Neb. Admin. Code tit. 181 — Special Health Programs

Chapter 1 Nebraska Chronic Renal Disease Program

Neb. Admin. Code tit. 181, ch. 1 Nebraska Chronic Renal Disease Program {#sec-181-nac-1 omnilex-key=us-ne-regs-official--title-181--181 NAC 1}

001. SCOPE AND AUTHORITY . These regulations implement the Nebraska Chronic Renal Disease Program established by Nebraska Revised Statutes (Neb. Rev. Stat.) §§ 71-4901, 71-4903, and 71-4904.

002. DEFINITIONS . The definitions set out in Neb. Rev. Stat. §§ 71-4901 to 71-4904 and the following are adopted for this chapter.

002.01 ADEQUATE NOTICE. A notice from the Department mailed at least ten days before the effective date of the action(s) that states the action(s) to be taken, the reason(s) for the intended action(s), and the specific regulation that supports or requires the action(s).

002.02 CHRONICKIDNEY DISEASE. The slow loss of kidney function over time. End-Stage Renal Disease (ESRD) is the final stage of chronic kidney disease.

002.03 CLIENT. An individual applying for or receiving assistance from the Nebraska Chronic Renal Disease Program.

002.04 COMPLETE APPLICATION. An initial application or renewal application which contains all of the required information and documentation, with attestation from the applicant to its truth and completeness.

002.05 DEPRIVED. An individual within two years of applying for assistance from the Program who has directly or indirectly given away or sold property for less than fair market value for the purpose of qualifying for assistance.

002.06 EXPLANATION OF BENEFITS. An insurance company’s written explanation regarding a claim showing what it paid on a client’s behalf. May also be called a remittance advice.

002.07 THIRD-PARTY. An entity responsible for, or otherwise under an obligation to provide, the payment of all or part of the cost of the care and treatment of a person with chronic kidney disease or chronic renal disease.

003. ELIGIBILITY AND APPLICATION . To be eligible for participation in the Chronic Renal Disease Program, an applicant must meet all statutory requirements and the following:

(A) Be diagnosed with chronic kidney disease or chronic renal disease;

(B) Require dialysis to maintain or improve his or her condition. An individual who has received a kidney transplant must have been a client prior to receiving the transplant and must be within three years of receiving the transplant in order to be served;

(C) Annual income must be at or below three-hundred (300) percent of the federal poverty level in order to participate. The income level is adjusted based on household size; and

(D) Accept any Medicaid benefits for which the applicant may be eligible and benefits from any other programs, including any third-party payment, to the maximum extent possible.

003.01 APPLICATION. Clients must submit, through the staff at a licensed health clinic where the client receives dialysis, a complete application provided by the Department and the following:

(A) Income-verifying and household information;

(B) Insurance information;

(C) Medical certification that verifies the individual requires dialysis to maintain or improve his or her condition; and

(D) Documentation of:

(i) United States citizenship or alien status; and

(ii) Nebraska residency.

003.02 APPROVAL. An approved application establishes client eligibility for seven years, provided the client continues to meet the eligibility requirements in this chapter. The service start date for a client is the first day of the month in which the complete Department approved application is received by the Department. The service start date may be adjusted upon the discretion of the Department.

003.03 PROVISIONAL APPROVAL. The Chronic Renal Disease Program may assist clients on a provisional basis subject to the limitations noted in this chapter. Provisional services require additional documentation or explanation at the time of application and are provided for 12 (twelve) months or less after which the client must provide updated documentation to continue participation. Provisional services may be adjusted or discontinued at the discretion of the Department. Client situations which may qualify for provisional approval include:

(A) Those who are recently out-of-work due to their chronic kidney disease or chronic renal disease diagnosis;

(B) Those who are homeless;

(D) Those who are awaiting a disability determination due to their diagnosis.

003.04 DENIAL. When an individual does not meet the eligibility requirements in this chapter, the Department must send adequate notice to the individual stating the reason for the denial.

003.05 RE-APPLICATION. To re-apply after a denial, a new complete application is required.

003.06 PAYMENT. Payment for any services prior to the client’s service start date shall not be authorized.

004. MAINTENANCE OF CLIENT ELIGIBILITY . The client, or the client’s representative, is responsible for informing the Department, in writing, within thirty (30) days of the following changes:

(A) When the client’s annual income increases above three hundred (300) percent of the federal poverty level;

(B) In the number of persons living in the home;

(C) To the treatment status which includes whether or not the client is still receiving dialysis, has had a kidney transplant, or has died;

(D) To the client’s residency; or

(E) To the client’s home address and primary phone number.

004.01 RENEWAL APPLICATIONS. A complete application must be submitted for each active client every seven years calculated from the service start date stated in the client eligibility letter. The renewal application must be received by the Department within sixty (60) days of the service end date noted on the client eligibility letter and include the documentation required by this chapter for initial approval.

005. BENEFITS . Benefits are set out below.

005.01 COVERED SERVICES. The Department may assist in paying for the following services that are directly related to the care and treatment of chronic kidney disease or chronic renal disease:

(A) Pharmaceutical products listed on the Chronic Renal Disease Program’s Reimbursable Drug Formulary.

(B) Dialysis procedures listed on the Chronic Renal Disease Program’s Reimbursement Procedures for Dialysis Services. Procedures must be provided through a licensed health clinic as described in 175 Nebraska Administrative Code (NAC) 7.

(C) All services must be prescribed by a licensed health care provider possessing appropriate specialized knowledge in the diagnosis and treatment of chronic kidney disease or chronic renal disease.

005.02 NON-COVERED SERVICES. The Department does not pay for the following:

(A) Any service denied by Medicare, Medicaid or any other health insurance as not medically necessary for the client;

(B) Any service related to the treatment of diabetes or other non-renal related conditions; or

006. LIMITATIONS . The annual amount paid by the Department on behalf of any one client will not exceed one and a one half percent (1.5%) of the amount allocated to the Department to operate the Chronic Renal Disease Program by the Nebraska Legislature for that state fiscal year. This amount may be adjusted upon the discretion of the Department based on the availability of funds and the number of clients served by the Chronic Renal Disease Program. A client will be given adequate notice that he or she has met his or her annual Program allotment. Service costs not covered by the Program after all other available insurance resources have determined and paid their share are the responsibility of the client.

006.01 OUT-OF-STATE SERVICES. Only out-of-state dialysis service providers or pharmacies, within fifty (50) miles of the Nebraska border that have signed a Chronic Renal Disease Program Service Provider Enrollment Form, may receive payment from the Department for providing covered services for a client subject to the limitations noted in this chapter.

006.02 PAYER OF LAST RESORT. The Chronic Renal Disease Program is a payer of last resort. Primary insurance providers, private, Medicaid or Medicare, must be invoiced first and have paid on a client’s behalf before an invoice is sent to the Chronic Renal Disease Program for payment consideration.

006.03 TERMINATION. Clients are no longer eligible for participation in the Chronic Renal Disease Program under the following circumstances:

(A) Clients who stop dialysis treatments will be terminated from participation twelve (12) months after the month in which the course of dialysis is terminated;

(B) Clients who receive a kidney transplant and no longer require dialysis will be terminated from participation thirty-six(36) months after the month in which the kidney transplant is received;

(D) If the client moves out-of-state he or she is terminated from participation effective the date of the move;

(E) If the client fails to provide updated income-verifying or insurance documentation within the time frame requested by the Department;

(F) Misrepresentation on the part of a client;

(G) Upon death;

(H) If there have been no payments for pharmaceutical or dialysis services processed on a client’s behalf in one year. The year is calculated from the start of each state fiscal year;

(I) Failure to inform the Department of changes to the client status as required by this chapter; or

(J) Failure to submit a renewal application when due.

007. PROVIDER REQUIREMENTS AND PAYMENTS . To participate in the Chronic Renal Disease Program, service providers must be licensed by the Department, or its equivalent in another state. Service providers must complete and sign the Chronic Renal Disease Program’s Service Provider Enrollment Form prior to participation. Providers not meeting the standards set out in the Provider Enrollment Form are not eligible to receive payment for covered services.

007.01 PHARMACEUTICAL PAYMENT. Only pharmaceutical products listed on the Chronic Renal Disease Program’s Reimbursable Drug Formulary are eligible for payment. Payments are made in accordance with the Provider Standards noted in the Chronic Renal Disease Program’s Service Provider Enrollment Form and follow the Payment procedures outlined in this chapter. Invoicing procedures are outlined in the Chronic Renal Disease Program’s Reimbursement Procedures for Pharmacies and may be adjusted upon the discretion of the Department.

007.02 PAYMENT DETERMINATION. The pharmaceutical payment amount is based on Nebraska Medicaid fee for service allowable cost. Any remaining cost after the Department has paid is the responsibility of the client. Payment is subject to the limitations in this chapter and is made on behalf of a client directly to the pharmacy.

007.03 DIALYSIS SERVICE PAYMENT. The Department pays up to fifty (50) percent of the client co-pay after all other insurances or third-party payers have paid their share. The payment percentage may be adjusted upon the discretion of the Department. The remaining dialysis service cost after the Chronic Renal Disease Program has paid is the responsibility of the client. Payments are made directly to the service provider in accordance with the Provider Standards in the Chronic Renal Disease Program Service Provider Enrollment Form and follow the Payment procedures outlined in this chapter. Invoicing procedures are outlined in the Chronic Renal Disease Program’s Reimbursement Procedures for Dialysis Services and may be adjusted upon the discretion of the Department.

008. PAYMENT . Payment for pharmaceuticals and dialysis services must be approved by the Department. Claims may be approved for payment when all of the following conditions are met:

(A) A Chronic Renal Disease Program Service Provider Enrollment Form is on file with the Department for the entity claiming payment;

(B) The client was approved for participation when the service was provided;

(D) No more than six months have elapsed from the date of service until when the claim is received by the Chronic Renal Disease Program. Payment may be made by the Department for claims received more than six months after the date of service if the circumstances which delayed the submittal were beyond the provider’s control. The Department may determine whether the circumstances were beyond the provider’s control based on documentation submitted by the provider.

008.01 PROVIDER’S FAILURE TO COOPERATE IN SECURING THIRD-PARTY PAYMENT. The Department shall deny payment of a provider's claims if the provider fails to apply third-party payments to covered services, file necessary claims, or cooperate in matters necessary to secure payment by insurance or other responsible third-parties.

008.02 THIRD-PARTY REFUNDS. Whenever a service provider receives a third-party payment after a claim has been paid by the Department, the provider shall refund the Department for the full amount of the payment. The refund must be accompanied by a copy of the documentation, such as the Explanation of Benefits or electronic coordination of benefits.

009. RIGHT TO A FAIR HEARING . The fair hearing process is conducted in accordance with 184 NAC 1. If a client is denied services, has his or her case terminated or believes the Department acted erroneously, the client may request a fair hearing. The request must be in writing and filed with the Department within (30) days of the mailing date on the written notice from the Department. The request must:

(A) Include a brief summary of the Department’s action being challenged;

(B) Describe the reason for the challenge; and

History

Effective 2022-06-14

Chapter 2 Screening of Infants for Inherited and Congenital Infant-or Childhood-on-Set Diseases

Neb. Admin. Code tit. 181, ch. 2 Screening of Infants for Inherited and Congenital Infant-or Childhood-on-Set Diseases {#sec-181-nac-2 omnilex-key=us-ne-regs-official--title-181--181 NAC 2}

TITLE 181 SPECIAL HEALTH PROGRAMS

CHAPTER 2 SCREENING OF INFANTS FOR INHERITED AND CONGENITAL INFANT OR CHILDHOOD-ON SET DISEASES

001. AUTHORITY. These regulations implement the law governing screening of infants for inherited and congenital infant or childhood-on set diseases, Nebraska Revised Statutes (Neb. Rev. Stat.) §§ 71-519 to 71-524.

