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HF 3610

1st Engrossment - 81st Legislature (1999 - 2000) Posted on 12/15/2009 12:00am

KEY: stricken = removed, old language.
underscored = added, new language.
  1.1                          A bill for an act 
  1.2             relating to health; providing patient protections; 
  1.3             modifying the Health Care Administrative 
  1.4             Simplification Act; requiring coverage for medical 
  1.5             clinical trials; amending Minnesota Statutes 1998, 
  1.6             sections 62D.17, subdivision 1; 62J.38; 62J.51, by 
  1.7             adding subdivisions; 62J.52, subdivisions 1, 2, and 5; 
  1.8             62J.60, subdivision 1; 62Q.56; and 62Q.58; Minnesota 
  1.9             Statutes 1999 Supplement, section 45.027, subdivision 
  1.10            6; proposing coding for new law in Minnesota Statutes, 
  1.11            chapters 62J; and 62Q. 
  1.12  BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA: 
  1.13     Section 1.  Minnesota Statutes 1999 Supplement, section 
  1.14  45.027, subdivision 6, is amended to read: 
  1.15     Subd. 6.  [VIOLATIONS AND PENALTIES.] The commissioner may 
  1.16  impose a civil penalty not to exceed $10,000 per violation upon 
  1.17  a person who violates any law, rule, or order related to the 
  1.18  duties and responsibilities entrusted to the commissioner unless 
  1.19  a different penalty is specified.  If a civil penalty is imposed 
  1.20  on a health carrier as defined in section 62A.011, the 
  1.21  commissioner must divide 50 percent of the amount among any 
  1.22  policy holder or certificate holder affected by the violation.  
  1.23     Sec. 2.  Minnesota Statutes 1998, section 62D.17, 
  1.24  subdivision 1, is amended to read: 
  1.25     Subdivision 1.  The commissioner of health may, for any 
  1.26  violation of statute or rule applicable to a health maintenance 
  1.27  organization, or in lieu of suspension or revocation of a 
  1.28  certificate of authority under section 62D.15, levy an 
  2.1   administrative penalty in an amount up to $25,000 for each 
  2.2   violation.  In the case of contracts or agreements made pursuant 
  2.3   to section 62D.05, subdivisions 2 to 4, each contract or 
  2.4   agreement entered into or implemented in a manner which violates 
  2.5   sections 62D.01 to 62D.30 shall be considered a separate 
  2.6   violation.  In determining the level of an administrative 
  2.7   penalty, the commissioner shall consider the following factors: 
  2.8      (1) the number of enrollees affected by the violation; 
  2.9      (2) the effect of the violation on enrollees' health and 
  2.10  access to health services; 
  2.11     (3) if only one enrollee is affected, the effect of the 
  2.12  violation on that enrollee's health; 
  2.13     (4) whether the violation is an isolated incident or part 
  2.14  of a pattern of violations; and 
  2.15     (5) the economic benefits derived by the health maintenance 
  2.16  organization or a participating provider by virtue of the 
  2.17  violation. 
  2.18     Reasonable notice in writing to the health maintenance 
  2.19  organization shall be given of the intent to levy the penalty 
  2.20  and the reasons therefor, and the health maintenance 
  2.21  organization may have 15 days within which to file a written 
  2.22  request for an administrative hearing and review of the 
  2.23  commissioner of health's determination.  Such administrative 
  2.24  hearing shall be subject to judicial review pursuant to chapter 
  2.25  14.  If an administrative penalty is levied, the commissioner 
  2.26  must divide 50 percent of the amount among any enrollee affected 
  2.27  by the violation. 
  2.28     Sec. 3.  Minnesota Statutes 1998, section 62J.38, is 
  2.29  amended to read: 
  2.30     62J.38 [COST CONTAINMENT DATA FROM GROUP PURCHASERS.] 
  2.31     (a) The commissioner shall require group purchasers to 
  2.32  submit detailed data on total health care spending for each 
  2.33  calendar year.  Group purchasers shall submit data for the 1993 
  2.34  calendar year by April 1, 1994, and each April 1 thereafter 
  2.35  shall submit data for the preceding calendar year. 
