1.1                          A bill for an act 
  1.2             relating to health; providing patient protections; 
  1.3             requiring coverage for medical clinical trials; 
  1.4             amending Minnesota Statutes 1998, sections 62D.17, 
  1.5             subdivision 1; 62J.38; 62Q.56; and 62Q.58; Minnesota 
  1.6             Statutes 1999 Supplement, section 45.027, subdivision 
  1.7             6; proposing coding for new law in Minnesota Statutes, 
  1.8             chapter 62Q.  
  1.9   BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA: 
  1.10     Section 1.  Minnesota Statutes 1999 Supplement, section 
  1.11  45.027, subdivision 6, is amended to read: 
  1.12     Subd. 6.  [VIOLATIONS AND PENALTIES.] The commissioner may 
  1.13  impose a civil penalty not to exceed $10,000 per violation upon 
  1.14  a person who violates any law, rule, or order related to the 
  1.15  duties and responsibilities entrusted to the commissioner unless 
  1.16  a different penalty is specified.  If a civil penalty is imposed 
  1.17  on a health carrier as defined in section 62A.011, the 
  1.18  commissioner must divide 50 percent of the amount among any 
  1.19  policy holder or certificate holder affected by the violation.  
  1.20     Sec. 2.  Minnesota Statutes 1998, section 62D.17, 
  1.21  subdivision 1, is amended to read: 
  1.22     Subdivision 1.  The commissioner of health may, for any 
  1.23  violation of statute or rule applicable to a health maintenance 
  1.24  organization, or in lieu of suspension or revocation of a 
  1.25  certificate of authority under section 62D.15, levy an 
  1.26  administrative penalty in an amount up to $25,000 for each 
  1.27  violation.  In the case of contracts or agreements made pursuant 
  2.1   to section 62D.05, subdivisions 2 to 4, each contract or 
  2.2   agreement entered into or implemented in a manner which violates 
  2.3   sections 62D.01 to 62D.30 shall be considered a separate 
  2.4   violation.  In determining the level of an administrative 
  2.5   penalty, the commissioner shall consider the following factors: 
  2.6      (1) the number of enrollees affected by the violation; 
  2.7      (2) the effect of the violation on enrollees' health and 
  2.8   access to health services; 
  2.9      (3) if only one enrollee is affected, the effect of the 
  2.10  violation on that enrollee's health; 
  2.11     (4) whether the violation is an isolated incident or part 
  2.12  of a pattern of violations; and 
  2.13     (5) the economic benefits derived by the health maintenance 
  2.14  organization or a participating provider by virtue of the 
  2.15  violation. 
  2.16     Reasonable notice in writing to the health maintenance 
  2.17  organization shall be given of the intent to levy the penalty 
  2.18  and the reasons therefor, and the health maintenance 
  2.19  organization may have 15 days within which to file a written 
  2.20  request for an administrative hearing and review of the 
  2.21  commissioner of health's determination.  Such administrative 
  2.22  hearing shall be subject to judicial review pursuant to chapter 
  2.23  14.  If an administrative penalty is levied, the commissioner 
  2.24  must divide 50 percent of the amount among any enrollee affected 
  2.25  by the violation. 
  2.26     Sec. 3.  Minnesota Statutes 1998, section 62J.38, is 
  2.27  amended to read: 
  2.28     62J.38 [COST CONTAINMENT DATA FROM GROUP PURCHASERS.] 
  2.29     (a) The commissioner shall require group purchasers to 
  2.30  submit detailed data on total health care spending for each 
  2.31  calendar year.  Group purchasers shall submit data for the 1993 
  2.32  calendar year by April 1, 1994, and each April 1 thereafter 
  2.33  shall submit data for the preceding calendar year. 
