HOUSE BILL No. 5571 February 12, 1998, Introduced by Reps. Schroer, Wallace, Anthony, Parks, LaForge, Baade, Bogardus, Crissman, Scott, Brater, Profit, Murphy, Hale and Gire and referred to the Committee on Insurance. A bill to create the experimental treatment dispute resolu- tion commission; to provide for the creation of independent panels of experts; to provide for the powers and duties of the commission and the panels; to provide for certain appeals and reviews; and to require health care plans to provide certain information and follow certain recommendations. THE PEOPLE OF THE STATE OF MICHIGAN ENACT: 1 Sec. 1. This act shall be known and may be cited as the 2 "experimental treatment dispute resolution act". 3 Sec. 2. As used in this act: 4 (a) "Commission" means the experimental treatment dispute 5 resolution commission created in section 5. 6 (b) "Enrollee" means an individual covered under a health 7 care plan. 03595'97 DKH 2 1 (c) "Health care plan" or "plan" means a medical, surgical, 2 or health care benefit plan, contract, policy, or certificate 3 issued under the insurance code of 1956, 1956 PA 218, MCL 500.100 4 to 500.8302, the nonprofit health care corporation reform act, 5 1980 PA 350, MCL 550.1101 to 550.1704, or the public health code, 6 1978 PA 368, MCL 333.1101 to 333.25211. 7 (d) "Material familial affiliation" means any relationship 8 as a spouse, child, parent, sibling, spouse's parent, or child's 9 spouse. 10 (e) "Material financial affiliation" means any financial 11 interest of more than 5% of total annual revenue or total annual 12 income of an entity or individual to which section 9(2) applies. 13 Material financial affiliation does not include payment by the 14 plan to the members of the panel for the services required by 15 this act. 16 (f) "Material professional affiliation" means any 17 physician-patient relationship, any partnership or employment 18 relationship, a shareholder or similar ownership interest in a 19 professional corporation, or any independent contractor arrange- 20 ment that constitutes a material financial affiliation with an 21 entity or individual to which section 9(2) applies. Material 22 professional affiliation does not include affiliations that are 23 limited to staff privileges at a health facility. 24 (g) "Medical and scientific evidence" means the following 25 sources: 26 (i) Peer-reviewed scientific studies published in or 27 accepted for publication by medical journals that meet nationally 03595'97 3 1 recognized requirements for scientific manuscripts and that 2 submit most of their published articles for review by experts who 3 are not part of the editorial staff. 4 (ii) Peer-reviewed literature, biomedical compendia and 5 other medical literature that meet the criteria of the national 6 institute of health's national library of medicine for indexing 7 in index medicus, excerpta medicus (EMBASE), medline and MEDLARS 8 data base health services technology assessment research 9 (HSTAT). 10 (iii) Medical literature recognized by the secretary of 11 health and human services, under section 1861(t)(2) of part C of 12 title XVIII of the social security act, 42 U.S.C. 1395x. 13 (iv) The following standard reference compendia: the 14 American hospital formulary service-drug information, the 15 American medical association drug evaluation, the American dental 16 association accepted dental therapeutics, and the United States 17 pharmacopoeia-drug information. 18 (v) Findings, studies, or research conducted by or under the 19 auspices of federal government agencies and nationally recognize 20 federal research institutes including the federal agency for 21 health care policy and research, national institutes of health, 22 national cancer institute, national academy of sciences, health 23 care financing administration, congressional office of technology 24 assessment, and any national board recognized by the national 25 institutes of health for the purpose of evaluating the medical 26 value of health services. 03595'97 4 1 (vi) Peer-reviewed abstracts accepted for presentation at 2 major medical association meetings. 3 (h) "Panel" means a panel of independent experts selected by 4 the commission under section 9. 5 Sec. 5. (1) The experimental treatment dispute resolution 6 commission is created within the department of consumer and 7 industry services. 8 (2) The commission shall consist of the following members, 9 appointed by the governor with the advice and consent of the 10 senate: 11 (a) One representative of the health insurance industry in 12 this state. 13 (b) One representative of the health maintenance organiza- 14 tion industry in this state. 15 (c) One representative from a nonprofit health care corpora- 16 tion located in this state. 17 (d) One representative from each of the following: 18 (i) The university of Michigan medical school. 19 (ii) Wayne state university school of medicine. 20 (iii) Michigan state university college of osteopathic medi- 21 cine or college of human medicine. 