no restriction on a recipient's right to select providers of the recipient's choice; Agree that if the Program denies payment or requests repayment on the basis that an otherwise covered service was not medically necessary, the provider may not seek payment for that service from the recipient; Agree that if the Program denies payment due to late billing, the provider may not seek payment from the recipient. The program covers the following vision care services: A maximum of one optometric examination every 2 years for recipients 21 years old or older and a maximum of one every year for recipients younger than 21 years old, to determine the extent of visual impairment or the correction required to improve visual acuity, unless the time limitations are waived by the Department, based on medical necessity; Subject to §B, of this regulation, a maximum of one pair of eyeglasses every year, unless the time limitations are waived by the Department, based on medical necessity; Examination and eyeglasses for a recipient with a medical condition, other than normal physiological change necessitating a change in eyeglasses (before the normal time limits specified in §§A and B of this regulation have been met) when a preauthorization has been procured; Visually necessary optometric care rendered by an optometrist when these services are: Provided by the optometrist or a licensed employee; Related to the patient's health needs as diagnostic, preventive, curative, palliative, or rehabilitative services; and Adequately described in the patient's record; and Optician services when the services are: Provided by the optician, optometrist, or ophthalmologist, or by an employee under the optician's, optometrist's, or ophthalmologist's supervision and control; Adequately described in the patient's record; Ordered or prescribed by an ophthalmologist or optometrist. Eyeglasses. The eyeglasses under §A(2) of this regulation shall have first quality, impact resistant lenses, except in cases where prescription requirements cannot be met with impact resistant lenses. Frames shall be made of fire-resistant, first-quality material. In order to be entitled to receive eyeglasses under §A(2) of this regulation, a recipient shall meet at least one of the following conditions: The recipient requires a diopter change of at least 0.50; The recipient requires a diopter correction of less than 0.50 and this has been preauthorized according to Regulation .06, of this chapter, based on medical necessity; The recipient's present eyeglasses have been damaged to the extent that they affect visual performance and cannot be repaired to effective performance standards, or are no longer usable due to a change in head size or anatomy; or The recipient's present eyeglasses have been lost or stolen. The following are not covered: Eyeglasses, ophthalmic lenses, optical aids, and optician services rendered to recipients 21 years old and older; Eyeglasses, ophthalmic lenses, optical aids, and optician services rendered to recipients which were not ordered as a result of a full or partial EPSDT screen; Repairs, except when repairs to eyeglasses are more cost-effective than replacing with new eyeglasses; Combination or metal frames except when required for proper fit; Cost of travel by the provider; A general screening of a Medical Assistance population; Visual training sessions which do not include orthoptic treatment; Routine adjustment. An optometrist certified by the Board as qualified to administer diagnostic pharmaceutical agents may use the following agents in strengths not greater than the strengths indicated: Agents directly or indirectly affecting the pupil of the eye, including the mydriatics and cycloplegics listed below: Phenylephrine hydrochloride (2.5 percent); Hydroxyamphetamine hydrobromide (1 percent); Cyclopentolate hydrochloride (0.5—2 percent); Tropicamide (0.5 and 1 percent); Cyclopentolate hydrochloride (0.2 percent) with Phenylephrine hydrochloride (1 percent); Dapiprazole hydrochloride (0.5 percent); and Hydroxyamphetamine hydrobromide (1 percent) and Tropicamide (0.25 percent); and Agents directly or indirectly affecting the sensitivity of the cornea including the: Topical anesthetics listed below: Proparacaine hydrochloride (0.5 percent); and Tetracaine hydrochloride (0.5 percent); and Diagnostic topical anesthetic and dye combinations listed below: Benoxinate hydrochloride (0.4 percent) — Fluorescein sodium (0.25 percent); and Proparacaine hydrochloride (0.5 percent) — Fluorescein sodium (0.25 percent). An optometrist certified by the Board as qualified to administer and prescribe topical therapeutic pharmaceutical agents is limited to: Ocular antihistamines, decongestants, and combinations of them, excluding steroids; Ocular antiallergy pharmaceutical agents; Ocular antibiotics and combinations of ocular antibiotics, excluding specially formulated or fortified antibiotics; Anti-inflammatory agents, excluding steroids; Ocular lubricants and artificial tears; Tropicamide; Homatropine; Nonprescription drugs that are commercially available; and Primary open-angle glaucoma medications, in accordance with a written treatment plan developed jointly between the optometrist and an ophthalmologist. The following services require written preauthorization: Optometric examinations to determine the extent of visual impairment or the correction required to improve visual acuity before expiration of the normal time limitations; Replacement of eyeglasses due to medical necessity or because the eyeglasses were lost, stolen, or damaged