002. DEFINITIONS. For purposes of these regulations, the following definitions are hereby adopted.

002.01 CONFIRMATORY TEST. A test or a panel of tests performed following a presumptive positive screening test which provides additional, more specific diagnostic information concerning the existence or non-existence of diseases screened for.

002.02 CUTOFF VALUE. A value on a screening test for a specific disease which gives a high degree of probability that all newborns with a greater or lower value, depending on the test method, will not have the disease.

002.03 DEPARTMENT. The Department of Health and Human Services of the State of Nebraska.

002.04 HOSPITAL. Any facility defined under Neb. Rev. Stat. § 71-419.

002.05 INSTITUTIONAL REVIEW BOARD (IRB). An Institutional Review Board qualifying and complying with requirements in the Code of Federal Regulations (CFR) Title 45 Part 46 Protection of Human Subjects, Effective July 14, 2009.

002.06 LABORATORY. A facility for the biological, microbiological, serological, chemical, immunological, hematological, biophysical, cytological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings. These examinations also include procedures to determine, measure, or otherwise describe the presence or absence of various substances or organisms in the body. Facilities only collecting or preparing specimens (or both) or only serving as a mailing service and not performing testing are not considered laboratories.

002.07 NEWBORN SCREENING ADVISORY COMMITTEE (NBSAC) - APPROVED PROTOCOLS. Follow-up practices recommended by the Newborn Screening Advisory Committee (NBSAC) and adopted by the Nebraska Newborn Screening Program, to rule out or help diagnose conditions in response to screening results that are out-of-range.

002.08 NEWBORN. An infant who is 28 days old or less.

002.09 NEWBORN SCREENING. A laboratory test applied to newborn specimens in a search for newborns with inherited or congenital infant or childhood-on set diseases. Screening will detect a high proportion of newborns with the disease (true positive). Some newborns who do not have the disease will be identified by the screening test as possibly affected (false positive).

002.10 NEWBORN SCREENING ADVISORY COMMITTEE. A committee whose membership is determined by the Department’s Chief Medical Officer which is comprised of a minimum of 15, and maximum of 25, stakeholders and representatives from, but not limited to, the following areas: Newborn and pediatric primary health care providers; medical and allied professionals from the sub-specialties associated with treatment for the disorders screened; clinical laboratorians; and consumers with technical, professional, or personal experience with newborn screening for congenital and inherited disorders.

002.11 PHYSICIAN. A person licensed to practice medicine and surgery or osteopathic medicine and surgery pursuant to the Medicine and Surgery Practice Act.

002.12 PRESUMPTIVE POSITIVE. A screening test result that is above or below the cutoff value or outside the normal range or value determined by an algorithm for assigning an interpretation of presumptive positive, depending on the test method.

002.13 PUBLIC HEALTH. The art and science dealing with the protection and improvement of community health by organized community effort and including preventive medicine and sanitary and social science.

002.14 PUBLIC HEALTH EMERGENCY. The condition that requires the Governor to declare a state of public health emergency. An occurrence or imminent threat of an illness or health condition, caused by bioterrorism, epidemic or pandemic disease, or a novel and highly fatal infectious agent or biological toxin that poses a substantial risk of a significant number of human fatalities or incidents of permanent or long-term disability (World Health Organization (WHO) and Centers for Disease Control and Prevention (CDC), 2001). The declaration of a state of public health emergency permits the Governor to suspend state regulations or change the functions of state agencies, or both.

002.15 PUBLIC HEALTH RESEARCH. Research intended to generate or contribute to generalizable knowledge to improve public health practice. Generalizable knowledge is new information that has relevance beyond the population or program from which it was collected. Intended benefits of the research project may or may not include study participants, but always extends beyond study participants, and usually to society. Data collected exceeds requirements for care of the study participants or extend beyond the scope of the activity.

002.15(A) DEFINING PUBLIC HEALTH RESEARCH. For purposes of defining public health research, “generalizable” does not refer to the statistical concept of population estimation, or to the traditional public health method of collecting information from a sample to understand health in the sampled population. Holding public health activities to a standard of studying every case in order to classify an activity as non-research is not practical or reasonable.

002.16 RESIDUAL DRIED BLOOD SPOTS. The portion of the initial or repeat dried blood spot specimen remaining, after all punches have been removed for testing of the specimen for newborn screening purposes.

002.17 SUBMITTER. The person who sends the Collection and Reporting (CARe) Form to the testing laboratory for initial, repeat, or confirmatory screening tests, including, the hospital, the laboratory, or the physician.

002.18 TEST METHOD. A laboratory examination which measures blood constituents associated with screened diseases.

003. SPECIFICATION OF DISEASES. All infants born in the state of Nebraska must be tested for the diseases identified in Neb. Rev. Stat. § 71-519 and the following diseases:

(A) Argininosuccinic Acidemia;

(B) Beta-ketothiolase Deficiency;

(D) Citrullinemia;

(E) Congenital Adrenal Hyperplasia;

(F) Cystic Fibrosis;

(G) Glutaric Acidemia type 1 ;

(H) Homocystinuria ;

(I) Isovaleric Acidemia ;

(J) Long-chain Hydroxyacyl-CoA Dehydrogenase Deficiency;

(K) Maple Syrup Urine Disease ;

(L) Methylmalonic Acidemia (Mutase Deficiency);

(M) Methylmalonic Acidemia (Cbl A and B);

(N) Multiple Carboxylase Deficiency;

(O) Propionic Acidemia;

(P) Severe Combined Immune Deficiencies;

(Q) Tyrosinemia;

(R) Trifunctional Protein Deficiency;

(S) Very Long-chain Acyl-CoA Dehydrogenase Deficiency;

(T) 3-Hydroxy 3-Methyl Glutaric Aciduria; and

(U) 3-Methylcrotonyl-CoA Carboxylase Deficiency.

004. SPECIMEN COLLECTION.

004.01 SPECIMEN REQUIREMENTS.

004.01(A) SPECIMEN COLLECTION ON APPROVED FORMS. The specimen requirements of the testing laboratory for each specific analyte must be followed. The testing laboratory must accept only specimens that are dried blood spots that have been collected on the form approved by the Department to be used for all Nebraska births.

004.01(B) APPROVED STANDARDS OF COLLECTION. Collection of dried blood spot specimens must comply with the Clinical and Laboratory Standards Institute (CLSI) “Blood Collection on Filter Paper for Newborn Screening Programs; Approved Standard”, 7^th edition, published 2021.

004.01(B)(i) PREFERRED METHOD OF DRIED BLOOD SPOT SPECIMEN COLLECTION. Heel stick with direct application is the preferred method. The submitter must forward the dried blood spots to the testing laboratory within 24 hours of specimen collection. On weekends and holidays if no transport service is available, the next earliest available transport service must be used.

004.01(C) UMBILICAL CORD BLOOD. Umbilical cord blood must not be used.

004.01(D) SUBSTITUTION OF BLOOD. Urine must not be substituted for blood specimens.

004.01(E) COLLECTION AND REPORTING FORM. The Collection and Reporting (CARe) form approved by the Department must be the sole method of form attached to the filter paper collection device for dried blood spot specimen collection for all newborn screening.

005. PHYSICIAN DUTIES.

005.01 SPECIMEN COLLECTION. For all live births, the newborn's physician must cause the collection for testing of a newborn screening specimen for inherited and congenital infant-or childhood-on-set diseases between 24 to 48 hours of age or immediately prior to the newborn's discharge, whichever occurs first.

005.01(A) PRIOR TO 24 HOURS OF AGE. If the initial specimen for any infant is collected prior to 24 hours of age, the newborn's physician or designee must collect or cause to be

005.01(B) SICK, LOW BIRTH WEIGHT, OR PREMATURE INFANTS. Newborns transferred to neonatal intensive care units (NICU) must have a specimen collected prior to transfer, and information communicated as required in this chapter at. The attending physician at the hospital neonatal intensive care unit (NICU) must verify and otherwise ensure a specimen is collected prior to the provision of any treatment, excluding respiratory treatment. The specimen may be collected prior to 24 hours of age. If the first specimen is collected at less than 24 hours of age, or if the newborn was less than 2000 grams at birth, a repeat specimen must be collected at 48-72 hours of age. A third specimen must be collected at 28 days of life or upon discharge, whichever occurs first, on all infants less than 2000 grams at birth, or who had any prior abnormal screen result.

005.01(C) BLOOD TRANSFUSION. If a newborn requires a blood transfusion, even if prior to 24 hours of age, the specimen must be collected before the blood transfusion.

005.01(C)(i) SPECIMEN COLLECTION ASSURANCE AND TIMING PRIOR TO BLOOD TRANSFUSION. The specimen should be collected at the time blood is collected for the typing and cross match prior to transfusion unless a dried blood spot specimen was verified to have been collected prior to the typing and cross match. The newborn's physician or designee must collect or cause to be collected a repeat specimen by 48-72 hours of age if the pre-transfusion specimen was collected at less than 24 hours of age, regardless of prior test results.

005.01(D) NO SPECIMEN COLLECTED. Upon notification by the hospital that a newborn was discharged before a screening sample was collected, the newborn's physician or designee must collect, or cause to be collected, a screening specimen within 48 hours of parental notification.

005.01(E) NEWBORN TRANSFER TO ANOTHER HOSPITAL.

005.01(E)(i) BEFORE 24 HOURS OF AGE. The physician at the hospital of birth must collect, or cause to be collected, a blood specimen immediately prior to discharge for testing for inherited and congenital infant-or childhood-on-set diseases if the newborn is transferred to another hospital, either in- or out-of-state, even if this occurs before the infant is 24 hours of age. If the specimen is collected at less than 24 hours of age, the physician or designee at the hospital of birth must document and inform the receiving physician that a specimen for testing for such diseases was collected prior to 24 hours of age and notify the receiving physician that another specimen must be collected between 48 and 72 hours of age.

005.01(E)(ii) AFTER 24 HOURS OF AGE. The physician at the hospital of birth must collect or cause to be collected a blood specimen for testing for inherited and congenital infant-or childhood-on-set diseases from any newborn being transferred to another hospital after the newborn is 24 hours of age and notify the physician upon transfer that a blood specimen for such diseases has been collected. The transferring physician must immediately notify the receiving physician if the specimen needs to be repeated, or if confirmatory testing is required.

005.01(E)(iii) TRANSFER FORMS. All physicians, or the physician’s designee, transferring newborns to another hospital must notify the receiving physician in writing of the following information and fax or secure email a copy of the written information to the Nebraska Newborn Screening Program (NNSP) within 24 hours:

(1) Date of transfer;

(2) Person completing form or other written notification;

(3) Hospital of birth;

(4) Infant’s name;

(5) Date and time of birth;

(6) Date and time of specimen collection;

(7) Transferring physician;

(8) Whether the newborn screening specimen was or was not collected at the hospital of birth;

(9) Whether the newborn screening specimen was or was not collected prior to 24 hours of age;

(10) Whether the newborn was transfused, and if so, whether the specimen was collected prior to transfusion;

(11) The type and time of transfusion if the specimen was collected post-transfusion;

(12) If the tests have not been performed and an initial specimen needs to be collected;

(13) If the specimen was collected prior to 24 hours, or following transfusion, and a repeat specimen needs to be collected;

(14) Receiving hospital; and

(15) Receiving physician, if known.

005.01(E)(iv) USE OF TRANSFER FORMS TO NOTIFY RECEIVING PHYSICIAN. The transfer form, approved by the Department, may be used to notify the receiving physician, and is included as a convenience for the transferring physician.

005.02 UNSATISFACTORY SPECIMEN. Upon receiving notice from the testing laboratory that a specimen is unsatisfactory, the newborn's physician or designee must collect, or cause to be collected, a repeat specimen within 48 hours of parental notification.

005.03 SCREENING TEST RESULTS RECEIVED. Once the physician receives the results of the newborn screening tests, the physician or designee must place, or cause to be placed, the results in the newborn's patient record.

