This chapter defines the reimbursed services for the diagnosis and treatment of breast cancer, cervical cancer, or precancerous cervical lesions, outlines the requirements for patient eligibility, and outlines the reimbursement and billing procedures for the reimbursed services. This chapter also defines the: Responsibilities and duties of the Department, the participating local health department, the hospital-coordinated breast and cervical cancer screening program, the health care provider who determines patient eligibility and refers patients to the Program, and the following participating providers: Physician; Physician assistant; Certified nurse midwife; Nurse practitioner; Nurse anesthetist; Physical therapist; Pharmacy; Hospital; Medical supply company; Home health services provider; Medical laboratory; Freestanding ambulatory surgical center; and Occupational therapist; and Process for termination from the Program and the procedure for appealing termination. In this chapter, the following terms have the meanings indicated. Terms Defined. “Admission” means the formal acceptance by a hospital of a patient who is to be provided with room, board, and medically necessary services in an area of the hospital where the patient stays at least overnight. “Ambulatory surgical center” means a distinct, Medicare-certified entity that operates exclusively for the purpose of providing surgical services to patients not requiring hospitalization. “Annual gross income” means the total amount received per year from all sources before taxes are withheld. “Applicant” means an individual who has applied to be eligible to have certain health care costs associated with the diagnosis and treatment of breast cancer, cervical cancer, or a precancerous cervical lesion paid for by the Department. “Biopsy” means the removal and microscopic examination of tissue from the living human body, performed to establish a precise diagnosis. “Breast reconstruction” means surgery performed after the removal of a breast as a result of breast cancer to reestablish symmetry between the two breasts. “Certified nurse anesthetist” means a registered nurse who: By reason of certification under COMAR 10.27.06, may practice in Maryland under the terms of those regulations; or Meets the certification requirements in the jurisdiction in which the service is provided, if the service is provided out-of-State. “Certified nurse midwife” means a registered nurse who: By reason of certification under COMAR 10.27.05, may practice in Maryland under the terms of those regulations; or Meets the certification requirements in the jurisdiction in which the service is provided, if the service is provided out-of-State. “Certified nurse practitioner” means a registered nurse who: By reason of certification under COMAR 10.27.07, may practice in Maryland under the terms of those regulations; or Meets the certification requirements in the jurisdiction in which the service is provided, if the service is provided out-of-State. “Cervical carcinoma in-situ” means cancer that involves only the intraepithelial layer of the cervix. “Clinical breast examination” is a physical examination of the breast performed by a qualified health professional for the purpose of detecting breast cancer. “Clinically significant mass” means the presence of a discrete, dominant, palpable lump that raises the level of concern by either a patient or a provider. “Controlled clinical trial” means a research study that: Is conducted with cancer patients to evaluate the safety and effectiveness of a new treatment; Is conducted after basic research in laboratory and animal studies have been well tested, and researchers have reason to believe that the new treatment will be as good as, or better than, current standard treatment; Is reviewed for medical ethics, patient safety, and scientific merit by a research institution; Includes an informed consent in which the patient is given information about the study and the potential benefits and risks; and Involves review of the protocol and progress of the study and provides for monitoring the data and the safety of the patient during and after the study by researchers at places other than the institution at which the study is conducted. “Department” means the Maryland Department of Health. “Diagnosis” means a histopathologic finding of breast cancer, cervical cancer, or a precancerous cervical lesion in a biopsy specimen. “Direct supervision” means that the physical therapist employer is physically present in the same area of the facility as the physical therapy assistant who provides service. “Disposable medical supplies” means consumable medical items with minimal or no potential for reuse. “Durable medical equipment” means equipment which satisfies all of the following requirements: Can withstand repeated use; Is used to serve a medical purpose; and Is appropriate for use in the home. “Eligible patient” means an applicant who has been determined to meet certain general, medical, health insurance, and financial criteria. “Excisional biopsy” means the removal of the entire tumor mass for cytologic examination. “Experimental drug” means a drug or biological not: Approved by the Food and Drug Administration for the treatment of breast cancer or cervical cancer; and Used under the protocol of a peer-reviewed, Phase-III controlled clinical trial approved by: The National Institutes of Health (NIH) or one of the NIH’s centers or cooperative groups; The Food and Drug Administration through an investigational new drug exemption; The Department of Veterans Affairs; or A qualified nongovernmental research entity as identified in guidelines issued by the NIH. “Experimental treatment” means a medical procedure or service for breast cancer, cervical cancer, or a precancerous cervical lesion that is not performed under the protocol of a peer-reviewed, Phase-III controlled clinical trial approved by: The National Institutes of Health (NIH) or one of the NIH's centers or cooperative groups; The Food and Drug Administration through an investigational new drug exemption; The Department of Veterans Affairs; or A qualified nongovernmental research entity as identified in guidelines issued by the NIH. “Explanation of benefits” means the statement sent to a patient or provider, or both, in a health plan that lists: The health care services provided; The amounts paid by the plan; and The total amount billed to the patient. “Family” means the unit comprised of the applicant or the applicant and one or more of the following: Spouse; A financially dependent child; or A financially dependent relative. “Freestanding ambulatory surgical center” means a unit capable of providing ambulatory surgical services which is not located in a hospital setting and which is: Certified by Medicare through the Health Care Finance Administration (HCFA) regional office to furnish ambulatory surgical services directly to patients; and Licensed by the State. “Homebound” means the status of a patient who is confined to the home due to a medical condition. “Home health services provider” means a public or private agency or organization, or part of any agency or organization, that: Meets one of the following licensure requirements: Is licensed pursuant to Health-General Article, §§19-401—19-408, Annotated Code of Maryland; If the entity is part of a hospital or related institution located in Maryland, is licensed pursuant to Health-General Article, §§19-301—19-359, Annotated Code of Maryland; If the entity is located outside of Maryland, is legally authorized to provide home health services in the jurisdiction in which the service is provided; or Is a registered nurse licensed pursuant to Health Occupations Article, §§8-101 and 8-301—8-315, Annotated Code of Maryland, with a contractual agreement with the Department to provide skilled nursing care; Provides nursing or physical therapy services in the home; and Meets the requirements for participation in Medicare. “Hospital” means an institution which falls within the jurisdiction of Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland, and is licensed pursuant to COMAR 10.07.01 or other applicable standards established by the jurisdiction in which the service is provided. “Initial physical therapy evaluation” means the determination of the condition of the patient by a physical therapist through the administration of appropriate tests and a written case history on the first visit. “Innovator multiple source drug” has the meaning set forth at 42 U.S.C. §1396r-8(k)(7), as amended, which is incorporated by reference. “Insurer” means a private carrier, nonprofit health service plan, or health maintenance organization that administers or provides reimbursement for health care benefits on an expense-incurred basis. “Intermittent basis” means a service which is furnished on or at medically predictable and recurring intervals. “Invasive cervical cancer” means cancer which has spread beyond the intraepithelial layer of the cervix or beyond to other body tissues and organs. “Invoice” means a: Form issued or approved by the Department for use by a provider in submitting bills for payment; or Bill issued by a manufacturer or wholesaler to the provider which indicates proof of purchase and the price paid by the provider. “Legend drug” means a substance used as a medicine which is prescribed by a licensed health care provider in accordance with federal or State law. “Local health department” means the Baltimore City or a county-wide organization providing health services operated by the local health officer and under the supervision of the Department. “Mammogram” means an X-ray of the breast that is performed to detect breast cancer. “Maryland Health Insurance Plan (MHIP)” means the nonprofit entity established under Insurance Article, §§14-501—14-509, Annotated Code of Maryland, to provide affordable, comprehensive health coverage for medically uninsurable Maryland residents. “Medical Assistance” means the program administered by the State under Title XIX of the Social Security Act which provides comprehensive medical and other health-related care for eligible and medically needy low income individuals. “Medical case manager” means the participating physician or participating nurse practitioner who is responsible for making the medical decisions about the course of diagnosis and treatment for an eligible patient. “Medical laboratory” means a licensed or certified facility operated for the examination of material derived from the human body, by one or more scientific disciplines, for the purpose of obtaining information that may be used to aid in the diagnosis, treatment, and management of breast and cervical cancer. “Medicare” means the medical insurance program administered by the federal government under Title XVIII of the Social Security Act, 42 U.S.C. §1395 et seq. “Needle biopsy” means the removal of tissue from a solid mass with a needle. “Needle localization” means the application of radiologically guided needles to isolate breast lesions preoperatively. “Negative mammogram” means the X-ray revealed: Nothing of medical significance to comment on; A finding which is non-significant, but which may need to be described; or A finding which is probably non-significant, but which may need to be described and which suggests the need for short interval follow-up. “Occupational therapist” means an individual licensed by the Maryland Board of Occupational Therapy Practice or similarly licensed in the state in which the service is provided. “Oncologist” means a physician who specializes in the treatment of cancer. “Over-the-counter drug” means a substance used as a medicine that does not