# COMAR Title 10 — Maryland Department of Health

## Subtitle 14 — Cancer Control

### Chapter 04 — Breast Cancer Program

**Authority:** Health-General Article, §20-116, Annotated Code of Maryland

**Administrative History:** Effective date: November 10, 2003 (30:22 Md. R. 1581)

**Administrative History:** Regulation .04 amended effective March 16, 2015 (42:5 Md. R. 486)

#### Regulation .01 Purpose and Scope.

*COMAR 10.14.04.01*

A. This chapter:

  (1) Establishes the requirements for participating medical providers;

  (2) Sets criteria for applicant eligibility;

  (3) Outlines services covered; and

  (4) 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.

B. This chapter operates in conjunction with the:

  (1) Breast and Cervical Cancer Program; and

  (2) Reimbursement for Breast and Cervical Cancer Diagnosis and Treatment Program, as set forth in COMAR 10.14.02.

C. 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.

#### Regulation .02 Definitions.

*COMAR 10.14.04.02*

A. In this chapter, the following terms have the meanings indicated.

B. Terms Defined.

  (1) “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.

  (2) “Applicant” means an individual who has applied to receive services under this chapter.

  (3) “Biennial” means once every other year.

  (4) “Breast and Cervical Cancer Program” means the program that is:

    (a) Administered by:

      (i) A local health department; or

      (ii) A private entity that contracts with the Department to render services in Baltimore City and Calvert County under the Breast and Cervical Cancer Program;

    (b) Established for the early detection of breast and cervical cancer; and

    (c) Funded by:

      (i) The federal Centers for Disease Control and Prevention;

      (ii) The Breast Cancer Program under Health-General Article, §20-116, Annotated Code of Maryland; or

      (iii) Both.

  (5) “Breast Cancer Program” means the program created by Health-General Article, §20-116, Annotated Code of Maryland, to provide:

    (a) 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;

    (b) Annual screening mammograms and clinical breast examinations to low-income, underinsured and low-income, uninsured women 50 years old or older; and

    (c) Diagnosis and treatment for individuals who are identified by the Breast Cancer Program as being in need.

  (6) “Clinical breast examination” means a physical examination of the breast performed by a health care professional for the purpose of detecting breast cancer.

  (7) “Contract” means the written agreement between a local health department and a health care provider for the provision of breast cancer services.

  (8) “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.

  (9) “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.

  (10) “Department” means the Maryland Department of Health.

  (11) “Diagnosis” means a histopathologic finding of breast cancer in a biopsy specimen.

  (12) “Eligible individual” means an applicant who meets the requirements of Regulation .03 of this chapter.

  (13) “Enrollee” means an eligible individual who has been accepted into the Breast Cancer Program.

  (14) “Free-standing ambulatory surgical center” means a facility that:

    (a) Provides ambulatory surgical services;

    (b) Is physically separate from a hospital or hospital grounds;

    (c) Is certified by Medicare to provide ambulatory surgical services in Maryland or a jurisdiction bordering Maryland under the laws of that jurisdiction; and

    (d) Complies with COMAR 10.09.42.02 and .03B.

  (15) “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:

    (a) Meets one of the following licensure requirements:

      (i) 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;

      (ii) 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;

      (iii) 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

      (iv) 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;

    (b) Provides nursing or physical therapy services in the home; and

    (c) Meets the requirements for participation in Medicare.

  (16) “Hospital” means an institution which is located:

    (a) In Maryland, that is:

      (i) Subject to the provisions of Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland; and

      (ii) Licensed pursuant to COMAR 10.07.01; or

    (b) In a jurisdiction bordering Maryland, that is licensed pursuant to applicable standards established by the jurisdiction in which the hospital is located.

  (17) “Local health department” means a governmental entity that provides public health services on behalf of a county in Maryland or Baltimore City.

  (18) “Mammogram” means an X-ray examination of the breast to detect breast cancer that uses equipment:

    (a) Specifically dedicated for mammography, including:

      (i) X-ray tubes;

      (ii) Filters;

      (iii) Compression devices;

      (iv) Screens;

      (v) Films; and

      (vi) Cassettes; and

    (b) That is designed to deliver an average radiation exposure of less than one rad mid-breast with two views for each breast.

  (19) “Medical Assistance” means the program that:

    (a) Provides comprehensive medical and other health-related care for eligible individuals; and

    (b) Is administered by the State under Title XIX of the Social Security Act, 42 U.S.C. §1396.