22 (e) One representative from the Michigan health and hospital 23 association. 24 (f) One representative from the Michigan nurses 25 association. 26 (g) One representative from the Michigan state medical 27 society. 03595'97 5 1 (h) Four representatives from the general public. 2 (3) The director of community health and the insurance com- 3 missioner shall be ex officio members of the commission without 4 vote. 5 (4) The members first appointed to the commission shall be 6 appointed within 30 days after the effective date of this act. 7 (5) Members of the commission shall serve for terms of 3 8 years or until a successor is appointed, whichever is later, 9 except that of the members first appointed, 4 shall serve for 10 1 year, 4 shall serve for 2 years, and 5 shall serve for 11 3 years. 12 (6) If a vacancy occurs on the commission, the governor 13 shall make an appointment for the unexpired term in the same 14 manner as the original appointment. 15 (7) The governor may remove a member of the commission for 16 incompetency, dereliction of duty, malfeasance, misfeasance, or 17 nonfeasance in office, or any other good cause. 18 (8) The first meeting of the commission shall be held within 19 60 days after the effective date of this act. At the first meet- 20 ing, the commission shall elect from among its members a chair- 21 person and other officers as it considers necessary or 22 appropriate. After the first meeting, the commission shall meet 23 at least quarterly, or more frequently at the call of the chair- 24 person or if requested by 7 or more members. 25 (9) A majority of the members of the commission constitute a 26 quorum for the transaction of business at a meeting of the 03595'97 6 1 commission. A majority of the members present and serving are 2 required for official action of the commission. 3 (10) The business that the commission may perform shall be 4 conducted at a public meeting of the commission held in compli- 5 ance with the open meetings act, 1976 PA 267, MCL 15.261 to 6 15.275. However, any meeting or portion of a meeting on an indi- 7 vidual enrollee's appeal is not subject to the open meetings act, 8 1976 PA 267, MCL 15.261 to 15.275. 9 (11) A writing prepared, owned, used, in the possession of, 10 or retained by the commission in the performance of an official 11 function is subject to the freedom of information act, 1976 12 PA 442, MCL 15.231 to 15.246. However, information as to an 13 individual enrollee's appeal is exempt from the freedom of infor- 14 mation act, 1976 PA 442, MCL 15.231 to 15.246. 15 (12) Members of the commission shall serve without 16 compensation. However, members of the commission may be reim- 17 bursed for their actual and necessary expenses incurred in the 18 performance of their official duties as members of the 19 commission. 20 Sec. 7. (1) Upon request of an enrollee or a person autho- 21 rized in writing to act on behalf of an enrollee, the commission 22 shall appoint a panel to review a plan's coverage decision 23 regarding experimental or investigational therapies for an 24 enrollee who meets all of the following criteria: 25 (a) The enrollee has either of the following: 03595'97 7 1 (i) A terminal condition that, according to the enrollee's 2 physician's current diagnosis, has a high probability of causing 3 death within 2 years from the date of the request for review. 4 (ii) A chronic condition that according to the enrollee's 5 physician's current diagnosis reoccurs frequently and is of a 6 duration of more than 6 months. 7 (b) The enrollee's physician certifies that the enrollee has 8 a condition, as described in subdivision (a)(i) or (ii), for 9 which standard therapies have not been effective in improving the 10 condition of the enrollee, or for which standard therapies would 11 not be medically appropriate for the enrollee, or for which there 12 is no more beneficial standard therapy covered by the plan than 13 the therapy proposed pursuant to subdivision (c). 14 (c) Either the enrollee's physician who is under contract 15 with or employed by the plan has recommended a drug, device, pro- 16 cedure, or other therapy that the physician certifies in writing 17 is likely to be more beneficial to the enrollee than any avail- 18 able standard therapies, or the enrollee, or the enrollee's phy- 19 sician who is a licensed, board-certified or board-eligible phy- 20 sician qualified to practice in the area of practice appropriate 21 to treat the enrollee's condition, has requested a therapy that, 22 based on 2 medical and scientific evidence documents, is likely 23 to be more beneficial for the enrollee than any available stan- 24 dard therapy. The physician certification under this subdivision 25 shall include a statement of the evidence relied upon by the phy- 26 sician in certifying his or her recommendation. Nothing in this 27 subdivision requires the plan to pay for the services of a 03595'97 8 1 nonparticipating physician that are provided pursuant to this 2 subdivision and that are not otherwise covered under the plan. 3 (d) The enrollee has been denied coverage by the plan for a 4 drug, device, procedure, or other therapy recommended or 5 requested under subdivision (c). 