This chapter establishes a cancer registry within the Department, defines key terms, details the information to be contained in a cancer report, and specifies requirements of reporting facilities, nursing facilities, assisted living programs, and general hospice care programs. In addition, this chapter identifies requestors authorized to receive confidential data, allows a fee to be charged for data reports, and incorporates by reference the Maryland Cancer Registry Data Use Manual and Procedures (July 2016). In this chapter, the following terms have the meanings indicated. Terms Defined. “Assisted living program” has the meaning stated in COMAR 10.07.14.02B. “Cancer registry” means a computerized system to register all cases of reportable human cancer or reportable human central nervous system (CNS) tumors of Maryland residents and nonresidents diagnosed or treated in Maryland. “Cancer report” means a one-time abstract from one or more of the following documents maintained by a reporting facility, nursing facility, assisted living program, or general hospice care program of each new case of reportable human cancer or CNS tumor diagnosed or treated, and any other case of reportable human cancer or CNS tumor initially diagnosed or treated for time periods as designated by the Secretary: Medical record; Pathology report; and Radiological report. Case of a Reportable Human CNS Tumor. “Case of a reportable human CNS tumor” means an identified human tumor, irrespective of histologic type or behavior, occurring as a primary tumor in any of the following sites or subsites with International Classification of Diseases for Oncology, Third Edition (ICD-O-3) topography codes C70.0 — C72.9 and C75.1 — C75.3: The brain; The meninges; The spinal cord; The cauda equina; A cranial nerve; The pituitary gland; The pineal gland; or The craniopharyngeal duct. “Case of a reportable human CNS tumor” includes all benign and uncertain behavior tumors of the CNS (ICD-10-CM Codes D18.02, D32.0 — D33.9, D35.2 — D35.4, D42.0 — D43.9, D44.3 — D44.5, Q85.00 — Q85.09 and D49.6, and all tumors of the CNS of benign and uncertain behavior with ICD-O-3 codes of “0” or “1”), which includes codes from: The International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM); and The International Classification of Diseases for Oncology, Third Edition (ICD-O-3). “Case of reportable human cancer” means the identification of a human cancer from the following list, which includes codes from the International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) and the International Classification of Diseases for Oncology, Third Edition (ICD-O-3): All malignant neoplasms with ICD-10-CM Codes C00 — C43.9, C44.00, C44.09, C44.10_, C44.19_, C44.20_, C44.29_, C44.30_, C44.39_, C44.40, C44.49, C44.50_, C44.59_, C44.60_, C44.69_, C44.70_, C44.79_, C44.80, C44.89, C44.90, C44.99, C45._ — C96._, or with ICD-O-3 behavior code of “3”, including genital skin cancer of the vagina, clitoris, vulva, prepuce, penis, and scrotum and excluding other sites of skin cancer with ICD-O-3 topography codes C44.0 — C44.9 with one of the following ICD-O-3 histologies: M-8000 — 8005 Neoplasms, malignant, not otherwise specified of skin; M-8010 — 8046 Epithelial carcinomas of skin; M-8050 — 8084 Papillary and squamous cell carcinomas of skin (C44.02, C44.12_, C44.22_, C44.32_, C44.42, C44.52_, C44.62_, C44.72_, C44.82, C44.92); or M-8090 — 8110 Basal cell carcinomas (C44.01, C44.11_, C44.21_, C44.31_, C44.41, C44.51_, C44.61_, C44.71_, C44.81, C44.91); All malignant neoplasms with the following ICD-10-CM codes where ICD-O-3 behavior is “3” and ICD-O-3 histologies are reported except as follows: If there is evidence of multiple foci, lymph node involvement, or metastasis, C37 — Thymoma (M-8580); C7A.020 — Malignant carcinoid tumor of the appendix (M-8240); C54.1 — Endometrial stroma, low grade (M-8931); If there is evidence of multiple foci, lymph node involvement, or metastasis, D48.1 — Stromal Tumor of the digestive system (GIST 8639); D48.60 — Phylloides tumor (M-9020); D45 — Polycythema (M-9950); D47.Z9 — Plasmacytoma (M-9731, M-9734); D47.3 — Essential thrombocythemia (M-9962), D46.0, D46.1, D46.20, D46.21, D46A, D46B — Low grade myelodysplastic syndrome lesions (M-9980), D46.22 — High grade myelodysplastic syndrome lesions (M-9983), D46.C — Myelodysplastic syndrome with 5q deletion (M-9986), D469 — Myelodysplastic syndrome, unspecified (M-9975), D47.1 — Myelofibrosis with myeloid metaplasia (primary myelofibrosis) (M-9961), D47.Z1 — post-transplant lymphoproliferative disorder (M-9989), C94.40, C94.41, C94.42, D47.9, D47.Z9 — lympho and myeloproliferative disease (M-9960, M-9970); C88.2 — Alpha and gamma heavy chain disease (M-9762) or Franklin disease (M-9763); C88.0 — Waldenstrom macroglobulinemia (M-9761); D46.4 — Refractory anemia (M-9980); or D46.1 — Refractory anemia with ringed sideroblasts (M-9982), refractory anemia with excess blasts (M-9983), or refractory anemia with excess blasts in transformation (M-9984); All cases of carcinoma in situ with ICD-10-CM Codes D00._ — D09.9, D47.Z2, D49.511 — D49.519, D49.59, D78.31 — D78.34, and D89.40 — D89.49, or with ICD-O-3 behavior code of “2”, including genital skin cancers of the vagina, clitoris, vulva, prepuce, penis, and scrotum and excluding other skin cancers with ICD-O-3 topography codes C44.0_ — C44.9_ with one of the following ICD-O-3 histologies: M-8000 — 8005 Neoplasms, malignant, not otherwise specified of skin; M-8010 — 8046 Epithelial carcinomas of skin; M-8050 — 8084 Papillary and squamous cell carcinomas of skin; and M-8090 — 8110 Basal cell carcinomas; or All cases of intraepithelial neoplasia with ICD-O-3 histology code of M-8077/2: Including squamous intraepithelial neoplasia of the larynx (LIN), vagina (VAIN), vulva (VIN), and anus (AIN) (ICD-10-CM codes D02.0, D07.2, D07.1, and D01.3; and ICD-O-3 topography codes C52, C51, and C21._); and Excluding squamous intraepithelial neoplasia of the cervix (CIN III) and glandular intraepithelial neoplasia of the prostate (PIN) (ICD-10-CM codes D06._ and D07.5; and ICD-O-3 topography codes C53 and C61.9). “Computerized file” means an electronic data file using software approved for use by the Secretary, containing complete cancer report information transferable to a master electronic database system maintained by the Department. “Department” means the Maryland Department of Health or a designee. “Freestanding ambulatory care facility” has the meaning stated in Health-General Article, §19-3B-01, Annotated Code of Maryland. “Freestanding laboratory” means a facility, place, establishment, or institution which performs a laboratory examination for a person, authorized by law to request the examination, in connection with the diagnosis of a reportable human cancer or CNS tumor, and is licensed by the State pursuant to COMAR 10.10.03, and: Not under the administrative control of a hospital; or Under the administrative control of a hospital for a diagnosis of reportable human cancer or CNS tumor of a nonhospitalized patient. “General hospice care program” has the meaning stated in COMAR 10.07.21.02. “Hospital” means a facility which is licensed by the State pursuant to COMAR 10.07.01. “Maryland Cancer Registry Data Use Manual and Procedures” means the document that describes the Maryland cancer registry procedures for release of cancer data and that outlines the procedures to obtain both non-confidential aggregate data and confidential individual-level data. “Nursing facility” has the meaning stated in COMAR 10.07.02.01B. “Physician” means an individual who: Practices medicine, as defined in Health Occupations Article, §14-101, Annotated Code of Maryland; and Diagnoses or treats a case of reportable human cancer or a reportable human CNS tumor at a practice located in Maryland. “Reporting facility” means any of the following: A hospital, freestanding laboratory, freestanding ambulatory care facility, or therapeutic radiological center; or A physician who has care of or has diagnosed a case of reportable human cancer or reportable human CNS tumor for a nonhospitalized patient not otherwise reported. “Secretary” means the Secretary of Health or a designee of the Secretary. “Therapeutic radiological center” means a facility or institution: Performing radiological treatment for a person authorized by law to request the treatment in connection with a reportable human cancer or a reportable human CNS tumor; and Licensed or registered by the State pursuant to COMAR 10.05.03 and not under the administrative control of a hospital. The Maryland Cancer Registry Data Use Manual and Procedures (Maryland Department of Health, July 2016) is incorporated by reference. There is a cancer registry established within the Department, whose purpose is to collect reportable human cancer data and reportable human CNS tumor data to further the cancer control goals of the State. The cancer control goals of the State are to reduce the incidence and mortality of reportable human cancer and reportable human CNS tumors and racial, ethnic, gender, age, and geographic disparities in reportable human cancer and CNS tumor incidence and mortality in Maryland, by: Advancing the understanding of reportable human cancer and reportable human CNS tumor demographics; Describing reportable human cancer and reportable human CNS tumor sources, causes, risk factors, preventive measures, diagnostic tests, screening tests, treatment, and survival; and Evaluating the cost, quality, efficacy, and appropriateness of diagnostic, therapeutic, rehabilitative, and preventive services and programs related to reportable human cancer and reportable human CNS tumors. Research that will further the cancer control goals of the State is research whose protocols have been reviewed by Department staff who have found that the research will: Advance scientific knowledge or advance knowledge of clinical practice related to cancer; Have approaches, aims, and methods that will allow the researcher to perform descriptive analyses or test hypotheses; Have one or more investigators who have training and experience with the approaches and methods; and Be conducted in a scientific environment likely to contribute to the success of the research. A cancer report shall contain the following information, using the standard nomenclature contained in the North American Association of Central Cancer Registries' Standards for Cancer Registries, Volume II, Data Standards and Data Dictionary: Reasonably obtained patient demographic information, including risk factors; Information on the industrial or occupational history of an individual with cancer, to the extent such information is available; Relevant information on the: Initial diagnosis, including the date of the diagnosis; Initial treatment; Extent of the disease by the end of the first hospitalization; and Extent of the disease within 2 months of diagnosis, if the information is available to the reporting facility, nursing facility, assisted living program, or general hospice care program; Facility and other provider identification information; and Other requirements as considered necessary by the Secretary. A reporting facility shall submit a: Cancer report to the Secretary in a computerized file containing standard information required by the Secretary; Computerized file not less than quarterly; and Completed report of any new individual case of a reportable human cancer or reportable human CNS tumor not later than 6 months after diagnosis or treatment. A nursing facility, an assisted living program, or a general hospice care program shall submit a cancer report containing information that is under the control of the facility to the Secretary if the Secretary requests a cancer report on a patient who has been a resident of the nursing facility, assisted living program, or general hospice care program. Information obtained under this chapter is not a medical record under Health-General Article, §4-301, Annotated Code of Maryland, but is subject to the confidentiality requirements of Health-General Article, §§4-101 — 4-103, Annotated Code of Maryland. The Secretary may release confidential data to: An institution or individual researcher for medical, epidemiological, health care, or other cancer-related or CNS tumor-related research approved by the Secretary and the Department's Institutional Review Board (IRB) in order to further the cancer control goals of the State set forth in Regulation .04 of this chapter; A reporting facility which: Routinely submits information on cases of reportable human cancer or reportable human CNS tumors to the cancer registry; Has been formally accepted as a participant in the cancer registry system; and Requests data relating to patients reported by the facility; An out-of-State cancer registry or cancer control agency which requests routine data if the: Patient is a resident of the other state; and Other state has authority to provide equivalent information on Maryland residents to this State; Each county health officer and the Baltimore City Commissioner of Health; and Another governmental agency performing its lawful duties pursuant to State or federal law. The Secretary may release confidential information, subject to: A determination by the Secretary that a recipient of the information disclosed will maintain the confidentiality of the disclosed information; and An agreement signed by the Secretary and by the recipient of the confidential information that the recipient of the information will maintain the confidentiality of the disclosed information. The Secretary shall release confidential data to a