Amendment #13 to H.4773

Amendment #13 to H4773

Establishing a statewide sickle cell disease steering committee and registry

Mr. Williams of Springfield moves to amend the bill by adding the following section:

SECTION XXXX. Chapter 32A of the General Laws is hereby amended by adding the following section:-

SECTION 3. (a)(1) Notwithstanding any general or special law to the contrary, there is hereby established a Statewide Steering Committee on Sickle Cell Disease within the Department of Public Health.

(2) The Steering Committee under this section shall consist of:

(A) two representatives from the Massachusetts Sickle Cell Disease Association, including the Executive Director or their designee;

(B) three medical professionals from major Sickle Cell Disease treatment centers in the commonwealth who shall be appointed by the commissioner;

(D) the President of the Massachusetts Chapter of the National Association of Social Workers or their designee;

(E) two members who shall be appointed by the commissioner, one of whom shall be an expert on the biology of the disease, and one of whom shall be an expert on the psycho-social aspect of the disease;

(F) two representatives of the Department of Elementary and Secondary Education who shall be appointed by the commissioner, including one of whom is knowledgeable about the right to comparable education, supportive services, and accommodations under section 504 of the Rehabilitation Act of 1973;

(G) one representative of the Black and Latino Caucus who shall be appointed by the commissioner;

(H) one representative of the Asian Caucus who shall be appointed by the commissioner;

(I) two sickle cell disease patients who shall be appointed by the Governor, one of which shall be over 25 years in age and the other shall be between 18 and 25 years in age;

(J) a parent of a minor child with sickle cell disease who shall be appointed by the Governor;

(K) a parent of a secondary or post-secondary school-age youth with sickle cell disease who shall be appointed by the commissioner; and

(L) one representative who has a background in racial health disparities who shall be appointed by the Governor.

The representatives of nongovernmental organizations shall serve staggered 3–year terms. The appropriate appointing authority shall fill vacancies of unexpired terms within 60 days.

(3) The Steering Committee under this section shall:

(A) establish institution and community partnerships, including hospitals and institutions of higher education;

(B) establish a statewide network of stakeholders, including parents, home health care providers, school-based nurses, and the Massachusetts Sickle Cell Disease Association, who are committed to caring for individuals with sickle cell disease collaboratively in an inclusive setting;

(C) establish a statewide network of racially and culturally competent stakeholders who include general and special education administrators, teachers, and paraprofessionals;

(D) oversee the development of educational materials for individuals with sickle cell disease, the public, and health care providers about the assistance available to such individuals in the commonwealth, including local school district responsibilities for the care of such individuals;

(E) identify funding sources for implementing or supporting the actions, studies, and policies required by federal and state laws and regulations or recommended by the Steering Committee, including funding from:

(i) state, federal, and local government sources; and

(ii) private sources;

(F) investigate and report on a standard of basic, multidisciplinary care for patients across the Commonwealth and

(G) establish subcommittees as appropriate.

(4) The department may, in consultation with the Statewide Steering Committee, provide services relating to sickle cell disease, including:

(A) educational programs on sickle cell disease for individuals affected by the disease, including:

(i) education on the rights of individuals with sickle cell disease, such as, without limitation, the right not to be discriminated against and the right to receive appropriate educational programming, health-related services, and accommodations necessary to access such programming and services;

(ii) expectations, options, and responsibilities of families of individuals with sickle cell disease;

(iii) challenges and responsibilities of caregivers of individuals with sickle cell disease;

(iv) obligations of employees at primary and secondary schools; and

(v) challenges and responsibilities of health care providers;

(B) social services support to individuals with sickle cell disease, including support from social workers and community health workers to provide information on services that may be available to the individual;

(D) genetic counseling;

(E) assistance with any available reimbursement for medical expenses related to sickle cell disease;

(F) education and counseling services for parents and other family members and caretakers after the receipt of sickle cell trait test results from the Newborn Screening Program as required by section 270.006(A)(2)(e) of chapter 105, Code of Massachusetts Regulations, provided that, with the consent of parents and other family members and caretakers, such services may be provided in whole or in part by the Massachusetts Sickle Cell Disease Association; and

(G) any other programs or services necessary to decrease the use of acute care services by individuals with sickle cell disease.

(5) The department shall, in consultation with any other agency of the commonwealth as the department determines appropriate, provide the services in paragraph (4) through community–based organizations, including specifically, pre-K, elementary, and secondary schools as well as institutions for higher education for all affected school-age children, youth, and older students to the extent practicable.