require a prescription under federal or State law. “Participating health care provider” means a local health department, hospital, or a participating: Certified nurse midwife; Freestanding ambulatory surgical center; Home health services provider; Hospital; Medical laboratory; Medical supply company; Nurse anesthetist; Nurse practitioner; Pharmacy; Physical therapist; Physician; Physician assistant; Occupational therapist; or Other appropriate health care providers. “Part-time basis” means services usually furnished during several visits per week, but not exceeding one visit per discipline per day, unless unusual circumstances are documented by the physician, which are reasonable and necessary to the treatment of breast and cervical cancer. “Patient contribution amount” means the amount of money required by an individual's health insurance policy to be paid by the individual for a given medical service received, excluding the deductible. “Pharmacist” means an individual licensed to practice pharmacy in Maryland. “Pharmacy” means an establishment or institution requiring a permit in accordance with Health Occupations Article, Title 12, Annotated Code of Maryland. “Phase-III controlled clinical trial” means a research study using an experimental drug or treatment which: Has been shown to be effective in the treatment of breast or cervical cancer; and May be compared with current standard treatment to evaluate which is more effective. “Physical therapist” means an individual licensed or registered by the Maryland Board of Physical Therapy Examiners or similarly licensed or registered in the state in which the service is provided. “Physical therapist assistant” means an individual licensed as a physical therapy assistant, working under the direct supervision of a physical therapist, and performing those physical therapy procedures that are assigned by a physical therapist within the scope of Health Occupations Article, Title 13, Annotated Code of Maryland. “Physical therapy aide” means a non-licensed individual in the employ of a physical therapist. “Physician” means an individual who is licensed to practice medicine in the jurisdiction in which the service is provided. “Physician assistant” means an individual who: Is licensed to practice medicine under the supervision of a physician under Health Occupations Article, Title 15, Annotated Code of Maryland; or Meets the licensure requirements in the jurisdiction in which the service is provided, if the service is provided out-of-State. “Prescriber” means a participating health care provider licensed to prescribe legend drugs in the state in which the service is provided. “Prescription” means a written order for medication, medical supplies, or equipment signed by the prescriber. “Program” means the Breast and Cervical Cancer Diagnosis and Treatment Program within the Department established to: Reimburse for breast and cervical cancer diagnostic and treatment services provided by participating health care providers to eligible patients; and Pay for MHIP coverage, if available, for eligible patients in lieu of providing direct reimbursement to participating health care providers. “Progress note” means a dated, written notation which summarizes facts about the patient care given and the patient response during a given period of time that: Specifically addresses the established goals of treatment; Is consistent with the patient plan of care; Is written immediately following each visit; and Is part of the permanent patient record. “Radiological examination of a breast surgical specimen” means an X-ray of the surgically removed tissue to ensure that the specimen contains the area of suspicion. “Release of patient information” means a Departmental consent form signed by the patient granting permission to certain individuals to allow the release of certain medical and demographic information for the purpose of follow-up, reimbursement, and medical case management. “Resident” means an individual who is currently living in, and intends to remain living within, Maryland. “Single source drug” means a drug that is: Available from only one producer or distributor; and Produced or distributed under an original new drug application approved by the Food and Drug Administration, including a drug marketed by a producer or distributor operating under the new drug application. “Stage I breast cancer” means a tumor 2 centimeters or less in greatest dimension without regional lymph node or distant metastasis. “Staging” means the categorization of a cancer according to tumor size, regional lymph node involvement, and metastasis to distant areas in the body. “Treatment” means the medical management and care of a patient for breast cancer, cervical cancer, or a precancerous cervical lesion. “Utilization control agent” means the organization responsible for reviewing the use of hospital services to determine medical necessity and lengths of stay according to applicable professional standards. To be eligible to have a covered service reimbursed under the Program, an applicant shall: Be a resident; Be screened for breast cancer or cervical cancer, or both, by a: Hospital; Local health department; or Health care provider; Be found to have an eligible medical condition as described in §B of this regulation; Meet the health insurance criteria specified in §C of this regulation; Meet the financial eligibility criteria of an annual gross income that is not more than 250 percent of the federal poverty guidelines, as amended, which are incorporated by reference and updated periodically in the Federal Register by the U.S. Department of Health and Human Services; and Receive a medical service only from participating health care providers for breast cancer diagnosis, breast cancer treatment, cervical cancer diagnosis, or cervical cancer or precancer treatment, or any combination of these services. A medical condition which may render an applicant medically eligible includes the following: A mammogram, or breast ultrasound, or other diagnostic breast imaging requiring further diagnosis; A clinical breast examination requiring further diagnosis; A Pap test, or human papilloma virus test, or other approved cervical cancer screening test requiring further diagnosis; A breast biopsy which indicates the need for further diagnosis or treatment; or A cervical biopsy which indicates the need for further diagnosis or treatment. Health insurance statuses which may render an applicant eligible include the following: The applicant is not currently covered by health insurance, including Medical Assistance; The applicant is covered by Medicare which: Does not provide reimbursement for the covered medical procedure or service; Has a deductible for the year that has not been met; or Has a patient contribution amount for the reimbursed medical procedure or service that the applicant is required to pay; or The applicant has health insurance other than Medical Assistance or Medicare which: Does not provide reimbursement for the covered medical procedure or service; Requires that a deductible be paid by the applicant for the covered medical procedure or service; Reimburses at a rate lower than the Medical Assistance approved rate in the State; or Has a patient contribution amount for the reimbursed medical procedure or service that the applicant is required to pay; The applicant is enrolled in one of the following Medical Assistance programs: Family Planning; Primary Adult Care (PAC); Specified Low Income Medicare Beneficiary (SLMB); or Qualified Medicare Beneficiary (QMB). An applicant is not eligible if: The applicant is enrolled in a Medical Assistance program other than those listed in §C(4) of this regulation; During diagnosis or treatment of breast or cervical cancer, the applicant becomes enrolled in a Medical Assistance program other than those cited in §C(4) of this regulation; or Any of the criteria established in §§A—D of this regulation are not met. An applicant is responsible for the following: Furnishing factual information regarding the applicant’s eligibility, including but not limited to verifying documents regarding financial eligibility and the applicability of health insurance; Completing, which may include the applicant providing the applicant's social security number, and signing the application form, provided that the Program informs the applicant that: The applicant's disclosure of the applicant's social security number on the application is voluntary; The Program's request for the applicant's social security number is authorized by federal law under the Social Security Act (42 U.S.C. 405(c), as amended); and The applicant's social security number will be used only for the Program's administrative purposes; and Completing and submitting a Medical Assistance application when notified by the Program that the applicant is considered potentially eligible. Social Security Number Collection. An applicant is not required to have or disclose a social security number to be eligible for Program benefits. An applicant's disclosure of the applicant's social security number on the application form is voluntary. The Program's request for the applicant's social security number is authorized by federal law under the Social Security Act at 42 U.S.C. §405(c)(2)(C)(i) and (vi), as amended. The Program may only use the social security number provided by an applicant to establish the identity of the applicant for administrative purposes. The Program may request a copy of an applicant's social security card for administrative purposes. An eligible patient is responsible for the following: Keeping the Program, local health department, hospital, or health care provider who determines the patient’s eligibility for the Program informed of any change in health insurance status; Selecting and using only a participating health care provider; and Signing the release of patient information form for the Program developed and approved by the Department. To be considered a participating physician in the Program, the provider shall: Provide a medical procedure or service related to the diagnosis and treatment of breast cancer, cervical cancer, or a precancerous cervical lesion; Have a current license to practice medicine in Maryland or a jurisdiction bordering Maryland; Agree to accept, for each covered medical procedure performed or service provided, the following reimbursement including, if applicable, a medical management fee as described in Regulation .15 of this chapter: The current Medical Assistance approved rate in the State for an eligible patient who is uninsured or who has insurance that does not provide coverage for a reimbursed procedure or service; The reimbursement rate approved by the insurer plus the payment of the outstanding deductible and patient contribution amount by the Department for an eligible patient who has insurance, other than Medicare, that provides coverage for a reimbursed procedure or service; The reimbursement rate approved by Medicare plus the payment of the outstanding deductible and the patient contribution amount by the Department for an eligible patient who is covered by Medicare; or For an eligible patient who has insurance that provides reimbursement for a covered procedure or service that is less than the current Medical Assistance approved rate, the reimbursement rate approved by the insurer plus the difference between the reimbursement rate approved by the insurer and the current Medical Assistance approved rate in the State plus the payment of the outstanding deductible by the Department; Agree to abide by the provisions set forth in §A of this regulation by signing and sending to the Department the