requestor in response to a written request only, in accordance with Health-General Article, §§4-101 and 4-102, Annotated Code of Maryland. A reporting facility that in good faith submits a cancer report to the Secretary is not liable in any cause of action arising from the submission of the cancer report to the Secretary. The use or publication of any statistics, information, or other material that summarizes or refers to confidential records in the aggregate, without disclosing the identity of any person who is the subject of the confidential record is not subject to the provisions of Health-General Article, §4-102, Annotated Code of Maryland. The Secretary shall release cancer data in accordance with the procedures outlined in the Maryland Cancer Registry Data Use Manual and Procedures. To assure compliance by a reporting facility, nursing facility, assisted living program, or general hospice care program with Regulation .05 of this chapter, the Secretary may, upon advance notice, inspect a representative sample of medical records, pathology reports, or radiological reports maintained by the facility of cases of reportable human cancer and reportable human CNS tumors. The Secretary may charge a reasonable fee to cover the cost of providing data reports to appropriate requestors, as allowed by COMAR 10.01.08.04. All applicable fees shall be paid in full in advance of filling the request. After receiving all necessary information to support a request to release cancer registry data, the Secretary shall act in a timely manner and decide on the request with one of the following outcomes: Final approval; Interim approval, if the request has been accepted with one or more conditions which shall be met before final approval is granted; or Disapproval. The Secretary, in accordance with State Government Article, §2-1246, Annotated Code of Maryland, shall submit an annual report to the Governor and General Assembly on the activities of the cancer registry, including use of cancer registry data. Nothing in this chapter is intended to limit or otherwise restrict the Secretary from obtaining cancer report information on Maryland residents from sources located either inside or outside the State. Health-General Article, §§2-104, 18-104, 18-203 and 18-204, Annotated Code of Maryland; 42 U.S.C. §280(e) Effective date: September 28, 1992 (19:19 Md. R. 1707) Regulation .01 amended effective April 21, 1997 (24:8 Md. R. 616) Regulation .02B amended effective April 26, 1993 (20:8 Md. R. 723); April 21, 1997 (24:8 Md. R. 616); June 23, 2003 (30:12 Md. R. 788) Regulation .04 amended effective April 21, 1997 (24:8 Md. R. 616) Regulation .04C amended effective June 23, 2003 (30:12 Md. R. 788) Regulation .05B amended effective June 23, 2003 (30:12 Md. R. 788) Regulation .06B, D amended effective June 23, 2003 (30:12 Md. R. 788) Chapter revised effective March 22, 2010 (37:6 Md. R. 478) Regulation .01 amended effective January 13, 2011 (38:1 Md. R. 11); April 15, 2013 (40:7 Md. R. 611); February 27, 2017 (44:4 Md. R. 253) Regulation .02B amended effective January 13, 2011 (38:1 Md. R. 11); April 15, 2013 (40:7 Md. R. 611); February 27, 2017 (44:4 Md. R. 253) Regulation .02-1 adopted effective April 15, 2013 (40:7 Md. R. 611) Regulation .02-1 amended effective February 27, 2017 (44:4 Md. R. 253) Regulation .05C amended effective January 13, 2011 (38:1 Md. R. 11) Regulation .06B amended effective January 13, 2011 (38:1 Md. R. 11) Regulation .07G adopted effective April 15, 2013 (40:7 Md. R. 611) Regulation .07G amended effective February 27, 2017 (44:4 Md. R. 253) Regulation .08A amended effective January 13, 2011 (38:1 Md. R. 11) 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) The following terms have the meanings indicated. Terms Defined. “Department” means the Maryland Department of Health. “Diagnosis” means a histopathologic finding of breast cancer in a biopsy specimen. “Treating physician” means an individual authorized under the Medical Practice Act to practice medicine in Maryland who, in Maryland, treats a patient for breast cancer. The Department shall provide a standardized written summary in layman's language that: Lists effective methods of treating breast cancer that may be medically practicable including all types of surgical treatment and radiological, hormonal, and chemotherapeutic treatment and combinations of these treatments; and Describes the advantages, disadvantages, risks, and procedures associated with each method of treatment. The Department shall update the standardized written summary annually. The Department shall provide a statement indicating acknowledgement of receipt of the standardized written summary to be signed by the patient. The Department shall distribute copies of the standardized written summary and the acknowledgement of receipt statement to all hospitals, clinics, other facilities, and physicians' offices where treatment of breast cancer is performed. At any time before, but not more than 5 days after, a treating physician informs a patient of a diagnosis of breast cancer, and before treatment, the treating physician shall give the patient: The standardized written summary provided by the Department; or An equivalent summary including the requirements under Regulation .02A written in language that the patient understands. A treating physician may not undertake any of the treatments described in Regulation .02A(1) until a breast cancer patient has been given the written summary described in §A(1) and (2) of this regulation. A treating physician who provides a patient with the written summary required under these regulations shall have the patient sign a statement provided by the Department acknowledging receipt of the summary and shall have a copy of this signed acknowledgement placed in the patient's medical record which is used by the treating physician. The requirements under this regulation do not apply if the: Treating physician certifies in writing in the patient's medical record that one of the treatments for breast cancer described in Regulation .02A(1) occurred within 5 days of the physician informing the patient of the diagnosis; and Treatment within this period of time was necessary to save the life of the patient. These regulations should not be interpreted to require a waiting period between diagnosis and treatment. This regulation is supplemental and additional to any other requirements established by other laws upon a treating physician and may not be regarded as in derogation or substitution of any requirements now existing upon a treating physician, such as the need to obtain informed consent for treatment. Health-General Article, §20-113, Annotated Code of Maryland Effective date: November 14, 1988 (15:23 Md. R. 2658) Regulation .01B amended effective January 20, 1992 (19:1 Md. R. 31) Regulation .03 amended effective January 20, 1992 (19:1 Md. R. 31) Chapter recodified from COMAR 10.06.05 to COMAR 10.14.03 in July, 1993 This chapter: Establishes the requirements for participating medical providers; Sets criteria for applicant eligibility; Outlines services covered; and Delineates the responsibilities of the Department and local health departments for breast cancer screening, diagnosis, and treatment services under the Breast Cancer Program created by Health-General Article, §20-116, Annotated Code of Maryland. This chapter operates in conjunction with the: Breast and Cervical Cancer Program; and Reimbursement for Breast and Cervical Cancer Diagnosis and Treatment Program, as set forth in COMAR 10.14.02. This chapter addresses the purpose set forth in Health-General Article, §20-116, Annotated Code of Maryland, by providing the services funded under the Breast Cancer Program through the programs cited in §B of this regulation. In this chapter, the following terms have the meanings indicated. Terms Defined. “Annual gross income” means the total amount of income received by the applicant and, if applicable, the applicant's spouse, each year from all sources before taxes are withheld. “Applicant” means an individual who has applied to receive services under this chapter. “Biennial” means once every other year. “Breast and Cervical Cancer Program” means the program that is: Administered by: A local health department; or A private entity that contracts with the Department to render services in Baltimore City and Calvert County under the Breast and Cervical Cancer Program; Established for the early detection of breast and cervical cancer; and Funded by: The federal Centers for Disease Control and Prevention; The Breast Cancer Program under Health-General Article, §20-116, Annotated Code of Maryland; or Both. “Breast Cancer Program” means the program created by Health-General Article, §20-116, Annotated Code of Maryland, to provide: At least biennial screening mammograms and clinical breast examinations to low-income, underinsured and low-income, uninsured women 40 years old through 49 years old; Annual screening mammograms and clinical breast examinations to low-income, underinsured and low-income, uninsured women 50 years old or older; and Diagnosis and treatment for individuals who are identified by the Breast Cancer Program as being in need. “Clinical breast examination” means a physical examination of the breast performed by a health care professional for the purpose of detecting breast cancer. “Contract” means the written agreement between a local health department and a health care provider for the provision of breast cancer services. “Copayment” means the set amount of money that an individual who is enrolled in a health insurance plan is responsible for paying each time the individual receives a medical service after the deductible, if applicable, has been paid. “Deductible” means a specific sum of money that an individual who is enrolled in a health insurance plan is required to pay before the individual's health insurance plan reimburses the individual or the individual's medical provider for covered medical services received. “Department” means the Maryland Department of Health. “Diagnosis” means a histopathologic finding of breast cancer in a biopsy specimen. “Eligible individual” means an applicant who meets the requirements of Regulation .03 of this chapter. “Enrollee” means an eligible individual who has been accepted into the Breast Cancer Program. “Free-standing ambulatory surgical center” means a facility that: Provides ambulatory surgical services; Is physically separate from a hospital or hospital grounds; Is certified by Medicare to provide ambulatory surgical services in Maryland or a jurisdiction bordering Maryland under the laws of that jurisdiction; and Complies with COMAR 10.09.42.02 and .03B. “Home health services provider” means a public or private agency, organization, or part of an agency or organization licensed in Maryland or a jurisdiction bordering Maryland that: Meets one of the following licensure requirements: If the provider is a home health agency located in Maryland, the provider is licensed under Health-General Article, Title 19, Subtitle 4, Annotated Code of Maryland; If the provider is a home health agency located in a jurisdiction bordering Maryland, the provider is legally authorized to provide home health services under the laws of that jurisdiction; If the provider is part of a hospital or related institution located in Maryland, the provider is licensed under Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland; or If the provider is an individual who has a contractual agreement with the Department to provide skilled nursing care to eligible individuals, the individual is a nurse who is licensed under Health Occupations Article, Title 8, Subtitle 3, Annotated Code of Maryland, to practice registered nursing; Provides nursing or physical therapy services in the home; and Meets the requirements for participation in Medicare. “Hospital” means an institution which is located: In Maryland, that is: Subject to the provisions of Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland; and Licensed pursuant to COMAR 10.07.01; or In a jurisdiction bordering Maryland, that is licensed pursuant to applicable standards established by the jurisdiction in which the hospital is located. “Local health department” means a governmental entity that provides public health services on behalf of a county in Maryland or Baltimore City. “Mammogram” means an X-ray examination of the breast to detect breast cancer that uses equipment: Specifically dedicated for mammography, including: X-ray tubes; Filters; Compression devices; Screens; Films; and Cassettes; and That is designed to deliver an average radiation exposure of less than one rad mid-breast with two views for each breast. “Medical Assistance” means the program that: Provides comprehensive medical and other health-related care for eligible individuals; and Is administered by the State under Title XIX of the Social Security Act, 42 U.S.C. §1396. “Medical laboratory” means a laboratory that: Examines tissue specimens in connection with the diagnosis, treatment, or control of human disease or the assessment of human health or nutritional or medical conditions; and Is in compliance with the applicable license requirements for a medical laboratory providing services for Maryland residents including, but not limited to the requirements: For Medicare certification; Set forth in Health-General Article, Title 17, Annotated Code of Maryland; Set forth in COMAR 10.10.01 — 10.10.08; and Of the federal Clinical Laboratories Improvement Act, 42 U.S.C. §263a. “Medical supply company” means a provider of disposable medical supplies or durable medical equipment