  2.36     (b) The commissioner shall require each group purchaser to 
  3.1   submit data on revenue, expenses, and member months, as 
  3.2   applicable.  Revenue data must distinguish between premium 
  3.3   revenue and revenue from other sources and must also include 
  3.4   information on the amount of revenue in reserves and changes in 
  3.5   reserves.  Expenditure data, including raw data from claims, may 
  3.6   must distinguish between expenses incurred for patient care and 
  3.7   administrative costs.  Expenditure data must be provided 
  3.8   separately for the following categories or and for other 
  3.9   categories required by the commissioner:  physician services, 
  3.10  dental services, other professional services, inpatient hospital 
  3.11  services, outpatient hospital services, emergency, pharmacy 
  3.12  services and other nondurable medical goods, mental health, and 
  3.13  chemical dependency services, other expenditures, subscriber 
  3.14  liability, and administrative costs.  Administrative costs shall 
  3.15  include costs for marketing; advertising; overhead; 
  3.16  underwriting; lobbying; claims processing; provider contracting 
  3.17  and credentialing; detection and prevention of payment for 
  3.18  fraudulent or unjustified requests for reimbursement or 
  3.19  services; concurrent or prospective utilization review as 
  3.20  defined in section 62M.02; expenses incurred to acquire a 
  3.21  hospital, clinic, health care facility, or the assets thereof; 
  3.22  capital costs incurred on behalf of a hospital or clinic; lease 
  3.23  payments; or any other expenses incurred to a hospital, clinic, 
  3.24  or other health care provider pursuant to a partnership, joint 
  3.25  venture, integration, or affiliation agreement.  The 
  3.26  commissioner may require each group purchaser to submit any 
  3.27  other data, including data in unaggregated form, for the 
  3.28  purposes of developing spending estimates, setting spending 
  3.29  limits, and monitoring actual spending and costs. 
  3.30     (c) The commissioner may collect information on: 
  3.31     (1) premiums, benefit levels, managed care procedures, and 
  3.32  other features of health plan companies; 
  3.33     (2) prices, provider experience, and other information for 
  3.34  services less commonly covered by insurance or for which 
  3.35  patients commonly face significant out-of-pocket expenses; and 
  3.36     (3) information on health care services not provided 
  4.1   through health plan companies, including information on prices, 
  4.2   costs, expenditures, and utilization. 
  4.3      (d) All group purchasers shall provide the required data 
  4.4   using a uniform format and uniform definitions, as prescribed by 
  4.5   the commissioner. 
  4.6      Sec. 4.  Minnesota Statutes 1998, section 62J.51, is 
  4.7   amended by adding a subdivision to read: 
  4.8      Subd. 19a.  [UNIFORM EXPLANATION OF BENEFITS 
  4.9   DOCUMENT.] "Uniform explanation of benefits document" means the 
  4.10  document associated with and explaining the details of a group 
  4.11  purchaser's claim adjudication for services rendered, which is 
  4.12  sent to a patient. 
  4.13     Sec. 5.  Minnesota Statutes 1998, section 62J.51, is 
  4.14  amended by adding a subdivision to read: 
  4.15     Subd. 19b.  [UNIFORM REMITTANCE ADVICE REPORT.] "Uniform 
  4.16  remittance advice report" means the document associated with and 
  4.17  explaining the details of a group purchaser's claim adjudication 
  4.18  for services rendered, which is sent to a provider. 
  4.19     Sec. 6.  Minnesota Statutes 1998, section 62J.52, 
  4.20  subdivision 1, is amended to read: 
  4.21     Subdivision 1.  [UNIFORM BILLING FORM HCFA 1450.] (a) On 
  4.22  and after January 1, 1996, all institutional inpatient hospital 
  4.23  services, ancillary services, and institutionally owned or 
  4.24  operated outpatient services rendered by providers in Minnesota, 
  4.25  and institutional or noninstitutional home health services that 
  4.26  are not being billed using an equivalent electronic billing 
  4.27  format, must be billed using the uniform billing form HCFA 1450, 
  4.28  except as provided in subdivision 5. 
  4.29     (b) The instructions and definitions for the use of the 
  4.30  uniform billing form HCFA 1450 shall be in accordance with the 
  4.31  uniform billing form manual specified by the commissioner.  In 
  4.32  promulgating these instructions, the commissioner may utilize 
  4.33  the manual developed by the National Uniform Billing Committee, 
  4.34  as adopted and finalized by the Minnesota uniform billing 
  4.35  committee.  