designated Departmental form; Agree not to bill an eligible patient, who is uninsured or is covered by Medicare or other insurance, for an additional charge for the reimbursed medical procedure performed or service provided; Agree to: Be the medical case manager for an eligible patient; or Coordinate the reimbursed medical procedure or service with the designated medical case manager and submit the result of the procedure to the medical case manager; Agree to the following medical guidelines: That a negative mammogram alone is not sufficient to evaluate a clinically significant mass, and to perform or arrange for further diagnostic evaluation of the mass; That a surgeon shall examine the patient and make the final determination of further diagnostic and treatment procedures needed when a needle biopsy performed by a non-surgeon is negative for cancer; To perform or arrange for needle localization of the mass before excisional biopsy; To perform or arrange for radiological examination of the breast surgical specimen after biopsy to accurately identify the mass; To refer an eligible patient with a mammography assessment recommending biopsy to a surgeon for evaluation and a decision regarding the ultimate course of action; To implement the diagnostic tests or procedures required for cancer staging determination in keeping with the best interests of the patient and to determine staging on the cancer found; To consult an oncologist before any treatment is initiated for Stage I or greater breast cancer or invasive cervical cancer; and To consult with a radiation oncologist if radiation treatment is a medical option; Agree to maintain the results of the reimbursed medical procedures performed as set forth in §E(6)—(9) of this regulation; Agree to maintain administrative and health records, including medical records, to document compliance with this chapter for a minimum of 6 years and, upon request, allow the Department access to the records; and Place no restriction on the eligible patient's right to choose a provider. An eligible medical provider may be, but is not limited to, one of the following: Anesthesiologist; Clinical-anatomical or cytopathological pathologist; Diagnostic, therapeutic, or nuclear radiologist; Family practitioner; Medical internist; Medical or gynecological oncologist; Obstetrician-gynecologist; or Surgeon. Reimbursed medical procedures include, but are not limited to, the following: Breast cancer diagnostic procedures including, but not limited to: Cyst aspiration; Diagnostic ultrasound; Incisional, excisional, or other breast biopsy; Needle biopsy; and Needle localization; Breast cancer treatment procedures including, but not limited to: Adjuvant hormonal therapy; Adjuvant or sole chemotherapy; Adjuvant or sole radiation therapy; Lumpectomy with radiation; Lymph node dissection; Modified radical mastectomy; Radical mastectomy; and Simple mastectomy; Contingent upon available funds, breast reconstruction procedures including, but not limited to: Construction of breast mound; Augmentation mammoplasty; Reduction mammoplasty; and Mastopexy; Cervical cancer or precancerous cervical lesion diagnostic procedures including, but not limited to: Colposcopically directed cervical or vaginal biopsy, or both; Colposcopy; Endocervical curettage; and Endometrial biopsy if the patient has taken Tamoxifen for the treatment of breast cancer or has had cervical cancer documented; Cervical cancer or precancerous cervical lesion treatment procedures including, but not limited to: Conization; Cryosurgery; Dilation and curettage; Electric loop resection; Hysterectomy; and Laser treatment; and Follow-up to treatment for breast cancer, cervical cancer, or a precancerous cervical lesion including, but not limited to: Follow-up office visits with the medical case manager; and Medical and laboratory tests ordered by the medical case manager. Non-reimbursed medical procedures and services include but are not limited to: A screening mammogram; A Pap or human papilloma virus test; An experimental treatment other than a Phase-III controlled clinical trial for breast or cervical cancer; A procedure or service not related to the diagnosis and treatment of breast and cervical cancer; Organ transplants; and Nipple reconstruction or tattooing, or both. The participating physician is responsible for the following: Medical liability for the medical procedure performed on a referred, eligible patient; Accepting a referral of an eligible patient from a local health department, hospital, or other health care provider; Performing a medical test needed by the eligible patient; Charging the patient for a non-reimbursed medical procedure performed; Submitting a bill for the reimbursed medical procedure performed or service provided on the designated Departmental form within 12 months of the date of service as follows: If an eligible patient is uninsured or is insured, but the insurance does not provide coverage for the reimbursed medical procedure or service, the participating physician shall send to the Department the bill for the procedure or service, with a denial from the applicable insurance carrier, on the form designated by the Department; If an eligible patient is covered by Medicare or other insurance, the participating physician shall bill: Medicare or the other insurance for the procedure or service in accordance with Medicare or the other insurance billing specifications; and The Department for the outstanding deductible and patient contribution amount. Maintaining reports of the results of the following diagnostic tests and sending to the Department upon request: Sonogram or other breast cancer test which identifies an area as suspicious; Breast biopsy in which cancer is present; and Cervical biopsy which identifies a change associated with: Cervical carcinoma in situ; Cervical intraepithelial neoplasia; Invasive cervical cancer; or The human papilloma virus; Maintaining reports of the results of the following diagnostic tests and sending to the Department upon request: Sonogram or other breast cancer test that is negative or shows a benign finding; Breast biopsy in which cancer is not present; and Cervical biopsy which is negative or shows a benign finding; Maintaining and sending to the Department upon request, reports pertaining to the staging of the cancer; and Maintaining and sending to the Department, upon request, the result of a treatment procedure. The participating physician may not bill the Department under this Program for: Completion of a form; A broken or missed appointment; A professional service rendered by mail or telephone; or A professional service provided to a patient enrolled in a Medical Assistance program other than those listed in Regulation .03C(4) of this chapter. The Program shall reimburse for claims submitted pursuant to this regulation as set forth in Regulation .21 of this chapter. To be considered a participating physician assistant in the Program, the provider shall: Be licensed to practice as a physician assistant in Maryland or a jurisdiction bordering Maryland; Have a current written executed delegation agreement with a licensed supervising physician who is licensed to practice medicine in Maryland or a jurisdiction bordering on Maryland, if required by that jurisdiction; Agree to accept, for each reimbursed medical procedure performed or service provided, the following reimbursement including, if applicable, a medical management fee as described in Regulation .15 of this chapter: The current Medical Assistance approved rate in the State of an eligible patient who is uninsured or has insurance that does not provide coverage for a certain procedure or services; The reimbursement rate approved by the insurer plus the payment of the deductible and patient contribution amount by the Department for an eligible patient who has insurance, other than Medicare, that provides coverage for a certain procedure or service; The reimbursement rate approved by Medicare plus the payment of the deductible and patient contribution amount by the Department for an eligible patient who is covered by Medicare only; or For an eligible patient who has insurance that provides coverage for a reimbursed procedure or service that is less than the current Medical Assistance approved rate, the reimbursement rate approved by the insurer plus the difference between the reimbursement rate approved by the insurer, and the Medical Assistance approved rate in the State plus the payment of the deductible and patient contribution amount by the Department; Agree to abide by the provisions set forth in this section by signing and sending to the Department the designated Departmental form; and Agree to the medical, financial, and reporting requirements of the Program pursuant to Regulation .04A(5), (6), (7)(a)—(e), and (8)—(10) of this chapter. An eligible health care provider may be a physician assistant. The reimbursed medical services include services related to breast and cervical cancer rendered to participants in accordance with: The functions allowed under: The Physician Assistant’s Practice Act; COMAR 10.32.03; and The physician assistant’s written delegation agreement with a physician; or If out-of-State, the functions authorized in the state in which the services are provided. Non-reimbursed medical procedures and services include a procedure or service not related to the diagnosis and treatment of breast and cervical cancer. The participating physician assistant shall accept the responsibilities pursuant to Regulation .04E—G of this chapter. To be considered a participating certified nurse midwife in the Program, the provider shall: Be a certified nurse midwife in Maryland or a jurisdiction bordering on Maryland and hold all certifications as required by the Maryland Board of Nursing; Agree to accept, for each reimbursed medical procedure performed or service provided, the following reimbursement including, if applicable, a medical management fee as described in Regulation .15 of this chapter: The current Medical Assistance approved rate in the State for an eligible patient who is uninsured or has insurance that does not provide coverage for a certain procedure or service; The reimbursement rate approved by the insurer plus the payment of the deductible by the Department for an eligible patient who has insurance, other than Medicare, that provides coverage for a certain procedure or service; The reimbursement rate approved by Medicare plus the payment of the deductible and patient contribution amount by the Department for an eligible patient who is covered by Medicare only; or For an eligible patient who has insurance that provides coverage for a reimbursed procedure or service that is less than the current Medical Assistance approved rate, the reimbursement rate approved by the insurer plus the difference between the reimbursement rate approved by the insurer, and the Medical Assistance approved rate in the State plus the payment of the deductible by the Department; Agree to abide by the provisions set forth in this section by signing and sending to the Department the designated Departmental form; and Agree to the medical, financial, and reporting requirements of the Program pursuant to Regulation .04A(5), (6), (7)(a)—(e), and (8)—(10) of this chapter. If out-of-State, the provider shall meet the regulatory requirements of the state in which the services are provided. The reimbursed medical procedure includes but is not limited to: Colposcopically directed cervical or vaginal biopsy or both: Colposcopy; Cyst aspiration; Endocervical curettage; Endometrial biopsy if the patient has taken Tamoxifen for the treatment of breast cancer or if