that, to the extent required by law, is licensed and legally authorized to practice or deliver services in Maryland or in a jurisdiction bordering Maryland under the laws of that jurisdiction. “Medicare” means the medical insurance program administered by the federal government under Title XVIII of the Social Security Act, 42 U.S.C. §1395. “Nurse anesthetist” means a registered nurse who is: Certified as a nurse anesthetist in Maryland or a jurisdiction bordering Maryland under the laws of that jurisdiction; and Currently collaborating with an anesthesiologist or other physician who is licensed to practice medicine: In Maryland as prescribed by COMAR 10.27.06; or In a jurisdiction bordering Maryland under the laws of that jurisdiction. “Nurse practitioner” means a registered nurse who is certified: By the Maryland Board of Nursing to engage in the activities specified in COMAR 10.27.07; or As a nurse practitioner in a jurisdiction bordering Maryland under the laws of that jurisdiction. “Participating medical provider under the Breast and Cervical Cancer Program” means a health care provider who has entered into a written agreement with a local health department or the private entity that contracts with the Department to render services in Baltimore City and Calvert County under the Breast and Cervical Cancer Program to provide breast cancer services to an enrollee. “Participating medical provider under the Reimbursement for Breast and Cervical Cancer Diagnosis and Treatment Program” means any of the following: A physician who meets the requirements of COMAR 10.14.02.04A; A nurse practitioner who meets the requirements of COMAR 10.14.02.05A; A nurse anesthetist who meets the requirements of COMAR 10.14.02.06A; A physical therapist who meets the requirements of COMAR 10.14.02.07A; A pharmacy that meets the requirements of COMAR 10.14.02.08A; A hospital that meets the requirements of COMAR 10.14.02.09A; A medical supply company that meets the requirements of COMAR 10.14.02.10A; A home health service provider that meets the requirements of COMAR 10.14.02.11A; A medical laboratory that meets the requirements of COMAR 10.14.02.12A; or A free-standing ambulatory surgical center that meets the requirements of COMAR 10.14.02.13A. “Pharmacy” means an establishment or institution that holds a permit to provide pharmacy services under Health Occupations Article, Title 12, Subtitle 4, Annotated Code of Maryland. “Physical therapist” means an individual who is licensed or registered to practice physical therapy: In Maryland under Health Occupations Article, Title 13, Subtitle 3, Annotated Code of Maryland; or In a jurisdiction bordering Maryland under the laws of that jurisdiction. “Physician” means an individual who is licensed to practice medicine: In Maryland under Health Occupations Article, Title 14, Subtitle 3, Annotated Code of Maryland; or In a jurisdiction bordering Maryland under the laws of that jurisdiction. “Recipient of service” means an enrollee who has received a covered service under this chapter. “Registered nurse” means an individual who is licensed to practice registered nursing: In Maryland under Health Occupations Article, Title 8, Subtitle 3, Annotated Code of Maryland; or In a jurisdiction bordering Maryland under the laws of that jurisdiction. “Reimbursement for Breast and Cervical Cancer Diagnosis and Treatment Program” means the program operated by the Department to pay for breast and cervical cancer diagnostic and treatment procedures for eligible women under COMAR 10.14.02. “Resident” means an individual who is currently residing in Maryland. “Screening” means a medical test to detect cancer. “Surgical consult” means a consultation with a surgeon for advice on the recommended follow-up of the results of screening tests that are not considered normal. “Treatment” means the medical management and care of a patient for breast cancer. “Ultrasound” means a medical test in which high frequency sound waves are used to make an image of a specific area of the breast to determine if a breast lump is a fluid-filled cyst or a solid mass. The Breast Cancer Program created by Health-General Article, §20-116, Annotated Code of Maryland, provides State funding for breast cancer screening, diagnosis, and treatment for eligible individuals under this chapter. Services funded under the Breast Cancer Program shall be delivered through two previously existing programs as follows: Breast cancer screening and diagnostic services shall be provided to an enrollee through local health departments and private entities that contract with the Department to render services in Baltimore City and Calvert County under the Breast and Cervical Cancer Program; and Breast cancer diagnostic and treatment services shall be provided to an enrollee through the Reimbursement for Breast and Cervical Cancer Diagnosis and Treatment Program. An applicant is eligible for services under the Breast Cancer Program if the applicant meets the eligibility requirements of either Regulation .04 or .05 of this chapter. To be eligible to receive breast cancer services under this chapter through the Breast and Cervical Cancer Program, an applicant shall: Be a resident of Maryland; Be 40 years old or older; Meet the financial eligibility criteria specified in §B of this regulation; Meet the health insurance criteria specified in §C of this regulation; and Be determined to be eligible to receive covered services by a: Local health department or an agency or organization designated by the local health department; or Private entity that contracts with the Department to render services in Baltimore City or Calvert County. Financial Eligibility Criteria. Financial eligibility under this chapter is based on annual gross income and family size. To be financially eligible to receive breast cancer services under this chapter through the Breast and Cervical Cancer Program, an applicant may not have an annual gross income that exceeds 250 percent of the most recent federal poverty guidelines updated annually in the Federal Register by the United States Department of Health and Human Services in accordance with 42 U.S.C. §9902(2). For the purposes of determining family size under the federal poverty guidelines set forth at §B(2) of this regulation, the following individuals are family members of the applicant: The applicant; The applicant's spouse; The applicant's financially dependent children; and The applicant's financially dependent relatives. To be eligible to receive breast cancer services under this chapter through the Breast and Cervical Cancer Program, an applicant shall meet one of the following health insurance criteria: The applicant is not currently covered by health insurance; or The applicant is currently covered by health insurance that: Does not provide reimbursement for a service covered under this chapter; or Requires the applicant to pay a co-pay, co-insurance, or a deductible that has not been met for a service covered under this chapter. An applicant may not receive breast cancer services under this chapter through the Breast and Cervical Cancer Program if: The applicant is enrolled in Medical Assistance; or The applicant is enrolled in a health maintenance organization. To be eligible to receive breast cancer services under this chapter through the Reimbursement for Breast and Cervical Cancer Diagnosis and Treatment Program, an applicant shall meet the eligibility requirements specified in COMAR 10.14.02.03. The following breast cancer services are covered for enrollees under this chapter through the Breast and Cervical Cancer Program: Annual clinical breast examinations; Mammograms that are provided: Annually to enrollees 50 years old or older; and At least on a biennial basis to enrollees 40 years old through 49 years old; and Follow-up clinical breast examinations, mammograms, ultrasounds, and surgical consults as considered medically necessary by the participating medical provider under the Breast and Cervical Cancer Program. The following breast cancer services are covered for enrollees under this chapter through the Reimbursement for Breast and Cervical Cancer Diagnosis and Treatment Program: A physician's services as described in COMAR 10.14.02.04C; A nurse practitioner's services as described in COMAR 10.14.02.05C; A nurse anesthetist's services as described in COMAR 10.14.02.06C; A physical therapist's services as described in COMAR 10.14.02.07B; A pharmacy's services as described in COMAR 10.14.02.08B; A hospital's services as described in COMAR 10.14.02.09B; A medical supply company's services as described in COMAR 10.14.02.10B; A home health service provider's services as described in COMAR 10.14.02.11B; A medical laboratory's services as described in COMAR 10.14.02.12B; or A free-standing ambulatory surgical center's services as described in COMAR 10.14.02.13B. The following breast cancer services are not covered for enrollees under this chapter: A physician's services as described in COMAR 10.14.02.04D; A nurse practitioner's services as described in COMAR 10.14.02.05D; A nurse anesthetist's services as described in COMAR 10.14.02.06D; A physical therapist's services as described in COMAR 10.14.02.07C; A pharmacy's services as described in COMAR 10.14.02.08C; A hospital's services as described in COMAR 10.14.02.09C; A medical supply company's services as described in COMAR 10.14.02.10C; A home health service provider's services as described in COMAR 10.14.02.11D; A medical laboratory's services as described in COMAR 10.14.02.12C; or A free-standing ambulatory surgical center's services as described in COMAR 10.14.02.13C. The Department shall: Award grants to local health departments and private entities in Baltimore City and Calvert County as specified by Health-General Article, §20-116, Annotated Code of Maryland, for use in providing breast cancer screening services to eligible women under the Breast and Cervical Cancer Program; and Reimburse a participating medical provider under the Reimbursement for Breast and Cervical Cancer Diagnosis and Treatment Program for performing covered breast and cervical cancer diagnosis and treatment services on enrollees, pursuant to funding provided under Health-General Article, §20-116, Annotated Code of Maryland. A local health department and the private entities in Baltimore City and Calvert County shall: Enter into written agreements with health care providers to provide breast cancer services to enrollees using the contracts developed by the Department for use in the Breast and Cervical Cancer Program; Reimburse a participating medical provider under the Breast and Cervical Cancer Program for performing covered services on enrollees; Determine eligibility of applicants using the criteria specified in Regulation .05 of this chapter; Recruit eligible individuals; and Provide enrollees, recipients of services, and medical providers with assistance in obtaining program-related information and services. In order to assure the availability of breast cancer diagnostic and treatment services, a local health department shall comply with COMAR 10.14.02.15B. The implementation and ongoing administration of this chapter is contingent upon the availability of funds. Health-General Article, §20-116, Annotated Code of Maryland Effective date: November 10, 2003 (30:22 Md. R. 1581) Regulation .04 amended effective March 16, 2015 (42:5 Md. R. 486) This chapter: Defines the Maryland Cancer Fund; Describes how contributions may be made to the Maryland Cancer Fund; Sets forth the responsibilities of the Maryland Department of Health and the Comptroller with respect to the Maryland Cancer Fund; Identifies eligible applicants; and Outlines the grant application process for the Maryland Cancer Fund. In this chapter, the following terms have the meanings indicated. Terms Defined. “Annual family income” means the total amount received per year from all sources before taxes are withheld. “Applicant” means a person who has applied to receive a grant under the Maryland Cancer Fund. “Applied research” means research that is undertaken to determine: Possible uses for the findings of basic research; or New ways of achieving some specific objective. “Authorized representative” means an individual or organization that has received permission from an individual diagnosed with cancer to perform certain tasks on the individual's behalf. “Basic research” means experimental or theoretical work undertaken to acquire new knowledge or understanding of cancer. “Case management” means the coordination of services by a health care professional for an individual for cancer: Screening; Diagnosis; or Treatment. “Capital expenditures” means money spent to add or expand property, equipment, and assets that will benefit an organization in the long term. "Center for Cancer Prevention and Control (CCPC)" means a unit of the Maryland Department of Health within the Prevention and Health Promotion Administration. “Clinical research” means research: Conducted primarily on patients; and Designed to answer questions about the etiology, prevention, early detection, diagnosis, or treatment of cancer. “Community-based participatory research” means a collaborative, partnership approach to research that equitably involves community members, organizational representatives, and researchers in all aspects of the research process. “Comptroller” means the Comptroller of the Treasury. “Coinsurance” means the percent of allowable charges for a medical service that an individual with health insurance is responsible for paying. “Copayment (copay)” means the set amount of money that an individual with health