005.04 PRESUMPTIVE POSITIVE SCREENING TEST RESULT. The newborn's physician or designee must obtain a specimen for repeat or confirmatory testing from the newborn within 48 hours after notification by the testing laboratory of any presumptive positive screening result including out of range, inconclusive, or abnormal interpretations. Repeat dried blood spot specimens must be submitted to the newborn screening laboratory that tested the initial specimen in accordance with approved protocols for follow-up. Confirmatory tests must be ordered, and confirmatory specimens sent in accordance with approved protocols only to laboratories meeting standards established by the Department.

005.05 REASONABLE ATTEMPT. The physician or designee must make a reasonable attempt to cause the collection of a repeat or confirmatory specimen as appropriate to the situation whenever the initial specimen was collected at less than 24 hours or after a transfusion; is determined to be unacceptable for testing for any condition on the screening panel; results of any screening test are out of range, presumptive positive, inconclusive, or abnormal; or if an infant is found to have been discharged without the screen. A reasonable attempt means that the physician or designee must:

(i) Immediately notify the parent, guardian, or custodian by telephone, if possible, and in writing;

(ii) If there has been no response within 5 days, notify the parent, guardian, or custodian in writing by certified mail, return receipt requested, or equivalent; and

(iii) If there has been no response within 10 days of first notification, notify the Nebraska Newborn Screening Program (NNSP) in writing that obtaining the specimen was not accomplished.

005.05(A) ENFORCEMENT. In the event that a parent fails to respond to notification, the physician must assure that such steps are taken as indicated in this chapter and Neb. Rev. Stat. § 71-524.

005.06 PATIENT EDUCATION. The physician or an individual to whom the physician has delegated authority, must:

005.06(A) PHYSICIAN OR PHYSICIAN DELIGATE MUST PROVIDE EDUCATION REGARDING REQUIRED NEWBORN SCREENING. Physician or physician delegate must provide information to the newborn’s parent or legal guardian in accordance with Neb. Rev. Stat. § 71-519(7). There is no provision for dissent from, or refusal of, the required newborn screening tests specified in this chapter.

006. HOSPITAL OR OTHER SUBMITTER DUTIES.

006.01 COLLECTION AND REPORTING FORM. The hospital or other submitter designated by the newborn’s attending physician must complete all information and collect the specimen on the Department approved collection and reporting form. The hospital or other submitter must retain the designated copy for inclusion into the newborn's medical record and send the remaining copies to the testing laboratory designated by the Department within 24 hours after specimen collection.

006.02 NO SPECIMEN COLLECTED. The hospital or other submitter designated by the newborn’s attending physician must immediately notify the newborn's physician or designee by telephone and in writing if the newborn was discharged before a screening sample was collected and document this notification in the newborn's medical record.

006.03 NO TEST RESULTS. The birthing hospital or facility must maintain a monitoring mechanism to track results for all births occurring at or in route and admitted to their facility. If test results are not received by the hospital or other submitter within 10 days after the specimen was submitted to the testing laboratory, the hospital or other submitter must immediately contact the testing laboratory to determine if the testing laboratory received the specimen and performed the appropriate analyses, and document this contact in the newborn's medical record.

006.03(A) PHYSICIAN NOTIFICATION. If the testing laboratory did not receive a specimen, the hospital or other submitter must immediately notify the physician by telephone and in writing and document this notification in the newborn's medical record.

006.03(B) DOCUMENTATION. If the testing laboratory did receive the specimen and completed the appropriate analyses, a duplicate report must be obtained and placed in the newborn’s medical record.

006.03(C) NEBRASKA NEWBORN SCREENING PROGRAM (NNSP) NOTIFICATION. If the testing laboratory did receive the specimen but has not yet performed the appropriate analyses, the hospital or other submitter must immediately notify the Nebraska Newborn Screening Program (NNSP).

006.04 SCREENING TEST RESULTS RECEIVED. When the hospital or other submitter receives the completed copy of the Collection and Reporting (CARe) Form or other record of screening test results from the testing laboratory, the hospital or other submitter must place the screening test results in the newborn’s medical record and appropriately retain those results for 25 years from the newborn’s date of birth.

007. TESTING LABORATORY DUTIES.

007.01 GENERAL RULES.

007.01(A) ELECTRONIC TRANSMISSION. The testing laboratory must report all of the information on the collection and reporting form electronically, at its own expense, to the Nebraska Newborn Screening Program (NNSP) in electronic format that provides complete demographic and test results records for each infant and that provides the reporting functions as specified by the Department in this chapter and in contract. The testing laboratory must provide, at its own expense, the necessary software and hardware.

007.01(B) TEST PERFORMANCE. The testing laboratory must perform all tests required in the contract between the Department and the laboratory at least six days a week.

007.01(C) CONTACT PERSON. The testing laboratory must keep the Nebraska Newborn Screening Program (NNSP) informed of the contact person responsible for newborn screening.

007.01(D) SCREENING TESTS. Except as provided in the disaster preparedness plan as required in the contract, the screening tests must be completed only by the laboratory designated by contract with the Department beginning with the effective date of the contract.

007.01(E) CONFIRMATORY TESTS. Confirmatory tests may be done by any laboratory including the laboratory designated by the Department as long as it is certified under the Clinical Laboratory Improvement Amendments (CLIA) and meets standards as set forth in this chapter. The contracted newborn screening laboratory will append to the laboratory report for all presumptive positive screening results, disorder specific recommendations for immediate testing and clinical follow-up, as approved by the Department.

(i) Confirmatory testing laboratories must be Clinical Laboratory Improvement Amendments (CLIA) certified and maintain data to support validation of the assays and normal reference ranges for neonates and infants for whom confirmatory testing is provided.

(ii) Confirmatory testing laboratories must provide, at a minimum, written or electronic laboratory reports back to the specimen submitter that includes:

(1) Name of the test;

(2) Validated age-appropriate normal reference ranges for the analytes tested when confirming for endocrinopathies (Congenital Adrenal Hyperplasia and Congenital Primary Hypothyroidism) and hemoglobinopathies;

(3) Test method and relative amounts of hemoglobin’s when confirming for hemoglobinopathies;

(4) Identification of ratios when hemoglobin’s A and S are present;

(5) Test results in quantitative values (except hemoglobin’s above) and units of measure consistent with units of measure in the normal reference ranges or values;

(6) Interpretation of results appropriate to the age of the newborn or infant;

(7) Name and address where testing was completed;

(8) Name and phone number of person providing the interpretation; and

(9) Written acknowledgement of conditions that may interfere with the appropriate interpretation of results.

007.02 REPORTING AND RECORD KEEPING. Testing laboratories must maintain records and make reports in the following manner:

007.02(A) ELECTRONIC REPORT. The laboratory must provide an electronic report to the Department which includes the following information:

(i) All information contained on the Department approved form;

(ii) The serial number located on the Department approved form;

(iii) If applicable, identification of any unsatisfactory specimen and the reason for its unsatisfactory nature;

(iv) Screening, repeat, and confirmatory test results, including numerical data where

applicable; and

(v) Any notifications to the physician, the Nebraska Newborn Screening Program (NNSP), or the submitter.

007.02(B) BLOOD SPOT STORAGE, USE, AND DISPOSAL RECORDS. The testing

laboratory must maintain for 25 years an index or catalog of the residual dried blood spots processed in the laboratory that includes the following information:

(i) The serial number or unique identifier of each specimen processed;

(ii) The test results of each specimen processed;

(iii) Verification of disposal of specimens not released for research, public health, quality assurance, or diagnostic purposes. This information may be batched by test completion date so long as each serial number or unique identifier can be linked with its test completion date;

(iv) Date of disposal;

(v) Location of disposal if other than the laboratory;

(vi) For specimens released for public health research, documentation as required in this chapter; and

(vii) Signature of the person who released, disposed of, or witnessed the disposal of the specimen; or for specimens disposed of by a contractor, written evidence that the contract for disposal of residual dried blood spots requires disposal be done in accordance with this chapter.

007.02(C) QUALITY ASSURANCE REPORTS. The testing laboratory must provide to the Nebraska Newborn Screening Program (NNSP), copies of written reports of participation in and results of appropriate quality assurance proficiency testing programs offered by the Centers for Disease Control and Prevention (CDC) of the United States Department of Health and Human Services and any other professional laboratory organization.

007.03 UNSATISFACTORY SPECIMEN. If a specimen is unsatisfactory for any reason for

any test(s), including but not limited to, being of insufficient volume or quality, the testing laboratory must reject it. Within 24 hours of receiving any unsatisfactory specimen, the testing laboratory must:

(A) Notify the submitter and physician or designee by telephone and in writing that the specimen was unsatisfactory and that a repeat specimen must be collected within 48 hours of notification to the parent, guardian, or custodian;

(B) Schedule any tests possible on the specimen received in accordance with the testing laboratory’s standard operating procedure and testing times; and

007.04 NEGATIVE SCREENING, NEGATIVE REPEAT SCREENING, AND NEGATIVE CONFIRMATORY TEST RESULTS. Within 24 hours of obtaining a negative screening, negative repeat screening, or negative confirmatory test result, the testing laboratory must:

(A) Send a copy of the test results to the submitter; and

(B) Enter the applicable information identified in this chapter into the Department’s electronic database or database accessible to the Department.

007.05 PRESUMPTIVE POSITIVE SCREENING, POSTIVE REPEAT SCREENING, OR POSITIVE CONFIRMATORY TEST RESULTS. Immediately after obtaining any presumptive positive screening, positive repeat screening, or positive confirmatory test result, the testing laboratory must:

(A) Provide test result information to the submitter and physician or designee by telephone and in writing;

(B) Utilize the Nebraska Newborn Screening Program (NNSP) telephone number provided by the Department and relay the information on the form approved by the Department and the presumptive positive or positive results; and

007.06 STANDARDIZED LABORATORY TEST METHODS. The testing laboratory must use only the standardized test methods provided for in the contract with the Department and the methods used must produce results for which the specified cutoff value, or cutoff value and algorithms for assigning presumptive positive results are appropriate. The screening test approved analytical method, cutoff value, and algorithms for assigning presumptive positive results (identification protocol) will be specified in the contract between the Department and the laboratory conducting newborn screening testing for the diseases specified in these regulations. Identification protocols used by the performing laboratory must be agreed upon in contract by the Department with the advice of the Newborn Screening Advisory Committee.

007.07 NEWBORN SCREENING ADVISORY COMMITTEE TECHNICAL OVERSITE. The Newborn Screening Advisory Committee is responsible for reviewing technical aspects of the identification protocol for the initial screening test relevant to repeat and confirmatory testing. The Committee must make recommendations for approval, disapproval, or revision to identification protocols. The Department has final decision authority for contractually agreed upon tests, analytic methods, and identification protocols for normal and abnormal results and reporting specifications.

007.08 STORAGE OF RESIDUAL DRIED BLOOD SPOTS. The testing laboratory must store the residual dried blood spots for 90 days. Specimens must be refrigerated in sealed bags of low gas permeability.

007.09 USE OF RESIDUAL DRIED BLOOD SPOTS. Residual dried blood spots may be used for public health research, further patient diagnostic testing, and public health purposes, for example, quality assurance and improvement of newborn screening practices.

