SUBCHAPTER 43H ‑ SICKLE CELL SYNDROME: GENETIC
COUNSELING:
CHILDREN AND YOUTH SECTION
SECTION .0100 ‑ SICKLE CELL SYNDROME PROGRAM
10A NCAC 43H .0101 RESERVED FOR FUTURE CODIFICATION
10A NCAC 43H .0102 EDUCATION
A program for voluntary testing shall begin no sooner than
60 days after the implementation of an adequate and effective education
program.
History Note: Authority G.S. 130A‑129;
Eff. February 1, 1976;
Readopted Eff. December 5, 1977;
Amended Eff. September 1, 1990.
10A NCAC 43H .0103 TESTING
(a) Testing services are made available to individuals
requesting these services, especially those in the childbearing age groups.
The division shall provide, without cost, testing and counseling services in
conjunction with the local health departments. Voluntary testing shall not be
done without adequate counseling and educational services.
(b) Testing shall be encouraged by the sickle cell syndrome
program on a voluntary individual basis.
History Note: Authority G.S. 130A‑129;
Eff. February 1, 1976;
Amended Eff. April 22, 1977;
Readopted Eff. December 5, 1977;
Amended Eff. September 1, 1990; July 1, 1982.
10A NCAC 43H .0104 RESERVED FOR FUTURE CODIFICATION
10A NCAC 43H .0105 LABORATORY SERVICES
The laboratory services of the state laboratory of public
health shall be available only to health departments and local physicians
unless otherwise approved by the program.
History Note: Authority G.S. 130A‑129;
Eff. February 1, 1976;
Readopted Eff. December 5, 1977;
Amended Eff. September 1, 1990.
10A NCAC 43H .0106 FORMS FOR COLLECTING BLOOD
Forms used for the collection of blood specimens may be
obtained by writing the Sickle Cell Syndrome Program, Division of Public
Health, 1915 Mail Service Center, Raleigh, North Carolina 27699-1915. All information
requested on the form shall be given. Age of patient, blood transfusion
information, and other factors are considered when interpreting the test
results. Final results cannot be reported unless the address of the sender is
indicated on each form.
History Note: Authority G.S. 130A‑129;
Eff. February 1, 1976;
Readopted Eff. December 5, 1977;
Amended Eff. September 1, 1990.
10A NCAC 43H .0107 RESERVED FOR FUTURE CODIFICATION
10A NCAC 43H .0108 RESERVED FOR FUTURE CODIFICATION
10A NCAC 43H .0109 COUNSELING
Adequate follow‑up procedures and counseling
techniques shall be provided to patients who have positive test results.
History Note: Authority G.S. 130A‑129;
Eff. February 1, 1976;
Readopted Eff. December 5, 1977;
Amended Eff. September 1, 1990.
10A NCAC 43H .0110 ELIGIBILITY REQUIREMENTS
(a) Eligibility requirements for medical services shall be
based on income and diagnosis. In order to be considered for medical services,
the individual must be diagnosed as having one of the following disorders:
(1) sickle cell anemia,
(2) sickle cell/hemoglobin D disease,
(3) sickle cell/hemoglobin C disease,
(4) sickle cell beta thalassemia, or
(5) sickle cell hemoglobin that coexist with
other abnormal hemoglobins with symptomatic abnormal clinical manifestations.
(b) Financial eligibility for sickle cell syndrome program
medical services shall be determined in accordance with rules found in 10A NCAC
45A.
History Note: Authority G.S. 130A‑129;
Eff. February 1, 1976;
Amended Eff. April 22, 1977;
Readopted Eff. December 5, 1977;
Amended Eff. September 1, 1990; July 1, 1981.
10a ncac 43h .0111 MEDICAL SERVICES COVERED
The following medical services are covered under the N.C.
Sickle Cell Syndrome Program if the North Carolina Division of Public Health
Sickle Cell Program Supervisor determines that these services are related to
sickle cell disease:
(1) hospital outpatient care including emergency room
visits. The total number of emergency room visits per fiscal year shall not
exceed three times the average number of emergency visits per patient over the
previous two fiscal years, and it will be adjusted annually on July 1.
