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124996 2021


124975. The Legislature hereby finds and declares that: (a) Each person in the State of California is entitled to healthcare commensurate with his or her health care needs, and toprotection from inadequate health services not in the person's bestinterests. (b) Hereditary disorders, such as sickle cell anemia, cysticfibrosis, and hemophilia, are often costly, tragic, and sometimesdeadly burdens to the health and well-being of the citizens of thisstate. (c) Detection through screening of hereditary disorders can leadto the alleviation of the disability of some hereditary disorders andcontribute to the further understanding and accumulation of medicalknowledge about hereditary disorders that may lead to their eventualalleviation or cure. (d) There are different severities of hereditary disorders, thatsome hereditary disorders have little effect on the normalfunctioning of individuals, and that some hereditary disorders may bewholly or partially alleviated through medical intervention andtreatment. (e) All or most persons are carriers of some deleterious recessivegenes that may be transmitted through the hereditary process, andthat the health of carriers of hereditary disorders is substantiallyunaffected by that fact. (f) Carriers of most deleterious genes should not be stigmatizedand should not be discriminated against by any person within theState of California. (g) Specific legislation designed to alleviate the problemsassociated with specific hereditary disorders may tend to beinflexible in the face of rapidly expanding medical knowledge,underscoring the need for flexible approaches to coping with geneticproblems. (h) State policy regarding hereditary disorders should be madewith full public knowledge, in light of expert opinion and should beconstantly reviewed to consider changing medical knowledge and ensurefull public protection. (i) The extremely personal decision to bear children should remainthe free choice and responsibility of the individual, and should notbe restricted by the state. (j) Participation of persons in hereditary disorders programs inthe State of California should be wholly voluntary, except forinitial screening for phenylketonuria (PKU) and other geneticdisorders treatable through the California newborn screening program. All information obtained from persons involved in hereditarydisorders programs in the state should be held strictly confidential. (k) In order to minimize the possibility for the reoccurrence ofabuse of genetic intervention in hereditary disorders programs, allprograms offering screening programs for heredity disorders shallcomply with the principles established in the Hereditary DisordersAct (Section 27). The Legislature finds it necessary to establish auniform statewide policy for the screening for heredity disorder inthe State of California.124977. (a) It is the intent of the Legislature that, unlessotherwise specified, the program carried out pursuant to this chapterbe fully supported from fees collected for services provided by theprogram. (b) (1) The department shall charge a fee to all payers for anytests or activities performed pursuant to this chapter. The amountof the fee shall be established by regulation and periodicallyadjusted by the director in order to meet the costs of this chapter.Notwithstanding any other provision of law, any fees charged forprenatal screening and followup services provided to persons enrolledin the Medi-Cal program, health care service plan enrollees, orpersons covered by health insurance policies, shall be paid in fulldirectly to the Genetic Disease Testing Fund, subject to all termsand conditions of each enrollee's or insured's health care serviceplan or insurance coverage, whichever is applicable, including, butnot limited to, copayments and deductibles applicable to theseservices, and only if these copayments, deductibles, or limitationsare disclosed to the subscriber or enrollee pursuant to thedisclosure provisions of Section 1363. (2) The department shall expeditiously undertake all stepsnecessary to implement the fee collection process, includingpersonnel, contracts, and data processing, so as to initiate the feecollection process at the earliest opportunity. (3) The director shall convene, in the most cost-efficient mannerand using existing resources, a working group comprised of healthinsurance, health care service plan, hospital, consumer, anddepartment representatives to evaluate newborn and prenatal screeningfee billing procedures, and recommend to the department ways toimprove these procedures in order to improve efficiencies and enhancerevenue collections for the department and hospitals. In performingits duties, the working group may consider models in other states.The working group shall make its recommendations by March 1, 2005. (4) Effective for services provided on and after July 1, 2002, thedepartment shall charge a fee to the hospital of birth, or, forbirths not occurring in a hospital, to families of the newborn, fornewborn screening and followup services. The hospital of birth andfamilies of newborns born outside the hospital shall make payment infull to the Genetic Disease Testing Fund. The department shall notcharge or bill Medi-Cal beneficiaries for services provided underthis chapter. (c) (1) The Legislature finds that timely implementation ofchanges in genetic screening programs and continuous maintenance ofquality statewide services requires expeditious regulatory andadministrative procedures to obtain the most cost-effectiveelectronic data processing, hardware, software services, testingequipment, and testing and followup services. (2) The expenditure of funds from the Genetic Disease Testing Fundfor these purposes shall not be subject to Section 12102 of, andChapter 2 (commencing with Section 10290) of Part 2 of Division 2 of,the Public Contract Code, or to Division 25.2 (commencing withSection 38070). The department shall provide the Department ofFinance with documentation that equipment and services have beenobtained at the lowest cost consistent with technical requirementsfor a comprehensive high-quality program. (3) The expenditure of funds from the Genetic Disease Testing Fundfor implementation of the Tandem Mass Spectrometry screening forfatty acid