insurance is responsible for paying each time the individual receives a medical service. “County” means a county of this State or Baltimore City. “Current Procedure Terminology (CPT)” means the uniform descriptive terms and identifying codes for reporting medical services and procedures performed by physicians. “Deductible” means the amount of money that an individual with health insurance is required to pay before the individual's health insurance starts coverage. “Department” means the Maryland Department of Health. “Diagnosis” means a histopathologic finding of cancer in a: Biopsy; or Surgical specimen. Educational Institution. “Educational institution” means an organization whose primary mission is to educate individuals. “Educational institution” includes: Private and public elementary schools; Middle schools; High schools; Colleges; Universities; Graduate schools; and Research institutions. “Family” means the unit comprised of all of the following that apply: For a financially independent adult 18 years old or older diagnosed with cancer, the adult diagnosed with cancer or the adult diagnosed with cancer and one or more of the following: Spouse; Financially dependent child; or Financially dependent relative; or For a financially dependent child, the child and one or more of the following: Parent, foster parent, or guardian; Sibling living in the household; or Half brother or half sister living in the household. “Federal poverty level” means the poverty guidelines, as amended, which are updated periodically in the Federal Register by the U.S. Department of Health and Human Services and which are incorporated by reference by COMAR 10.11.03.01–1. “Fund” means the Maryland Cancer Fund. Grant. “Grant” means financial assistance from the State to support an applicant's activities related to cancer: Research; Primary prevention; Secondary prevention; and Treatment. “Grant” does not mean a contract. “Governmental entity” means a federal, State, or local governmental organization. “Health Services Cost Review Commission (HSCRC)” means the independent organization within the Department that is responsible for reviewing and approving rates for hospitals pursuant to Health-General Article, Title 19, Subtitle 2, Annotated Code of Maryland. “Hospital” means an institution that: Operates 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. “Laboratory” means a licensed or certified facility operated for the examination of material derived from the human body for the purpose of obtaining information for the diagnosis, treatment, and management of a disease. “Local health department” means a governmental entity in a county in Maryland that provides public health services. “Major medical equipment” means equipment that: Costs in excess of $500; and Is used for the provision of medical or health services. “Maryland Comprehensive Cancer Control Plan” means the most recent edition of the cancer plan developed by the Department. “Maryland Health Insurance Plan (MHIP)” means a State-administered program that: Is operated by a unit within the Maryland Insurance Administration under Insurance Article, Title 14, Subtitle 5, Annotated Code of Maryland; and Provides health insurance coverage to medically uninsurable Maryland residents. “Medical Assistance” means the program administered by the State under Title XIX of the Social Security Act, 42 U.S.C. §§1396 — 1396v, which provides comprehensive medical and other health-related care for eligible categorically and medically needy persons. “Medicare” means the medical insurance program administered by the federal government under Title XVIII of the Social Security Act, 42 U.S.C. §§1395 — 1395hhh. “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 procedure or service received, excluding the deductible. “Physician” means an individual who is licensed to practice medicine in the jurisdiction in which the service is provided. “Premium” means the amount of money than an individual pays in regular installments to a health insurer for a health insurance policy. Primary Prevention. “Primary prevention” means activities to prevent or reduce the development of cancer. “Primary prevention” includes interventions such as: Tobacco use prevention and cessation; Protection from ultraviolet light; Proper nutrition and physical activity; and Reduction of exposure to environmental and occupational carcinogens. Research. “Research” means activities to develop or advance the understanding of cancer or the techniques or modalities effective in the prevention, cure, screening, diagnosis, or treatment of cancer. “Research” includes basic, clinical, applied, translational, and community-based participatory research. “Secondary prevention” means activities to detect and diagnose cancer in its early stages, when the chances of treatment and control are the greatest. “Secretary” means the Secretary of Health. “Translational research” means using or applying new discoveries to benefit patient care. “Treatment” means the medical management and care of a patient that is provided for: Obtaining a cancer diagnosis, determining the full extent of the cancer spread, or treating the cancer, including: Surgery; Chemotherapy; Radiation therapy; Hormonal therapy; Biopsy; Imaging procedures; Laboratory testing; Home health services; and Medical supplies or medical equipment; Treating medical complications resulting from cancer screening or treatment; Treating other co-morbid conditions in order to treat cancer; or Providing palliative or end-of-life care. “Uninsured” means that an individual: Does not have any health insurance; or Has health insurance that does not cover the cancer prevention, screening, diagnosis, or treatment services provided under the Fund. The Maryland Cancer Fund is a nonlapsing, special fund created by Health-General Article, §20-117, Annotated Code of Maryland, for cancer research, prevention, and treatment, which is generated from: Contributions from the income tax checkoff system under Tax-General Article, §2-112, Annotated Code of Maryland; and Any other donations to the Fund. The Department may only expend funds: In accordance with an appropriation approved by the General Assembly in the annual State budget; or Through an approved budget amendment under State Finance and Procurement Article, §§7-209 and 7-210, Annotated Code of Maryland. The Department may only make grant awards under the Fund for cancer: Research; Primary prevention; Secondary prevention; or Treatment. Any unspent portions of the Fund shall remain in the Fund and may not revert to the General Fund of the State. Money expended from the Fund is supplemental to, and is not intended to take the place of, funding that would otherwise be appropriated to the Department for cancer: Research; Primary prevention; Secondary prevention; or Treatment. An individual or each spouse in the case of a joint income tax return may contribute an amount to the Fund by: Deducting the amount of the contribution from any refund due under a tax return; or Adding the amount of the contribution to the income tax to be paid with a tax return. The Department: Shall administer the Fund; May not spend more than 5 percent of the proceeds received from the Comptroller for the Fund to promote further donations to the Fund; and Shall provide a grant in each fiscal year to persons to conduct one or more of the following cancer-related activities: Research; Primary prevention; Secondary prevention; or Treatment. The Comptroller shall: Include in the individual income tax return form: A checkoff designated as the Maryland Cancer Fund contribution; and A description that the Fund may only be used for cancer: Research; Primary prevention; Secondary prevention; or Treatment; Collect the checkoff contributions and other donations and account to the Treasurer for the money collected; Distribute the amount necessary to administer the checkoff system to an administrative cost account; After the distribution under §C of this regulation, distribute the remainder of the money to the Fund; and Notify the Department annually of: The gross amount of donations to the Fund through the income tax checkoff system; The gross amount of other donations to the Fund; and The costs of administration of the income tax checkoff system by the Comptroller. Subject to any limitations imposed under §B of this regulation, the following persons are eligible to receive a grant from the Department for cancer research, primary prevention, secondary prevention, or treatment: Physicians; Hospitals; Laboratories; Educational institutions; Local health departments; Governmental entities; and Another person or organization with expertise in cancer research, primary prevention, secondary prevention, or treatment. The Department may limit the persons eligible to receive a grant in §A of this regulation based on: Availability of funds; and The Department's ability to account for and monitor the grant funding. In order to be eligible to receive a grant, an applicant: May be a nonprofit or for-profit entity; Shall have an office located in Maryland; and May only propose work that will serve or benefit one or more Maryland residents. A grantee that is funded to conduct cancer research by the Fund may use the grant funds: For basic, clinical, translational, applied, or community-based participatory research; To support: The individuals engaged in the research; and The individual's support staff; and To purchase office supplies. A grantee that is funded to conduct cancer primary prevention or secondary prevention by the Fund may use the grant funds for: Education; Outreach; Policy changes; Provider interventions; Clinical services; Case management; Quality assurance; Data collection; or Partnership development. If a grantee is funded to conduct cancer secondary prevention services, the Fund shall provide to the grantee reimbursement for a clinical service at a rate not higher than the rate that: Medicare pays for the clinical service in the region; or The HSCRC has approved for the clinical service, if the clinical service is provided by a HSCRC-regulated facility. If a grantee is funded to conduct cancer secondary prevention or treatment, the grantee shall only provide clinical services to individuals who: Are Maryland residents; and Have an annual family income that is not more than 250 percent of the federal poverty guidelines. If a grantee is funded to conduct cancer treatment, a grantee may use the grant funds: For grants awarded before January 1, 2014 to provide MHIP reimbursement, to pay up to a maximum of $15,000 for direct costs per individual per year for the premium, deductible, coinsurance, and copay of the MHIP costs and for services not covered under MHIP; or To pay up to a specified amount, as determined by the Department, for direct costs per individual per year for the: Deductible and patient contribution amount for the reimbursed medical procedure or service for insured individuals; and Medical procedure or service not covered under their health insurance policy for individuals who meet the eligibility criteria of §D of this regulation; or To pay up to a maximum of $20,000 for direct costs per individual per year for the cancer treatment costs under the individual’s treatment plan: Who meet the eligibility criteria in §D of this regulation; and At a rate not to exceed the rate that Medical Assistance pays for clinical services or the rate that the HSCRC has approved for the clinical services, if treatment is provided by a HSCRC-regulated facility. If a grantee is funded to pay for cancer treatment: Under §E(1) of this regulation, the grantee shall only pay or direct the Department to pay MHIP the following for services directly related to the treatment of cancer for the individual diagnosed with cancer: Premiums; Deductibles; Coinsurance; and Copays; Under §E(2) of this regulation, the grantee shall only pay or direct the Department to pay the deductible and patient contribution amount for the reimbursed medical procedure or service that the individual is required to pay for the services directly related to the diagnosis and treatment of cancer; and May not pay any amount for the individual’s spouse, children, or other family members’ health insurance costs. For the purpose of §F(1) and (2) of this regulation, the Department shall pay the health insurance costs out of the funds that are set aside for the grantee. In addition to the direct costs allowed under §E of this regulation, the Fund shall also pay a maximum of 7 percent of the indirect costs to local health department grantees or non-local health department grantees. A grantee may not use grant funds from the Fund to pay for: Major medical equipment purchases; Renovations; Capital expenditures; or Cancer prevention or cancer treatment that would be provided by an individual's existing health insurance, including: Medical Assistance; Medicare; or Private health insurance. A person may obtain an application packet from the CCPC for a cancer: Research grant; Primary prevention grant; Secondary prevention grant; or Treatment grant. An applicant may: Apply for one or more grants in any fiscal year; and Combine multiple requests for cancer research, primary prevention, or secondary prevention grants within a single application, provided that the information required for separate grant applications is included in the combined application. An applicant for a cancer research grant shall: Submit a completed application to the CCPC by the due date listed in the application packet; and Include in the application packet the following information as specified in the Department’s application