  4.36     (c) Services to be billed using the uniform billing form 
  5.1   HCFA 1450 include:  institutional inpatient hospital services 
  5.2   and distinct units in the hospital such as psychiatric unit 
  5.3   services, physical therapy unit services, swing bed (SNF)  
  5.4   services, inpatient state psychiatric hospital services, 
  5.5   inpatient skilled nursing facility services, home health 
  5.6   services (Medicare part A), and hospice services; ancillary 
  5.7   services, where benefits are exhausted or patient has no 
  5.8   Medicare part A, from hospitals, state psychiatric hospitals, 
  5.9   skilled nursing facilities, and home health (Medicare part B); 
  5.10  and institutional owned or operated outpatient services such as 
  5.11  waivered services, hospital outpatient services, including 
  5.12  ambulatory surgical center services, hospital referred 
  5.13  laboratory services, hospital-based ambulance services, and 
  5.14  other hospital outpatient services, skilled nursing facilities, 
  5.15  home health, including infusion therapy, freestanding renal 
  5.16  dialysis centers, comprehensive outpatient rehabilitation 
  5.17  facilities (CORF), outpatient rehabilitation facilities (ORF), 
  5.18  rural health clinics, and community mental health centers,; home 
  5.19  health services such as home health intravenous therapy 
  5.20  providers, waivered services, personal care attendants, and 
  5.21  hospice; and any other health care provider certified by the 
  5.22  Medicare program to use this form. 
  5.23     (d) On and after January 1, 1996, a mother and newborn 
  5.24  child must be billed separately, and must not be combined on one 
  5.25  claim form. 
  5.26     Sec. 7.  Minnesota Statutes 1998, section 62J.52, 
  5.27  subdivision 2, is amended to read: 
  5.28     Subd. 2.  [UNIFORM BILLING FORM HCFA 1500.] (a) On and 
  5.29  after January 1, 1996, all noninstitutional health care services 
  5.30  rendered by providers in Minnesota except dental or pharmacy 
  5.31  providers, that are not currently being billed using an 
  5.32  equivalent electronic billing format, must be billed using the 
  5.33  health insurance claim form HCFA 1500, except as provided in 
  5.34  subdivision 5. 
  5.35     (b) The instructions and definitions for the use of the 
  5.36  uniform billing form HCFA 1500 shall be in accordance with the 
  6.1   manual developed by the administrative uniformity committee 
  6.2   entitled standards for the use of the HCFA 1500 form, dated 
  6.3   February 1994, as further defined by the commissioner. 
  6.4      (c) Services to be billed using the uniform billing form 
  6.5   HCFA 1500 include physician services and supplies, durable 
  6.6   medical equipment, noninstitutional ambulance services, 
  6.7   independent ancillary services including occupational therapy, 
  6.8   physical therapy, speech therapy and audiology, podiatry 
  6.9   services, optometry services, mental health licensed 
  6.10  professional services, substance abuse licensed professional 
  6.11  services, nursing practitioner professional services, certified 
  6.12  registered nurse anesthetists, chiropractors, physician 
  6.13  assistants, laboratories, medical suppliers, and other health 
  6.14  care providers such as home health intravenous therapy 
  6.15  providers, personal care attendants, day activity centers, 
  6.16  waivered services, hospice, and other home health services, and 
  6.17  freestanding ambulatory surgical centers. 
  6.18     Sec. 8.  Minnesota Statutes 1998, section 62J.52, 
  6.19  subdivision 5, is amended to read: 
  6.20     Subd. 5.  [STATE AND FEDERAL HEALTH CARE PROGRAMS.] (a) 
  6.21  Skilled nursing facilities and ICF/MR services billed to state 
  6.22  and federal health care programs administered by the department 
  6.23  of human services shall use the form designated by the 
  6.24  department of human services. 
  6.25     (b) On and after July 1, 1996, state and federal health 
  6.26  care programs administered by the department of human services 
  6.27  shall accept the HCFA 1450 for community mental health center 
  6.28  services and shall accept the HCFA 1500 for freestanding 
  6.29  ambulatory surgical center services. 
  6.30     (c) State and federal health care programs administered by 
  6.31  the department of human services shall be authorized to use the 
  6.32  forms designated by the department of human services for 
  6.33  pharmacy services and for child and teen checkup services. 
  6.34     (d) State and federal health care programs administered by 
  6.35  the department of human services shall accept the form 
  6.36  designated by the department of human services, and the HCFA 
  7.1   1500 for supplies, medical supplies, or durable medical 
  7.2   equipment.  Health care providers may choose which form to 
  7.3   submit. 