cervical cancer has been documented; Medically necessary services within the provider’s scope of practice as described in COMAR 10.27.05; or If out-of-State, nurse midwife services authorized in the state in which the services are provided. Non-reimbursed medical procedures and services include a procedure or service not related to the diagnosis and treatment of breast and cervical cancer. The participating certified nurse midwife shall accept the responsibilities pursuant to Regulation .04E—G of this chapter. To be considered a participating nurse practitioner in the Program, the provider shall: Be a certified nurse practitioner in Maryland or a jurisdiction bordering Maryland; Have a current written attestation with a physician who is licensed to practice medicine in Maryland or a jurisdiction bordering Maryland, if required by that jurisdiction; Agree to accept, for each reimbursed medical procedure performed or service provided, the following reimbursement including, if applicable, a medical management fee as described in Regulation .15 of this chapter: The current Medical Assistance approved rate in the State for an eligible patient who is uninsured or has insurance that does not provide coverage for a certain procedure or service; The reimbursement rate approved by the insurer plus the payment of the deductible and patient contribution amount by the Department for an eligible patient who has insurance, other than Medicare, that provides coverage for a certain procedure or service; The reimbursement rate approved by Medicare plus the payment of the deductible and patient contribution amount by the Department for an eligible patient who is covered by Medicare only; or For an eligible patient who has insurance that provides coverage for a reimbursed procedure or service that is less than the current Medical Assistance approved rate, the reimbursement rate approved by the insurer plus the difference between the reimbursement rate approved by the insurer and the Medical Assistance approved rate in the State plus the payment of the deductible by the Department; Agree to abide by the provisions set forth in this section by signing and sending to the Department the designated Departmental form; and Agree to the medical, financial, and reporting requirements of the Program pursuant to Regulation .04A(5)—(6), (7)(a)—(e), and (8)—(10) of this chapter. An eligible health care provider may be a certified nurse practitioner. The reimbursed medical procedure includes but is not limited to: Colposcopically directed cervical or vaginal biopsy or both; Colposcopy; Cyst aspiration; Endocervical curettage; and Endometrial biopsy if the patient has taken Tamoxifen for the treatment of breast cancer or if cervical cancer has been documented. Non-reimbursed medical procedures and services include a procedure or service not related to the diagnosis and treatment of breast and cervical cancer. The participating nurse practitioner shall accept the responsibilities pursuant to Regulation .04E, F, and G of this chapter. To be considered a participating nurse anesthetist in the Program, the provider shall: Be a certified nurse anesthetist in Maryland or a jurisdiction bordering Maryland; Be currently collaborating with an anesthesiologist or other physician who is licensed to practice medicine in Maryland or a jurisdiction bordering Maryland in the manner prescribed by COMAR 10.27.06 or by the jurisdiction in which the service is provided; Agree to accept, for each covered medical procedure performed or service provided, the following reimbursement including, if applicable, a medical management fee as described in Regulation .15 of this chapter: The current Medical Assistance approved rate in the State for an eligible patient who is uninsured or who has insurance that does not provide coverage for a reimbursed procedure or service; The reimbursement rate approved by the insurer plus the payment of the deductible and the patient contribution amount by the Department for an eligible patient who has insurance, other than Medicare, that provides coverage for a certain procedure or service; The reimbursement rate approved by Medicare plus the payment of the deductible and patient contribution amount by the Department for an eligible patient who is covered by Medicare only; or For an eligible patient who has insurance that provides reimbursement for a covered procedure or service that is less than the current Medical Assistance approved rate, the reimbursement rate approved by the insurer plus the difference between the reimbursement rate approved by the insurer and the Medical Assistance approved rate in the State plus the payment of the deductible by the Department; Agree to abide by the provisions set forth in this section by signing and sending to the Department the designated Departmental form; and Agree to the medical, financial, and reporting requirements of the Program pursuant to Regulation .04A(5),(6), (9), and (10) of this chapter. An eligible health care provider may be a certified nurse anesthetist. The reimbursed medical procedure is anesthesia required for the diagnosis and treatment of breast cancer or cervical cancer. Non-reimbursed medical procedures and services include an anesthesia procedure or service not related to the diagnosis and treatment of breast cancer and cervical cancer. The participating nurse anesthetist provider shall accept the responsibilities pursuant to Regulation .04E(1)—(5), F, and G of this chapter. To be considered a participating physical therapist in the Program, the provider shall: Be a physical therapist licensed to practice physical therapy in Maryland or a jurisdiction bordering Maryland; Agree to abide by the provisions set forth in this regulation by signing and sending to the Department the designated Departmental form; Follow standard health and safety procedures to protect an eligible patient from potential hazards; Agree to the medical and reporting requirements of the Program pursuant to Regulation .04A(5), (9), and (10) of this chapter; Agree to accept, as payment in full, the amount paid by the Program pursuant to §E of this regulation plus the amount paid by the eligible patient’s health insurer, if applicable; and Agree not to bill an eligible patient an additional charge for the covered service. The Program shall reimburse a participating physical therapist for a medically necessary physical therapy service ordered in writing by a participating physician when the service is: Provided by a physical therapist or by a physical therapist assistant under the direct supervision of a physical therapist; Provided in a physical therapy office or the patient's home; Considered one or more of the following: Diagnostic; Rehabilitative; or Therapeutic; Directly related to the written treatment order; Of sufficient complexity and sophistication, or the condition of the patient is such that the service of a physical therapist is required; Rendered pursuant to a written treatment order which: Is signed and dated by the prescribing physician; Specifies the following: Body part to be treated; Type of modality or treatment to be rendered; Expected result of physical therapy treatment; and Frequency and duration of treatment; Is kept on file by the physical therapist as a part of the permanent patient record subject to review by the Department or its designee; Is not altered by the physical therapist unless medically indicated, whereby the physical therapist shall make a necessary change and sign the treatment order, advising the prescribing physician of the change and noting it in the patient record; Recorded in the permanent record to include the following: The treatment order; The initial evaluation by the physical therapist; Significant past history; Pertinent diagnoses and prognoses; Contraindications, if applicable; and Progress notes, at least once every 2 weeks; For a written treatment order for treatment exceeding 30 days and the participating physician: Reviews and rewrites the order monthly; or Initials and dates a copy of the original order monthly; and For an initial physical therapy evaluation, on a one-time basis, per condition, when the requirements of this regulation are met. The Program does not reimburse for services: Performed by a physical therapy assistant when not under the direct supervision of the physical therapist; Performed by a physical therapy aide; or Not directly related to the treatment of breast and cervical cancer. The participating physical therapist is responsible for the following: Submitting to the Department, within 12 months of the date of service, a request for payment on the designated form; Certifying on the invoice that the treatment order is on file and was in effect at the time that services were rendered; and Specifying on the invoice the type of treatment provided. Reimbursement Principles. The Department shall reimburse the participating physical therapist: The current Medical Assistance approved rate in the State for a covered service performed in the provider’s office for an eligible patient who is uninsured or has insurance that does not provide coverage for the reimbursed procedure or service; The outstanding deductible and patient contribution for a covered service performed in the provider’s office for an eligible patient who has Medicare or other insurance that provides reimbursement for a covered procedure or service; and For covered services performed in the home of an eligible patient pursuant to Regulation .11F of this chapter. The Department may not reimburse the participating physical therapist for: Services rendered by mail or telephone; Completion of a form or report; A broken or missed appointment; or A service which is provided at no charge to the general public. The participating physical therapist shall obtain recovery pursuant to Regulation .17 of this chapter. The Program shall reimburse for claims submitted pursuant to this regulation as set forth in Regulation .21 of this chapter. To be considered a participating pharmacy in the Program, the provider shall: Obtain a permit from the Department pursuant to Health Occupations Article, Title 12, Annotated Code of Maryland; Agree to abide by the provisions set forth in this regulation by signing and sending to the Department the designated Departmental form; Agree to accept, as payment in full, the amount paid by the Program pursuant to §E of this regulation plus the amount paid by the eligible patient's health insurer, if applicable; Agree not to bill an eligible patient for an additional charge for the reimbursed pharmacy services provided; and Maintain adequate prescription and administrative records for a minimum of 5 years and, upon request, allow the Department access to the records. Reimbursed pharmacy services include but are not limited to the following: A prescription, when ordered and signed by a prescriber for an eligible patient, within the limits established by the Program which includes: A legend drug, including but not limited to the following drug classifications: Analgesic; Antidepressant; Antiemetic; Anti-infective; Antineoplastic agent; Benzodiazepine; Colony stimulating factor; Hormone; and Individual vitamin; and An especially formulated enteral or parenteral nutritional preparation required for a patient with a documented pathologic condition, when treatment is medically necessary and life sustaining; Hypodermic needle and syringe; Over-the-counter iron preparation; Durable medical equipment as specified in Regulation .10B of this chapter; and A disposable medical supply as specified in Regulation .10B of this chapter. Non-reimbursed pharmacy services include but are not