(6) The Steering Committee, in conjunction with the department and other relevant stakeholders, shall study and make recommendations on:

(A) how to enhance access to services for individuals with sickle cell disease with a focus on areas in the commonwealth where there is a statistically high number of individuals with sickle cell disease or in areas where there is a lack of providers with expertise in treating sickle cell disease;

(B) whether to establish a sickle cell disease registry and if recommended, the process and guidelines for establishing a registry and obtaining information consistent with informed consent and protecting data privacy;

(C) how to enhance the coordination of health care services for individuals with sickle cell disease who are transitioning from pediatric to adult health care, including the identification of available resources for individuals who are transitioning and

(D) how to engage with community–based health fairs and other community–sponsored events in areas with a statistically high number of individuals with sickle cell disease to provide outreach and education on living with sickle cell disease and how to access health care services.

(b) in consultation with the Steering Committee, the department shall establish and implement a system that provides information on the sickle cell trait to any individual who has the sickle cell trait and, if the individual is a minor, to the individual’s family.

(1) how the sickle cell trait impacts the health of an individual with the trait;

(2) how the sickle cell trait is passed from a parent to a child and

(3) implications for pregnancy.

(d) The department shall maintain in a conspicuous location on its website a list of resources for health care practitioners to use to improve their understanding and clinical treatment of individuals with sickle cell disease or the sickle cell trait, including information on the health impacts of carrying the sickle cell trait.

(e) For the purposes of this section, the following word shall, unless the context clearly requires otherwise, have the following meaning:-

“Steering Committee”, the Statewide Steering Committee on Sickle Cell Disease.

SCD REGISTRY AND REPORTS- COMPREHENSIVE DATA COLLECTION ON PEOPLE LIVING WITH SCD OR ITS VARIANTS

SECTION 5. (a)(1) Notwithstanding any general or special law to the contrary, the commissioner of public health or designee shall, in accordance with regulations adopted by the Department of Public Health pursuant to subsection (b), and in consultation with the Massachusetts Sickle Cell Disease Association, establish and maintain a system for the reporting of information on sickle cell disease and its variants. Said system shall include a record of the cases of sickle cell disease and its variants which occur in the commonwealth along with such information concerning the cases as may be appropriate to form the basis for: (A) conducting comprehensive epidemiologic surveys of sickle cell disease and its variants in the commonwealth; and (B) evaluating the appropriateness of measures for the treatment of sickle cell disease and its variants.

(2) Hospitals, medical laboratories, and other facilities that provide screening, diagnostic or therapeutic services to patients with respect to sickle cell disease and its variants shall report the information prescribed by the regulation promulgated pursuant to subsection (b).

(3) Any provider of health care who diagnoses or provides treatment for sickle cell disease and its variants, except for cases directly referred to the provider or cases that have been previously admitted to a hospital, medical laboratory or other facility described in paragraph (2), shall report the information prescribed by the regulation adopted pursuant to subsection (b).

(b) The Department of Public Health shall, by regulation:

(1) prescribe the form and manner in which information on cases of sickle cell disease and its variants must be reported in compliance with any applicable federal privacy law;

(2) prescribe the information that must be included in each report, which must include, without limitation: (A) the name, address, age and ethnicity of the patient; (B) the variant of sickle cell disease with which the person has been diagnosed; (C) the method of treatment; (D) any other diseases from which the patient suffers; (E) information concerning the usage of and access to health care services by the patient; and (F) if a patient diagnosed with sickle cell disease and its variants dies, his or her age at death and cause of death; and

(3) establish a protocol for allowing appropriate access to and preserving the confidentiality of the records of patients needed for research into sickle cell disease and its variants;

(4) establish a protocol for allowing information, in accordance with the preceding subsections, to be communicated with the Statewide Steering Committee on Sickle Cell Disease, the Sickle Cell Disease Services Program, and within the department as determined appropriate by the commissioner.

(c) The chief administrative officer of each healthcare facility in the commonwealth shall make available to the commissioner or designee the records of the healthcare facility for each case of sickle cell disease and its variants. The Department of Public Health shall abstract from the records of a healthcare facility or shall require a healthcare facility to abstract from its own records such information as is required by regulations promulgated pursuant to subsection (b). The department shall compile the information in a timely manner and not later than 6 months after receipt of the abstracted information from the health care facility. The department shall, by regulation, adopt a schedule of fees that must be assessed to a healthcare facility for each case from which information is abstracted by the department. Any person who violates this section is subject to an administrative penalty established by regulation by the department.

(d) The department shall publish reports based upon the information obtained pursuant to subsections (a), (b), and (c) and shall make other appropriate uses of the information to report and assess trends in the usage of and access to health care services by patients with sickle cell disease and its variants in a particular area or population, advance research and education concerning sickle cell disease and its variants and improve treatment of sickle cell disease and its variants and associated disorders. The reports must include, without limitation:

(1) information concerning the locations in which patients diagnosed with sickle cell disease and its variants reside, the demographics of such patients and the utilization of health care services by such patients;

(2) the information described in paragraph (1), specific to patients diagnosed with sickle cell disease and its variants who are over 60 years of age or less than 5 years of age; and

(3) information on the transition of patients diagnosed with sickle cell disease and its variants from pediatric to adult care upon reaching 18 years of age.