packet: An executive summary stating: How the grant funds will be used; What institutions and other persons will be involved in the research; Whether basic, clinical, applied, translational, or community-based research is being proposed; Whether the proposed research is included in a recommendation of the Maryland Comprehensive Cancer Control Plan; and How the grant money is expected to further the knowledge of cancer; A statement of the need for the cancer research, including: Previous literature in the area; and Any work that the applicant has done in the research area; A proposed cancer research plan describing: How the grant funds will be used; Who will be involved in the research; What the anticipated results of the research with the grant funds will be; and What goals, objectives, and activities will be pursued with the grant funds; A brief professional resume or curriculum vitae of: The principal investigator; and Other key staff; A description of how the proposed research will help to eliminate disparities between racial and ethnic minorities and the white population; A list of the institutional review boards to which the research will be submitted for review and approval before the research is initiated, including the: Department's Institutional Review Board; and Applicant's relevant institutional review board; A timeline showing the expected start date and completion date for each activity to be conducted under the grant, including application to and approval from the: Department's Institutional Review Board; and Applicant's relevant institutional review board; An organizational chart showing where the work under the research grant is located within the applicant's organization; A statement that the grant funds will not be used to supplant any existing funding for this cancer research and, if an applicant receives funding for a similar cancer research activity, a listing of the funding: Source; Amount; and Period for the activity; A line item budget for the cancer research grant; and A written budget justification for each line item request. An applicant for a cancer primary prevention grant shall: Submit a completed application to the CCPC by the due date listed in the application packet; and Include in the application packet the following information, as specified in the Department's application packet: An executive summary describing: How the grant funds will be used; What persons will be involved in the grant activities; What cancer primary prevention activities will be conducted; Whether the primary prevention activities are included in a recommendation in the Maryland Comprehensive Cancer Control Plan; What population groups will be served and in what jurisdiction groups will be served; What types of services will be offered, including education and policy initiatives: What the eligibility for services will be; and What outcome is expected as a result of the funding; A statement of the need for the cancer primary prevention intervention; A description of previous literature in the area documenting the effectiveness of the cancer primary prevention intervention; A proposed cancer primary prevention plan describing the: Estimated number of persons to be served; Goals, objectives, and activities to be conducted with the grant funds; Evaluation measures for each activity; How the grant funds will be used; Who will be involved in the plan; and What the expected results of the activity with the grant funds are; A description of how the primary prevention plan will address the goal of eliminating disparities between racial and ethnic minorities and the white population; A list of key staff to be involved in the project, including: If existing staff will be used in the project, a description of the experience of the key staff in carrying out similar cancer primary prevention activities; or If new staff will be hired for the grant, a job description of the staff that will be responsible for carrying out the project; A description of the previous experience of the applicant's organization in implementing similar cancer primary prevention activities; A timeline showing the expected start date and completion date for each activity to be conducted under the grant; An organizational chart showing: Where the activities under the cancer primary prevention grant falls within the applicant's organizational structure; and The relationship of the applicant with other organizations involved in the project; A statement that the grant funds will not be used to supplant any existing funding for this cancer primary prevention activity and, if an applicant receives funding for a similar cancer primary prevention activity a list of the funding: Source; Amount; and Period for the activity; A line item budget for the cancer primary prevention grant; and A written budget justification for each line item requested. An applicant for a cancer secondary prevention grant shall: Submit a completed application to the CCPC by the due date stated in the application packet; and Include in the application packet the following information, as specified in the Department's application packet: An executive summary describing: How the grant funds will be used; What persons will be involved in the application; What cancer secondary prevention activities will be conducted; Whether the proposed activities are included in a recommendation in the Maryland Comprehensive Cancer Control Plan; What population groups will be served and in what jurisdiction groups will be served; What services will be offered, such as: Outreach; Screening; Case management; Quality assurance; Data collection; and Partnership building; What the eligibility for services will be; and What outcome is expected as a result of the grant funds; A description of previous literature in the area documenting the effectiveness of the cancer secondary prevention activity; A description and justification of the need for the cancer secondary prevention activity in the population group to be served; A description of the population to be served including, at a minimum, a description of the following for the individuals to be served: Age; Race; Gender; Residency; Educational level; Income level; and Health insurance requirements of persons to be served; A description of the screening guidelines to be used for clinical services and the eligibility guidelines for these services, including age, symptoms, and, if appropriate, risk factors; A description of the reimbursement levels to be used for clinical services provided with grant funds; A proposed cancer secondary prevention plan describing: The estimated number of individuals to be served; The goals, objectives, and activities to be conducted with the grant funds; Evaluation measures for each activity; Who will be involved in the plan; and What the expected results of the funded activity are; A description of how the proposed cancer secondary prevention activities will address the goal of eliminating disparities between racial and ethnic minorities and the white population; A list of key staff to be involved in the project, including: If existing staff will be used in the project, a description of the experience of the key staff in carrying out similar cancer secondary prevention activities; or If new staff will be hired for this activity, a job description of the staff responsible for carrying out the project; A description of the previous experience of the applicant's organization in implementing similar cancer secondary prevention activities; A timeline showing the expected start date and completion date for each activity to be conducted with the grant funds; An organizational chart showing: Where the cancer secondary prevention grant activities fall within the applicant's organizational structure; and The relationship of the applicant with other organizations involved in the project; A statement that the grant funds will not be used to supplant any existing funding for this cancer secondary prevention activity and, if an applicant receives funding for a similar cancer secondary prevention activity, a list of the funding: Source; Amount; and Period for the activity; A line item budget for the cancer secondary prevention grant; and A written budget justification for each line item requested. An applicant for a cancer treatment grant shall submit a completed application to the CCPC. Cancer treatment grants are open and continuous throughout the year to the extent that funding is available. An applicant seeking a cancer treatment grant to pay for cancer treatment costs shall include in the Department's application packet: A completed cancer treatment grant application for each individual for whom grant funds are being requested, including the: Name; Phone number; Mailing address; County; and Signature of the: Individual diagnosed with cancer if the individual is an adult; or Parent or guardian if the individual diagnosed with cancer is younger than 18 years old; A letter written by the individual’s physician on the physician’s letterhead: Confirming: That the individual has been diagnosed with or treated for cancer or the individual has a finding suggestive of cancer and needs to obtain a cancer diagnosis; and The dates of diagnosis or treatment; and Containing the physician's: Full name; Address; Specialty; and Medical license number; Proof of current Maryland residency for at least 6 months before the application date for each individual for whom grant funds are being requested in one of the following forms: Maryland driver’s license or State identification card; Lease or rental agreement; Property tax bill; Motor vehicle registration; Pay check or stub with name and home address; Utility bill; Voter registration card; or W-2 statement issued not more than 12 months ago; Proof of annual family income for each individual for whom grant funds are being requested, including a copy of at least one of the following: Most recent: Income tax return; or W-2 form; Pay stubs for two: Consecutive pays; or Pays in the same month; Social security entitlement letter; or Notarized letter from the individual stating that the individual is not working and does not have any income; Documentation of the eligibility of the individual for grant funds, including: The family size of the individual for whom the applicant is applying; and The family’s annual household income; Certification that the applicant will: Keep financial records, as described in Regulation .16B of this chapter; Send demographic and fiscal information on each individual covered to the CCPC at the end of the grant period; and Act as the authorized representative of the individual. Attestation that grant funds will not be used to supplant any existing funding for this cancer treatment activity; and If the applicant currently receives funding for a similar cancer treatment activity, a list of the funding: Source; Amount; and Period for the activity. An applicant seeking a cancer treatment grant to pay for deductibles and patient contribution costs through their health insurance policy under Regulation .08E(2) of this chapter shall include in the Department’s application packet: A completed and signed Maryland Cancer Fund — Cancer Treatment Grant application that; Certifies that the applicant shall pay: The deductible and patient contribution amount; and Costs for services not covered under the individual’s health insurance policy for a time period not to exceed 1 year; and Includes a treatment plan for a total request not to exceed a specified amount, as determined by the Department, per individual per year, including the: Deductible and patient contribution amount; and Costs for services not covered under the individual’s health insurance policy. Documentation of the individual’s health insurance policy. An applicant seeking a cancer treatment grant to pay directly for cancer treatment costs under Regulation .08E(3) of this chapter shall include in the Department’s application packet: A completed Maryland Cancer Fund — Cancer Treatment Grant application; and A signed document that certifies that the applicant shall pay directly for cancer treatment costs for the individual for a time period not to exceed 1 year; and certifies that the applicant shall: Reimburse the provider in an amount not greater than the Medical Assistance rate for the medical procedure or the HSCRC-regulated rate for the medical procedure performed, if the medical procedure is performed in a HSCRC-regulated facility; or Accept the Medical Assistance rate as payment in full for the cancer treatment procedures performed, if the applicant is a medical provider; and Includes a treatment plan for a total request not to exceed $20,000 per individual, including: The planned cancer treatment procedures; and The Medical Assistance or HSCRC-regulated rate for each procedure. Each fiscal year the CCPC shall determine: The amount of money available for grants under the Maryland Cancer Fund; The allocation of funding for cancer: Research; Primary prevention; Secondary prevention; and Treatment; and The maximum grant award amount for each type of grant. Each year the Department shall consider for award, funding for one or more of the following types of grant applications for cancer: Research; Primary prevention; Secondary prevention; and Treatment. The CCPC shall develop one or more evaluation committees or shall contract with one or more external consultants with expertise in cancer research and prevention to review the cancer research and primary prevention and secondary prevention grant applications that are submitted for funding under the Maryland Cancer Fund. Due to