007.09(A) REQUIREMENTS FOR USE OF RESIDUAL DRIED BLOOD SPOTS. Residual dried blood spots may be used for public health research only when:

(i) The Division of Public Health Chief Medical Officer and the Newborn Screening Advisory Committee have reviewed and approved the application for research containing, but not limited to, the following information:

(1) The full report of the review and approval of the research by a Human Subjects Review or Institutional Review Board (IRB);

(2) The qualifications of the applicant and of the principal investigator, if other than the applicant, including education, experience, prior publications, and

recommendations of professional colleagues who have knowledge and experience of scientific or medical research;

(3) The purpose of the research project, a summary of the project, and the

anticipated time of completion of the project;

(4) The location where the research project will be conducted and the equipment,

personnel, and other resources available to the applicant to carry out the project;

(5) The identity of the individual or entity funding the research project, a description of the availability of funds for the research project, and any conditions on the receipt or continuation of the funding;

(6) The specific data or biological sample information requested and a description of the use to be made of it and, if subject-identifying data is requested, a substantiation of the need for access to the subject-identifying data;

(7) A description of the measures to be taken to secure the data and biological sample information and to maintain the confidentiality of such during the research project, for disposal of the data and biological sample upon completion of the study, and to assure that the results of the study will not divulge or make public, information that will disclose the identity of any individual subject;

(8) A written assurance agreement that the research will be published in the public domain and communication of research results will not be restricted on the basis of the proprietary interests of commercial, private, or other partners;

(9) A description of the process that will be used for obtaining written consent from the legally responsible parent or guardian of the individuals whose specimens will be requested;

(10) If contact with a subject or subject’s parent or legal guardian is planned or expected beyond obtaining consent as required in this chapter, substantiation of the need for the contact and a description of the method to be used to obtain permission from the subject or subject’s parent or legal guardian for the contact;

(11) Such additional information as the Department determines to be necessary to assure that release of data to the applicant is appropriate and consistent with this chapter; and

(12) A Material Transfer Agreement (MTA) between the newborn screening laboratory responsible for the storage and release of specimens and the specimen recipients. The Material Transfer Agreement (MTA) must address prohibitions on secondary transfer and secondary research of dried blood spot specimens (DBS) without state authorization; data sharing back to the state program; intellectual property rights, publication requirements, and acknowledgement of state resource use in publications.

(ii) Specimens released that meet the requirements of this chapter, with or without patient identifying information, the laboratory must keep records documenting the following:

(1) Who had access to the specimen;

(2) To whom the specimen was released;

(3) The amount of specimen released; and

(4) Evidence from the research entity that written consents were obtained from the legally responsible parent or guardian of the individuals whose specimens were released.

(iii) The blood spot is not released for public health research until after the 90-day storage time. During the 90-day storage time, it must be available for clinical purposes for the patient.

007.09(B) LABORATORY RECORD KEEPING REQUIREMENTS FOR USE OF RESIDUAL DRIED BLOOD SPOTS. Per this chapter must be retained for 25 years.

007.09(C) USE OF RESIDUAL DRIED BLOOD SPOTS FOR PATIENT DIAGNOSTIC TESTING. Residual dried blood spots may be used for patient diagnostic testing when the ordering physician files with the laboratory a written request for specimen retrieval and a written authorization for release of the specimen signed by the parent or legal guardian.

007.09(D) USE OF RESIDUAL BLOOD SPOTS FOR PUBLIC HEALTH PURPOSES. Residual dried blood spots may be used for public health purposes as follows:

(i) They may be used for quality assurance and improvement of newborn screening practices subject to the following:

(1) Only dried blood spots deemed unsatisfactory for testing may be released to the submitting hospital to use as examples of poor specimen quality;

(2) The filter paper portion of the Collection and Report (CARe) Form containing the dried blood spots must be detached from the written patient identification part of the form prior to release;

(3) The bar code and filter paper serial number linking the dried blood spot to the patient identification information must be removed from the residual dried blood spot prior to release; and

(4) Requests for return of unsatisfactory specimens must be made by the submitting facility through the Nebraska Newborn Screening Program (NNSP).

(ii) They may be used for other public health purposes when:

(1) The Division of Public Health Chief Medical Officer has determined there is a

valid public health purpose;

(2) The Division of Public Health Chief Medical Officer has informed the Newborn Screening Advisory Committee about the public health use of the residual dried blood spots;

(3) Patient information linking the specimen to the patient will be protected;

(4) There are assurances that all applicable provisions of federal law will be complied with; and

(5) The blood spot is not released or used for the public health purpose until after the 90-day storage time. During the 90-day storage time it must be available for clinical or identification purposes for the patient unless a public health emergency is declared.

007.10 DATA REPORTS. Reported data may be made available by the Department for purposes of research in aggregate statistical form or de-identified anonymous form. Written requests for release of this data for the purposes of research must be made to the Nebraska Newborn Screening Program (NNSP).

007.11 DISPOSAL OF RESIDUAL DRIED BLOOD SPOTS. Residual dried blood spots not released under this chapter must be disposed of within 30 days of the end of the 90-day storage time. Destruction of the specimens, by incineration, by autoclaving and shredding, or by some other reasonable and prudent means, must ensure that identifying information cannot be linked to the residual dried blood spots.

008. BIRTHS NOT ATTENDED BY A PHYSICIAN. In the event a birth is not attended by a physician, the person registering the birth (who may be the parent) must ensure that:

(A) The newborn has a newborn screening blood spot specimen collected as set out in this chapter (between 24 and 48 hours of birth);

(B) The specimen is submitted to the testing laboratory designated by the Department as set out in this chapter (within 24 hours of collection); and

(C) In response to a positive screening result, a confirmatory specimen is submitted to a testing laboratory in accordance with this chapter within 48 hours of receipt of the newborn screening result.

009. ENFORCEMENT. Enforcement will be as outlined in Neb. Rev. Stat. §§ 71-519 through 71-524.

010. LABORATORY COLLECTION AND REMITTANCE OF FEES. There is hereby assessed a fee of $20 for each infant screened for the diseases specified in this chapter. The laboratory conducting the tests for such diseases must collect a fee of $20 per infant screened, and submit the amounts collected to the Department for credit to the Department of Health and Human Services Cash Fund on a monthly basis.

History

Effective 2024-09-17

Chapter 3 Administrative Appeal Procedures for Applicants, Food Vendors and Local Agencies Participating in Special Supplemental Nutrition Program for Women, Infants and Children (wic Program) and the Commodity Supplemental Nutrition Program (csfp) in the State of Nebraska

Neb. Admin. Code tit. 181, ch. 3 Administrative Appeal Procedures for Applicants, Food Vendors and Local Agencies Participating in Special Supplemental Nutrition Program for Women, Infants and Children (wic Program) and the Commodity Supplemental Nutrition Program (csfp) in the State of Nebraska {#sec-181-nac-3 omnilex-key=us-ne-regs-official--title-181--181 NAC 3}

001. SCOPE AND AUTHORITY . These regulations implement Nebraska Revised Statutes (Neb. Rev. Stat.) §§ 71-2225 to 71-2230.

002. DEFINITIONS . Definitions in 7 Code of Federal Regulations Part 246 and the following definitions apply to this chapter.

002.01 APPLICANT. A person or entity making application to the Department to participate in the Special Supplemental Food Program for Women, Infants and Children (WIC Program), the Commodity Supplemental Food Program (CSFP) or both, as an approved food vendor or local agency.

003. HEARING . An applicant whose application is denied based on vendor selection criteria for minimum variety and quantity of authorized supplemental foods, a vendor whose authorization is denied based on a determination that the vendor is attempting to circumvent a sanction or whose contract is terminated for cause, or a vendor that is disqualified or has a fine or civil money penalty imposed in lieu of disqualification may request a hearing before the Department.

003.01 ACTIONS NOT SUBJECT TO HEARING. The actions listed in 7 CFR 246.18(a)(iii) are not subject to being reviewed in a hearing. An applicant may request an abbreviated administrative review for those actions listed 7 CFR § 246.18 except as otherwise provided.

004. NOTIFICATION OF ADVERSE ACTION . Notification of Adverse Action shall include the following information:

004.01 WRITTEN NOTICE - INITIAL APPLICATION DENIAL. Whenever an application to be a vendor or local agency is denied, the Department shall provide the applicant with a written notice of the denial or adverse action that meets the requirements of 7 CFR 246.18 as of the effective date of this chapter.

004.02 WRITTEN NOTICE – ADVERSE ACTION. Whenever adverse action is taken against a participating vendor or local agency, the Department shall provide the vendor or local agency with a written notice of the adverse action that meets the requirements of 7 CFR 246.18 as of the effective date of this chapter.

004.03 ADVERSE ACTION - FINALITY. The decision to take adverse action is final according to the following.

004.03(A) INITIAL APPLICATION DENIED. The decision to deny an initial application by an applicant to participate in the Program is effective for a vendor on the date of receipt of the notice. A denial of a local agency application is effective immediately. An applicant may request a hearing on the denial within 15 days of the date of the notice.

004.03(B) PARTICIPATING VENDOR OR AGENCY. The decision to take adverse action against a participating vendor shall become final 15 days after the date of the notice and the decision to take adverse action against a local agency shall become final sixty (60 day) days after the date of the notice unless the vendor or local agency, within the applicable period, files a request for hearing with the Department.

005. HEARING PROCEDURE . The procedure for hearings is described below:

005.01 CONDUCT. All hearings shall be conducted in accordance with the 184 Nebraska Administrative Code (NAC) 1.

005.02 DECISION. On the basis of the evidence at the hearing, the determination to take adverse action shall be affirmed, modified, or set aside. A copy of the decision setting forth the bases of the decision, shall be sent by either registered or certified mail to the vendor or local agency within 90 days from the date the Department receives the request for a hearing from a vendor and within 60 days from the date the Department receives the request for a hearing from a local agency. The decision shall become final thirty (30) days after a copy thereof is mailed unless the vendor, or local agency seeks judicial review within such thirty day period in accordance with the Administrative Procedure Act, Neb. Rev. Stat. §§ 84-901 to 84-920.

006. CONTINUING RESPONSIBILITIES . Appealing an adverse action does not relieve a local agency or a vendor permitted to continue in the Special Supplemental Food Program for Women, Infants and Children (WIC Program) or the Commodity Supplemental Food Program (CSFP) while its appeal is in process, from the responsibility of continued compliance with the terms of any written agreement or contract with the local agency or the Department.

History

Effective 2022-06-06

Chapter 4 Special Supplemental Nutrition Program for Women, Infants and Children (wic Program) and the Commodity Supplemental Food Program (csfp) Fair Hearing Procedures

Neb. Admin. Code tit. 181, ch. 4 Special Supplemental Nutrition Program for Women, Infants and Children (wic Program) and the Commodity Supplemental Food Program (csfp) Fair Hearing Procedures {#sec-181-nac-4 omnilex-key=us-ne-regs-official--title-181--181 NAC 4}

001. SCOPE AND AUTHORITY . These regulations implement Nebraska Revised Statute (Neb. Rev. Stat.) §§ 71-2225 to 71-2230.

002. DEFINITIONS . Definitions in 7 Code of Federal Regulations (CFR) Part 246 and Part 247 and the following definitions apply to this chapter.

002.01 ADVERSE ACTION. Any action by the local agency or the Department which results in a) a claim against the participant for repayments of the cash value of improperly issued benefits, b) the denial of participation in the program to an applicant, or c) the participant's disqualification from the program.

002.02 PROGRAM. The Special Supplemental Nutrition Program for Women, Infants and Children or the Commodity Supplemental Food Program.

002.03 REQUEST FOR HEARING. Any clear expression, either verbal or written, by the applicant or participant, the applicant or participant's parent, caretaker, or other representative that he or she desires an opportunity to present his or her case to the Department or other higher authority.

003. RIGHT OF FAIR HEARING . The Department shall grant the right of fair hearing whenever an applicant or a participant is the subject of an adverse action by a local agency.

003.01 NOTICE OF APPEAL RIGHTS. The local agency taking the adverse action shall inform each applicant or participant in writing of the adverse action and include the information required by 7 CFR 246.9 or 247.33 as applicable. In the event a participant is disqualified or a claim is made for cash repayment, notification of such action shall be given at least (15) days before the effective date of the adverse action. In the event of dual participation in more than one program, the adverse action is effective immediately.

003.02 REQUEST FOR HEARING. The local agency shall not limit or interfere with the applicant or participant's freedom to request a hearing.

003.02(A) REQUEST SUBMISSION. The request for a fair hearing shall be submitted to the local agency and then transmitted to the Department or may be submitted directly to the Department. The Local Program Director is responsible for sending the request to the Department.

