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26th Legislature(2009-2010)

Bill Text 26th Legislature

00 Enrolled SB 10                                                                                                          
01 Requiring health care insurers to provide insurance coverage for medical care received by a                             
02 patient during certain approved clinical trials designed to test and improve prevention,                                
03 diagnosis, treatment, or palliation of cancer; directing the Department of Health and Social                            
04 Services to provide Medicaid services to persons who participate in those clinical trials; and                          
05 relating to experimental procedures under a state plan offered by the Comprehensive Health                              
06 Insurance Association.                                                                                                  
07                           _______________                                                                               
08    * Section 1. AS 21.42 is amended by adding a new section to read:                                                  
09            Sec. 21.42.415. Coverage for clinical trials related to cancer. (a) A health                             
10       care insurer that offers, issues for delivery, delivers, or renews a health care insurance                        
11       plan in the state shall cover routine patient care costs incurred by a patient enrolled in                        
12       an approved clinical trial related to cancer, including leukemia, lymphoma, and bone                              
13       marrow stem cell disorders.                                                                                       
01            (b)  The health care insurer is required to provide coverage under this section                              
02       only if the patient's treating physician determines that                                                          
03                 (1)  there is no clearly superior noninvestigational treatment alternative;                             
04       and                                                                                                               
05                 (2)  available clinical or preclinical data provide a reasonable                                        
06       expectation that the treatment provided in the clinical trial will be at least as                                 
07       efficacious as any noninvestigational alternative.                                                                
08            (c)  The coverage to be provided under (a) of this section must include                                      
09       payment for the costs of                                                                                          
10                 (1)  prevention, diagnosis, treatment, and palliative care of cancer;                                   
11                 (2)  medical care for an approved clinical trial related to cancer that                                 
12       would otherwise be covered under a health care insurance plan if the medical care                                 
13       were not in connection with an approved clinical trial related to cancer;                                         
14                 (3)  items or services necessary to provide an investigational item or                                  
15       service;                                                                                                          
16                 (4)  the diagnosis or treatment of complications;                                                       
17                 (5)  a drug or device approved by the United States Food and Drug                                       
18       Administration without regard to whether the United States Food and Drug                                          
19       Administration approved the drug or device for use in treating a patient's particular                             
20       condition, but only to the extent that the drug or device is not paid for by the                                  
21       manufacturer, distributor, or provider of the drug or device;                                                     
22                 (6)  services necessary to administer a drug or device under evaluation                                 
23       in the clinical trial; and                                                                                        
24                 (7)  transportation for the patient that is primarily for and essential to                              
25       the medical care.                                                                                                 
26            (d)  The coverage to be provided under (a) of this section may not include the                               
27       cost of                                                                                                           
28                 (1)  a drug or device that is associated with the clinical trial that has not                           
29       been approved by the United States Food and Drug Administration;                                                  
30                 (2)  housing, companion expenses, or other nonclinical expenses                                         
31       associated with the clinical trial;                                                                               
01                 (3)  an item or service provided solely to satisfy data collection and                                  
02       analysis and not used in the clinical management of the patient;                                                  
03                 (4)  an item or service excluded from coverage under the patient's                                      
04       health care insurance plan; and                                                                                   
05                 (5)  an item or service paid for or customarily paid for through grants or                              
06       other funding.                                                                                                    
07            (e)  The coverage required by this section is subject to the standard policy                                 
08       provisions applicable to other benefits, including deductible, coinsurance, or                                    
09       copayment provisions.                                                                                             
10            (f)  This section does not apply to a fraternal benefit society.                                             
11            (g)  In this section, "approved clinical trial" means a scientific study using                               
12       human subjects designed to test and improve prevention, diagnosis, treatment, or                                  
13       palliative care of cancer, or the safety and effectiveness of a drug, device, or procedure                        
14       used in the prevention, diagnosis, treatment, or palliative care of a subject, if the study                       
15       is approved by                                                                                                    
16                 (1)  an institutional review board that complies with 45 CFR Part 46;                                   
17       and                                                                                                               
18                 (2)  one or more of the following:                                                                      
19                      (A)  the United States Department of Health and Human                                              
20            Services, National Institutes of Health, or its institutes or centers;                                       
21                      (B)  the United States Department of Health and Human                                              
22            Services, United States Food and Drug Administration;                                                        
23                      (C)  the United States Department of Defense;                                                      
24                      (D)  the United States Department of Veterans Affairs; or                                          
25                      (E)  a nongovernmental research entity abiding by current                                          
26            National Institutes of Health guidelines.                                                                    
27    * Sec. 2. AS 21.55.140(a) is amended to read:                                                                      
28            (a)  A state plan may not provide benefits for charges for the following:                                    
29                 (1)  care for an injury or disease either                                                               
30                      (A)  arising out of and in the course of an employment subject                                     
31            to a workers' compensation or similar law or where the benefit is available to                               
01            be provided under a workers' compensation policy or equivalent self-insurance                                
02            to a sole proprietor, business partner, or corporation officer; or                                           
03                      (B)  to the extent benefits are payable without regard to fault                                    
04            under a coverage statutorily required to be contained in a motor vehicle or                                  
05            other liability insurance policy or equivalent self-insurance;                                               
06                 (2)  treatment for cosmetic purposes other than surgery for the prompt                                  
07       repair of an accidental injury sustained while covered or for replacement of an                                   
08       anatomic structure removed during treatment of tumors;                                                            
09                 (3)  travel, other than transportation covered under AS 21.55.110(17);                                  
10                 (4)  private room accommodations to the extent it is in excess of the                                   
11       institution's most common charge for a semiprivate room;                                                          
12                 (5)  services or articles to the extent that the charge exceeds the                                     
13       reasonable charge in the locality for the service;                                                                
14                 (6)  services or articles that are determined not to be medically                                       
15       necessary, except for the fabrication or placement of the prosthesis as specified in                              
16       AS 21.55.110(12) and (2) of this subsection;                                                                      
17                 (7)  services or articles that are not within the scope of the license or                               
18       certificate of the institution or individual rendering the services or articles;                                  
19                 (8)  services or articles furnished, paid for, or reimbursed directly by or                         
20       under any law of a government, except as otherwise provided in this chapter;                                      
21                 (9)  services or articles for custodial care or designed primarily to assist                            
22       an individual in the activities of daily living;                                                                  
23                 (10)  service charges that would not have been made if no insurance                                     
24       existed or that the covered individual is not legally obligated to pay;                                           
25                 (11)  eyeglasses, contact lenses, or hearing aids or the fitting of them;                               
26                 (12)  dental care not specifically covered by this chapter;                                             
27                 (13)  services of a registered nurse who ordinarily resides in the                                      
28       covered individual's home, or who is a member of the covered individual's family or                               
29       the family of the covered individual's spouse;                                                                    
30                 (14)  experimental procedures, except during an approved clinical                                   
31       trial; in this paragraph, "approved clinical trial" has the meaning given in                                  
01       AS 21.42.415; and                                                                                             
02                 (15)  services and supplies for which the patient was not charged.                                      
03    * Sec. 3. AS 47.07.030 is amended by adding a new subsection to read:                                              
04            (e)  The department shall provide the services set out in (a) and (b) of this                                
05       section to an eligible person, notwithstanding the person's participation in an approved                          
06       clinical trial. In this subsection, "approved clinical trial" has the meaning given in                            
07       AS 21.42.415.                                                                                                     
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