limited to: An over-the-counter drug, excluding iron preparations; A legend drug for which federal finance participation is prohibited pursuant to 42 CFR §441.25; An experimental drug; and A drug not directly related to the diagnosis and treatment of breast or cervical cancer or a complication of treatment for breast or cervical cancer. The participating pharmacy responsibilities are as follows: Monitoring an eligible patient’s file for contraindications and toxicity; and Submitting a bill on the designated Departmental form for the reimbursed: Medication; Durable medical equipment; and Disposable medical supply. The Department shall reimburse the participating pharmacy: Pursuant to COMAR 10.09.03.07A—G, H(1)—(3), and (5)—(6); and For the deductible or patient contribution amount, or both. The participating pharmacy shall obtain recovery pursuant to COMAR 10.09.03.08. Periodic peer review may be performed by the Department or its designee. Except as provided in §I of this regulation, a drug manufacturer shall pay drug rebates to the Department for reimbursable pharmacy services in the same manner and amount that rebates are provided to the State for State-Only and Pharmacy Assistance recipients' purchases of drugs in accordance with §1927(c) of Title XIX of the Social Security Act (42 U.S.C. §1396r-8(c)) which is incorporated by reference. Limitations. The Department shall provide notice to a drug manufacturer who fails to provide adequate rebates in accordance with this chapter indicating that the manufacturer shall pay the drug rebate unless: The manufacturer submits a written request to the Secretary for a waiver of the rebate requirement; and The Secretary grants a waiver under §I(2) of this regulation. The Secretary shall grant a waiver to the requirement set forth in §H of this regulation only if the Secretary determines that the drug manufacturer has demonstrated that: The drug is a single source drug or an innovator multiple source drug; The Department has determined that the drug is essential to the health of the eligible patient; The drug has been given a rating of I-A by the Food and Drug Administration; and The physician has obtained the Department's authorization for use of the drug before prescribing the drug to the eligible patient. No manufacturer or its designee may dispute or request repayment of any rebate paid under §H of this regulation more than 3 years after the date the rebate was paid. Except when a manufacturer has been granted a waiver to the rebate requirement under §I of this regulation, the Program may not pay for a drug under this chapter if the manufacturer has not provided a rebate to the Program in accordance with §H of this regulation. To be considered a participating hospital in the Program, the provider shall: Be licensed as a hospital in Maryland or a jurisdiction bordering Maryland; Agree to abide by the provisions set forth in this regulation by signing and sending to the Department the designated Departmental form; Agree to accept, as payment in full, the amount paid by the Program pursuant to §E of this regulation; Agree not to bill an eligible patient for an additional charge for the reimbursed hospital services provided; and Maintain adequate records for a minimum of 5 years and, upon request, allow the Department access to the records. The participating hospital shall receive reimbursement for the following services: Medically necessary inpatient hospital service for the number of days, per admission, including preoperative days certified by the utilization control agent, which is: Necessary for the provision of diagnostic, curative, palliative, or rehabilitative treatment for breast cancer or cervical cancer; and Described in the eligible patient's medical record in sufficient detail to support the invoices submitted for services; and Medically necessary outpatient hospital service which is: Necessary for the provision of diagnostic, curative, palliative, or rehabilitative treatment for breast cancer or cervical cancer; and Described in the eligible patient's medical record in sufficient detail to support the invoices submitted for services. Limitations. The limitations on coverage of some hospital inpatient and outpatient services contained in COMAR 10.09.92.05 apply to this Program. Preauthorization Requirements. The following surgical procedures require preauthorization when performed on a hospital inpatient basis unless the patient is already a hospital inpatient for another condition, or an unrelated procedure is being done simultaneously which itself requires surgical hospitalization. If an emergency necessitates performing any of the listed procedures on an inpatient basis, the provider shall request and obtain post-authorization before billing. The procedures are: Biopsy; Breast biopsy if a two-stage procedure is planned for a possible malignancy; Colposcopy; Cryotherapy alone; Cryotherapy with biopsy or dilation and curettage, or both; Dilation and curettage; Excision of benign lesion; and Hysteroscopy. Authorization is required by the Program for all preoperative inpatient days. The participating hospital is responsible for: Submitting a bill for the reimbursed services provided on the designated Departmental form as follows: If an eligible patient is uninsured, or is insured but the insurance does not provide coverage for the reimbursed service, the participating hospital shall send the Department the bill for the service, with a denial from the patient’s insurance carrier, within 12 months of the date of discharge or outpatient service; or If an eligible patient is covered by Medicare or other insurance, the participating hospital shall bill: Medicare or the other insurance for the procedure or service; and The Department for the outstanding deductible and patient contribution amount; Documenting the sum collected from the eligible patient's insurer as a patient collection; and Submitting properly completed attachments with the bill as requested by the Department. Reimbursement Principles. The Program shall reimburse for a room and board charge for the day of admission, and may not reimburse for a room and board charge for the day of discharge from the participating hospital. The participating hospital may not collect a total payment, including the eligible patient's insurance and the Department's payment, which exceeds the provider's rate established by the Department or its designee. A participating hospital may not bill the Program a charge exceeding that charged the general public for a similar service. The Department may not reimburse the participating hospital for: Completion of a form or report; A broken or missed appointment; A professional service rendered by mail or telephone; or A service which is provided at no charge to the general public. The Department may not make direct payment to an eligible patient. Reimbursement Rates. A participating hospital located in Maryland shall be reimbursed by the Department: Pursuant to COMAR 10.09.92.07A(2)—(4) and B for an eligible patient who is uninsured or who has insurance that does not provide coverage for the reimbursed service; Pursuant to COMAR 10.09.92.07A(8) and (9) for an eligible patient who is covered by Medicare; or For an eligible patient who has insurance other than Medicare that provides coverage for the reimbursed service, the outstanding deductible and patient contribution amount required by the insurer. A participating hospital located in a state bordering Maryland shall be reimbursed by the Department: Pursuant to COMAR 10.09.92.07B for an eligible patient who is uninsured or who has insurance that does not provide coverage for the reimbursed service; Pursuant to COMAR 10.09.92.07A(8) and (9) for an eligible patient who is covered by Medicare; or For an eligible patient who has insurance other than Medicare that provides coverage for the reimbursed services, the outstanding deductible and patient contribution amount required by the insurer. A participating hospital located in the District of Columbia shall be reimbursed by the Department: Pursuant to COMAR 10.09.92.08A and B for an eligible patient who is uninsured or who has insurance that does not provide coverage for the reimbursed service; Pursuant to COMAR 10.09.92.07A(8) and (9) for an eligible patient who is covered by Medicare; or For an eligible patient who has insurance other than Medicare that provides coverage for the reimbursed services, the outstanding deductible, and patient contribution required by the insurer. The Program shall reimburse for claims submitted pursuant to this regulation as set forth in Regulation .21 of this chapter. To be considered a participating medical supply company in the Program, the provider of disposable medical supplies and durable medical equipment shall: To the extent required by law, be licensed and legally authorized to practice or deliver services in Maryland or a jurisdiction bordering Maryland; Agree to abide by the provisions set forth in this regulation by signing and sending to the Department the designated Departmental form; Agree to accept, as payment in full, the amount paid by the Department pursuant to §F of this regulation plus, if applicable, the amount paid by the eligible patient's health insurer and the patient contribution amount; Agree not to bill an eligible patient for an additional charge for the eligible disposable medical supplies and eligible durable medical equipment other than the patient contribution amount, excluding the deductible; and Maintain adequate records for a minimum of 6 years and, upon request, allow the Department access to the records. The Department shall reimburse for the following: Eligible disposable medical supplies, including but not limited to: Central catheter for administration of intravenous solutions; Administration set for intravenous medication; Parenteral feeding equipment, as follows: Administration set; Dravon clamp; Filter; and Injection cap; and Enteral feeding equipment, as follows: Adapter; Administration set; Feeding syringe; and Nasogastric tube; Eligible durable medical equipment for purchase or rental, including but not limited to: A delivery system comprised of a pump and pole assembly for an enteral or parenteral feeding; An individually form-fitted arm support stocking for a recipient prescribed by the participating physician as medically necessary, not to exceed two stockings at one time or three stockings in a 12-month period for a non-institutionalized individual; IV pole for use with parenteral administration of medication; External ambulatory infusion pump with administrative equipment, when the usual and customary mode of therapy has been tried and shown to be unsuccessful or impractical; Breast prosthesis, including surgical brassiere; and A wig when the following conditions are met: Hair loss is a direct result of the administration of chemotherapy or radiation for the treatment of breast or cervical cancer; The cost does not exceed $350; and The wig is prescribed by an oncologist. The Department may not reimburse for the following: A disposable medical supply which is not directly related to the diagnosis and treatment of breast cancer or cervical cancer; and Durable medical equipment as follows: Head covering; and An item not directly related to the diagnosis and treatment of breast cancer or cervical cancer. Preauthorization is required for the disposable medical supply and durable medical equipment pursuant to COMAR 10.09.12.06A—F and H. Reimbursement Procedures. The participating medical supply company: Shall submit the request for payment for the reimbursed service on the form designated by the Department within 12 months of