  7.4      (e) Personal care attendant and waivered services billed on 
  7.5   a fee-for-service basis directly to state and federal health 
  7.6   care programs administered by the department of human services 
  7.7   shall use either the HCFA 1450 or the HCFA 1500 form, as 
  7.8   designated by the department of human services. 
  7.9      Sec. 9.  [62J.581] [STANDARDS FOR MINNESOTA UNIFORM HEALTH 
  7.10  CARE REIMBURSEMENT DOCUMENTS.] 
  7.11     Subdivision 1.  [MINNESOTA UNIFORM REMITTANCE ADVICE 
  7.12  REPORT.] All group purchasers and payers shall provide a uniform 
  7.13  remittance advice report to health care providers when a claim 
  7.14  is adjudicated.  The uniform remittance advice report shall 
  7.15  comply with the standards prescribed in this section. 
  7.16     Subd. 2.  [MINNESOTA UNIFORM EXPLANATION OF BENEFITS 
  7.17  DOCUMENT.] All group purchasers and payers shall provide a 
  7.18  uniform explanation of benefits document to health care patients 
  7.19  when a claim is adjudicated.  The uniform explanation of 
  7.20  benefits document shall comply with the standards prescribed in 
  7.21  this section. 
  7.22     Subd. 3.  [SCOPE.] For purposes of sections 62J.50 to 
  7.23  62J.61, the uniform remittance advice report and the uniform 
  7.24  explanation of benefits document format specified in subdivision 
  7.25  4 shall apply to all health care services delivered by a health 
  7.26  care provider or health care provider organization in Minnesota, 
  7.27  regardless of the location of the payer.  Health care services 
  7.28  not paid on an individual claims basis, such as capitated 
  7.29  payments, are not included in this section.  A health plan 
  7.30  company is excluded from the requirements in subdivisions 1 and 
  7.31  2 if they comply with section 62A.01, subdivisions 2 and 3. 
  7.32     Subd. 4.  [SPECIFICATIONS.] The uniform remittance advice 
  7.33  report and the uniform explanation of benefits document shall be 
  7.34  provided by use of a paper document conforming to the 
  7.35  specifications in this section or by use of the ANSI X12N 835 
  7.36  standard electronic format as established under United States 
  8.1   Code, title 42, sections 1320d to 1320d-8, and as amended from 
  8.2   time to time for the remittance advice.  The commissioner, after 
  8.3   consulting with the administrative uniformity committee, shall 
  8.4   specify the data elements and definitions for the uniform 
  8.5   remittance advice report and the uniform explanation of benefits 
  8.6   document. 
  8.7      Subd. 5.  [EFFECTIVE DATE.] The requirements in 
  8.8   subdivisions 1 and 2 are effective 12 months after the date of 
  8.9   required compliance with the standards for the electronic 
  8.10  remittance advice transaction under United States Code, title 
  8.11  42, sections 1320d to 1320d-8, and as amended from time to 
  8.12  time.  The requirements in subdivisions 1 and 2 apply regardless 
  8.13  of when the health care service was provided to the patient. 
  8.14     Sec. 10.  Minnesota Statutes 1998, section 62J.60, 
  8.15  subdivision 1, is amended to read: 
  8.16     Subdivision 1.  [MINNESOTA HEALTH CARE IDENTIFICATION 
  8.17  CARD.] All individuals with health care coverage shall be issued 
  8.18  health care identification cards by group purchasers as of 
  8.19  January 1, 1998, unless the requirements of section 62A.01, 
  8.20  subdivisions 2 and 3, are met.  The health care identification 
  8.21  cards shall comply with the standards prescribed in this section.
  8.22     Sec. 11.  Minnesota Statutes 1998, section 62Q.56, is 
  8.23  amended to read: 
  8.24     62Q.56 [CONTINUITY OF CARE.] 