(2) physicians' office visits;
(3) drugs on a formulary established by the program
based upon the following factors: the medical needs of sickle cell patients,
the efficacy and cost effectiveness of the drugs, the availability of generic
or other less costly alternatives, and the need to maximize the benefits to
patients utilizing finite Program dollars. A copy of this formulary may be
obtained free of charge by writing to the N.C. Sickle Cell Syndrome Program,
1929 Mail Service Center, Raleigh, North Carolina, 27699-1929 or on the
Purchase of Medical Care Services website at http://www.ncdhhs.gov/control/pomcs/guides/billing_sicklecell.pdf;
(4) medical supplies and equipment;
(5) preventive dentistry including education,
examinations, cleaning, and X-rays; remedial dentistry including tooth removal,
restoration, and endodontic treatment for pain prevention; and emergency dental
care to control bleeding, relieve pain, and treat infection; dental care,
including:
(a) preventive dentistry including education,
examinations, cleaning, and X-rays;
(b) remedial dentistry including tooth removal,
restoration, and endodontic treatment for pain prevention; and
(c) emergency dental care to control bleeding,
relieve pain, and treat infection;
(6) eye care (when the Division of Services for the
Blind will not provide coverage); and
(7) the cost of inpatient care per client per year for
a maximum of two admissions per fiscal year.
History Note: Authority G.S. 130A-129;
Eff. February 1, 1976;
Amended Eff. April 22, 1977;
Readopted Eff. December 5, 1977;
Amended Eff. July 1, 1982; January 1, 1982;
Temporary Amendment Eff. November 7, 1983, for a period of 120 days to expire on March 4, 1984;
Amended Eff. October 1, 1984; March 1, 1984;
Temporary Amendment Eff. October 14, 1988, for a period of 180 days to expire on April 12, 1989;
Temporary Amendment Expired April 12, 1989;
Amended Eff. September 1, 1990;
Temporary Amendment Eff. June 19, 1996;
Temporary Amendment Expired March 11, 1997;
Amended Eff. August 1, 2000;
Temporary Amendment Eff. December 17, 2001; December 1, 2001;
Amended Eff. April 1, 2003;
Temporary Amendment Eff. January 27, 2004;
Amended Eff. January 1, 2014; October 1, 2006; July 1,
2004.
10A NCAC 43H .0112 RESERVED FOR FUTURE CODIFICATION
10A NCAC 43H .0113 PROCEDURE FOR REQUESTING SERVICES
(a) Any provider (physician, hospital, dentist) rendering
services to a patient with one of the named disorders may request reimbursement
services through the Sickle Cell Syndrome Program. The request shall be made
by completing the appropriate program authorization request form. The form
shall include:
(1) biographical data of patient;
(2) diagnoses (primary and secondary);
(3) provider information including service
date(s);
(4) request and describe service;
(5) describe and justify treatment or service,
list other providers and state drug information if applicable;
(6) check number services provided for
ambulatory visits and answer all questions pertaining to patient's treatment
and financial support; and
(7) signature of physician or dentist, address
and date of request.
(b) A financial eligibility form shall be submitted in
accordance with rules found in 10A NCAC 45A.
History Note: Authority G.S.130A-129;
Eff. February 1, 1976;
Readopted Eff. December 5, 1977;
Amended Eff. July 1, 1982; April 1, 1982;
Temporary Amendment Eff. June 19, 1996;
Temporary Amendment Expired on March 11, 1997;
Amended Eff. August 1, 2000.
10A NCAC 43H .0114 RESERVED FOR FUTURE CODIFICATION
10A NCAC 43H .0115 REIMBURSEMENT
Reimbursement shall be made in accordance with rules found
in 10A NCAC 45A.
History Note: Authority G.S. 143B‑193;
Eff. February 1, 1976;
Readopted Eff. December 5, 1977;
Amended Eff. April 1, 1982.
10A NCAC 43H .0116 CLAIMS FOR REIMBURSEMENT
Claims for payment shall be submitted in accordance with
rules found in 10A NCAC 45A.
History Note: Authority G.S. 143B‑193;
Eff. February 1, 1976;
Readopted Eff. December 5, 1977;
Amended Eff. April 1, 1982.