003.02(B) REQUEST FORMAT. The request for hearing shall be signed by the applicant, the participant, or the applicant or participant's parent, caretaker, or other representative, and shall contain sufficient information to identify the applicant or participant and the adverse action regarding for which the request is being made. No particular written form shall be required. The local agency or the Department shall put the request for a hearing in writing, if necessary.

004. NOTIFICATION OF ADVERSE ACTION . The local agency taking the adverse action shall inform each applicant or participant in writing of the adverse action and include the information required by 7 CFR Part 246.9 or 247.33 as applicable.

004.01 INITIAL APPLICATION OR DENIAL. The written notice of adverse action shall include the cause or causes for such action, the effective date of the action, and applicant's appeal rights as set forth in this chapter. Such notification shall be provided by the agency taking the adverse action.

004.02 ADVERSE ACTION. Whenever adverse action is taken against a participant disqualifying him or her from the program, such participant shall be provided with 15 days advance written notice of the adverse action, the cause or causes for such action, the effective date of the action, and the participant's right to request a hearing as described in this chapter. If a claim is pursued against a participant seeking repayment of the cash value of improperly issued benefits, such participant shall be provided with the information stated above and, in addition, the reason(s) for the claim, and the value of the improperly issued benefits which must be paid. Such notification shall be provided by the agency taking the adverse action.

005. TIME LIMIT FOR REQUEST . Adverse actions shall follow appropriate timelines as described below.

005.01 PERIOD FOR REQUESTING A HEARING. An applicant or participant who has been notified of adverse action may request a fair hearing before the Department as provided in 7 CFR Part 246.9 or 247.33 as applicable.

005.02 DENIAL OR DISMISSAL OF REQUEST. The Department shall not deny or dismiss a request for a fair hearing except as provided in 7 CFR Part 246.9 or 247.33 as applicable.

005.03 CONTINUATION OF BENEFITS. A participant who appeals a disqualification notice before the disqualification takes effect shall continue to receive program benefits until the hearing official reaches a decision or the certification period expires, whichever occurs first. A participant whose certification period has expired or who becomes categorically ineligible may not receive benefits after the certification period has ended. An applicant either at initial certification or whose certification has expired or has become categorically ineligible during the certification period may not receive benefits during the hearing process.

005.04 TIMING OF NOTICE AND HEARING. The Department shall set the date, time, and place of the hearing within seven (7) calendar days after it receives a request for a fair hearing.

005.04(A) NOTICE. The Department shall send the notice of hearing to the applicant or participant to ensure receipt no later than ten (10) calendar days before the hearing, using certified or registered mail.

005.04(B) HEARING. A hearing shall be held within twenty-one (21) calendar days of receipt of the request for a fair hearing, unless the appellant requests a continuance or the hearing officer orders a continuance, as provided in this chapter.

006. RESCHEDULING OPPORTUNITY . An applicant or participant shall be provided with one opportunity to reschedule the hearing date upon specific written request submitted to the Department. The hearing date may also be rescheduled at the order of the hearing official or officer. Any continued hearing shall be held within thirty-one (31) calendar days of the request for hearing, unless good cause is demonstrated for not holding the hearing within such period of time.

007. RIGHTS OF APPLICANT OR PARTICIPANT . The Department shall specifically provide the appellant or representative an opportunity to examine the documents and record appeal, prior to and during the hearing. Appellants or representatives shall also have the opportunity to be represented or assisted by a person other than the participant or applicant as follows:

(A) Be represented by legal counsel, which means any person licensed to practice law in Nebraska;

(B) Be assisted by other persons, such as a relative or friend, except that such other person may not provide legal advice, serve as an advocate or spokesperson, question witnesses or otherwise assume duties customarily performed by persons engaged in the practice of law;

(D) Advance arguments without undue interference;

(E) Question or refute any testimony or evidence, including an opportunity to confront and cross-examine adverse witnesses; and

(F) Submit evidence to establish all pertinent facts and circumstances in the case.

008. HEARING DECISIONS . On the basis of the evidence presented at the hearing, the determination to take adverse action shall be affirmed, modified, or set aside. A copy of the decision setting forth the findings of fact and reasons upon which the decision is based shall be sent by either registered or certified mail to the applicant or participant at his or her last address of record within forty-five (45) days of the receipt of the request for a hearing. This decision shall become final thirty (30 days) after the copy is mailed unless the applicant or participant appeals within such thirty day period in accordance with the Administrative Procedure Act, Neb. Rev. Stat. §§ 84-901 to 84-920.

009. POST DECISION BENEFITS . Benefits to the applicant or participant shall be handled as follows:

009.01 DECISIONS FOR APPLICANT OR PARTICIPANT. If the decision is in favor of the applicant or participant and benefits were denied or discontinued, benefits shall begin immediately.

009.02 DISQUALIFICATION. If the decision concerns disqualification and is in favor of the agency, the local agency shall terminate continued benefits, as indicated in the decision, as soon as administratively feasible.

009.03 REPAYMENT OF BENEFITS. If the decision regarding repayment of benefits by the participant is in favor of the agency, the local agency or the Department shall resume efforts to collect the claim, even during the pendency of judicial review.

History

Effective 2021-04-25

Chapter 6 Cancer Drug Repository Program

Neb. Admin. Code tit. 181, ch. 6 Cancer Drug Repository Program {#sec-181-nac-6 omnilex-key=us-ne-regs-official--title-181--181 NAC 6}

001. SCOPE AND AUTHORITY . These regulations apply to the Cancer Drug Repository Program Act pursuant to Nebraska Revised Statutes (Neb. Rev. Stats.) §§ 71-2422 to 71-2430.

002. DEFINITIONS . Definitions set out in Neb. Rev. Stat. § 71-2423 apply to this chapter.

003. DONATING CANCER DRUGS . Any person or entity who wishes to donate cancer drugs to the program must contact a participant to obtain a form on which they must specify the cancer drug to be donated. The form must include:

(A) Name of the cancer drug;

(B) Quantity of the cancer drug;

(D) The relationship between the person or entity donating the cancer drugs and the person to whom the cancer drug was prescribed;

(E) Signature of the person donating the cancer drug; and

(F) Date the form was signed.

003.01 ACCEPTABLE CANCER DRUGS. Acceptable drugs for dispensing or distribution under the program include those listed by category in Neb. Rev. Stat. § 71-2426 and includes the following: any cancer drug that does not require refrigeration, freezing, or other special temperature requirements beyond controlled room temperature.

003.02 UNACCEPTABLE CANCER DRUGS. Cancer drugs that are not acceptable for dispensing or distribution under the program are those set out in Neb. Rev. Stat. §§ 71-2426, any cancer drug that requires refrigeration, freezing, or other special temperature requirements beyond controlled room temperature because the safety of the cancer drug can no longer be ensured, or any cancer drug that is a controlled substance because federal law prohibits their return.

004. DISPENSING AND DISTRIBUTION REQUIREMENTS . Only those licensees who are authorized to dispense as set out in Neb. Rev. Stat. § 38-2850 may dispense cancer drugs.

004.01 AUTHORIZED TO DISPENSE. The following persons are authorized pursuant to Neb. Rev. Stat. § 38-2850 to dispense drugs:

(A) Licensed physicians who do not charge a handling fee for the cancer drugs;

(B) Licensed physicians who charge a handling fee for the cancer drugs and who hold a valid dispensing practitioner pharmacy license; and

004.02 ACCEPTABLE USES OF DONATED DRUGS. Cancer drugs accepted by a participant from the donor may be:

(A) Dispensed to an ultimate user of the cancer drug; or

(B) Distributed to another participant for dispensing.

004.03 PATIENT NOTIFICATION. Patients for whom cancer drugs are dispensed under the program must be notified by the prescribing practitioner that the cancer drugs they receive were originally dispensed to another patient and were returned for re-dispensing through the program.

004.04 STORAGE REQUIREMENTS. The participant that receives donated cancer drugs for dispensing or distribution must:

(A) Provide equipment for the storage of cancer drugs donated to the program at controlled room temperature that must be stored between 59 and 86 degrees Fahrenheit;

(B) Maintain the inventory of donated cancer drugs separate from all other drug inventory of the participant; and

004.05 RECORD KEEPING REQUIREMENTS. A perpetual inventory log of all cancer drugs received, dispensed and distributed by a participant under the program must be maintained.

004.05(A) PERPETUAL LOG BOOK REQUIREMENTS. The perpetual inventory log must contain the following information regarding all cancer drugs received, dispensed and distributed by a participant under the program:

(i) Name of the cancer drug;

(ii) Quantity of the cancer drug;

(iii) Expiration date of the cancer drug;

(iv) Lot number of the cancer drug;

(v) Name of participant;

(vi) Name of person who donated the cancer drug;

(vii) Name of person to whom the cancer drug was originally prescribed;

(viii) Name of person to whom the cancer drug was dispensed;

(ix) Date the cancer drug was dispensed;

(x) Name of the prescribing practitioner who wrote the prescription for the cancer drug to be dispensed under the program;

(xi) Name of the participant to which the cancer drug was distributed;

(xii) Date the cancer drug was distributed to another participant;

(xiii) Date of destruction of the expired cancer drug; and

(xiv) Whether a handling fee was charged and the amount of any such fee.

004.05(B) RECORDS RETENTION. Copies of all prescriptions dispensed must be maintained by the participant to document the receipt of a prescription for the cancer drug to be dispensed and must be kept for 5 years pursuant to Neb. Rev. Stat. § 38-2871.

004.06 HANDLING FEE. A handling fee may be charged for dispensing donated drugs.

004.06(A) DISPENSING PERMIT. A participant that receives donated cancer drugs may charge a handling fee to the ultimate user for dispensing or distribution of cancer drugs under the program, except that a physician must hold a valid dispensing practitioner pharmacy license in order to charge the handling fee.

004.06(B) FEE LIMITS. If a handling fee is charged to the ultimate user to whom the cancer drug is dispensed or to the entity to which the cancer drug was distributed, the handling fee must not exceed the Medicaid provider dispensing fee that is applicable at the time the dispensing or distribution occurs.

005. PARTICIPANT REGISTRY . Any licensee listed in 181 Nebraska Administrative Code (NAC) 6-004 that wants to participate in the program must provide the Department with the information set out in Neb. Rev. Stat. §71-2430. It is the responsibility of a participant to notify the Department of any change in the required information or when the participant no longer wishes to participate in the program.

History

Effective 2020-12-23

Chapter 7 Immunosuppressant Drug Repository Program

Neb. Admin. Code tit. 181, ch. 7 Immunosuppressant Drug Repository Program {#sec-181-nac-7 omnilex-key=us-ne-regs-official--title-181--181 NAC 7}

001. SCOPE AND AUTHORITY . These regulations implement the Immunosuppressant Drug Repository Program under Nebraska Revised Statutes (Neb. Rev. Stat.) §§ 71-2436 to 71-2443 of the Immunosuppressant Drug Repository Program Act, and the Uniform Credentialing Act.

002. DEFINITIONS . Definitions set out in the Immunosuppressant Drug Repository Program Act apply to this chapter.

003. DONATING IMMUNOSUPPRESSANT DRUGS . Any person or entity who wishes to donate immunosuppressant drugs to the program must contact a participant to obtain a form on which they must specify the immunosuppressant drug to be donated. The form must include:

(A) Name of the immunosuppressant drug;

(B) Quantity of the immunosuppressant drug;

(D) The relationship between the person or entity donating the immunosuppressant drug and the person to whom the immunosuppressant drug was prescribed;

(E) Signature of the person donating the immunosuppressant drug; and

(F) Date the form was signed.

003.01 ACCEPTABLE IMMUNOSUPPRESSANT DRUGS. Acceptable drugs for dispensing or distribution under the program include those listed by category in Neb. Rev. Stat. § 71-2440 and includes any immunosuppressant drug that does not require refrigeration, freezing, or other special temperature requirements beyond controlled room temperature.