the date of service as follows: If an eligible patient is uninsured, or is insured but the insurance does not provide coverage for the reimbursed service, the participating medical supply company shall send the Department the bill for the service, with a denial from the patient’s insurance carrier; or If an eligible patient is covered by Medicare or other insurance, the participating medical supply company shall bill: Medicare or the other insurance for the service; and The Department for the outstanding deductible, patient contribution amount, and if the insurer pays less than the current Medical Assistance approved rate for the service, the difference between the insurance reimbursement rate and the Medical Assistance approved rate in the State; May not bill the Program a charge exceeding the usual and customary charge to the general public for a similar item; and Shall bill the Program the usual and customary charge for the prosthetic device and an individually form-fitted arm support stocking including: Fitting; Dispensing; and Follow-up care. Reimbursement Procedures. The Department shall reimburse the participating medical supply company: Pursuant to COMAR 10.09.12.07F—K for an eligible patient who is uninsured or who has insurance that does not provide coverage for the reimbursed service; Pursuant to COMAR 10.09.12.07R and S for an eligible patient who is covered by Medicare; or The outstanding deductible and patient contribution amount required by the insurer for an eligible patient who has insurance, other than Medicare, that provides coverage for the reimbursed service. The Department may not reimburse for: Completion of a form; A broken or missed appointment; A professional service rendered by mail or telephone; or A service rendered to the general public at no charge. The Program shall reimburse for claims submitted pursuant to this regulation as set forth in Regulation .21 of this chapter. To be considered a participating home health services provider in the Program, the provider of home health services shall: Be a home health services provider licensed in Maryland or a jurisdiction bordering Maryland; Agree to abide by the provisions set forth in this regulation and apply for participation in the Program by signing and sending to the Department the designated Departmental form; Comply with COMAR 10.09.04.03A, B(2),(3), C(4), and D, if offering skilled nursing care; Accept, as payment in full for covered services rendered, the amount paid by the Program pursuant to §D of this regulation plus, if applicable, the amount paid by the eligible patient's health insurer and the patient contribution amount, and agree not to bill an eligible patient an additional charge for the covered services; and Maintain the patient care, medical supply, billing, and the patient contribution amount records for a minimum of 6 years and, upon request, allow the Department access to the records. The Program shall reimburse for a service listed in §C of this regulation when the service is: Provided upon the written order of the participating physician and furnished under the current plan of treatment; Rendered to an eligible patient who is certified by the participating physician as homebound; Consistent with the current diagnosis and treatment of the patient condition; In accordance with accepted standards of practice; Required by the medical condition rather than the convenience or preference of the patient; Considered under accepted standards of practice to be a specific and effective treatment for the condition; Required on a part-time, intermittent basis; Rendered in the home of the eligible patient by a participating home health services provider; Adequately described in the signed and dated progress note; and Directly related to the diagnosis and treatment of breast cancer or cervical cancer. The Program provides reimbursement for the following: Skilled nursing care provided by a licensed nurse when the complexity of the service requires the judgment, knowledge, and skill of a licensed nurse; Physical therapy, provided by a licensed physical therapist as specified in Regulation .07 of this chapter; Occupational therapy provided by a licensed occupational therapist as specified in Regulation .14 of this chapter; Medical supplies and equipment as specified in Regulation .10B of this chapter; and Other supplies which are used during a reimbursed home health visit as part of the treatment ordered by the participating physician. The Program does not reimburse for services: Not directly related to the treatment of breast and cervical cancer; and Pursuant to COMAR 10.09.04.05A, B, D, G, N, and P; Rendered by Home Health Aides; and Rendered by social workers. The participating home health services provider is responsible for: Submitting a bill for the reimbursed service provided on the form designated by the Department within 12 months of the date of service, as follows: If an eligible patient is uninsured or is insured, but the insurance does not provide coverage for a reimbursed service, the participating home health services provider shall send the Department the bill for the service; or If an eligible patient is covered by Medicare or other insurance, the participating home health services provider shall bill: Medicare or the other insurance for the procedure or service; and The Department for the outstanding deductible and patient contribution amount; and Not billing the Department under this Program a charge in excess of that charged the general public for a similar service or for a service rendered at no charge to the general public. Reimbursement Rates. A non-hospital-based participating home health services provider located in Maryland, or a participating home health services provider located in a jurisdiction bordering Maryland shall be reimbursed by the Department: Pursuant to COMAR 10.09.04.07D for an eligible patient who is uninsured or who has insurance that does not provide coverage for the reimbursement service; and For the outstanding deductible and patient contribution amount, if applicable, for an eligible patient who is covered by Medicare or other insurance. The Program shall reimburse for claims submitted pursuant to this regulation as set forth in Regulation .21 of this chapter. To be considered a participating medical laboratory in the Program, the provider shall: Be in compliance with the applicable license requirements for a medical laboratory providing services for Maryland residents including, but not limited to: Requirements for Medicare certification; Compliance with the requirements pursuant to COMAR 10.10.03.01 if operating in Maryland; and Requirements for the Federal Clinical Laboratory Improvement Act of 1988, 42 U.S.C. §263a; Agree to accept as payment in full for the reimbursed service, the amount paid by the Program as specified in §E of this regulation plus, if applicable, the amount paid by the eligible patient's health insurer and the patient contribution amount; Agree not to bill an eligible patient for an additional charge for the medical laboratory services provided; Abide by the provisions set forth in this regulation by signing and sending to the Department the designated Departmental form; Place no restriction on the eligible patient's right to select a provider; and Maintain records adequate to substantiate the ordering, performance, and reporting of laboratory procedures performed or referred for a minimum of 6 years, and, upon request, allow the Department access to the records. A reimbursed service includes but is not limited to the following: Preparation, analysis, and interpretation of a cervical biopsy, endometrial biopsy, vaginal biopsy, and breast biopsy; and A laboratory procedure or service related to the diagnosis and treatment of breast cancer, cervical cancer, or a precancerous cervical lesion. A non-reimbursed service includes but is not limited to the following: A laboratory service not directly related to the diagnosis and treatment of breast cancer, cervical cancer, or a precancerous cervical lesion; A service for which there does not exist an order signed by a participating health care provider; A procedure for which the laboratory has not been certified by Medicare; A service not provided according to the laws and regulations of the jurisdiction in which the service is rendered; A procedure that is investigational or experimental in nature; and A service included and paid for by the Program as part of the total charge submitted by an inpatient facility or hospital outpatient department. Reimbursement Procedures. The participating medical laboratory is responsible for: Submitting a bill for the reimbursed service provided on the form designated by the Department within 12 months of the date of service as follows: If an eligible patient is uninsured or has insurance that does not provide coverage for the reimbursed service, the participating medical laboratory shall send the bill to the Department; or If an eligible patient is covered by Medicare or other insurance, the participating medical laboratory shall bill: Medicare or the other insurance for the service; and The Department for the outstanding deductible and patient contribution amount; and Keeping in the records, for each invoice, a copy of the signed orders from a participating health care provider requesting the service. Payment Procedures. The Department shall pay the participating medical laboratory for a reimbursed service: Pursuant to COMAR 10.09.09.07E for an eligible patient who is uninsured or has insurance that does not provide coverage for the reimbursed service; or Pursuant to COMAR 10.09.09.07F and G(1) and 100 percent of co-insurance for an approved procedure for an eligible patient who is covered by Medicare. The Department may not reimburse for: Completion of a form or report; A broken or missed appointment; and A service which is normally provided at no charge. The Program shall reimburse for claims pursuant to this regulation as set forth in Regulation .21 of this chapter. To be considered a participating freestanding ambulatory surgical center in the Program, the provider shall: Be Medicare certified to provide ambulatory surgical services in Maryland or a jurisdiction bordering Maryland; Comply with COMAR 10.09.42.02 and .03B; Agree to abide by the provisions set forth in this regulation by signing and sending to the Department the designated Departmental form; Agree to accept, as payment in full for the reimbursed service, the amount paid by the Program as specified in §E of this regulation plus, if applicable, the amount paid by the eligible patient's health insurer and the patient contribution amount; Agree not to bill an eligible patient, who is either uninsured or who is insured with Medicare only, for the reimbursed service; Agree not to bill an eligible patient, who has insurance coverage other than Medicare only, for an additional charge for the reimbursed service other than the patient contribution amount; Maintain adequate records for a minimum of 6 years and, upon request, allow the Department access to the records; and Agree to the medical requirements of the Program pursuant to Regulation .04A(8)—(10) of this chapter. The Program shall reimburse a participating freestanding ambulatory surgical center for a service when the service: Complies with COMAR 10.09.42.04; and Is directly related to the diagnosis and treatment of breast cancer, cervical cancer, or a precancerous cervical lesion including, but not limited to, the following: Breast biopsy; Conization; Dilation and curettage; Laser treatment; Mastotomy; and Simple or partial mastectomy excluding modified radical mastectomy and