10A NCAC 43H .0117 RESERVED FOR FUTURE CODIFICATION
10A NCAC 43H .0118 REIMBURSEMENT RATES
Reimbursement rates for the sickle cell syndrome program are
found in 10A NCAC 45A .0400.
History Note: Filed as a Temporary Rule Eff. August 15,
1982, for a period of 120 days to expire on December 12, 1982;
Authority G.S. 143B‑193;
Eff. October 1, 1982.
SECTION .0200 ‑ SICKLE CELL CONTRACT FUNDS
10A NCAC 43H .0201 RESERVED FOR FUTURE CODIFICATION
10A NCAC 43H .0202 DEFINITIONS
The following definitions shall apply throughout this
Subchapter:
(1) "Sickle cell disease" means sickle cell
anemia (Hgb.SS), sickle C disease (Hgb.SC), sickle D disease (Hgb.SD), sickle‑Thalassemia
(Hgb. S‑Thal), and includes sickle cell hemoglobin that co‑exists
with other abnormal hemoglobins with symptomatic abnormal clinical
manifestations.
(2) "Education" means making the general
population aware of sickle cell syndrome (i.e., the difference between sickle
cell disease and the carrier status of abnormal hemoglobins.) This term also
means educational sessions for provision of sickle cell information to the lay
public and medical and non‑medical professionals.
(3) "Counseling" means a clear communication
of the diagnosis, psychological, social, and genetic factors relating to the
specific condition. Counseling also includes information on risk,
reoccurrence, and prognosis, and alternatives for prevention and treatment of
the condition diagnosed.
(4) "Counseling follow‑up" means that
the initial counseling session was not adequately completed and there is the
need to follow‑up with additional counseling session in order to provide
the necessary genetic information based on test results.
(5) "Case management services" means the
facilitation and provision of medical, educational, and psychosocial services
provided through developing and monitoring individual service care plans.
History Note: Authority G.S. 130A‑124;
Eff. April 1, 1985;
Amended Eff. September 1, 1990.
10A NCAC 43H .0203 PROVIDER ELIGIBILITY
(a) Funds may be awarded to any public or private non‑profit
agency that can demonstrate the capacity to provide comprehensive sickle cell
services as described in Rule .0205 of this Subchapter.
(b) All contract agency staff involved in provision of
comprehensive sickle cell services shall be qualified and adequately trained
within six months after being employed by the agency.
History Note: Authority G.S. 130A‑124;
Eff. April 1, 1985;
Amended Eff. September 1, 1990.
10A NCAC 43H .0204 CLIENT ELIGIBILITY
Anyone who is a resident of North Carolina can receive
sickle cell services as otherwise provided in these Rules. All services
provided by the contract agency shall be provided free of charge.
History Note: Authority G.S. 130A‑124;
Eff. April 1, 1985;
Amended Eff. September 1, 1990.
10A NCAC 43H .0205 SCOPE OF SERVICES
(a) Contract providers shall provide comprehensive sickle
cell services. Comprehensive sickle cell services include education,
counseling, counseling follow‑up, medical reimbursement assistance, and
case management services.
(b) Within the service limitations of this Section and
commensurate with funds available to pay for those services as specified in the
approved contract budget, the number and type of services offered will be
negotiated annually with each provider, approved by the program, and detailed
in the addendum of the contract.
History Note: Authority G.S. 130A‑124;
Eff. April 1, 1985.
10A NCAC 43H .0206 ALLOCATION OF FUNDS
(a) Each provider will receive an allocation based on the
previous year's allocation as long as service objectives are met and delivered
according to all other aspects of the rules of the Section.
(b) New funds shall be distributed based on the following
considerations:
(1) One‑half of the weight shall be given
to the incidence of sickle cell disease in the contractor's service area as a
percentage of the incidence of sickle cell disease in all contractors' service
areas. The incidence of sickle cell disease in all contractors' service areas
shall be considered to be one per 294 of the non‑white population;
(2) One‑quarter of the weight shall be
given to the total rural population in the contractor's service area as a
percentage of the rural population in all contractors' service areas. Rural
population shall be that determined by the most recent official U.S. census;
(3) One‑quarter of the weight shall be
given to the square miles in the contractor's service area as a percentage of
all square miles in all contractors' service areas.