  (20) “Medical laboratory” means a laboratory that:

    (a) 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

    (b) Is in compliance with the applicable license requirements for a medical laboratory providing services for Maryland residents including, but not limited to the requirements:

      (i) For Medicare certification;

      (ii) Set forth in Health-General Article, Title 17, Annotated Code of Maryland;

      (iii) Set forth in COMAR 10.10.01 — 10.10.08; and

      (iv) Of the federal Clinical Laboratories Improvement Act, 42 U.S.C. §263a.

  (21) “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.

  (22) “Medicare” means the medical insurance program administered by the federal government under Title XVIII of the Social Security Act, 42 U.S.C. §1395.

  (23) “Nurse anesthetist” means a registered nurse who is:

    (a) Certified as a nurse anesthetist in Maryland or a jurisdiction bordering Maryland under the laws of that jurisdiction; and

    (b) Currently collaborating with an anesthesiologist or other physician who is licensed to practice medicine:

      (i) In Maryland as prescribed by COMAR 10.27.06; or

      (ii) In a jurisdiction bordering Maryland under the laws of that jurisdiction.

  (24) “Nurse practitioner” means a registered nurse who is certified:

    (a) By the Maryland Board of Nursing to engage in the activities specified in COMAR 10.27.07; or

    (b) As a nurse practitioner in a jurisdiction bordering Maryland under the laws of that jurisdiction.

  (25) “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.

  (26) “Participating medical provider under the Reimbursement for Breast and Cervical Cancer Diagnosis and Treatment Program” means any of the following:

    (a) A physician who meets the requirements of COMAR 10.14.02.04A;

    (b) A nurse practitioner who meets the requirements of COMAR 10.14.02.05A;

    (c) A nurse anesthetist who meets the requirements of COMAR 10.14.02.06A;

    (d) A physical therapist who meets the requirements of COMAR 10.14.02.07A;

    (e) A pharmacy that meets the requirements of COMAR 10.14.02.08A;

    (f) A hospital that meets the requirements of COMAR 10.14.02.09A;

    (g) A medical supply company that meets the requirements of COMAR 10.14.02.10A;

    (h) A home health service provider that meets the requirements of COMAR 10.14.02.11A;

    (i) A medical laboratory that meets the requirements of COMAR 10.14.02.12A; or

    (j) A free-standing ambulatory surgical center that meets the requirements of COMAR 10.14.02.13A.

  (27) “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.

  (28) “Physical therapist” means an individual who is licensed or registered to practice physical therapy:

    (a) In Maryland under Health Occupations Article, Title 13, Subtitle 3, Annotated Code of Maryland; or

    (b) In a jurisdiction bordering Maryland under the laws of that jurisdiction.

  (29) “Physician” means an individual who is licensed to practice medicine:

    (a) In Maryland under Health Occupations Article, Title 14, Subtitle 3, Annotated Code of Maryland; or

    (b) In a jurisdiction bordering Maryland under the laws of that jurisdiction.

  (30) “Recipient of service” means an enrollee who has received a covered service under this chapter.

  (31) “Registered nurse” means an individual who is licensed to practice registered nursing:

    (a) In Maryland under Health Occupations Article, Title 8, Subtitle 3, Annotated Code of Maryland; or

    (b) In a jurisdiction bordering Maryland under the laws of that jurisdiction.

  (32) “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.

  (33) “Resident” means an individual who is currently residing in Maryland.

  (34) “Screening” means a medical test to detect cancer.

  (35) “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.

  (36) “Treatment” means the medical management and care of a patient for breast cancer.

  (37) “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.

#### Regulation .03 Overview of Funding and Delivery of Services.

*COMAR 10.14.04.03*

A. 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.

B. Services funded under the Breast Cancer Program shall be delivered through two previously existing programs as follows:

  (1) 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

  (2) Breast cancer diagnostic and treatment services shall be provided to an enrollee through the Reimbursement for Breast and Cervical Cancer Diagnosis and Treatment Program.