6 (e) The specific drug, device, procedure or other therapy 7 recommended under subdivision (c) would be a covered service, 8 except for the plan's determination that the therapy is experi- 9 mental or investigational. 10 (2) The plan shall provide to the commission a copy of the 11 following documents within 5 business days of the plan's receipt 12 of a request for an external, independent review by an enrollee 13 or person authorized in writing to act on behalf of an enrollee: 14 (a) The medical records relevant to the enrollee's condition 15 for which the proposed therapy has been recommended, provided the 16 documents are within the plan's possession. Any medical records 17 provided to the plan after the initial documents are provided to 18 the panel shall be forwarded by the plan to the panel within 5 19 business days. The confidentiality of the medical records shall 20 be maintained pursuant to confidentiality requirements recognized 21 or created by law. 22 (b) A copy of any relevant documents used by the plan in 23 determining whether the proposed therapy should be covered, and 24 any statement by the plan explaining the reasons for the plan's 25 decision not to provide coverage for the proposed therapy. The 26 plan shall provide, upon request, a copy of the documents 27 required by this subdivision, except for the documents described 03595'97 9 1 in subdivisions (a) and (c), to the enrollee and the enrollee's 2 physician. 3 (c) Any information submitted by the enrollee or the 4 enrollee's physician to the plan in support of the enrollee's 5 request for coverage of the proposed drug, device, procedure, or 6 other therapy. 7 Sec. 9. (1) If the commission determines that an enrollee 8 satisfies section 7(1), the commission shall select an indepen- 9 dent panel of at least 3 physicians or other providers who are 10 experts in the treatment of the enrollee's medical condition and 11 knowledgeable about the recommended therapy. Neither the plan 12 nor the enrollee shall choose or control the choice of the physi- 13 cian or other provider experts. 14 (2) The commission shall ensure that no member of a panel 15 has any material professional, familial, or financial affiliation 16 with any of the following: 17 (a) The plan that has denied the proposed treatment under 18 review. 19 (b) Any officer, director, or management employee of the 20 plan described in subdivision (a). 21 (c) The physician, the physician's medical group, or the 22 independent practice association proposing the therapy that is 23 under review. 24 (d) The institution at which the proposed therapy that is 25 under review would be provided. 26 (e) The enrollee whose medical condition and the proposed 27 treatment is under review. 03595'97 10 1 (f) The development or manufacture of the principal drug, 2 device, procedure, or other therapy proposed for the enrollee 3 whose treatment is under review. 4 Sec. 11. (1) The panel experts shall render their analyses 5 and recommendations within 30 days of their appointment by the 6 commission. If the enrollee's physician determines that the pro- 7 posed therapy would be significantly less effective if not 8 promptly initiated, the analyses and recommendations of the panel 9 experts shall be rendered within 7 days of the request for expe- 10 dited review. 11 (2) Each panel expert's analysis and recommendation shall be 12 in written form and shall state the reasons the requested therapy 13 is or is not likely to be more beneficial for the enrollee than 14 any available standard therapy, and the reasons that the expert 15 recommends that the therapy should or should not be provided by 16 the plan, citing the enrollee's specific medical condition, the 17 relevant documents provided, and the relevant medical and scien- 18 tific evidence. 19 (3) The panel experts shall provide the plan and the 20 enrollee's physician with their analyses and recommendations, a 21 description of the qualifications of each expert, and any other 22 information that the panel chooses to provide to the plan and the 23 enrollee's physician. 24 (4) If the majority of experts on the panel recommend pro- 25 viding the proposed therapy, the recommendation shall be binding 26 on the plan and the plan shall provide coverage for the proposed 27 therapy. If the recommendations of the experts on the panel are 03595'97 11 1 evenly divided as to whether the therapy should be provided, then 2 the panel's decision shall be in favor of coverage. If less than 3 a majority of the experts on the panel recommend providing the 4 therapy, the plan is not required to provide the therapy. 5 Coverage for the services required under this section shall be 6 provided subject to the terms and conditions generally applicable 7 to other benefits under the plan contract. 03595'97 Final page. DKH