(e) The department shall provide any qualified researcher whom the department determines is conducting valid scientific research with data from the reported information upon the researcher’s: (1) compliance with appropriate conditions as established under the regulations of the department; and (2) payment of a fee established by the department by regulation to cover the cost of providing the data.

(f) The commissioner or designee shall analyze the information obtained pursuant to subsections (a), (b) and (c) and the reports published pursuant to subsection (d) to determine whether any trends exist in the usage of and access to health care services by patients with sickle cell disease and its variants in a particular area or population.

(g) If the commissioner or designee determines that a trend exists in the usage of and access to health care services by patients with sickle cell disease and its variants in a particular area or population, the commissioner or designee shall work with appropriate governmental, educational and research entities to investigate the trend, advance research in the trend and facilitate the treatment of sickle cell disease and its variants and associated disorders.

(h) The department shall not reveal the identity of any patient, physician, or health care facility which is involved in any reporting required by this section unless the patient, physician or health care facility gives prior written consent to such a disclosure. A person or governmental entity that provides information to the department pursuant to this section shall not be held liable in a civil or criminal action for sharing confidential information unless the person or organization has done so in bad faith or with malicious purpose.

(i) For the purposes of this section, the following words shall, unless the context clearly requires otherwise, have the following meanings:-

“Sickle cell disease and its variants”, an inherited disease caused by a mutation in a gene for hemoglobin in which red blood cells have an abnormal crescent shape that causes them to block small blood cells and die sooner than normal.

SCD REGISTRY AND REPORTS- DATA COLLECTION ON SCD TRAIT

SECTION 6. (a)(1) Notwithstanding any general or special law to the contrary, if a newborn screening for hereditary disorders performed pursuant to section 270.006(A)(2)(e) of chapter 105, Code of Massachusetts Regulations detects the presence of sickle cell trait, the laboratory performing the screening shall notify the physician responsible for the newborn’s care and shall document the patient’s information in the central registry established pursuant to paragraph (2) in a manner and on forms prescribed by the department of public health.

(2) The physician responsible for such newborn’s care shall provide the patient’s parents with information concerning the availability, benefits, and role of genetic counseling performed by a genetic counselor licensed pursuant to section 253 of chapter 112 of the General Laws, including a document available in multiple languages (as determined by the department) that identifies at least 10 genetic counselors and the public health care payers and private health care payers which contract with each such genetic counselor. In the case a physician described in the preceding sentence is not identified, the laboratory described in paragraph (1) shall provide the patient’s parents with such information relating to genetic counseling. Genetic counseling concerning a diagnosis of sickle cell trait shall include, but not be limited to, information concerning the fact that one or both of the parents carries sickle cell trait and the risk that other children born to the parents may carry sickle cell trait or may be born with sickle cell disease.

(b)(1) The commissioner of public health shall establish a central registry of patients diagnosed with sickle cell trait. The information in the central registry shall be used for the purposes of compiling statistical information and assisting the provision of follow-up counseling, intervention, and educational services to patients and to the parents of patients who are listed in the registry including, but not limited to, information concerning the availability and benefits of genetic counseling performed by a genetic counselor licensed pursuant to section 253 of chapter 112 of the General Laws.

(2) The commissioner shall establish a system to notify the parents of patients who are listed in the registry that follow-up consultations with a physician are recommended for children diagnosed with sickle cell trait. Such notifications shall be provided: at least once when the patient is in early adolescence, when the patient may begin to participate in strenuous athletic activities that could result in adverse symptoms for a person with sickle cell trait; at least once during later adolescence, when the patient should be made aware of the reproductive implications of sickle cell trait; and at such other intervals as the commissioner may require.

(3) The commissioner shall establish a system under which the department shall make reasonable efforts to notify patients listed in the registry who reach the age of 18 years of the patient’s inclusion in the registry and of the availability of educational services, genetic counseling, and other resources that may be beneficial to the patient.

(4) Information on newborn infants and their families compiled pursuant to this section may be used by the department and agencies designated by the commissioner of public health for the purposes of carrying out this act, but otherwise, the information shall not be a public record and shall be confidential and not divulged or made public so as to disclose the identity of any person to whom it relates, except as exempted or consented in accordance with section 10 of chapter 66 or section 70G of chapter 111 of the General Laws, respectively.

Additional co-sponsor(s) added to Amendment #13 to H4773

Establishing a statewide sickle cell disease steering committee and registry

Representative:

Russell E. Holmes

David M. Rogers