oxidation, amino acid, and organic acid disorders, andscreening for congenital adrenal hyperplasia may be implementedthrough the amendment of the Genetic Disease Branch ScreeningInformation System contracts and shall not be subject to Chapter 3(commencing with Section 12100) of Part 2 of Division 2 of the PublicContract Code, Article 4 (commencing with Section 19130) of Chapter5 of Part 2 of Division 5 of Title 2 of the Government Code, and anypolicies, procedures, regulations or manuals authorized by thoselaws. (d) (1) The department may adopt emergency regulations toimplement and make specific this chapter in accordance with Chapter3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title2 of the Government Code. For the purposes of the AdministrativeProcedure Act, the adoption of regulations shall be deemed anemergency and necessary for the immediate preservation of the publicpeace, health and safety, or general welfare. NotwithstandingChapter 3.5 (commencing with Section 11340) of Part 1 of Division 3of Title 2 of the Government Code, these emergency regulations shallnot be subject to the review and approval of the Office ofAdministrative Law. Notwithstanding Section 11346.1 and Section11349.6 of the Government Code, the department shall submit theseregulations directly to the Secretary of State for filing. Theregulations shall become effective immediately upon filing by theSecretary of State. Regulations shall be subject to public hearingwithin 120 days of filing with the Secretary of State and shallcomply with Sections 11346.8 and 11346.9 of the Government Code orshall be repealed. (2) The Office of Administrative Law shall provide for theprinting and publication of these regulations in the California Codeof Regulations. Notwithstanding Chapter 3.5 (commencing with Section11340) of Part 1 of Division 3 of Title 2 of the Government Code,the regulations adopted pursuant to this chapter shall not berepealed by the Office of Administrative Law and shall remain ineffect until revised or repealed by the department. (3) The Legislature finds and declares that the health and safetyof California newborns is in part dependent on an effective andadequately staffed genetic disease program, the cost of which shallbe supported by the fees generated by the program.124980. The director shall establish any regulations and standardsfor hereditary disorders programs as the director deems necessary topromote and protect the public health and safety. Standards shallinclude licensure of master level genetic counselors and doctorallevel geneticists. Regulations adopted shall implement theprinciples established in this section. These principles shallinclude, but not be limited to, the following: (a) The public, especially communities and groups particularlyaffected by programs on hereditary disorders, should be consultedbefore any regulations and standards are adopted by the department. (b) The incidence, severity, and treatment costs of eachhereditary disorder and its perceived burden by the affectedcommunity should be considered and, where appropriate, state andnational experts in the medical, psychological, ethical, social, andeconomic effects or programs for the detection and management ofhereditary disorders shall be consulted by the department. (c) Information on the operation of all programs on hereditarydisorders within the state, except for confidential informationobtained from participants in the programs, shall be open and freelyavailable to the public. (d) Clinical testing procedures established for use in programs,facilities, and projects shall be accurate, provide maximuminformation, and the testing procedures selected shall produceresults that are subject to minimum misinterpretation. (e) No test or tests may be performed on any minor over theobjection of the minor's parents or guardian, nor may any tests beperformed unless the parent or guardian is fully informed of thepurposes of testing for hereditary disorders and is given reasonableopportunity to object to the testing. (f) No testing, except initial screening for phenylketonuria (PKU)and other diseases that may be added to the newborn screeningprogram, shall require mandatory participation, and no testingprograms shall require restriction of childbearing, and participationin a testing program shall not be a prerequisite to eligibility for,or receipt of, any other service or assistance from, or toparticipate in, any other program, except where necessary todetermine eligibility for further programs of diagnoses of or therapyfor hereditary conditions. (g) Pretest and posttest counseling services for hereditarydisorders shall be available through the program or a referral sourcefor all persons determined to be or who believe themselves to be atrisk for a hereditary disorder. Genetic counseling shall be providedby a physician, a certified advanced practice nurse with a geneticsspecialty, or other appropriately trained licensed health careprofessional and shall be nondirective, shall emphasize informing theclient, and shall not require restriction of childbearing. (h) All participants in programs on hereditary disorders shall beprotected from undue physical and mental harm, and except for initialscreening for phenylketonuria (PKU) and other diseases that may beadded to newborn screening programs, shall be informed of the natureof risks involved in participation in the programs, and thosedetermined to be affected with genetic disease shall be informed ofthe nature, and where possible the cost, of available therapies ormaintenance programs, and shall be informed of the possible benefitsand risks associated with these therapies and programs. (i) All testing results and personal information generated fromhereditary disorders programs shall be made available to anindividual over 18 years of age, or to the individual's parent orguardian. If the individual is a minor or incompetent, all testingresults that have positively determined the individual to eitherhave, or be a carrier of, a hereditary disorder shall be giventhrough a physician or other source of health care. (j) All testing results and personal information from hereditarydisorders programs obtained from any individual, or from specimensfrom any individual, shall be held confidential and be considered aconfidential medical