the need for timeliness in the cancer treatment grants, the CCPC shall review each application for cancer treatment. The evaluation committee or external consultants shall review: Cancer research grant applications based on: Scientific need; The degree to which the cancer research plan will achieve the goals and objectives set forth in the plan; The inclusion of a plan for Institutional Review Board approval; The feasibility of the timeline in delivering goals and objectives of the plan; The experience and expertise of the principal investigator; The degree to which a grant application addresses eliminating disparities between racial and ethnic minorities and the white population; Whether the research is recommended in the Maryland Comprehensive Cancer Plan; The lack of other resources or funding for the proposed research; and The amount of the funding requested; Cancer primary prevention grant applications based on: The need for the cancer primary prevention activity; The previously documented effectiveness of the primary prevention intervention; The degree to which the cancer primary prevention plan will achieve the goals and objectives set forth in the plan; The degree to which a grant application addresses eliminating disparities between racial and ethnic minorities and the white population; The experience of the applicant in cancer primary prevention; Whether the primary prevention intervention is recommended in the Maryland Comprehensive Cancer Control Plan; The lack of other resources or funding for the proposal; and The amount of funding requested; and Cancer secondary prevention grant applications based on: The previously documented effectiveness of the secondary prevention intervention; The need for the cancer secondary prevention intervention in the population group to be served; The degree to which the cancer secondary prevention plan will achieve the goals and objectives of the plan; The feasibility of the timeline in delivering the goals and objectives of the plan; The extent to which medical guidelines for screening and diagnosis are being followed; The percent of the budget allocated to clinical services; The degree to which the grant application addresses eliminating disparities between racial and ethnic minorities and the white population; The experience of the applicant in cancer secondary prevention; Whether the secondary prevention intervention is recommended in the Maryland Comprehensive Cancer Control Plan; The lack of other resources or funding for the proposal; and The amount requested. After reviewing each cancer research, primary prevention, and secondary prevention grant application, the evaluation committee or external consultant shall make a recommendation to the CCPC about whether to award grant funds to each applicant. The CCPC shall review each cancer treatment application based on: Completeness; Availability of funds; and Whether the application meets the relevant application process requirements set forth in this chapter. The Director of the CCPC shall recommend an application to the Secretary for approval based upon: The evaluation committee's or external consultant's recommendations for awarding the cancer research, primary prevention, secondary prevention, and treatment grants for each application; and The availability of funds. The Secretary shall: Consider the grant recommendations of the CCPC for the cancer: Research; Primary prevention; Secondary prevention; and Treatment; and Make the final determination on which grant applications to approve. A grant period expires 1 year from the date of award of the grant, unless extended as set forth in Regulation .16 of this chapter. A person awarded a grant under this chapter may apply for a no-cost extension of the grant period for the award before the expiration of the grant period, as set forth in §J of this regulation, by submitting a written request for an extension to the CCPC. In evaluating whether to grant an extension of the grant period, the CCPC: Shall assess whether progress has been made on the grant; and If progress has been made based on the reports submitted pursuant to Regulation .16C of this chapter, may recommend to the Secretary that an extension be granted. The Secretary may approve an extension for up to 1 year based on: The recommendation of the CCPC; and Whether progress has been shown on the grant pursuant to Regulation .16C of this chapter. Payments Under the Grant. The Department may not make more than monthly payments during the grant period to a person awarded a grant under this chapter. Before the first payment under the grant, at the request of the person awarded the grant under this chapter, the Department may approve an advanced payment for the grant based on financial need, if a request for advanced payment was specified in the grant application. If a financial or progress report required in §B or C of this regulation is overdue, the Department may withhold payment until the report is submitted. Financial Reports and Records. A person awarded a grant shall: Establish a separate account to track expenditures under the grant; Maintain accurate records, including documentation of each transaction pertaining to the grant; and Submit to the Department monthly invoices for payment and an annual financial expenditure report containing the signature of the financial officer of the entity affiliated with the grant award. The Department may audit the accounts referenced in §B(1) of this regulation at any time. A person awarded a grant under this chapter shall submit to the Department within 90 days after the date the grant period ends: A final financial expenditure report; and A refund of any unexpended funds. A person awarded a grant under this chapter shall retain all records pertaining to a grant award for 3 years from the date the final financial expenditure report is submitted under §B(3) of this regulation. In the case of an audit or litigation, the Department may extend the time period under §B(3) or (4) of this regulation until the completion of the audit or litigation. Progress Reports. A grantee shall submit to the CCPC three copies of: An interim report describing the progress of the grant: 6 months after the date of award of the grant; and Every 6 months until the end of the grant; and A comprehensive final report, not later than 60 days after the date the grant period ends, that provides a summary of all of the activity conducted under the grant. A grantee receiving a cancer research grant shall include the following information in the comprehensive final report: Hypothesis; Methods; Results; Discussion of results and limitations of the research; and Conclusion. A grantee receiving a cancer primary prevention or secondary prevention grant shall include the following information in the comprehensive final report: Number of individuals served, by: Type of service; Age; Race; and Gender; Number of individuals with abnormal screening results, by type of cancer; Number of cancers diagnosed; and Other outcome measures. A grantee receiving a cancer treatment grant shall include the following information in the comprehensive final report for each individual receiving funds for cancer treatment: Type of cancer; Stage of cancer at diagnosis; Age; Race; Gender; County; and Amount of funds expended. The Department shall keep research results confidential as required by Health-General Article, §§4-101 — 4-103, Annotated Code of Maryland. Publications. A person who publishes results from activities supported by a grant approved by the Secretary under this chapter shall include in the publication the following acknowledgement: “Supported in part with funds from the Maryland Cancer Fund of the Maryland Department of Health.” A person awarded a grant under this chapter shall provide the Department with three copies of any published article pertaining to the activities conducted under the grant. Ownership of Equipment. A person awarded a grant under this chapter: Shall ensure that equipment purchased under a grant under this chapter is used for the sole purpose of the grant; Shall keep an inventory of all equipment purchased; and May not transfer the equipment to another entity without the written permission of the Department. Termination. The Secretary may terminate a grant: If a grantee fails to comply with: The requirements of this chapter; or State, federal, and municipal laws applicable to the performance of research under the grant; If a grantee fails to carry out the purposes for which the grant was awarded; In compliance with a court order; or At the request of the grantee. The Department and the State are not responsible for any expenses incurred by a grantee after cancellation of a grant. The grantee shall return all unexpended funds to the Department within 60 days of termination of a grant. Compliance with Existing Laws. A person awarded a grant under this chapter shall ensure that an activity conducted in the performance of the grant is in compliance with all State, federal, and local laws. Liability. A person awarded a grant under this chapter is solely responsible for the person's actions pertaining to research conducted under a grant award. The State and the Department are not liable for any claims, losses, liabilities, expenses, or damages arising from research conducted under a grant awarded under this chapter. Grant Agreements. A person awarded a grant under this chapter shall enter into a grant agreement with the Department. Health-General Article, §20-117; Tax-General Article, §2-112; Annotated Code of Maryland Effective date: Regulations .01 — .16 adopted as an emergency provision effective June 1, 2006 (33:15 Md. R. 1274); adopted permanently effective October 9, 2006 (33:20 Md. R. 1616) Regulation .02B amended as an emergency provision effective June 12, 2008 (35:14 Md. R. 1243); amended permanently effective October 20, 2008 (35:21 Md. R. 1824) Regulation .02B amended as an emergency provision effective December 22, 2008 (36:2 Md. R. 97); amended permanently effective April 6, 2009 (36:7 Md. R. 524) Regulation .02B amended effective March 18, 2013 (40:5 Md. R. 411) 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 .03A amended effective March 18, 2013 (40:5 Md. R. 411) Regulation .05C amended as an emergency provision effective June 12, 2008 (35:14 Md. R. 1243); amended permanently effective October 20, 2008 (35:21 Md. R. 1824) Regulation .07 amended as an emergency provision effective June 12, 2008 (35:14 Md. R. 1243); amended permanently effective October 20, 2008 (35:21 Md. R. 1824) Regulation .08 amended effective October 4, 2010 (37:20 Md. R. 1393); March 18, 2013 (40:5 Md. R. 411) 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 .08D, E amended as an emergency provision effective June 12, 2008 (35:14 Md. R. 1243); amended permanently effective October 20, 2008 (35:21 Md. R. 1824) Regulation .09 amended effective March 18, 2013 (40:5 Md. R. 411) Regulation .10A amended effective March 18, 2013 (40:5 Md. R. 411) Regulation .11 amended effective March 18, 2013 (40:5 Md. R. 411) Regulation .12 amended effective March 18, 2013 (40:5 Md. R. 411) Regulation .13 amended effective March 18, 2013 (40:5 Md. R. 411) Regulation .14 amended effective March 18, 2013 (40:5 Md. R. 411) Regulation .14C, D amended as an emergency provision effective June 12, 2008 (35:14 Md. R. 1243); amended permanently effective October 20, 2008 (35:21 Md. R. 1824) Regulation .14D, 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 .15 amended effective March 18, 2013 (40:5 Md. R. 411) Regulation .15B amended as an emergency provision effective June 12, 2008 (35:14 Md. R. 1243); amended permanently effective October 20, 2008 (35:21 Md. R. 1824) Regulation .16C amended effective March 18, 2013 (40:5 Md. R. 411) Regulation .16C 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 .16D amended effective October 4, 2010 (37:20 Md. R. 1393) This chapter establishes the financial eligibility criteria for an uninsured or underinsured individual to receive cancer treatment services and tobacco treatment products under the Cigarette Restitution Fund Program. In this chapter, the following terms have the meanings indicated. Terms Defined. “Applicant” means an individual who has applied to receive cancer treatment services or tobacco treatment products under this chapter. “Cancer Prevention, Education, Screening, and Treatment Program” means the program created by Health-General Article, §§13-1101—13-1119, Annotated Code of Maryland, to provide cancer prevention, education, screening, and treatment services in Maryland. “Cancer treatment service” means a medical service, medical supply, or medical equipment provided to: Treat cancer, including: Surgery; Chemotherapy; Radiation therapy; Hormonal therapy; Home health services; and Medical supplies and medical equipment; Treat medical complications resulting from cancer screening or treatment; Treat other comorbid conditions in order to treat cancer; and Serve the needs of cancer patients for palliative or end-of-life care. “Department” means the Maryland Department of Health. “Federal poverty level” means the amount of household income by family size that a family needs for basic necessities as determined by the federal poverty guidelines, as amended, which are updated annually in the Federal Register by the U.S. Department of Health and Human Services. “Gross annual household income” means the total income of the applicant and any member of the applicant’s household received each year from all sources before taxes are withheld or deductions are taken. “Local health department” means a governmental entity in a