003.02 UNACCEPTABLE IMMUNOSUPPRESSANT DRUGS. Unacceptable drugs for dispensing or distribution under the program include those listed by category in Neb. Rev. Stat. § 71-2440 and the following:

(A) An immunosuppressant drug that requires refrigeration, freezing, or other special temperature requirements beyond controlled room temperature because the effectiveness and safety of the immunosuppressant drug cannot be ensured; or

(B) Controlled substances because Federal Law prohibits their return.

004. DISPENSING AND DISTRIBUTION OF IMMUNOSUPPRESSANT DRUGS . Only those licensees who are authorized to dispense as set out in Neb. Rev. Stat. § 38-2850 may dispense immunosuppressant drugs.

004.01 DISPENSING AND DISTRIBUTION REQUIREMENTS. Participants must meet the requirements set out in Neb. Rev. Stat. § 71-2441 and these regulations.

004.01(A) AUTHORIZED TO DISPENSE. The following persons are authorized pursuant to Neb. Rev. Stat. § 38-2850 to dispense drugs:

(i) Licensed physicians who do not charge for the drugs;

(ii) Licensed physicians who hold a valid dispensing practitioner pharmacy license; and

(iii) Licensed pharmacists.

004.01(B) ACCEPTABLE USES OF DONATED DRUGS. Immunosuppressant drugs accepted by a participant from the donor may be:

(i) Dispensed to an ultimate user of the immunosuppressant drug; or

(ii) Distributed to another participant for dispensing.

004.01(C) PATIENT NOTIFICATION. Patients for whom immunosuppressant drugs are dispensed under the program must be notified by the prescribing practitioner that the immunosuppressant drugs they receive were originally dispensed to another patient and were returned for re-dispensing through the program.

004.02 STORAGE REQUIREMENTS. The participant that receives donated immunosuppressant drugs for dispensing or distribution must:

(A) Provide equipment for the storage of immunosuppressant drugs donated to the program at controlled room temperature that must be stored between 59 and 86 degrees Fahrenheit;

(B) Maintain the inventory of donated immunosuppressant drugs separate from all other drug inventory of the participant; and

004.03 RECORD KEEPING REQUIREMENTS. A perpetual inventory log of all immunosuppressant drugs received, dispensed and distributed by a participant under the program must be maintained.

004.03(A) PERPETUAL INVENTORY LOG BOOK REQUIREMENTS. The perpetual inventory log must contain the following information regarding all immunosuppressant drugs received, dispensed and distributed by a participant under the program:

(i) Name of the immunosuppressant drug;

(ii) Quantity of the immunosuppressant drug;

(iii) Expiration date of the immunosuppressant drug;

(iv) Lot number of the immunosuppressant drug;

(v) Name of participant;

(vi) Name of person who donated the immunosuppressant drug;

(vii) Name of person to whom the immunosuppressant drug was originally prescribed;

(viii) Name of person to whom the immunosuppressant drug was dispensed;

(ix) Date the immunosuppressant drug was dispensed;

(x) Name of the prescribing practitioner who wrote the prescription for the immunosuppressant drug to be dispensed under the program;

(xi) Name of the participant to which the immunosuppressant drug was distributed;

(xii) Date the immunosuppressant drug was distributed to another participant; and

(xiii) Date of destruction of the expired immunosuppressant drug.

004.03(B) RECORDS RETENTION. Copies of all prescriptions dispensed must be maintained by the participant to document the receipt of a prescription for the immunosuppressant drug to be dispensed and must be kept for five years pursuant to Neb. Rev. Stat. § 38-2871.

005. COMPLIANCE INSPECTIONS . Each participant has the responsibility to be in compliance, and to remain in compliance, with the regulations set out in this chapter. For the purpose of assuring initial and continued compliance, the Department will conduct inspections of participants. Participants must allow such inspections which includes allowing access to and the copying of records.

005.01 RESULTS OF INSPECTIONS. Notifications will be made in writing to the participant.

005.01(A) NOTIFICATION OF IMMINENT DANGER. If notified that the violations would create an imminent danger of death or serious physical harm or immediate adverse effect to the safety or security of the immunosuppressant drugs, the participant must cease participation in the program immediately.

005.01(B) NOTIFICATION OF NON-IMMINENT DANGER. If notified that the violations do not create an imminent danger of death or serious physical harm to the patients of the participant and no direct or immediate adverse effect to the safety or security of the immunosuppressant drugs, the participant must correct any deficiencies noted in the inspection within 30 days after receiving the inspection results.

005.01(C) CORRECTIVE ACTION. Participants that are not fully in compliance with these regulations within 30 days after receiving the inspection results will no longer be allowed to participate in the program.

History

Effective 2020-12-23

Chapter 8 Nonsurgical Pharmaceutical Gender Altering Treatments

Neb. Admin. Code tit. 181, ch. 8 Nonsurgical Pharmaceutical Gender Altering Treatments {#sec-181-nac-8 omnilex-key=us-ne-regs-official--title-181--181 NAC 8}

001. SCOPE AND AUTHORITY . This regulation governs the use of nonsurgical pharmaceutical gender altering treatments under the Let Them Grow Act, Nebraska Revised Statutes (Neb. Rev. Stat.) §§ 71-7301 to 71-7307.

002. DEFINITIONS . Definitions are set out in the Let Them Grow Act, and this chapter.

002.01 GENDER DYSPHORIA. A marked incongruence between a person’s experienced or expressed gender and the biological sex at birth for at least six months as manifested by the criteria set out in in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text-Revisions as published in March 2022.

002.02 GENDER NONCONFORMITY. For purposes of this chapter, gender nonconformity is a pattern of sexual identity different from the biological sex at birth expressed through observable behaviors as determined by a credentialed health care practitioner or mental health care practitioner.

002.03 LONG-LASTING AND INTENSE PATTERN OF GENDER NONCONFORMITY OR GENDER DYSPHORIA. A pattern of gender nonconformity being observed or treated for more than six continuous months or a diagnosis of gender dysphoria.

002.04 PRESCRIBED MEDICATIONS. For the purposes of this chapter, prescribed medications mean puberty blocking drugs or cross-sex hormones for the treatment of gender nonconformity or gender dysphoria.

002.05 TANNER SCALE OF PUBERTY. Also known as Sexual Maturity Rating is an objective classification system used to determine the development and sequence of secondary sex characteristics of children during puberty.

003. PUBERTY BLOCKING DRUGS . Prior to prescribing, dispensing, or administering puberty blocking drugs for the treatment of gender nonconformity or gender dysphoria to a patient who has not reached the age of majority, the prescribing practitioner must meet the following:

(A) Obtain three hours of Category 1 Continuing Competency Education for prescribing drugs for the purpose of treating gender nonconformity or gender dysphoria within the most recent biennial renewal period; (B) Determine or document:

(i) That gender nonconformity or gender dysphoria is driving the patient’s distress and not other mental or physical health conditions, that there is no reasonable expectation of natural resolution of gender nonconformity, and that there has been a long-lasting and intense pattern of gender nonconformity or gender dysphoria which began or worsened at the start of puberty; (ii) The severity of other mental or physical health conditions is being properly addressed and treated, and will not negatively impact treatment; (iii) Puberty blocking treatment is not likely to negatively impact, or exacerbate other mental or physical health conditions; (iv) The patient has received at least 40 contact hours of therapeutic treatment as required by this chapter; (v) The patient has at least six consecutive months of living primarily as the preferred gender; (vi) For individuals not suffering from gender dysphoria or for whom a clinical diagnosis of gender dysphoria is not available, that without puberty blocking treatment the patient will experience harm; (vii) Tanner stage of puberty development and if puberty blockers would be effective; and (viii) The appropriate supports are in place for the patient including appropriate social, and familial supports prior to initiating puberty blocking treatment;

(C) Discuss the following with the patient and parent or legal guardian or the patient, if the patient is an emancipated minor:

(i) The recommended dosage and route of treatment for the puberty blockers; and (ii) The minimum waiting period of seven calendar days as required by this chapter;

(D) Obtain signed informed consent and patient assent as required by this chapter; and (E) Document all the foregoing in the patient’s medical record.

004. CONTACT HOURS OF THERAPEUTIC TREATMENT . A patient who has not reached the age of majority must receive a minimum of 40 gender-identity-focused contact hours of therapeutic treatment prior to receiving prescribed medications subject to the following restrictions:

(A) The following may count toward the contact hours:

(i) An initial assessment of up to four consecutive hours; and (ii) Following an initial assessment, up to two hours per week;

(B) The therapeutic hours must:

(i) Be clinically objective and non-biased; (ii) Assess factors contributing to the patient’s presenting emotions, actions, and beliefs; and (iii) Not merely affirm the patient’s beliefs; and

(C) For an unemancipated minor, the therapeutic hours must include sufficient parental or legal guardian involvement to ensure adequate familial support during and post treatment.

005. ONGOING CONTACT HOURS OF THERAPEUTIC TREATMENT . A patient who has not reached the age of majority must receive at least one therapeutic contact hour every 90 days while puberty blocking drugs or cross-sex hormones are being administered to evaluate ongoing effects on the patient’s mental health.

006. ATTESTATION REQUIREMENTS FOR PRACTITIONERS .

006.01 PRESCRIBING PRACTITIONER. If the prescribing practitioner provided all or some of the contact hours of therapeutic treatment required by this chapter, the prescribing practitioner must sign an attestation as part of the documentation required by this chapter.

006.02 NON-PRESCRIBING PRACTITIONER. For contact hours of therapeutic treatment required by this chapter not provided by the prescribing practitioner, the prescribing practitioner must obtain an attestation from the other practitioner or practitioners as part of the documentation required by this chapter.

006.03 INITIAL 40 HOUR ATTESTATION REQUIREMENTS. The initial 40 gender-identity-focused contact hours attestation must include at least the following:

(A) Name of patient; (B) Patient date of birth; (C) Statement from the practitioner providing therapy detailing their training and experience with gender-identify-focused issues; (D) Number of all contact hours of therapeutic treatment spent with the patient; (E) Detailing the duration and frequency of those contact hours of therapeutic treatment; (F) The duration and frequency of gender nonconformity; (G) Any diagnosis of gender dysphoria; (H) Any other co-occurring psychiatric diagnosis as required in this chapter; (I) Appropriate support or referrals for the patient; (J) Patient level of engagement in the therapy; (K) Parental or legal guardian consent to therapy and their level of engagement in the therapy, or the consent of the patient, if the patient is an emancipated minor; (L) Any other relevant information regarding the patient; and (M) When the patient is an unemancipated minor, the ability of the patient to assent to therapy.

007. PATIENT INFORMED CONSENT FOR PUBERTY BLOCKING TREATMENT . A patient consent form must be obtained by the prescribing practitioner and include the following, in addition to information otherwise required in a consent form:

(A) Discussion of appropriateness of care has taken place; (B) All the known side effects of puberty blockers, the risks associated with taking them and the risks associated with discontinuing the treatment including, but not limited to, long-term effects on bone density, brain development, impact on fertility, sexual side effects including, but not limited to, loss of sexual gratification, and effects upon physical growth and development; (C) List of alternatives to treatment including, but not limited to, social, behavioral, and physical alternatives, and that these alternatives have been discussed with the patient and parent or legal guardian or the patient, if the patient is an emancipated minor; (D) Signed consent of a parent or legal guardian or the signed consent of the patient, if the patient is an emancipated minor; (E) When the patient is an unemancipated minor, patient assent to treatment; and (F) Whether the medication is being prescribed for off-label use or otherwise not approved by the Food and Drug Administration.