radical mastectomy. The Program does not reimburse for the following: A service that is not directly related to the diagnosis and treatment of breast cancer, cervical cancer, or a precancerous cervical lesion; and A service or procedure pursuant to COMAR 10.09.42.05. A participating freestanding ambulatory surgical center shall: Accept and perform the responsibilities pursuant to Regulation .04E(1)—(7) and (9) of this chapter; and Submit a bill for the reimbursed service provided for an eligible patient on the form designated by the Department within 12 months of the date of service as follows: If an eligible patient is uninsured or has insurance that does not provide coverage for the reimbursed service, the participating freestanding ambulatory surgical center shall send the bill to the Department; or If an eligible patient is covered by Medicare or other insurance, the participating freestanding ambulatory surgical center shall bill: Medicare or the other insurance the composite rate for the service or procedure performed; and The Department for the outstanding deductible and patient contribution amount. The Department shall pay the participating freestanding ambulatory surgical center for a reimbursed service: Pursuant to COMAR 10.09.42.06A, B, D, and E for an eligible patient who is uninsured or has insurance that does not provide coverage for the reimbursed service; Pursuant to COMAR 10.09.42.06F for an eligible patient who is covered by Medicare; or The outstanding deductible and patient contribution amount required by the insurer for an eligible patient who has insurance, other than Medicare, that provides coverage for the reimbursed service. The Program shall reimburse for claims submitted pursuant to this regulation as set forth in Regulation .21 of this chapter. To be considered a participating occupational therapist in the Program, the provider shall: Be an occupational therapist licensed to practice occupational therapy in Maryland or a jurisdiction bordering Maryland; Agree to abide by the provisions set forth in this regulation by signing and sending to the Department the designated departmental form; Follow standard health and safety procedures to protect an eligible patient from potential hazards; Agree to requirements of the Program set forth in Regulation .04A(5), (9), and (10) of this chapter; Agree to accept as payment in full the amount paid by the Program under §E of this regulation, plus the amount paid by the eligible patient's health insurer, if applicable; and Agree not to bill an eligible patient an additional charge for the service. The cost of an occupational therapist’s services are covered as set forth in COMAR 10.09.04.04B(4). The Program does not reimburse for services: Performed by an occupational therapy assistant if not under the direct supervision of a licensed occupational therapist; Performed by an occupational therapy aide; or Not directly related to the treatment of breast or cervical cancer. The participating occupational therapist is responsible for the following: Submitting to the Department, within 12 months of the date of service, a request for payment on the designated form; Certifying on the invoice that a treatment order is on file and was in effect at the time services were rendered; and Specifying on the invoice the type of treatment provided. Reimbursement Principles. The Department shall reimburse the participating occupational therapist: For a covered service performed in the provider’s office the amount of: The current Medical Assistance approved rate for the State for an eligible patient who is uninsured or has insurance that does not provide coverage for the reimbursed procedure or service; or The outstanding deductible and patient contribution for an eligible patient who is covered by Medicare or other insurance; and For covered services performed in the home of an eligible patient under Regulation .11F of this chapter. The Department may not reimburse the participating occupational therapist for: Services rendered by mail or telephone; Completion of a form or report; A broken or missed appointment; or A service which is provided at no charge to the general public. The participating occupational therapist shall obtain recovery under Regulation .17 of this chapter. The Program shall reimburse for claims submitted pursuant to this regulation as set forth in Regulation .21 of this chapter. A participating health care provider eligible to receive a medical management fee may be one of the following: Anesthesiologist; Certified nurse midwife; Family practitioner; Gynecologist; Medical internist; Medical oncologist; Nurse anesthetist; Nurse practitioner; Pathologist; Physician assistant; Radiation oncologist; Radiologist; Surgeon; and Participating health care provider who renders services pursuant to §B of this regulation. The Department shall reimburse a participating health care provider as outlined in §A of this regulation a medical management fee of $50 each time a reimbursed service: Is in compliance with the medical guidelines pursuant to Regulation .04A(7)(a)—(f) of this chapter; Involves a consult with an oncologist pursuant to Regulation .04A(7)(g) and (h) of this chapter; Is in compliance with the medical care management guidelines pursuant to Regulation .04A(6) of this chapter; or Is billed with the medical management fee for reporting and includes a copy of the relevant medical report including, but not limited to: Radiology; Biopsy; Operative; or Staging. The Program shall reimburse for claims pursuant to this regulation as set forth in Regulation .21 of this chapter. The Department is responsible for the following: Developing the necessary administrative forms needed for the Program including, but not limited to, a: Standard application form to determine eligibility of patients; Release of patient information form; and Participating health care provider agreement form; Distributing the administrative forms to the following: Freestanding ambulatory surgical center; Home health services provider; Certified nurse midwife; Hospital; Occupational therapist; Local health department; Medical laboratory; Medical supply company; Nurse anesthetist; Nurse practitioner; Pharmacy; Physical therapist; Physician assistant; Physician provider; and Other appropriate health care providers; Providing upon request a list of participating health care providers to local health department coordinators and health care providers for referral of eligible patients; Updating the list of participating health care providers not less than once a year; Reviewing and reimbursing a bill submitted by a participating physician for the reimbursed medical procedure and service using the payment guidelines specified in Regulations .04E(5) and .15 of this chapter; Reviewing and reimbursing a bill submitted by a participating physician assistant using the payment guidelines specified in Regulations .04-1 and .15 of this chapter; Reviewing and reimbursing a bill submitted by a participating certified nurse midwife using the payment guidelines specified in Regulations .04-2 and .15 of this chapter; Reviewing and reimbursing a bill submitted by a participating nurse practitioner using the payment guidelines specified in Regulations .05 and .15 of this chapter; Reviewing and reimbursing a bill submitted by a participating nurse anesthetist using the payment guidelines specified in Regulations .06 and .15 of this chapter; Reviewing and reimbursing a bill submitted by a participating physical therapist using the payment guidelines specified in Regulation .07 of this chapter; Developing a list of reimbursed medications and pharmacy services; Updating the medication and pharmacy service list at least annually; Developing and providing information to the pharmacy; Reviewing and paying a bill submitted by a participating pharmacy for reimbursed medication, pharmacy service, durable medical equipment, and disposable medical supplies according to Regulation .08E of this chapter; Reviewing and paying a disposable medical supply and durable medical equipment bill and the required deductible, if applicable, according to Regulation .10 of this chapter; Receiving the application for an eligible patient from the local health department, hospital, or health care provider; Developing and issuing to an eligible patient a letter identifying the patient as a participant in the Program; Reviewing and reimbursing a bill submitted by a participating home health services provider using the payment guidelines specified in Regulation .11 of this chapter; Reviewing and reimbursing a bill submitted by a participating medical laboratory using the payment guidelines specified in Regulation .12 of this chapter; Reviewing and reimbursing a bill submitted by a participating freestanding ambulatory surgical center using the payment guidelines specified in Regulation .13 of this chapter; Reviewing and reimbursing a bill submitted by an occupational therapist using the payment guidelines specified in Regulation .14 of this chapter; Reviewing and reimbursing in accordance with Regulation .22 of this chapter a bill submitted by: MHIP or an insurer under contract with MHIP; or A participating health care provider; and Ensuring compliance with the applicable regulations within this chapter by performing a periodic review of the records of a: Hospital; and Participating health care provider. The local health department, hospital, and a health care provider who refers a patient to the Program, are responsible for the following: Identifying potentially eligible patients; Assisting the applicant in completing the application form; Collecting the completed application form; Collecting verifying documentation from the applicant, including, but not limited to, proof of residency; Determining eligibility of the applicant using the general, medical, health insurance, and financial criteria specified in Regulation .03 of this chapter; Assisting an eligible patient in selecting a participating health care provider and assisting in scheduling an appointment with the participating health care provider for the reimbursed medical procedure or service; Having an eligible patient sign a release of information form; Providing an eligible patient with a copy of a temporary referral letter, identifying the patient as a participant in the Program, to be given to the participating health care provider until the card is issued to the eligible patient by the Department; Sending the original application with verifying information to the Department; and Evaluating patient progress through follow-up contact with the patient and the participating health care provider. If an additional diagnostic or treatment procedure is necessary, the local health department, hospital, or health care provider who determines patient eligibility and refers an eligible patient to the Program shall repeat the procedure as set forth in §B(6) of this regulation. The local health department, hospital, or other health care provider who determines patient eligibility and refers an eligible patient to the Program shall document in the patient’s medical record the result of the reimbursed diagnostic and treatment procedure performed. The Department shall reimburse a participating health care provider only for a medical service or procedure related to the diagnosis and treatment of breast cancer, cervical cancer, or a precancerous cervical lesion for an eligible patient. The Department shall reimburse a participating health care provider a medical management fee pursuant to Regulation .15 of this chapter. The participating health care provider shall reimburse the Department for an overpayment. Insurance