  8.25     Subdivision 1.  [CHANGE IN HEALTH CARE PROVIDER.] (a) If 
  8.26  enrollees are required to access services through selected 
  8.27  primary care providers for coverage, the health plan company 
  8.28  shall prepare a written plan that provides for continuity of 
  8.29  care in the event of contract termination between the health 
  8.30  plan company and any of the contracted primary care providers or 
  8.31  general hospital providers.  The written plan must explain: 
  8.32     (1) how the health plan company will inform affected 
  8.33  enrollees, insureds, or beneficiaries about termination at least 
  8.34  30 days before the termination is effective, if the health plan 
  8.35  company or health care network cooperative has received at least 
  8.36  120 days' prior notice; 
  9.1      (2) how the health plan company will inform the affected 
  9.2   enrollees about what other participating providers are available 
  9.3   to assume care and how it will facilitate an orderly transfer of 
  9.4   its enrollees from the terminating provider to the new provider 
  9.5   to maintain continuity of care; 
  9.6      (3) the procedures by which enrollees will be transferred 
  9.7   to other participating providers, when special medical needs, 
  9.8   special risks, or other special circumstances, such as cultural 
  9.9   or language barriers, require them to have a longer transition 
  9.10  period or be transferred to nonparticipating providers; 
  9.11     (4) who will identify enrollees with special medical needs 
  9.12  or at special risk and what criteria will be used for this 
  9.13  determination; and 
  9.14     (5) how continuity of care will be provided for enrollees 
  9.15  identified as having special needs or at special risk, and 
  9.16  whether the health plan company has assigned this responsibility 
  9.17  to its contracted primary care providers. 
  9.18     (b) If the contract termination was not for 
  9.19  cause, enrollees can request a referral to the terminating 
  9.20  provider for up to 120 days if they have special medical needs 
  9.21  or have other special circumstances, such as cultural or 
  9.22  language barriers. health plans must provide, upon request, a 
  9.23  referral to the terminating provider for up to 120 days if: 
  9.24     (1) they are engaged in a current episode of treatment for 
  9.25  the following conditions: 
  9.26     (i) an acute condition; 
  9.27     (ii) a life-threatening mental or physical illness; 
  9.28     (iii) pregnancy beyond the first trimester of pregnancy; or 
  9.29     (iv) a disabling or chronic condition that is in an acute 
  9.30  phase; or 
  9.31     (2) the enrollee: 
  9.32     (i) is receiving culturally appropriate services and the 
  9.33  health plan company does not have a provider in its preferred 
  9.34  provider network with special expertise in the delivery of these 
  9.35  culturally appropriate services within the time and distance 
  9.36  requirements of section 62D.124, subdivision 1; or 
 10.1      (ii) does not speak English and the health plan company 
 10.2   does not have a provider or interpreter in its preferred 
 10.3   provider network that speaks the language spoken by the enrollee 
 10.4   within the time and distance requirements of section 62D.124, 
 10.5   subdivision 1. 
 10.6   The health plan company must explain the criteria that it used 
 10.7   to determine its decision on the request for referral.  If a 
 10.8   referral is granted, the health plan company must explain how 
 10.9   the continuity of care will be provided. 
 10.10     The health plan company can require medical records and 
 10.11  other supporting documentation in support of the requested 
 10.12  referral.  Each request for referral to a terminating provider 
 10.13  shall be considered by the health plan company on a case-by-case 
 10.14  basis. 
 10.15     (c) If the contract termination was for cause, enrollees 
 10.16  must be notified of the change and transferred to participating 
 10.17  providers in a timely manner so that health care services remain 
 10.18  available and accessible to the affected enrollees.  The health 
 10.19  plan company is not required to refer an enrollee back to the 
 10.20  terminating provider if the termination was for cause. 
 10.21     Subd. 2.  [CHANGE IN HEALTH PLANS.] (a) The health plan 
 10.22  company shall prepare a written plan that provides a process for 
 10.23  coverage determinations for continuity of care for new enrollees 
 10.24  with special needs, special risks, or other special 
 10.25  circumstances, such as cultural or language barriers, who 
 10.26  request continuity of care with their former provider for up to 
 10.27  120 days.  The written plan must explain the criteria that will 
 10.28  be used for determining special needs cases, and how continuity 
 10.29  of care will be provided.  If enrollees are subject to a change 
 10.30  in health plans, health plans must provide, upon request, a 
 10.31  referral to their current provider for up to 120 days if: 
 10.32     (1) they are engaged in a current episode of treatment for 
 10.33  the following conditions: 
 10.34     (i) an acute condition; 
 10.35     (ii) a life-threatening mental or physical illness; 
 10.36     (iii) pregnancy beyond the first trimester of pregnancy; or 
 11.1      (iv) a disabling or chronic condition that is in an acute 
 11.2   phase; or 
 11.3      (2) the enrollee: 
 11.4      (i) is receiving culturally appropriate services and the 
 11.5   health plan company does not have a provider in its preferred 
 11.6   provider network with special expertise in the delivery of these 
 11.7   culturally appropriate services within the time and distance 
 11.8   requirements of section 62D.124, subdivision 1; or 
 11.9      (ii) does not speak English and the health plan company 
 11.10  does not have a provider or interpreter in its preferred 
 11.11  provider network that speaks the language spoken by the enrollee 
 11.12  within the time and distance requirements of section 62D.124, 
 11.13  subdivision 1. 