before expiration of the normal time limitations; Contact lenses; Subnormal vision aid examination and fitting; Orthoptic treatment sessions; Plastic lenses costing more than equivalent glass lenses unless there are six or more diopters of spherical correction or three or more diopters of astigmatic correction; Absorptive lenses, except cataract; Ophthalmic lenses or optical aids when the diopter correction is less than: -0.50 D. sphere for myopia in the weakest meridian; +0.75 D. sphere for hyperopia in the weakest meridian; +0.75 additional for presbyopia; ±0.75 D. cylinder for astigmatism; A change in axis of 5° for cylinders of 1.00 diopter or more; A total of 4 prism diopters lateral or a total of 1 prism diopters vertical. Preauthorization is issued when: Program procedures are met; Program limitations are met; The provider submits to the Department adequate documentation demonstrating that the service to be preauthorized is medically necessary. Preauthorization is valid only for services rendered or initiated within 60 days of the date issued. Preauthorization normally required by the Program is waived when the service is covered and approved by Medicare. However, if the entire or any part of a claim is rejected by Medicare, and the claim is referred to the Program for payment, payment will be made for services covered by the Program only if authorization for those services has been obtained before billing. Non-Medicare claims require preauthorization according to §§A — C of this regulation. Form for Request for Payment. The provider shall submit a request for payment on the form designated by the Department. The request for payment shall document the following, when applicable: Preauthorization; Prescriptions; Need for combination or metal frame; Laboratory invoices. The Department reserves the right to return to the provider, before payment, all invoices not properly completed. The provider shall charge the Program the provider’s customary charge to the general public for similar professional services. If the service is free to individuals not covered by Medicaid: The provider: May charge the Program; and Shall be reimbursed in accordance with §F of this regulation;and The provider’s reimbursement is not limited to the provider’s customary charge. The provider shall charge acquisition cost for eyeglass frames, eyeglass lenses, contact lenses, and other optical aids. Vision care services are reimbursed according to COMAR 10.09.23.01-1. The Department will pay professional fees for covered services at the lesser of: The provider’s customary charge to the general public unless the service is free to individuals not covered by Medicaid; or The Department's fee schedule. The Department will pay for materials at acquisition costs not to exceed the maximums established by the Department. Payments on Medicare claims are authorized if: The provider accepts Medicare assignments; Medicare makes direct payment to the provider; Medicare has determined that services were medically justified; Services are covered by the Program; Initial billing is made directly to Medicare according to Medicare guidelines. Supplemental payment on Medicare claims is made subject to the limitations of the State budget and the following provisions: Deductible insurance will be paid in full; Beginning with August 1, 2010 dates of service, coinsurance shall be paid: In full for the following: Mental health services; CPT codes that are priced by report; Claims for anesthesia services; Claims from a federally qualified health center; and HCPCS codes beginning with A through W; and For all other claims, at the lesser of: 100 percent of the coinsurance amount; or The balance remaining after the Medicare payment is subtracted from the Medicaid rate; and Services not covered by Medicare, but covered by the Program, according to §E, of this regulation. The provider may not bill the Department for: Services rendered by mail or telephone; Completion of forms and reports; Broken or missed appointments; or Providing a copy of a recipient's patient record when requested by another licensed provider on behalf of the recipient. The Department's payment for lenses, frames, case, fitting, and dispensing covers any routine follow-up and adjustments for 60 days, and no additional fees will be paid. The Department will make no direct payment to the recipient. Payment for contact lenses is made as follows: For the prescription, fitting, training, and adaptation of contact lenses which includes the: Specification of optical and physical characteristics; Fitting of lenses to the wearer; Training of the wearer; Incidental revision of the lenses during training; and Adaptation of the lenses to the wearer; For the supply of contact lenses; and For the follow-up of successfully fitted extended wear lenses. Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36. If the recipient has insurance or other coverage, or if any other person is obligated, either legally or contractually, to pay for or to reimburse the recipient for services covered by this chapter, the provider shall seek payment from that source first. If an insurance carrier rejects the claim or pays less than the amount allowed by the Medical Assistance Program, the provider may submit a claim to the Program. The provider shall submit a copy of the insurance carrier's notice or remittance advice with his invoice. If payment is made by both the Program and the insurance or other source for the same service, the provider shall refund to the Department, within 60 days of receipt, the amount paid by the Program, or the insurance or other source, whichever is less. A provider shall reimburse the Department for any overpayment. If the Department determines that a provider, ophthalmologist, optometrist, optician, any agent or employee of the provider, or any person with an ownership interest in the provider has failed to comply with applicable federal or State laws or regulations, the Department may initiate one or more of the following actions against the responsible party: Suspension from Program; Withholding of payment by the Program; Removal from the Program; Disqualification from future participation in the Program, either as a provider or as a person providing services for which Program payment will be claimed. If the Secretary of Health and Human Services suspends or removes a provider from participation in Medicare, the Department will take similar action. The Department will give the provider reasonable written notice of its intention to impose sanctions. In the notice, the Department will establish the effective date and the reasons for the proposed action, and advise the provider of the right to appeal. A provider who voluntarily withdraws from the Program or is removed or suspended from the Program according to this regulation shall notify recipients that he no longer honors Medical Assistance cards before he renders additional services. Providers filing appeals from administrative decisions made in connection with these regulations shall do so according to COMAR 10.09.36.09. Except when the language of a specific regulation indicates an intent by the Department to provide reimbursement for covered services to Program recipients without regard to the availability of federal financial participation, State regulations shall be interpreted in conformity with applicable federal statutes and regulations. Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland Effective date: January 1, 1976 (2:29 Md. R. 1740) Chapter revised September 14, 1977 (4:19 Md. R. 1469) Regulations .01, .04, and .05 amended as an emergency provision effective January 1, 1993 (20:2 Md. R. 108); amended permanently effective July 1, 1993 (20:12 Md. R. 996) Regulation .01 amended effective November 29, 1999 (26:24 Md. R. 1858) Regulation .01A amended effective March 12, 1984 (11:5 Md. R. 463) Regulation .01B amended effective October 10, 2005 (32:20 Md. R. 1655) Regulation .01J amended effective January 1, 1983 (9:25 Md. R. 2483) Regulation .03D, I—K amended effective November 29, 1999 (26:24 Md. R. 1858) Regulation .03F amended effective October 10, 2005 (32:20 Md. R. 1655) Regulation .03J amended effective January 6, 1983 (9:26 Md. R. 2572) Regulation .03K adopted effective January 30, 1984 (11:2 Md. R. 113) Regulation .04 amended effective November 29, 1999 (26:24 Md. R. 1858) Regulation .04A and B amended effective January 1, 1983 (9:25 Md. R. 2483) Regulation .04B amended effective August 27, 2007 (34:17 Md. R. 1508) Regulation .05 amended effective November 29, 1999 (26:24 Md. R. 1858) Regulation .05A amended effective August 27, 2007 (34:17 Md. R. 1508) Regulation .05B amended effective October 10, 2005 (32:20 Md. R. 1655) Regulation .06 amended effective November 29, 1999 (26:24 Md. R. 1858) Regulation .06A amended effective April 17, 1981 (8:8 Md. R. 721) Regulation .06B amended effective October 10, 2005 (32:20 Md. R. 1655) Regulation .06D adopted effective April 4, 1980 (7:7 Md. R. 708) Regulation .07 amended effective November 29, 1999 (26:24 Md. R. 1858); October 10, 2005 (32:20 Md. R. 1655); July 4, 2016 (43:13 Md. R. 712) Regulation .07C amended effective April 17, 1981 (8:8 Md. R. 721) Regulation .07D amended as an emergency provision effective July 1, 1982 (9:13 Md. R. 1347); adopted permanently effective November 1, 1982 (9:21 Md. R. 2106) Regulation .07D amended as an emergency provision effective July 1, 1984 (11:13 Md. R. 1170); adopted permanently effective October 29, 1984 (11:21 Md. R. 1813) Regulation .07D amended as an emergency provision effective October 1, 1986 (13:22 Md. R. 2393); adopted permanently effective February 9, 1987 (14:2 Md. R. 129) Regulation .07D amended effective August 10, 1987 (14:16 Md. R. 1774); January 2, 1995 (21:26 Md. R. 2186) Regulation .07E amended effective April 9, 1984 (11:7 Md. R. 625); March 24, 2008 (35:6 Md. R. 698); January 12, 2009 (36:1 Md. R. 21); February 27, 2017 (44:4 Md. R. 253) Regulation .07H amended as an emergency provision effective January 8, 1979 (6:2 Md. R. 72); emergency status extended until June 1, 1979 (6:12 Md. R. 1045); adopted permanently effective June 1, 1979 (6:11 Md. R. 979) Regulation .07I amended effective April 4, 2011 (38:7 Md. R. 430) Regulation .07M amended as an emergency provision effective July 1, 1978 (5:14 Md. R. 1131); adopted permanently effective November 3, 1978 (5:22 Md. R. 1673) Regulation .07M amended effective January 30, 1984 (11:2 Md. R. 113); September 10, 1984 (11:18 Md. R. 1584) Regulation .07M amended as an emergency provision effective January 28, 1991 (18:3 Md. R. 301); emergency status expired April 8, 1991 (18:9 Md. R. 1004) Regulation .07M amended as an emergency provision effective April 9, 1991 (18:9 Md. R. 1005); amended permanently effective October 7, 1991 (18:18 Md. R. 2004) Regulation .08A amended effective May 12, 1986 (13:9 Md. R. 1029) Regulation .09A, B amended effective August 17, 1981 (8:16 Md. R. 1365) Regulation .10 amended effective June 6, 1983 (10:11 Md. R. 974); January 24, 2011 (38:2 Md. R. 84) Regulation .11 adopted effective October 25, 1982 (9:21 Md. R. 2106)