(c) In order to maximize the utilization of sickle cell
funds, in the event a provider is expending funds at a rate which will, if
continued, result in an underexpenditure of funds at the end of the contract
period, the Sickle Cell Syndrome Program may after consulting with the provider
reduce the amount of funds budgeted by an amount consistent with the projected
level of underexpenditure. Funds projected to be unexpended may be reallocated
to other providers in accordance with community needs and performance records.
The Sickle Cell Syndrome Program shall notify the contract provider in writing
prior to any reduction of funds.
(d) A contract is signed annually with each provider. Contracts
for sickle cell funds are subject to annual renewal and are subject to the
availability of funds.
(e) A provider that consistently fails to meet acceptable
levels of performance as determined through site reviews by the program or data
from quarterly and annual reporting forms and has been offered state
consultation and technical assistance, may have sickle cell funding reduced or
discontinued. Recommendations to reduce or discontinue funding to a service
provider must be reviewed and approved by the State Health Director.
History Note: Authority G.S. 130A‑124;
Eff. April 1, 1985;
Amended Eff. December 1, 1987.
10A NCAC 43H .0207 REPORTING REQUIREMENTS
Contract providers shall submit monthly reports on the
Sickle Cell Program's monthly report form. Additional reports may be required
by the program for special programmatic needs.
History Note: Authority G.S. 130A‑124;
Eff. April 1, 1985.
10A NCAC 43H .0208 APPLICATION FOR FUNDS
(a) Contracts for sickle cell funds shall be awarded
through a request for proposal (RFP) process that includes notification of all
contract providers of the eligibility criteria and requirements for funding.
(b) Contract proposals for sickle cell funds shall be sent
to the Children and Youth Section. The proposal shall include the following
information:
(1) A service plan which includes an assessment
of needs, measurable objectives, and strategies for meeting the objectives.
(2) A proposed budget.
(3) An evaluation plan.
(c) Technical assistance in preparing a contract proposal
shall be available from central and regional staff.
(d) The Section shall approve or deny a proposal for funds
or request additional information within 60 days after receipt of a proposal.
If additional information is requested, the local provider shall have 45 days
to submit the information. Failure by the contract provider to submit the
additional information requested within 45 days shall be grounds for denying
the contract proposal. Upon receipt of the additional information, the Section
shall approve or deny a contract proposal for funds within 45 days.
History Note: Authority G.S. 130A‑124;
Eff. April 1, 1985;
Amended Eff. September 1, 1990.
10A NCAC 43H .0209 BUDGET OF CONTRACT FUNDS
Upon approval of an application for contract funds a budget
will be negotiated and a contract signed between the contractee and the
Children and Youth Section.
History Note: Authority G.S. 130A‑124;
Eff. April 1, 1985.
10A NCAC 43H .0210 RENEWAL OF CONTRACT FUNDS
Contracts for sickle cell funds are subject to annual
renewal based upon the extent to which objectives are met as described in
progress reports or site reviews by the program and contract requirements are
met.
History Note: Authority G.S. 130A‑124;
Eff. April 1, 1985.
SECTION .0300 ‑ GENETIC HEALTH CARE
10A NCAC 43H .0301 GENERAL
The Genetic Health Care Program is
administered by the Children and Youth Section.
History Note: Authority G.S. 130A‑124;
Eff. April 1, 1985;
Amended Eff. September 1, 1990.
10A NCAC 43H .0302 RESERVED FOR FUTURE CODIFICATION
10A NCAC 43H .0303 DEFINITIONS
The following definitions shall apply
throughout this Section:
(1) "Division" means the
Division of Public Health.
(2) "Branch" means the
Specialized Services.
(3) "GHC" means Genetic Health
Care.
(4) "Program" refers to the
central office staff responsible for statewide management of the Genetic Health
Care network.
(5) "Provider" means a public
or private nonprofit agency receiving Genetic Health Care Program funds.
History Note: Authority G.S. 130A‑124;
Eff. April 1, 1985.
10A NCAC 43H .0304 PROVIDER ELIGIBILITY
(a) Medical centers which provide pediatric,
obstetrical, and neonatal services are eligible to receive genetic funds.