or Other Coverage. If the patient has insurance or other coverage, the participating health care provider shall first seek payment from that source. The provider shall submit a copy of the insurance carrier’s notice or remittance advice with the invoice. If the insurance carrier provides coverage for a reimbursable procedure or service, the Department shall pay the deductible and patient contribution amount. If an insurance carrier rejects the claim or pays less than the amount of the allowed Medical Assistance Program rate, the provider may submit a claim to the Department. The Department shall pay the difference between what was paid by the insurance carrier and the maximum allowable Medical Assistance Program rate. If payment is made by both the Department and the insurance carrier or other source for the same service, the provider shall refund to the Department within 60 days of receipt the amount paid by the Department, or the Department may recoup those funds. The Department may not make a direct payment to the eligible patient. Responsibility for liability for services provided, and for the availability of appropriate insurance coverage, rests with the participating health care provider. If the Department determines that a participating health care provider has failed to comply with the applicable regulations of this chapter, the Department may terminate the written agreement with the provider by giving 30 days notice in writing to the participating health care provider. The participating health care provider may terminate the provider agreement with the Department by: Giving 30 days notice in writing to the Department; and Notifying eligible patients, for whom services have not been provided, of the provider's withdrawal from the Program. A provider filing an appeal of the Department’s decision to terminate the provider’s agreement with the Program shall do so according to State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland. A provider shall file an appeal within 30 days of receipt of written notice of termination. The Program may not reimburse claims received for payment more than 12 months after the date of service except as specified in §§B—D of this regulation. To obtain reimbursement from the Program, a health care provider that originally submits a claim to Medicare or another health insurer shall also submit the claim to the Program within a period whereby the Program receives the claim within the latter of: 12 months after the date of service; or 6 months from the Medicare or other health insurer remittance date as shown on the explanation of benefits. The Program shall pay a claim that is originally rejected for payment due to improper completion or incomplete information only if: The health care provider properly completes and resubmits the claim to the Program; and The Program receives the resubmitted claim within the latter of: The original 12 month period from the date of service; or 6 months after claim rejection. When the Program initially rejects a claim for payment in error, the Program shall pay the claim if the participating health care provider resubmits the claim and the resubmitted claim is received by the Program within the same period specified in §C of this regulation. In lieu of providing direct reimbursement to participating health care providers, the Program may pay MHIP, if available, to provide health coverage for individuals enrolled in the Program who are also eligible for MHIP. The Program may pay MHIP, if available, for health coverage for eligible patients, including: MHIP premiums; Pre-existing condition buy-downs; and Any MHIP fees. The Program may not pay any amount to MHIP, if available, for an eligible patient’s spouse, children, or other family members enrolled in MHIP. Fees Reimbursable to Participating Providers. The Program may reimburse participating health care providers for a bill the provider submits to the Department for patient contribution amounts and deductibles for services directly related to the treatment of breast and cervical cancer for individuals enrolled in MHIP through the Program, if funding is available for the payment of patient contribution amounts and deductibles under this section. The Program's decision regarding whether to pay for patient contribution amounts and deductibles shall be based solely on the availability of funding and may not be contingent upon any other factor. If MHIP does not provide coverage for a service covered by this chapter, the Program shall reimburse the participating health care provider as otherwise provided by this chapter. To obtain reimbursement, the participating health care provider shall submit to the Program: The bill for the service on the form designated by the Department; and A copy of the explanation of benefits or denial from MHIP. Payment to MHIP. The Department shall submit timely payments to MHIP for premiums, pre-existing condition buy-downs, and any MHIP fees for individuals enrolled in MHIP through the Program. The Department shall work with the designated MHIP staff to assure timely payments of MHIP invoices for individuals enrolled in MHIP through the Program to: Preserve MHIP coverage; and Resolve any existing issues related to the payment of MHIP premiums. Payment under this chapter is contingent on the availability of funds in accordance with State Finance and Procurement Article, §§7-234 and 7-235, Annotated Code of Maryland. Health-General Article, §§2-102, 2-104, and 2-105, Annotated Code of Maryland Effective date: Regulations .01—.12 under new Chapter, Reimbursement for Breast and Cervical Cancer Diagnosis and Treatment, adopted as an emergency provision effective March 31, 1993 (20:8 Md. R. 715); Regulations .03 and .10 amended as an emergency provision effective May 24, 1993 (20:12 Md. R. 995); amendments to Regulation .10 expired June 30, 1993; adopted permanently effective September 13, 1993 (20:18 Md. R. 1430) Regulations .01—.12 repealed and new Regulations .01—.20 adopted effective December 5, 1994 (21:24 Md. R. 1988) Chapter revised effective October 14, 2002 (29:20 Md. R. 1588) Regulation .02B amended as an emergency provision effective August 1, 2006 (33:21 Md. R. 1672); emergency status extended at 34:4 Md. R. 396; emergency status expired May 1, 2007; amended permanently effective May 7, 2007 (34:9 Md. R. 825) Regulation .03 amended effective April 21, 2008 (35:8 Md. R. 805) Regulation .03A amended as an emergency provision effective August 1, 2006 (33:21 Md. R. 1672); emergency status extended at 34:4 Md. R. 396; emergency status expired May 1, 2007; amended permanently effective May 7, 2007 (34:9 Md. R. 825) Regulation .03A amended effective January 26, 2009 (36:2 Md. R. 100) Regulation .08H, I adopted as an emergency provision effective August 1, 2006 (33:21 Md. R. 1672); emergency status extended at 34:4 Md. R. 396; emergency status expired May 1, 2007; adopted permanently effective May 7, 2007 (34:9 Md. R. 825) Regulation .08J adopted effective May 7, 2007 (34:9 Md. R. 825) Chapter revised as an emergency provision effective January 1, 2010 (37:6 Md. R. 474); revised permanently effective April 19, 2010 (37:8 Md. R. 616) Regulation .01B amended effective April 13, 2015 (42:7 Md. R. 569); May 18, 2020 (47:10 Md. R. 517) Regulation .02B amended as an emergency provision effective January 1, 2014 (41:2 Md. R. 88); amended permanently effective May 12, 2014 (41:9 Md. R. 521) Regulation .02B amended effective April 13, 2015 (42:7 Md. R. 569); May 18, 2020 (47:10 Md. R. 517) Regulation .03A, G amended effective May 18, 2020 (47:10 Md. R. 517) Regulation .03B, E amended effective April 13, 2015 (42:7 Md. R. 569) Regulation .03C, G amended as an emergency provision effective January 1, 2014 (41:2 Md. R. 88); amended permanently effective May 12, 2014 (41:9 Md. R. 521) Regulation .04 amended effective April 13, 2015 (42:7 Md. R. 569) Regulation .04A amended effective July 2, 2018 (45:13 Md. R. 666) Regulation .04A, E amended as an emergency provision effective January 1, 2014 (41:2 Md. R. 88); amended permanently effective May 12, 2014 (41:9 Md. R. 521); May 18, 2020 (47:10 Md. R. 517) Regulation .04-1 adopted effective May 18, 2020 (47:10 Md. R. 517) Regulation .04-2 adopted effective May 18, 2020 (47:10 Md. R. 517) Regulation .05A amended effective August 20, 2012 (39:16 Md. R. 1080); July 2, 2018 (45:13 Md. R. 666) Regulation .05A, B amended effective May 18, 2020 (47:10 Md. R. 517) Regulation .05A, D amended effective April 13, 2015 (42:7 Md. R. 569) Regulation .06A amended effective July 2, 2018 (45:13 Md. R. 666) Regulation .06A, B amended effective May 18, 2020 (47:10 Md. R. 517) Regulation .06A, D amended effective April 13, 2015 (42:7 Md. R. 569) Regulation .07 amended effective April 13, 2015 (42:7 Md. R. 569) Regulation .07A amended effective May 18, 2020 (47:10 Md. R. 517) Regulation .07F amended as an emergency provision effective January 1, 2014 (41:2 Md. R. 88); amended permanently effective May 12, 2014 (41:9 Md. R. 521) Regulation .08 amended as an emergency provision effective January 1, 2014 (41:2 Md. R. 88); amended permanently effective May 12, 2014 (41:9 Md. R. 521) Regulation .08 amended effective April 13, 2015 (42:7 Md. R. 569) Regulation .09 amended effective April 13, 2015 (42:7 Md. R. 569) Regulation .09C, G amended effective May 18, 2020 (47:10 Md. R. 517) Regulation .09E, G amended as an emergency provision effective January 1, 2014 (41:2 Md. R. 88); amended permanently effective May 12, 2014 (41:9 Md. R. 521) Regulation .10 amended effective April 13, 2015 (42:7 Md. R. 569) Regulation .10B amended effective May 18, 2020 (47:10 Md. R. 517) Regulation .10E, F amended as an emergency provision effective January 1, 2014 (41:2 Md. R. 88); amended permanently effective May 12, 2014 (41:9 Md. R. 521) Regulation .11 amended effective April 13, 2015 (42:7 Md. R. 569) Regulation .11E, F amended as an emergency provision effective January 1, 2014 (41:2 Md. R. 88); amended permanently effective May 12, 2014 (41:9 Md. R. 521) Regulation .12 amended effective April 13, 2015 (42:7 Md. R. 569) Regulation .12C, D amended effective May 18, 2020 (47:10 Md. R. 517) Regulation .12D, E amended as an emergency provision effective January 1, 2014 (41:2 Md. R. 88); amended permanently effective May 12, 2014 (41:9 Md. R. 521) Regulation .13A, E amended effective April 13, 2015 (42:7 Md. R. 569); May 18, 2020 (47:10 Md. R. 517) Regulation .13D, E amended as an emergency provision effective January 1, 2014 (41:2 Md. R. 88); amended permanently effective May 12, 2014 (41:9 Md. R. 521) Regulation .14 amended effective April 13, 2015 (42:7 Md. R. 569) Regulation .14A, B amended effective May 18, 2020 (47:10 Md. R. 517) Regulation .14E amended as an emergency provision effective January 1, 2014 (41:2 Md. R. 88); amended permanently effective May 12, 2014 (41:9 Md. R. 521) Regulation .15A, B amended effective May 18, 2020 (47:10 Md. R. 517) Regulation .15B amended effective April 13, 2015 (42:7 Md. R. 569) Regulation .16 amended effective May 18, 2020 (47:10 Md. R. 517) Regulation .17 amended effective May 18, 2020 (47:10 Md. R. 517) Regulation .17D amended effective April 13, 2015 (42:7 Md. R. 569) Regulation .18 amended effective May 18, 2020 (47:10 Md. R. 517) Regulation .19A, B amended effective May 18, 2020 (47:10 Md. R. 517) Regulation .20A amended effective May 18, 2020 (47:10 Md. R. 517) Regulation .21 amended effective May 18, 2020 (47:10 Md. R. 517) Regulation .22 amended as an emergency provision effective January 1, 2014 (41:2 Md. R. 88); amended permanently effective May 12, 2014 (41:9 Md. R. 521) Regulation .22A, D amended effective May 18, 2020 (47:10 Md. R. 517)