008. PUBERTY BLOCKING DRUG PRESCRIPTIONS . The following restrictions apply for a patient who has not reached the age of majority in addition to all other applicable laws relating to the administration, prescribing, delivery, sale, or use of puberty blocking drugs:

(A) Prescriptions must identify the drugs being prescribed are for the treatment of gender nonconformity or gender dysphoria; (B) Prescriptions must identify the patient’s parent or legal guardian or if the patient is an emancipated minor; (C) Prescribed medications picked up from a pharmacy are required to be picked up by the patient’s parent, legal guardian, or the patient if the patient is an emancipated minor; (D) Injectable prescribed medications must be administered either in the prescribing practitioner’s office or in the office of the patient’s primary care provider, by staff who are properly credentialed to administer drugs by injection; (E) The prescribing practitioner must document no adverse effects on the patient’s mental health during the course of treatment and that continued treatment is still medically appropriate as required by the chapter; and (F) The prescribing practitioner must document the ongoing contact hours of therapeutic treatment as required by this chapter.

009. PHARMACIST REQUIREMENTS . A pharmacist dispensing puberty blocking drugs, as defined in the Let Them Grow Act, to a patient under the age of 19 shall comply with the following restrictions:

(A) Prescribed medications picked up from a pharmacy are required to be picked up by the patient’s parent, legal guardian, or the patient if the patient is an emancipated minor; (B) Unless the individual taking receipt of the dispensed medications is personally and positively known to the pharmacist and or dispensing practitioner, the individual shall display a valid driver’s or operator’s license, a state identification card, or military identification card, an alien registration card, or a passport as proof of identification; and (C) Prescription drugs that are otherwise lawful to be sent by home delivery, must be delivered to the address of patient’s parent or legal guardian, or the patient’s address if the patient is an emancipated minor.

009.01 EXEMPTIONS. The additional requirements of this subsection shall not apply if the pharmacist documents that the patient began receiving the prescribed medication prior to October 1, 2023, that the medication is not being prescribed for the treatment of gender nonconformity or gender dysphoria, or that the patient has reached the age of 19. A pharmacist is not required to determine that the prescribing practitioner has complied with the additional requirements of this chapter prior to dispensing prescribed medications, as defined in this chapter, to a patient under the age of 19.

009.02 PHARMACIST AUTHORITY. This chapter does not otherwise limit or expand the scope of practice of a pharmacist. Prescriptions must continue to meet all other state and federal statutes, rules, and regulations.

010. PUBERTY BLOCKING DRUGS WAITING PERIOD . A minimum waiting period of seven calendar days is required between the time the prescribing practitioner obtains informed patient consent and the time the puberty-blocking drugs are prescribed, administered, or delivered to a patient who has not reached the age of majority.

011. USE OF CROSS-SEX HORMONES . Prior to prescribing, dispensing, or administering cross-sex hormones for the treatment of gender nonconformity or gender dysphoria to a patient who has not reached the age of majority, the prescribing practitioners must meet the following:

(i) Puberty blocking treatment, if occurring, has been successful at reducing patient distress and discomfort; (ii) That gender nonconformity or gender dysphoria is driving the patient’s distress and not other mental or physical health conditions, that there is no reasonable expectation of natural resolution of gender nonconformity, and that there has been a long-lasting and intense pattern of gender nonconformity or gender dysphoria which began or worsened at the start of puberty; (iii) There is an expectation of increased distress if puberty blocking treatment is terminated or cross-sex hormone treatment is not initiated; (iv) Cross-sex hormones would be effective and are not likely to negatively impact, or exacerbate other mental or physical health conditions; (v) The patient has received at least 40 contact hours of therapeutic treatment as required by this chapter; (vi) The patient has at least six consecutive months of living primarily as the preferred gender and has continued living primarily as the preferred gender; (vii) For individuals not suffering from gender dysphoria or for whom a clinical diagnosis of gender dysphoria is not available, documentation that without cross-sex hormone treatment the patient will experience harm; and (viii) The appropriate supports are in place for the patient including appropriate social, and familial support prior to initiating cross-sex hormone treatment;

(C) Discuss the following with the patient and parent or legal guardian or the patient, if the patient is an emancipated minor:

(i) The recommended dosage and route of treatment for the cross-sex hormones; and (ii) The minimum waiting period of seven calendar days as required by this chapter;

(D) Obtain signed informed consent and patient assent as required by this chapter; and (E) Document all the foregoing in the patient’s medical record.

012. PATIENT INFORMED CONSENT FOR CROSS-SEX HORMONE TREATMENT . A patient consent form must be obtained by the prescribing practitioner and include the following, in addition to information otherwise required in a consent form:

(A) Discussion of appropriateness of care has taken place; (B) All the known side effects of cross-sex hormone, the risks associated with taking them and the risks associated with discontinuing the treatment including, but not limited to, long-term effects on cardiovascular and cerebrovascular systems, metabolic disorders, increased risk of cancer, bone density, brain development, impact on fertility, sexual side effects including, but not limited to, loss of sexual gratification, and effects upon physical growth and development; (C) List of alternatives to treatment including, but not limited to, social, behavioral, and physical alternatives, and that these alternatives have been discussed with the patient and parent or legal guardian or the patient, if the patient is an emancipated minor; (D) Signed consent of a parent or legal guardian or the signed consent of the patient, if the patient is an emancipated minor; (E) When the patient is an unemancipated minor, patient assent to treatment; and (F) Whether the medication is being prescribed for off-label use or otherwise not approved by the Food and Drug Administration.

013. CROSS-SEX HORMONE PRESCRIPTIONS . The following restrictions apply for a patient who has not reached the age of majority in addition to all other applicable laws relating to the administration, prescribing, delivery, sale, or use of cross-sex hormones:

014. PHARMACIST REQUIREMENTS . A pharmacist dispensing cross-sex hormones, as defined in the Let Them Grow Act, to a patient under the age of 19 shall comply with the following restrictions:

014.01 EXEMPTIONS. The additional requirements of this subsection shall not apply if the pharmacist documents that the patient began receiving the prescribed medication prior to October 1, 2023, that the medication is not being prescribed for the treatment of gender nonconformity or gender dysphoria, or that the patient has reached the age of 19. A pharmacist is not required to determine that the prescribing practitioner has complied with the additional requirements of this chapter prior to dispensing prescribed medications, as defined in this chapter, to a patient under the age of 19.

014.02 PHARMACIST AUTHORITY. This chapter does not otherwise limit or expand the scope of practice of a pharmacist. Prescriptions must continue to meet all other state and federal statutes, rules, and regulations.

015. CROSS-SEX HORMONES WAITING PERIOD . A minimum waiting period of seven calendar days is required between the time the prescribing practitioner obtains informed patient consent and the time the cross-sex hormones are prescribed, administered, or delivered to a patient who has not reached the age of majority.

016. EXEMPTIONS . This chapter does not apply to the use of approved treatments for precocious puberty, or for treatments exempted in the Let Them Grow Act. A patient who has not reached the age of majority who began using puberty blocking drugs prior to October 1, 2023, but did not begin using cross-sex hormones prior to October 1, 2023, must comply with the requirements of this chapter prior to receiving cross-sex hormones.

017. COMPLIANCE . A prescriber who complies with this chapter satisfies the requirements of Neb. Rev. Stat. § 71-7304(4).

History

Effective 2024-03-17

Chapter 10 Screening of Newborns for Critical Congenital Heart Disease

Neb. Admin. Code tit. 181, ch. 10 Screening of Newborns for Critical Congenital Heart Disease {#sec-181-nac-10 omnilex-key=us-ne-regs-official--title-181--181 NAC 10}

001. SCOPE . These regulations implement the law governing screening of newborns for critical congenital heart disease set out in Nebraska Revised Stats.(Neb. Rev. Stats.) §§ 71-553 through 71-557.

002. DEFINITIONS . Definitions set out Neb. Rev. Stats. §§ 71-553 through 71-557 and the following apply to this chapter.

002.01 CRITICAL CONGENITAL HEART DISEASE (CCHD). One of seven targeted lesions for which newborn screening by pulse oximetry is intended to detect. The seven lesions are hypoplastic left heart syndrome, pulmonary atresia, tetralogy of Fallot, total anomalous pulmonary venous return, transposition of the great arteries, tricuspid atresia, and truncus arteriosus.

002.02 ECHOCARDIOGRAM. A diagnostic test that uses ultrasound waves to create an image of the heart muscle. Echocardiograms can show the size, shape, and movement of the heart’s valves and chambers as well as the flow of blood through the heart.

002.03 HOSPITAL. Any facility defined under Neb. Rev. Stat. § 71-419.

002.04 HYPOPLASTIC LEFT HEART SYNDROME. A structural birth defect that involves a number of underdeveloped or too small of structures on the left side of the heart including the left ventricle, mitral valve, aortic valve, ascending portion of the aorta. Often babies with this syndrome will also have an atrial septal defect, or hole between the left and right atria.

002.05 INCONCLUSIVE SCREEN RESULT. A result of the screening algorithm which is neither positive (failed) or negative (passed) but requires further screening to make a determination of positive or negative.

002.06 NEGATIVE SCREEN RESULT. An oxygen saturation screening test result that is above the cut-off, and the difference in measurement of the oxygen saturation between the right hand and foot is below a specified percent. A passed screen is a negative screen result for critical congenital heart disease.

002.07 NEONATAL INTENSIVE CARE UNIT (NICU). A hospital unit staffed and equipped to provide intensive care to premature, low birthweight and seriously ill newborns.

002.08 PHYSICIAN. A person licensed to practice medicine and surgery or osteopathic medicine and surgery.

002.09 POSITIVE SCREEN RESULT. An oxygen saturation screening test result that is below the cut off, or the difference in measurement of the oxygen saturation between the right hand and foot exceeds a specified percent. A failed screen is a positive screen result for possible critical congenital heart disease.

002.010 PRENATAL CARE PROVIDER. A licensed health care professional providing care to pregnant women before delivery of the newborn.

002.011 PULMONARY ATRESIA. A structural birth defect in which the pulmonary valve between the right ventricle and pulmonary artery is abnormal and does not open. This may also result in a small or missing right ventricle.

002.012 PULSE OXIMETRY. A non-invasive method of measuring the percent oxygen saturation of hemoglobin in the arterial blood.

002.013 TETRALOGY OF FALLOT. Structural birth defects of the heart affecting four parts. Ventricular septal defect is a hole in the wall between the two lower chambers of the heart. Pulmonary stenosis is a narrowing of the pulmonary valve and main pulmonary artery. The aortic valve is enlarged and open to both ventricles instead of just the left ventricle. Right ventricular hypertrophy is a thickening of the lower right chamber muscle wall.

002.014 TOTAL ANOMALOUS PULMONARY VENOUS RETURN. A condition present at birth in which the oxygen rich blood returns from the lungs to the right atrium or a vein flowing to the right atrium instead of the left side of the heart.

002.015 TRANSPOSITION OF THE GREAT OF ARTERIES. A birth defect in which the two main arteries going out of the heart, the pulmonary artery and the aorta, are switched in position.

002.016 TRICUSPID ATRESIA. A structural birth defect in which the tricuspid heart valve is either missing or abnormally developed.

002.017 TRUNCUS ARTERIOSIS. A structural birth defect in which only one vessel comes out of the right and left ventricles instead of the two normal vessels (pulmonary artery and aorta). There is usually also a ventricular septal defect or large hole between the two ventricles.

003. HOSPITAL AND BIRTHING FACILITY RESPONSIBILITIES . All hospital and birthing facilities must:

(A) Have and implement policies and procedures consistent with this chapter to screen all newborns for critical congenital heart disease. Screening must be done using pulse oximetry at 24 hours of life or soon after on day 2 of life, or prior to discharge whichever occurs first.

(B) Document that it notified the receiving hospital of the critical congenital heart disease screening results for every newborn transferred. If no results were available, the transferring facility must document it notified the receiving facility that the critical congenital heart disease screen needs to be completed.

(C) Complete screening for critical congenital heart disease using pulse oximetry. The probe and sensors must be placed on the right hand and one foot. If reusable probes and sensors are used, proper sanitation to prevent infection and communicable disease must be maintained. False negatives are possible, so negative screening results must not delay referral for pediatric cardiology evaluation of an infant otherwise suspected of having critical congenital heart disease. The results of all screening must be recorded in the newborn’s medical record.