Consideration will be given to other qualified public or private non‑profit
agencies for special categorical services.
(b) Providers must be able to demonstrate a
capability for providing genetic services as described in Rule .0306 of the
Subchapter.
(1) Each provider must have an
M.D. clinical geneticist and a Master's level genetic counselor. All clinical
and counseling staff must be board‑eligible or board‑certified by
the American Board of Medical Genetics.
(2) Each provider must
demonstrate evidence of an association with a cytogenetics laboratory, the
director of which must be board‑eligible or board‑certified by the
American Board of Medical Genetics.
(c) Current providers are eligible to receive
priority for program funds according to their compliance with rules and
performance expectations.
History Note: Authority G.S. 130A‑124;
Eff. April 1, 1985;
Amended Eff. September 1, 1990.
10A NCAC 43H .0305 CLIENT ELIGIBILITY
Any North Carolina resident suspected of
having a genetic disorder can be referred for genetic services. No family is
denied service because of inability to pay. All families who meet the
financial eligibility of the Children's Special Health Services Program will
receive service free of charge.
History Note: Authority G.S. 130A‑124;
Eff. April 1, 1985;
Amended Eff. September 1, 1990.
10A NCAC 43H .0306 SCOPE OF SERVICES
(a) Providers may utilize the Genetic Health
Care Program funds to provide the following services and programs:
(1) Complete diagnostic
evaluations, genetic counseling, and follow‑up. Diagnostic evaluations
include medical history, medical examination, and all laboratory tests
performed during the work‑up.
(2) Categorical screening
programs.
(3) Community outreach including
education, satellite clinics, and follow‑up.
(b) Providers may not utilize Genetic Health
Care funds for the following:
(1) Salary support for personnel
other than those who provide secretarial or direct clinical genetic services.
(2) Purchase of materials and
equipment unless used primarily in the delivery of genetic services.
(3) Provision of basic clinical
research.
(c) Within the service limitations of this
Section and commensurate with funds available to pay for those services as
specified in the approved contract budget, the number and type of services
offered will be negotiated annually with each provider, approved by the
program, and detailed in the addendum of the contract.
History Note: Authority G.S. 130A‑124;
Eff. April 1, 1985.
10A NCAC 43H .0307 ALLOCATION OF FUNDS
(a) Each provider will receive continuing allocations based
on the previous fiscal year as long as services are provided according to
program rules and service expectations are met, subject to the availability of funds.(b)
New monies will be distributed based on a statewide plan developed by the
program in accordance with the following:
(1) Population at risk;
(2) Service delivery gaps in given localities;
(3) Actual utilization of funds in previous
fiscal years, special population groups, and other management considerations
that relate to a provider's ability to effectively and efficiently use
additional funds.
(c) In order to maximize the utilization of genetic health
care funds, in the event a provider is expending funds at a rate which will, if
continued, result in an underexpenditure of funds at the end of the contract
period, the Genetic Health Care Unit may after consulting with the provider
reduce the amount of funds budgeted by an amount consistent with the projected
level of underexpenditure. Funds projected to be unexpended may be reallocated
to other providers in accordance with community needs and performance records.
The Genetic Health Care Unit shall notify the contract provider in writing
prior to any reduction of funds.
(d) A contract is signed annually with each provider.
Contracts for genetic health care funds are subject to annual renewal and are
subject to the availability of funds.
(e) A provider that consistently fails to meet acceptable levels
of performance as determined through site reviews by the program or data from
quarterly and annual reporting forms and has been offered state consultation
and technical assistance, may have genetic health care funding reduced or
discontinued. Recommendations to reduce or discontinue funding to a service
provider must be reviewed and approved by the State Health Director.
History Note: Authority G.S. 130A‑124;
Eff. April 1, 1985.
10A NCAC 43H .0308 REPORTING REQUIREMENTS
Providers receiving genetic funds must report
client and service data as required by the Children and Youth Section. These
reports are to be submitted on a quarterly basis. An annual report shall be
submitted within 45 days after the end of the contract period summarizing
client and service data, major program achievements and problem areas
accompanied with problem‑solving strategies.