record except for information that theindividual, parent, or guardian consents to be released, providedthat the individual is first fully informed of the scope of theinformation requested to be released, of all of the risks, benefits,and purposes for the release, and of the identity of those to whomthe information will be released or made available, except for datacompiled without reference to the identity of any individual, andexcept for research purposes, provided that pursuant to Subpart A(commencing with Section 46.101) of Part 46 of Title 45 of the Codeof Federal Regulations entitled "Basic HHS Policy for Protection ofHuman Subjects," the research has first been reviewed and approved byan institutional review board that certifies the approval to thecustodian of the information and further certifies that in itsjudgment the information is of such potentially substantial publichealth value that modification of the requirement for legallyeffective prior informed consent of the individual is ethicallyjustifiable. (k) A physician providing information to patients on expandednewborn screening shall disclose to the parent the physician'sfinancial interest, if any, in the laboratory to which the patient isbeing referred. (l) An individual whose confidentiality has been breached as aresult of any violation of the provisions of the Hereditary DisordersAct, as defined in subdivision (b) of Section 27, may recovercompensatory and civil damages. Any person who negligently breachesthe confidentiality of an individual tested under this article shallbe subject to civil damages of not more than ten thousand dollars($10,000), reasonable attorney's fees, and the costs of litigation.Any person who knowingly breaches the confidentiality of anindividual tested under this article shall be subject to payment ofcompensatory damages, and in addition, may be subject to civildamages of fifty thousand dollars ($50,000), reasonable attorney'sfees, and the costs of litigation, or imprisonment in the county jailof not more than one year. If the offense is committed under falsepretenses, the person may be subject to a fine of not more than onehundred thousand dollars ($100,000), imprisonment in the county jailof not more than one year, or both. If the offense is committed withthe intent to sell, transfer, or use individually identifiablehealth information for commercial advantage, personal gain, ormalicious harm, the person may be subject to a fine of not more thantwo hundred fifty thousand dollars ($250,000), imprisonment in thecounty jail of not more than one year, or both. (m) "Genetic counseling" as used in this section shall not includecommunications that occur between patients and appropriately trainedand competent licensed health care professionals, such asphysicians, registered nurses, and physicians assistants who areoperating within the scope of their license and qualifications asdefined by their licensing authority.124981. (a) No person shall use the title of genetic counselorunless the person has applied for and obtained a license from thedepartment. (b) The applicant for a genetic counselor license shall meetminimum qualifications that include but are not limited to all of thefollowing: (1) Has earned a master's degree or above from a programspecializing in or having substantial course content in genetics. (2) Has demonstrated competence by an examination administered orapproved by the department. (c) The license shall be valid for three years unless at any timeduring that period it is revoked or suspended. The license may berenewed prior to the expiration of the three-year period. (d) To qualify to renew the license, a licenseholder shall havecompleted 45 hours of continuing education units during thethree-year license renewal period. At least 30 hours of thecontinuing education units shall be in genetics. (e) The license fee for an original license and license renewalshall not exceed two hundred dollars ($200).124985. A violation of any of the provisions of the HereditaryDisorders Act (Section 27) or any of the regulations adopted pursuantto that act shall be punishable as a misdemeanor.124990. For the purposes of the Hereditary Disorders Act (Section27), hereditary disorders programs shall include, but not be limitedto, all antenatal, neonatal, childhood, and adult screening programs,and all adjunct genetic counseling services.124995. The following programs shall comply with the regulationsestablished pursuant to the Hereditary Disorders Act (Section 27): (a) The California Children's Services Program under Article 5(commencing with Section 123800) of Chapter 3 of Part 2. (b) Prenatal testing programs for newborns under Sections 125050to 125065, inclusive. (c) Medical testing programs for newborns under the Maternal andChild Health Program Act (Section 27). (d) Programs of the genetic disease unit under Section 125000. (e) Child health disability prevention programs under Article 6(commencing with Section 124025) of Chapter 3 of Part 2 and Section120475. (f) Genetically handicapped person's programs under Article 1(commencing with Section 125125) of Chapter 2. (g) Medi-Cal Benefits Program under Article 4 (commencing withSection 14131) of Chapter 7 of Part 3 of Division 9 of the Welfareand Institutions Code.124996. (a) The Genetic Disease Testing Fund is continued inexistence as a special fund in the State Treasury. The departmentmay charge a fee for any activities carried out pursuant to theHereditary Disorders Act, including licensing activities conductedpursuant to Section 124980. All moneys collected by the departmentunder the act shall be deposited in the Genetic Disease Testing Fund,that is continuously appropriated to the department to carry out thepurposes of the act. (b) It is the intent of the Legislature that the program carriedout pursuant to the act be fully supported from fees collected underthe act. (c) The director shall adopt regulations establishing the amountof fees for activities carried out pursuant to the act. (d) The "Hereditary Disorders Act" or "act" referred to in thissection is the act described in subdivision (b) of Section 27.Disclaimer: These codes may not be the most recent version. California may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.




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