county in Maryland that provides public health services. “Maryland Children’s Health Insurance Program” means the program administered by Medical Assistance to provide health insurance coverage to eligible children younger than 19 years old in Maryland. “Medical Assistance” means the program that: Provides comprehensive medical and other health-related care for eligible individuals; and Is administered by the State under Title XIX of the Social Security Act, 42 U.S.C. §§1396—1396v. “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. “Statewide academic health center” means: The University of Maryland Medical Group; The Johns Hopkins Institutions; The organization designated by the Department as stipulated by Health-General Article, §13-1115, Annotated Code of Maryland; or One or more of the organizations in §B(11)(a)—(c) of this regulation. “Tobacco product” means cigarettes, cigars, pipe tobacco, smokeless tobacco, and any other product containing tobacco in any form. “Tobacco treatment product” means all Food and Drug Administration-approved tobacco cessation medications, including both prescription and over-the-counter medications, that assist individuals to stop using tobacco products. “Tobacco Use Prevention and Cessation Program” means the program created by Health-General Article, §§13-1001—13-1014, Annotated Code of Maryland, to provide tobacco use prevention and cessation services in Maryland. “Underinsured” individual means an applicant: Who has private medical insurance, Medical Assistance, Medicare, or Maryland Children’s Health Insurance Program coverage; For whom the appropriate treatment is not adequately covered due to out-of-pocket costs including: Copayments; Coinsurance; or Deductibles; and Who the Department determines does not have the financial means to pay for appropriate treatment. “Uninsured” individual means an applicant who: Either: Does not have private medical insurance, Medical Assistance, Medicare, or Maryland Children's Health Insurance Program coverage; or Has private medical insurance, Medical Assistance, Medicare, or Maryland Children's Health Insurance Program coverage that does not provide insurance coverage for medically necessary services for a cancer treatment service or tobacco treatment product; and Does not have the financial means to pay for a cancer treatment service or tobacco treatment product as defined by the criteria established in this chapter. “University of Maryland Medical Group (UMMG)” means the University of Maryland Medical Systems Corporation, the University of Maryland Medical School, and the University of Maryland, Baltimore. The Department shall: Establish guidelines for defining financial eligibility of an: Uninsured or underinsured individual for the purpose of receiving cancer treatment services under the Cancer Prevention, Education, Screening and Treatment Program; and Uninsured individual for the purpose of receiving tobacco treatment products under the Tobacco Use Prevention and Cessation Program; and Review the written documentation submitted by a local health department or Statewide academic health center to assure that the criteria listed in Regulations .05 and .06 of this chapter are followed. If a local health department or a Statewide academic health center decides that grant funds under the Cigarette Restitution Fund Program will not be used to pay for cancer treatment services or tobacco treatment products: This chapter does not apply; and A local health department or a Statewide academic health center has no further responsibilities with respect to this chapter. If a local health department or a Statewide academic health center decides that grant funds under the Cigarette Restitution Fund Program will be used to pay for cancer treatment services or tobacco treatment products: This chapter applies; and A local health department or a Statewide academic health center shall adhere to the financial guidelines established by the Department for: Cancer treatment services as set forth in Regulation .05 of this chapter; and Tobacco treatment products as set forth in Regulation .06 of this chapter. A local health department or a Statewide academic health center shall use the following financial eligibility criteria for cancer treatment services under the Cancer Prevention, Education, Screening and Treatment Program: The basis for determining financial eligibility shall be the gross annual household income; An applicant with a gross annual household income above 250 percent of the federal poverty level is not eligible to receive cancer treatment services; Written documentation required for determination of the gross annual household income shall include: The household’s most recent federal income tax return; or If a household income tax return was not filed, the following: The most recent W-2 statement; Pay stubs from two consecutive pays; A Social Security entitlement letter; or A notarized letter from the applicant stating that the applicant is not working and does not have any income; The household income level for determining financial eligibility shall be based on the size of the family unit including the applicant and may include the following individuals as verified by the most recent tax return: The applicant’s spouse; Any financially dependent children; or Any financially dependent relative; and The type of written documentation that an applicant shall provide in order to document the size of the family unit includes the following: The most recent income tax return; A divorce decree, if applicable; or If a household income tax return was not filed, written documentation shall include the names, ages, and relationship to the applicant of individuals supported by the gross annual household income. A local health department or a Statewide academic health center may establish requirements for eligibility of cancer treatment services in addition to those cited in §A of this regulation. A local health department shall make tobacco treatment products available free of charge to an individual participating in the Cigarette Restitution Fund Program. 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, §§13-1001—13-1014 and 13-1101—13-1119, Annotated Code of Maryland Effective date: January 15, 2007 (34:1 Md. R. 32) Regulation .01 amended effective March 26, 2018 (45:6 Md. R. 320) Regulation .02B amended effective February 27, 2017 (44:4 Md. R. 254); March 26, 2018 (45:6 Md. R. 320) Regulation .03 amended effective February 27, 2017 (44:4 Md. R. 254) Regulation .03A amended effective March 26, 2018 (45:6 Md. R. 320) Regulation .04B amended effective February 27, 2017 (44:4 Md. R. 254); March 26, 2018 (45:6 Md. R. 320) Regulation .05 repealed and new Regulation .05 adopted effective February 27, 2017 (44:4 Md. R. 254) Regulation .06 repealed and new Regulation .06 adopted effective February 27, 2017 (44:4 Md. R. 254) This chapter: Defines the Cord Blood Transplant Program and Cord Blood Transplant Center Support Fund; Describes how funds may be allocated to the Cord Blood Transplant Center Support Fund; Sets forth the responsibilities of the Maryland Department of Health and the Comptroller with respect to the Cord Blood Transplant Program and Cord Blood Transplant Center Support Fund; Outlines the grant application process for the Cord Blood Transplant Center Support Fund; and Outlines grantee reporting requirements. In this chapter, the following terms have the meanings indicated. Terms Defined. “Comptroller” means the Comptroller of the Treasury. “Cord Blood Transplant Center” means a medical facility that: Uses cells obtained from a human umbilical cord or placenta to treat pediatric or adult patients afflicted with a disease or injury; and Is a member of the National Marrow Donor Program. “Department” means the Maryland Department of Health. “Fund” means the Cord Blood Transplant Center Support Fund. Grant. “Grant” means financial assistance from the State to support an applicant's activities related to cord blood transplantation. “Grant” does not mean a contract. “Program” means the Cord Blood Transplant Program. “Qualified medical institution” means a medical institution that: Is accredited by the Joint Commission on Accreditation of Health Care Organizations; Is located in the State; Has an established hematologic malignancies research program; and Meets all requirements established in the request for proposals issued by the Cord Blood Transplant Program. “Secretary” means the Secretary of Health. There is a Cord Blood Transplant Program in the Department. The purpose of the Program is to provide funding to qualified medical institutions to establish or maintain a cord blood transplant center. The Program administers the Fund to provide grants, subject to the limitations of the State budget, to qualified medical institutions to establish or maintain a cord blood transplant center. The purpose of the Fund is to promote economic development by supporting cord blood transplant centers at qualified medical institutions with a goal of being recognized as a regional center of excellence in the area of cord blood transplantation. The Fund is: A nonlapsing, special fund pursuant to Health-General Article, §13-3001, Annotated Code of Maryland; and Not subject to the State Finance and Procurement Article, §7-302, Annotated Code of Maryland. The Fund consists of any: Money appropriated in the State budget to the Fund; and Other money from any other source accepted for the benefit of the Fund. The Department may only expend funds in accordance with an appropriation approved by the General Assembly in the annual State budget. The Department may only make grant awards under the Fund for the establishment of or support for a cord blood transplant center at a qualified medical institution. Any unspent portions of the Fund shall remain in the Fund and may not revert or be credited to the general fund of the State, nor any other special fund of the State. The Department shall: Administer the Program and perform related administration activities, including: Develop and release an annual request for proposals; Convene an expert panel to review applications and select grantees; and Ensure that grantees remain in compliance with request for proposals requirements; Administer the Fund; Provide a grant or grants in each fiscal year, in accordance with the State budget, to qualified medical institutions; and Maintain records of grantee activities supported by the Fund. A grantee may use awarded funds to establish or maintain a cord blood transplant center, which includes support of: Individuals engaged in the establishment or maintenance of a cord blood transplant center; and Equipment necessary for the establishment or maintenance of a cord blood transplant center. A grantee may not use awarded funds to pay for activities not provided for in the approved grant application. An applicant for a cord blood transplant center grant shall: Submit a completed application to the Department by the due date listed in the annual request for proposals; and Include in the application packet the following information as specified in the annual request for proposals: Executive summary; Statement of the need for funding; Proposed work plan for the grant period; Brief professional resume or curriculum vitae of key staff involved in the grant activities; Description of how the requested funding will further the institution’s goal of being recognized as a cord blood transplantation regional center of excellence; Timeline detailing the expected start and completion dates for each activity to be conducted under the grant; Organizational chart indicating where the work under the grant will be located within the institution; Statement that the grant money will not be used to supplant any existing funding; Line item budget for the grant; and Written budget justification. The Department shall determine the amount of money available for grants under the Cord Blood Transplant Center Support Fund annually. Each year the Program shall consider awarding a grant to at least one qualified medical institution. The Program shall convene a grant evaluation committee to review the grant applications. Members of the evaluation committee may include one or more external individuals with expertise in cord blood transplantation. The evaluation committee shall review grant applications based on criteria stated in the Request for Proposals. The Program shall recommend a grant application to the Secretary for approval based on: The evaluation committee's recommendations for awarding the grants; and The availability of funds. The Secretary shall: Consider the grant award recommendations of the Program; and Make the final determination on which grant applications to approve. A grant period expires 1 year from the date of award of the grant. Payments Under the Grant. The Department may not make more than quarterly payments during the grant period to a grantee awarded a grant under this chapter. Before the first payment under the grant, at the request of the grantee in their submitted grant application, the Department may approve an advanced payment for the grant based on financial need. If a financial or progress report required in §B or C of this regulation is overdue, the Department may withhold payment until the report is submitted. Financial Reports and Records. A grantee shall: Establish a separate account to track expenditures under the grant; Maintain accurate records, including documentation of each transaction pertaining to the grant; and Submit to the Department quarterly invoices for payment and an annual financial expenditure report containing