 11.14  The health plan company may require medical records and other 
 11.15  supporting documentation to be submitted with the request for 
 11.16  referral.  Each request for referral to a current provider shall 
 11.17  be considered by the health plan company on a case-by-case 
 11.18  basis.  The health plan company must explain the criteria it 
 11.19  used to make its decision on the request for referral.  If a 
 11.20  referral is granted, the health plan company must explain how 
 11.21  continuity of care will be provided.  
 11.22     (b) This subdivision applies only to group coverage and 
 11.23  continuation and conversion coverage, and applies only to 
 11.24  changes in health plans made by the employer. 
 11.25     Subd. 2a.  [LIMITATIONS.] (a) Subdivisions 1 and 2 apply 
 11.26  only if the enrollee's health care provider agrees to: 
 11.27     (1) accept as payment in full the health plan company's 
 11.28  reimbursement rate for in-network providers for the same or 
 11.29  similar service or, at the discretion of the health plan 
 11.30  company, accept as payment in full the reimbursement rate 
 11.31  specified in a fee schedule established by the health plan 
 11.32  company; 
 11.33     (2) adhere to the health plan company's preauthorization 
 11.34  requirements; and 
 11.35     (3) provide the health plan company with all necessary 
 11.36  medical information related to the care provided to the enrollee.
 12.1      (b) Nothing in this section requires a health plan company 
 12.2   to provide coverage for a health care service or treatment that 
 12.3   is not covered under the enrollee's health plan.  
 12.4      Subd. 3.  [DISCLOSURES DISCLOSURE.] The written plans 
 12.5   required under this section must be made available upon request 
 12.6   to enrollees or prospective enrollees.  Information regarding an 
 12.7   enrollee's rights under this section must be included in member 
 12.8   contracts or certificates of coverage and must be provided by a 
 12.9   health plan company upon request of an enrollee or prospective 
 12.10  enrollee.  
 12.11     Sec. 12.  Minnesota Statutes 1998, section 62Q.58, is 
 12.12  amended to read: 
 12.13     62Q.58 [ACCESS TO SPECIALTY CARE.] 
 12.14     Subdivision 1.  [STANDING REFERRAL.] A health plan company 
 12.15  shall establish a procedure by which an enrollee may apply 
 12.16  for and, if appropriate, receive a standing referral to a health 
 12.17  care provider who is a specialist if a referral to a specialist 
 12.18  is required for coverage.  This procedure for a standing 
 12.19  referral must specify the necessary criteria and conditions, 
 12.20  which must be met in order for an enrollee to obtain a standing 
 12.21  referral managed care review and approval an enrollee must 
 12.22  obtain before such a standing referral is permitted. 
 12.23     Subd. 1a.  [MANDATORY STANDING REFERRAL.] An enrollee who 
 12.24  requests a standing referral to a specialist qualified to treat 
 12.25  the specific condition described in clauses (1) to (3) must be 
 12.26  given a standing referral to such a specialist if benefits for 
 12.27  such treatment are provided under the health plan and the 
 12.28  enrollee meets any of the following conditions:  
 12.29     (1) an acute condition; 
 12.30     (2) a life-threatening mental or physical illness; 
 12.31     (3) pregnancy beyond the first trimester of pregnancy; or 
 12.32     (4) a disabling or chronic condition that is in an acute 
 12.33  phase.  
 12.34     Subd. 2.  [COORDINATION OF SERVICES.] A primary care 
 12.35  provider or primary care group shall remain responsible for 
 12.36  coordinating the care of an enrollee who has received a standing 
 13.1   referral to a specialist.  The specialist shall not make any 
 13.2   secondary referrals related to primary care services without 
 13.3   prior approval by the primary care provider or primary care 
 13.4   group.  However, An enrollee with a standing referral to a 
 13.5   specialist may request primary care services from that 
 13.6   specialist that the specialist become the enrollee's primary 
 13.7   care provider and manage all medical care appropriate to the 
 13.8   enrollee.  The specialist, in agreement with the enrollee and 
 13.9   primary care provider or primary care group, may elect to 
 13.10  provide primary care services to that the enrollee, authorize 
 13.11  tests and services, and make secondary referrals according to 
 13.12  procedures established by the health plan company.  