(D) Consider newborns with oxygen saturation percentages of 95 percent or more in the right hand or foot and the difference between the hand and foot is 3 percent or less as having passed the screen.

(E) Consider oxygen saturation percentages between 90 percent and less than 95 percent on both the right hand and foot, or a difference of more than 3 percent between the hand and foot as an inconclusive result. The newborn must not be discharged and must be rescreened in one hour. If the rescreen remains inconclusive a third screen must be done in one hour. If on the third screen the results continue to not meet the pass criteria, this is a failed screen. The hospital or birthing facility must immediately notify the newborn’s physician of the failed screen for critical congenital heart disease.

(F) Consider oxygen saturation percentages less than 90 percent on any screen, initial or rescreen, as a failed screen. This is an indication of possible critical congenital heart disease. The hospital or birthing facility must immediately notify the newborn’s physician of this failed screen.

(G) Screen all newborns admitted to a neonatal intensive care unit for critical congenital heart disease. Screening of any newborn admitted to a neonatal intensive care unit for less than 8 days must follow the protocol set out in this chapter. For any newborn in a neonatal intensive care unit longer than 7 days, the screening requirement may be met by the level of care the newborn otherwise routinely receives in the unit, which may include including prolonged pulse oximetry monitoring, chest x-rays and echocardiogram, and continuous intensive monitoring and repeated physician exams.

(H) Maintain a method of verifying every newborn in its care received a screen for critical congenital heart disease. For any newborn discharged without such a screen, the hospital or birthing facility must notify the newborn’s physician and parents or legal guardian, and must reschedule an appointment to complete the screen.

(I) Monitor quality indicators which must include at a minimum the number and percent of newborns with failed screens, newborns transferred without a screen, newborns referred for a pediatric echocardiogram, and the age at screening for all newborns who failed a screen.

004. PHYSICIAN DUTIES . All physicians and prenatal care providers must:

(A) Provide information to expecting parents about newborn screening for critical congenital heart disease. The information must include the importance of screening for critical congenital heart disease, how it is done and that all newborns must have the test whether they are born in a hospital or birthing facility or not.

(B) If he or she is a newborn’s attending physician, the physician must verify the newborn screen for critical congenital heart disease has been completed and ensure the results are documented in the newborn’s medical record including any discharge summaries prior to discharge. Upon notification of a failed screen, the attending physician shall assess the infant, obtain or refer for echocardiogram and neonatal intensive care unit or cardiology evaluation.

(C) If a transfer to another facility is made, the attending physician must ensure the results of all screening, tests, and evaluations for critical congenital heart disease are provided to the receiving facility and physician.

005. BIRTHS OCCURRING OUTSIDE A HOSPITAL OR BIRTHING FACILITY . The parent or person registering the birth of a newborn not born in a hospital or birthing facility must ensure that all required screening for critical congenital heart disease occurs not sooner than 24 hours of life and prior to 48 hours in accordance with procedures specified in this chapter.

History

Effective 2020-03-25

Chapter 11 Native American Public Health Program

Neb. Admin. Code tit. 181, ch. 11 Native American Public Health Program {#sec-181-nac-11 omnilex-key=us-ne-regs-official--title-181--181 NAC 11}

001. SCOPE . The Department will administer the Native American Public Health program consistent with Nebraska Revised Statute (Neb. Rev. Stat.) §§ 71-7615 to 71-7622, known as the Native American Public Health Act (NAPHA).

002. DEFINITIONS . The following definitions apply to all regulations governing the Native American Public Health Act (NAPHA).

002.01 NEBRASKA’S FEDERALLY RECOGNIZED NATIVE AMERCIAN TRIBES. Ponca Tribe, Omaha Tribe, Santee Sioux Nation, and Winnebago Tribe.

002.02 INDIAN HEALTH ORGANIZATION. An organization physically located in Nebraska that is responsible for providing public health services to Native Americans.

002.03 PUBLIC HEALTH ORGANIZATION. An organization physically located in Nebraska that promotes and improves the health of community members through education, disease prevention, and injury prevention.

003. FUNDING . A minimum of $100,000 each, or equal amounts if the Native American Public Health Act (NAPHA) appropriation is less than $400,000, each year shall be for contracts with Nebraska’s federally recognized Native American Tribes. Any remaining funds can be made available in further amounts to the Tribes and to Indian Health Organizations and eligible Public Health Organizations.

History

Effective 2020-03-07

Chapter 40 Nebraska Breast and Cervical Cancer Program

Neb. Admin. Code tit. 181, ch. 40 Nebraska Breast and Cervical Cancer Program {#sec-181-nac-40 omnilex-key=us-ne-regs-official--title-181--181 NAC 40}

001. SCOPE AND AUTHORITY . These regulations govern and implement Nebraska Revised Statute (Neb. Rev. Stat.) §§ 71-7003.01 and 71-7010 by setting standards for client and provider eligibility and participation.

002. DEFINITIONS . The following definitions apply to this chapter.

002.01 PROVIDER. A provider offering screening, or diagnostic services for breast cancer, cervical cancer or cardiovascular services and who is listed as a participating provider.

002.02 CLIENT. An individual who has requested assistance in receiving education or services for breast cancer, cervical cancer, or cardiovascular disease screening, follow up, diagnostics, treatment or healthy supports, or is receiving such services.

002.03 COMPLETE ENROLLMENT FORM. An application provided by the Department which contains all the requested information and medical release form, with attestation to its truthfulness and completeness, all required signatures, submitted with all documentation is a complete application.

003. ELIGIBILITY . Providers and clients must meet statutory requirements and the following requirements:

003.01 CLIENT. Eligibility criteriafor the screening and diagnostic programs are as follows:

(A) SCREENING. To participate in the screening an individual must submit a complete enrollment form and meet the following:

(i) Be a woman between the ages of 21 – 74 years old;

(ii) Have an income at or below 225% of the Federal Poverty Guidelines as of the effective date of the enrollment date; and

(iii) Not have health coverage that would pay for preventive services.

(B) DIAGNOSTIC. To participate in the Diagnostic Program, an individual must submit a complete enrollment form and meet the following:

(i) Have an abnormal screening result within the last six months; and

(ii) Be 18 -74 years of age for breast cancer diagnostics; or

(iii) Be 21 -74 years of age, for cervical cancer diagnostics; and

(iv) Have an income at or below 225% of the Federal Poverty Guideline as of the effective date of the enrollment date; and

(v) Not have private, Medicare, or Medicaid insurance coverage that provides complete coverage for allowable program services.

003.02 PROVIDER. To participate as a provider in the Nebraska Breast and Cervical Cancer Program, a provider must meet the requirements in Neb. Rev. Stat. § 71-7010 and the following:

(A) Service providers must be licensed by the Department, or hold equivalent credentials in another state, and perform services in compliance with requirements set out in 42 United States Code (U.S.C,) § 300m as of the effective date of this chapter;

(B) Submit a complete enrollment form;

(D) Submit invoices and follow billing and payment procedures as set out in 181 Nebraska Administrative Code (NAC) 40; and

(E) Accept payment made through the program as payment in full and not bill clients for Services covered by the program for which theywere eligible at the time of service.

004. SERVICES . Covered services include those services specified in 42 U.S.C. § 300k and 42 U.S.C. § 300m as of the effective date of this chapter.

005. APPROVAL AND PAYMENT . Claims may be approved for payment when all the following conditions are met:

(A) The client was eligible for participation in the Program when the service was provided and is currently approved;

(B) The services provided are for covered services as described in 181 NAC 40;

(C) The Provider has agreed to provide reports of findings and recommendations which are necessary to compile cancer surveillance data and reports to the funder, the Centers for Disease Control and Prevention. Additionally, the provider shall ensure that the program receives the required documentations specified in the Provider Manual as of the date of this regulation;

(D) Invoice procedures outlined in the Provider Manual as of the effective date of this regulation are complied with; and

(E) All other claims and documentations pursuant to the program policy as set out in the Provider Manual as of the date of this regulation, are submitted.

005.01 PAYOR OF LAST RESORT. The Program is a payer of last resort. Primary insurance providers must be invoiced first and have paid on a client’s behalf before an invoice is sent to the program for payment by a provider.

006. LIMITS . The following limitations shall apply:

(A) Pursuant to 42 U.S.C. § 300n, this program shall not be accessed to provide inpatient hospital services or cancer treatment for any individual; and

(B) Provider payment shall be made based upon availability of funds and number of services provided to clients.

007. FAIR HEARING . If an applicant is denied participation in the program the applicant may request a fair hearing. The request must be in writing and filed with the Department within thirty (30) days of the mailing date on the written notice from the Department. The request must:

(A) Include a brief summary of the Department’s action being challenged;

(B) Describe the reason for the challenge; and

007.01 PROCEDURE. The hearing is conducted in accordance with 184 NAC 1.

History

Effective 2022-06-14

Neb. Admin. Code tit. 181 — Special Health Programs

Chapter 1 Nebraska Chronic Renal Disease Program

Neb. Admin. Code tit. 181, ch. 1 Nebraska Chronic Renal Disease Program {#sec-181-nac-1 omnilex-key=us-ne-regs-official--title-181--181 NAC 1}

Chapter 2 Screening of Infants for Inherited and Congenital Infant-or Childhood-on-Set Diseases

Neb. Admin. Code tit. 181, ch. 2 Screening of Infants for Inherited and Congenital Infant-or Childhood-on-Set Diseases {#sec-181-nac-2 omnilex-key=us-ne-regs-official--title-181--181 NAC 2}

Chapter 3 Administrative Appeal Procedures for Applicants, Food Vendors and Local Agencies Participating in Special Supplemental Nutrition Program for Women, Infants and Children (wic Program) and the Commodity Supplemental Nutrition Program (csfp) in the State of Nebraska

Chapter 4 Special Supplemental Nutrition Program for Women, Infants and Children (wic Program) and the Commodity Supplemental Food Program (csfp) Fair Hearing Procedures

Neb. Admin. Code tit. 181, ch. 4 Special Supplemental Nutrition Program for Women, Infants and Children (wic Program) and the Commodity Supplemental Food Program (csfp) Fair Hearing Procedures {#sec-181-nac-4 omnilex-key=us-ne-regs-official--title-181--181 NAC 4}

Chapter 6 Cancer Drug Repository Program

Neb. Admin. Code tit. 181, ch. 6 Cancer Drug Repository Program {#sec-181-nac-6 omnilex-key=us-ne-regs-official--title-181--181 NAC 6}

Chapter 7 Immunosuppressant Drug Repository Program

Neb. Admin. Code tit. 181, ch. 7 Immunosuppressant Drug Repository Program {#sec-181-nac-7 omnilex-key=us-ne-regs-official--title-181--181 NAC 7}

Chapter 8 Nonsurgical Pharmaceutical Gender Altering Treatments

Neb. Admin. Code tit. 181, ch. 8 Nonsurgical Pharmaceutical Gender Altering Treatments {#sec-181-nac-8 omnilex-key=us-ne-regs-official--title-181--181 NAC 8}

Chapter 10 Screening of Newborns for Critical Congenital Heart Disease

Neb. Admin. Code tit. 181, ch. 10 Screening of Newborns for Critical Congenital Heart Disease {#sec-181-nac-10 omnilex-key=us-ne-regs-official--title-181--181 NAC 10}

Chapter 11 Native American Public Health Program

Neb. Admin. Code tit. 181, ch. 11 Native American Public Health Program {#sec-181-nac-11 omnilex-key=us-ne-regs-official--title-181--181 NAC 11}

Chapter 40 Nebraska Breast and Cervical Cancer Program

Neb. Admin. Code tit. 181, ch. 40 Nebraska Breast and Cervical Cancer Program {#sec-181-nac-40 omnilex-key=us-ne-regs-official--title-181--181 NAC 40}

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