C. 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.

#### Regulation .04 Eligibility — Breast and Cervical Cancer Program.

*COMAR 10.14.04.04*

A. To be eligible to receive breast cancer services under this chapter through the Breast and Cervical Cancer Program, an applicant shall:

  (1) Be a resident of Maryland;

  (2) Be 40 years old or older;

  (3) Meet the financial eligibility criteria specified in §B of this regulation;

  (4) Meet the health insurance criteria specified in §C of this regulation; and

  (5) Be determined to be eligible to receive covered services by a:

    (a) Local health department or an agency or organization designated by the local health department; or

    (b) Private entity that contracts with the Department to render services in Baltimore City or Calvert County.

B. Financial Eligibility Criteria.

  (1) Financial eligibility under this chapter is based on annual gross income and family size.

  (2) 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).

  (3) 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:

    (a) The applicant;

    (b) The applicant's spouse;

    (c) The applicant's financially dependent children; and

    (d) The applicant's financially dependent relatives.

C. 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:

  (1) The applicant is not currently covered by health insurance; or

  (2) The applicant is currently covered by health insurance that:

    (a) Does not provide reimbursement for a service covered under this chapter; or

    (b) 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.

D. An applicant may not receive breast cancer services under this chapter through the Breast and Cervical Cancer Program if:

  (1) The applicant is enrolled in Medical Assistance; or

  (2) The applicant is enrolled in a health maintenance organization.

#### Regulation .05 Eligibility — Reimbursement for Breast and Cervical Cancer Diagnosis and Treatment Program.

*COMAR 10.14.04.05*

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.

#### Regulation .06 Covered Services.

*COMAR 10.14.04.06*

A. The following breast cancer services are covered for enrollees under this chapter through the Breast and Cervical Cancer Program:

  (1) Annual clinical breast examinations;

  (2) Mammograms that are provided:

    (a) Annually to enrollees 50 years old or older; and

    (b) At least on a biennial basis to enrollees 40 years old through 49 years old; and

  (3) 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.

B. The following breast cancer services are covered for enrollees under this chapter through the Reimbursement for Breast and Cervical Cancer Diagnosis and Treatment Program:

  (1) A physician's services as described in COMAR 10.14.02.04C;

  (2) A nurse practitioner's services as described in COMAR 10.14.02.05C;

  (3) A nurse anesthetist's services as described in COMAR 10.14.02.06C;

  (4) A physical therapist's services as described in COMAR 10.14.02.07B;

  (5) A pharmacy's services as described in COMAR 10.14.02.08B;

  (6) A hospital's services as described in COMAR 10.14.02.09B;

  (7) A medical supply company's services as described in COMAR 10.14.02.10B;

  (8) A home health service provider's services as described in COMAR 10.14.02.11B;

  (9) A medical laboratory's services as described in COMAR 10.14.02.12B; or

  (10) A free-standing ambulatory surgical center's services as described in COMAR 10.14.02.13B.

C. The following breast cancer services are not covered for enrollees under this chapter:

  (1) A physician's services as described in COMAR 10.14.02.04D;

  (2) A nurse practitioner's services as described in COMAR 10.14.02.05D;

  (3) A nurse anesthetist's services as described in COMAR 10.14.02.06D;

  (4) A physical therapist's services as described in COMAR 10.14.02.07C;

  (5) A pharmacy's services as described in COMAR 10.14.02.08C;

  (6) A hospital's services as described in COMAR 10.14.02.09C;

  (7) A medical supply company's services as described in COMAR 10.14.02.10C;

  (8) A home health service provider's services as described in COMAR 10.14.02.11D;

  (9) A medical laboratory's services as described in COMAR 10.14.02.12C; or

  (10) A free-standing ambulatory surgical center's services as described in COMAR 10.14.02.13C.

#### Regulation .07 Responsibilities of the Department.

*COMAR 10.14.04.07*

The Department shall:

A. 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

B. 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.

#### Regulation .08 Responsibilities of Local Health Departments and Private Entities.

*COMAR 10.14.04.08*

A. A local health department and the private entities in Baltimore City and Calvert County shall:

  (1) 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;

  (2) Reimburse a participating medical provider under the Breast and Cervical Cancer Program for performing covered services on enrollees;

  (3) Determine eligibility of applicants using the criteria specified in Regulation .05 of this chapter;

  (4) Recruit eligible individuals; and

  (5) Provide enrollees, recipients of services, and medical providers with assistance in obtaining program-related information and services.

B. 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.

#### Regulation .09 Funding Availability.

*COMAR 10.14.04.09*

The implementation and ongoing administration of this chapter is contingent upon the availability of funds.