 13.13     Subd. 3.  [DISCLOSURE.] Information regarding referral 
 13.14  procedures under this section must be included in any direct 
 13.15  marketing materials and in member contracts or certificates of 
 13.16  coverage and must be provided to an enrollee or prospective 
 13.17  enrollee by a health plan company upon request. 
 13.18     Sec. 13.  [62Q.75] [MEDICAL CLINICAL TRIALS.] 
 13.19     Subdivision 1.  [DEFINITIONS.] For purposes of this 
 13.20  section, "patient cost" means the cost of a medically necessary 
 13.21  health care service covered and provided by the health plan that 
 13.22  would normally be provided to or be available to the patient, 
 13.23  whether or not the patient participated in a clinical trial. 
 13.24  Patient cost does not include: 
 13.25     (1) the cost of an investigational drug or device; 
 13.26     (2) the cost of a nonhealth care service that an enrollee 
 13.27  may be required to receive as a result of treatment being 
 13.28  provided for the purposes of a clinical trial; 
 13.29     (3) costs associated with managing the research associated 
 13.30  with a clinical trial; or 
 13.31     (4) costs that would not be covered under the enrollee's 
 13.32  health plan. 
 13.33     Subd. 2.  [COVERAGE REQUIRED.] A health plan company shall 
 13.34  provide coverage for patient costs incurred by an enrollee in a 
 13.35  clinical trial for the treatment of a life-threatening condition 
 13.36  or prevention, early detection, and treatment of cancer if: 
 14.1      (1) the treatment is being provided or the studies are 
 14.2   being conducted in a phase III or phase IV clinical trial for 
 14.3   cancer, or the treatment is being provided in a phase III or 
 14.4   phase IV clinical trial for any other life-threatening 
 14.5   condition; 
 14.6      (2) the treatment is being provided in a clinical trial 
 14.7   approved by: 
 14.8      (i) the National Institute of Health; 
 14.9      (ii) a cooperative group or center of the National 
 14.10  Institute of Health; 
 14.11     (iii) the federal Food and Drug Administration in the form 
 14.12  of an investigational new drug application; 
 14.13     (iv) the federal Department of Veterans Affairs; 
 14.14     (v) the federal Department of Defense; or 
 14.15     (vi) a qualified research entity that meets the criteria 
 14.16  for the center of the National Institute of Health support grant 
 14.17  eligibility. 
 14.18     (3) the proposed treatment has been reviewed and approved 
 14.19  by a qualified institutional review board; and 
 14.20     (4) the facility and personnel providing the treatment are 
 14.21  providing treatment within their scope of practice, experience, 
 14.22  and training. 
 14.23     Subd. 3.  [PARTICIPATING PROVIDERS; COST SHARING.] A health 
 14.24  plan company may require that a qualified individual participate 
 14.25  in the trial through a participating provider if the provider 
 14.26  will accept the individual as a participant.  A health plan 
 14.27  company may apply cost-sharing requirements and other 
 14.28  limitations comparable to those applied to coverage for other 
 14.29  health services under the plan. 
 14.30     Sec. 14.  [QUALITY OF PATIENT CARE.] 
 14.31     The commissioner of health shall evaluate the feasibility 
 14.32  of collecting data on the quality of patient care provided in 
 14.33  hospitals, outpatient surgical centers, and other health care 
 14.34  facilities.  In this evaluation, the commissioner shall examine 
 14.35  the appropriate roles of the public and private sectors and the 
 14.36  need for risk adjusting data.  The evaluation must consider 
 15.1   mechanisms to identify the quality of nursing care provided to 
 15.2   consumers by examining variables such as skin breakdown and 
 15.3   patient injuries.  Any plan developed to collect data must also 
 15.4   address issues related to the release of this data in a useful 
 15.5   form to the public. 
 15.6      Sec. 15.  [EFFECTIVE DATE.] 
 15.7      Sections 1 to 3 and 11 to 14 are effective for all new 
 15.8   policies, contracts, or health benefit plans issued or renewed 
 15.9   on or after January 1, 2001.