History Note: Authority G.S. 130A‑124;
Eff. April 1, 1985;
Amended Eff. September 1, 1990.
10A NCAC 43H .0309 CLIENT AND THIRD PARTY FEES
(a) Providers are required to bill all
available and appropriate reimbursement sources including at least insurance
companies, Medicaid, other agency providers and parents/guardians. The
Children's Special Health Services Program may not be billed.
(b) Fees will be based on a public schedule
of charges approved by the Division of Public Health. Families that are
financially eligible for the Children's Special Health Services Program may not
be billed.
(c) All fees collected must be budgeted and
expended during the fiscal year earned or within the subsequent fiscal year.
Fees will be utilized, upon approval of the program, to either expand program
services or to reduce the amount of state appropriations.
(d) All fees brought forward from the prior fiscal year
shall be expended prior to the expenditure of state appropriations.
History Note: Authority G.S. 130A‑124;
Eff. April 1, 1985;
Amended Eff. September 1, 1990.
10A NCAC 43H .0310 APPLICATION FOR FUNDS
(a) Grants for special genetic health care
projects shall be awarded through a request for proposal (RFP) process that
includes notification of all contract providers of the eligibility criteria and
requirements for funding.
(b) Grant proposals for genetic health care
funds shall be sent to the Children and Youth Section. The grant proposal
shall include the following information:
(1) A project plan which
includes an assessment of the need for the special project, measurable project
objectives, and strategies for meeting the project objectives.
(2) A proposed budget.
(3) An evaluation plan.
(c) Technical assistance in preparing a grant
proposal shall be available from central and regional genetic health care staff.
(d) The Children and Youth Section shall
approve or deny a grant proposal for special project funds or request
additional information within 60 days after receipt of a grant proposal. If
additional information is requested, the local provider shall have 45 days to
submit the information. Failure by the contract provider to submit the
additional information requested within 45 days shall be grounds for denying
the grant proposal. Upon receipt of the additional information, the Children
and Youth Section shall approve or deny a grant proposal for special project
funds within 45 days.
History Note: Authority G.S. 130A‑124;
Eff. April 1, 1985;
Amended Eff. September 1, 1990.
10A NCAC 43H .0311 BUDGETING OF GRANT FUNDS
Upon approval of an application for grant
funds a budget will be negotiated and a contract signed between the grantee and
the Children and Youth Section.
History Note: Authority G.S. 130A‑124;
Eff. April 1, 1985.
10A NCAC 43H .0312 ANNUAL REPORT
Providers shall submit an annual report to the
Children and Youth Section within 45 days from the close of the contract
period. The report shall include an evaluation addressing progress in meeting
the objectives outlined in the application.
History Note: Authority G.S. 130A‑124;
Eff. April 1, 1985;
Amended Eff. September 1, 1990.
10A NCAC 43H .0313 RENEWAL OF GRANT FUNDS
Contracts for Genetic Health Care funds are
subject to annual renewal based upon the extent to which objectives are met as
described in progress reports or site reviews by the program and contract
requirements are met.
History Note: Authority G.S. 130A‑124;
Eff. April 1, 1985.
10A NCAC 43H .0314 SUBMISSION OF BLOOD SPECIMENS FOR
SCREENING OF NEWBORNS
(a) The attending physician shall draw a blood specimen for
each infant born in North Carolina and shall submit such specimens to the North
Carolina State Laboratory for Public Health for testing for the following
metabolic and other hereditary and congenital disorders:
(1) phenylketonuria (PKU);
(2) galactosemia;
(3) congenital primary hypothyroidism;
(4) congenital adrenal hyperplasia
(21-hydroxylase deficiency); and
(5) sickle cell disease.
(b) Notwithstanding Paragraph (a) of this Rule, parents or
guardians may object to screening in accordance with G.S. 130A‑125(b).
(c) The hearing screening component of the Department's
Newborn Screening Program is found in 10A NCAC 43F .1200.
History Note: Authority G.S. 130A‑125;
Eff. April 1, 1992;
Transferred and Recodified from 15A NCAC 21E .0501 Eff. February 10, 1993;
Amended Eff. April 1, 1994;
Temporary Amendment Eff. October 1, 1999;
Amended Eff. August 1, 2000.