the signature of the financial officer of the entity affiliated with the grant award. The Department may audit the accounts referenced in §B(1) of this regulation at any time. Within 90 days after the date the grant period ends, a grantee shall submit to the Department: A final financial expenditure report; and A refund of any unexpended funds. A grantee shall retain all records pertaining to a grant award for 3 years from the date the final financial expenditure report is submitted under §B(3) of this regulation. In the case of an audit or litigation, the Department may extend the time period under §B(3) or (4) of this regulation until the completion of the audit or litigation. Progress Reports. A grantee shall submit to the Program one electronic copy of: An interim report describing the progress of the grant: 6 months after the date of award of the grant; and Every 6 months until the end of the grant; and Not later than 60 days after the date the grant period ends, a comprehensive final report, that provides a summary of all of the activity conducted under the grant. The Department shall keep research results confidential as required by Health-General Article, §§4-101 — 4-103, Annotated Code of Maryland. Publications. A grantee who publishes results from activities supported by a grant approved by the Secretary under this chapter shall include in the publication the following acknowledgement: “Supported in part with funds from the Cord Blood Transplant Center Support Fund of the Maryland Department of Health.” A grantee shall provide the Department with one electronic copy of any published article pertaining to the activities conducted under the grant. Ownership of Equipment. A grantee: Shall ensure that equipment purchased under a grant under this chapter is used for the sole purpose of the grant; Shall keep an inventory of all equipment purchased; and May not transfer the equipment to another entity without the written permission of the Department. Termination. The Secretary may terminate a grant: If a grantee fails to comply with: The requirements of this chapter; or State, federal, and municipal laws applicable to the performance of research under the grant; If a grantee fails to carry out the purposes for which the grant was awarded; In compliance with a court order; or At the request of the grantee. The Department and the State are not responsible for any expenses incurred by a grantee after cancellation of a grant. The grantee shall return all unexpended funds to the Department within 60 days of termination of a grant. Compliance with Existing Laws. A grantee shall ensure that an activity conducted in the performance of the grant is in compliance with all State, federal, and local laws. Liability. A grantee is solely responsible for the institution's actions relating to the grant-making process or pertaining to activities conducted under a grant award. The State and the Department are not liable for any claims, losses, liabilities, expenses, or damages arising from activities relating to the grant-making process or conducted under a grant awarded under this chapter. Grant Agreements. A grantee shall enter into a grant agreement with the Department. Health-General Article, §§13-3001 — 13-3004, Annotated Code of Maryland Effective date: April 28, 2014 (41:8 Md. R. 472) This chapter sets forth the: Responsibilities of the Maryland Department of Health for the Professional and Volunteer Firefighter Innovative Cancer Screening Technologies Program established by Health-General Article, §§13-4001—13-4007, Annotated Code of Maryland; Responsibilities of a grantee that receives funds under the Professional and Volunteer Firefighter Innovative Cancer Screening Technologies Program; Application process for a grant under the Professional and Volunteer Firefighter Innovative Cancer Screening Technologies Program; and Reporting requirements for the Professional and Volunteer Firefighter Innovative Cancer Screening Technologies Program. In this chapter, the following terms have the meanings indicated. Terms Defined. “Applicant” means an entity that applies to receive a grant under the Professional and Volunteer Firefighter Innovative Cancer Screening Technologies Program. Cancer Screening Test. “Cancer screening test” means a test that is designed to find cancer in an individual who does not present cancer signs or symptoms. “Cancer screening test” includes, but is not limited to: A laboratory test; An imaging procedure; A medical procedure; and A genetic test. “Cost effectiveness” means a comparison between cost and expected health outcomes of a cancer test or intervention. “Department” means the Maryland Department of Health. “Grant” means funds distributed to a grantee under the Professional and Volunteer Firefighter Innovative Cancer Screening Technologies Program. “Grantee” means a local fire department, volunteer fire department, or volunteer fire company approved to receive funds under the Professional and Volunteer Firefighter Innovative Cancer Screening Technologies Program. “Health care provider” means a doctor of medicine or osteopathy, dentist, nurse practitioner, or physician assistant who is authorized to practice by the state in which the individual practices. “Local fire department” means a fire department operating in a Maryland county or Baltimore City. “Program” means the Professional and Volunteer Firefighter Innovative Cancer Screening Technologies Program. “Qualifications” means the education, experience, skills, and licensing of an individual associated with a Program grant application. “Volunteer fire company” means a volunteer fire company operating in a Maryland county or Baltimore City. “Volunteer fire department” means a volunteer fire department operating in a Maryland county or Baltimore City. The Department shall: Administer the Program; Provide one or more grants to local fire departments, volunteer fire companies, or volunteer fire departments to procure innovative cancer screening tests according to Health-General Article, §13-4003(a), Annotated Code of Maryland; Develop and distribute an application for Program grants each fiscal year if funding is available; Maintain a record of information submitted by a grantee to the Department; and Monitor the activities of a grantee to ensure compliance with the requirements of the Program. The following entities are eligible to apply for and receive a grant from the Department under the Program: A local fire department; A volunteer fire company; A volunteer fire department; and If authorized by a local fire department, volunteer fire company, or volunteer fire department, a county. A grantee may use awarded funds to: Procure and administer innovative cancer screening tests that are not otherwise conducted during routine physical examinations or covered by insurance to professional firefighters employed by a local fire department and volunteer firefighters who serve in a volunteer fire company or department; and Pay for activities directly associated with the grant that are approved by the Department. A grantee may not use awarded funds to pay for an activity that is not included in the approved grant application. An applicant: Shall submit a completed application to the Department by the due date listed in the request for applications; Shall include in the application all required information listed in the request for applications, including: The names and qualifications of the health care providers that will advise the applicant on the selection and administration of cancer screening tests; The number of firefighters to be screened; The selection criteria the applicant used to identify firefighters at the highest cancer risk based on the latest scientific and medical research; and A description of each test to be procured by the applicant, including: The claimed accuracy and reliability of the test; The scientific and clinical evidence supporting the claimed accuracy and reliability of the test; Whether the test employs innovative or novel technologies, such as DNA sequencing, genomics, proteomics, metabolomics, machine learning, artificial intelligence, big data analytics, or other state-of-the-art technology; Whether the test has the ability to simultaneously screen for two or more cancer types for which firefighters have a higher incidence or death rate; The cost of the test; and Whether the test is developed, manufactured, or commercialized by a business entity located in the State; and May voluntarily withdraw an application at any time. The county in which a volunteer fire company or department is located shall assist a volunteer fire company or a volunteer fire department in submitting an application. The Department shall: Determine the amount of money available for grants under the Program in each fiscal year; Develop a weighting formula to rate each application received by the Program; Make available the weighting formula on the Program website and include the weighting formula in the request for applications; Request additional information or changes to the application if necessary; and Reject an application that does not meet the application requirements. The Department shall review and prioritize applications based on the quality of the application received and the degree to which the tests listed on the application meet the following criteria: The scientific and clinical evidence supporting the claimed accuracy and reliability of test; Whether the test employs innovative or novel technologies; The ability of the test to simultaneously screen for two or more cancer types; The cost effectiveness of the test; and Whether the test is developed, manufactured, or commercialized by a business entity located in the State. The Department may review an application in consultation with one or more experts in cancer screening. If the Department receives applications for grant funds totaling more than the amount of funds appropriated for the Program, the Department shall award the funds on a pro rata basis. Funds shall be awarded under the Program for a maximum of 1 year.. Payments. The Department may approve an advance payment based on financial need. If a financial or progress report required by §B or C of this regulation is overdue, the Department may withhold payment of funds to a grantee until the financial or progress report is submitted. Financial Reports and Records. A grantee shall: Establish a separate account to track expenditures under the grant; Maintain accurate records, including documentation of each transaction associated with the grant; Submit invoices for payment of grant funds to the Department within the deadline specified by the Department; Submit a final report listing grant expenditures signed by the financial officer or designee of the grantee within the deadline specified by the Department; Submit a final invoice for any unbilled expenditures within the deadline specified by the Department; and Submit a refund of any unexpended funds within the deadline specified by the Department. The Department may audit the accounts referenced in §B(1) of this regulation at any time. A grantee shall retain all records pertaining to a grant for 3 years from the date the final report is submitted under §B(1) of this regulation. In the case of an audit or litigation, the Department may extend the time period under §B(1) or (3) of this regulation until the completion of the audit or litigation. Progress Reports. A grantee shall submit to the Program: Interim reports describing the progress of the grant; and A comprehensive final report that provides a summary of all activities conducted under the grant no later than the deadline specified by the Department, including the: Number of individuals screened; Tests used; Cost of the tests; and Cancers detected by the tests. Publications. A grantee who publishes results from activities supported by a grant approved under this chapter shall include in the publication the following acknowledgement: “Supported in part with funds from the Professional and Volunteer Firefighter Innovative Cancer Screening Technologies Program of the Maryland Department of Health.” A grantee shall provide the Department with one electronic copy of any published article associated with an activity conducted under a grant. Ownership of Cancer Screening Tests. A grantee: Shall ensure that a cancer screening test purchased under a Program grant is used for the sole purpose of the grant; Shall keep an inventory of cancer screening tests purchased; and May not transfer a cancer screening test to another entity without written permission from the Department. Termination. The Department may terminate a grant: If a grantee fails to comply with: The requirements of this chapter; or State, federal, and municipal laws applicable to the grant; If a grantee fails to carry out the purposes for which the grant was awarded; In compliance with a court order; or At the request of the grantee. The Department may not be held responsible for any expenses incurred by a grantee after cancellation of a grant. The grantee shall return all unexpended funds to the Department within 30 days of termination of a grant. Liability. A grantee shall be solely responsible for its actions related to the: Program application process; and Activities conducted under a grant. The Department may not be held liable for any claims, losses, liabilities, expenses, or damages arising from activities related to the: Program application process; or Activities conducted under a grant. Health-General Article, §§13-4001—13-4007, Annotated Code of Maryland Effective date: November 13, 2023 (50:22 Md. R. 975)