  2.34     (b) The commissioner shall require each group purchaser to 
  2.35  submit data on revenue, expenses, and member months, as 
  2.36  applicable.  Revenue data must distinguish between premium 
  3.1   revenue and revenue from other sources and must also include 
  3.2   information on the amount of revenue in reserves and changes in 
  3.3   reserves.  Expenditure data, including raw data from claims, may 
  3.4   must distinguish between expenses incurred for patient care and 
  3.5   administrative costs.  Expenditure data must be provided 
  3.6   separately for the following categories or and for other 
  3.7   categories required by the commissioner:  physician services, 
  3.8   dental services, other professional services, inpatient hospital 
  3.9   services, outpatient hospital services, emergency, pharmacy 
  3.10  services and other nondurable medical goods, mental health, and 
  3.11  chemical dependency services, other expenditures, subscriber 
  3.12  liability, and administrative costs.  Administrative costs shall 
  3.13  include costs for marketing; state and federal taxes; salaries 
  3.14  and benefits of central office staff who do not direct patient 
  3.15  care; advertising; overhead; underwriting; lobbying; claims 
  3.16  processing; provider contracting and credentialing; detection 
  3.17  and prevention of payment for fraudulent or unjustified requests 
  3.18  for reimbursement or services; clinical quality assurance and 
  3.19  other types of medical care quality improvement efforts; 
  3.20  concurrent or prospective utilization review as defined in 
  3.21  section 62M.02; payments made to acquire a hospital, clinic, 
  3.22  health care facility, or the assets thereof; capital costs paid 
  3.23  on behalf of a hospital or clinic; lease payments; or any other 
  3.24  payment made to a hospital, clinic, or other health care 
  3.25  provider pursuant to a partnership, joint venture, integration, 
  3.26  or affiliation agreement.  The commissioner may require each 
  3.27  group purchaser to submit any other data, including data in 
  3.28  unaggregated form, for the purposes of developing spending 
  3.29  estimates, setting spending limits, and monitoring actual 
  3.30  spending and costs. 
  3.31     (c) The commissioner may collect information on: 
  3.32     (1) premiums, benefit levels, managed care procedures, and 
  3.33  other features of health plan companies; 
  3.34     (2) prices, provider experience, and other information for 
  3.35  services less commonly covered by insurance or for which 
  3.36  patients commonly face significant out-of-pocket expenses; and 
  4.1      (3) information on health care services not provided 
  4.2   through health plan companies, including information on prices, 
  4.3   costs, expenditures, and utilization. 
  4.4      (d) All group purchasers shall provide the required data 
  4.5   using a uniform format and uniform definitions, as prescribed by 
  4.6   the commissioner. 
  4.7      Sec. 4.  Minnesota Statutes 1998, section 62Q.56, is 
  4.8   amended to read: 
  4.9      62Q.56 [CONTINUITY OF CARE.] 
  4.10     Subdivision 1.  [CHANGE IN HEALTH CARE PROVIDER.] (a) If 
  4.11  enrollees are required to access services through selected 
  4.12  primary care providers for coverage, the health plan company 
  4.13  shall prepare a written plan that provides for continuity of 
  4.14  care in the event of contract termination between the health 
  4.15  plan company and any of the contracted primary care providers or 
  4.16  general hospital providers.  The written plan must explain: 
  4.17     (1) how the health plan company will inform affected 
  4.18  enrollees, insureds, or beneficiaries about termination at least 
  4.19  30 days before the termination is effective, if the health plan 
  4.20  company or health care network cooperative has received at least 
  4.21  120 days' prior notice; 
  4.22     (2) how the health plan company will inform the affected 
  4.23  enrollees about what other participating providers are available 
  4.24  to assume care and how it will facilitate an orderly transfer of 
  4.25  its enrollees from the terminating provider to the new provider 
  4.26  to maintain continuity of care; 
  4.27     (3) the procedures by which enrollees will be transferred 
  4.28  to other participating providers, when special medical needs, 
  4.29  special risks, or other special circumstances, such as cultural 
  4.30  or language barriers, require them to have a longer transition 
  4.31  period or be transferred to nonparticipating providers; 
  4.32     (4) who will identify enrollees with special medical needs 
  4.33  or at special risk and what criteria will be used for this 
  4.34  determination; and 
  4.35     (5) how continuity of care will be provided for enrollees 
  4.36  identified as having special needs or at special risk, and 
  5.1   whether the health plan company has assigned this responsibility 
  5.2   to its contracted primary care providers. 
  5.3      (b) If the contract termination was not for cause, 
  5.4   enrollees can request a referral to the terminating provider for 
  5.5   up to 120 days if they have special medical needs or have other 
  5.6   special circumstances, such as cultural or language barriers.  
  5.7   The health plan company can require medical records and other 
  5.8   supporting documentation in support of the requested referral.  
  5.9   Each request for referral to a terminating provider shall be 
  5.10  considered by the health plan company on a case-by-case basis 
  5.11  enrollees must be notified of the change and informed of their 
  5.12  right to continue care with the terminating provider.  A health 
  5.13  plan company must continue to provide coverage for all covered 
  5.14  services provided by the terminating provider to an enrollee if 
  5.15  at the time of termination the provider is providing a covered 
  5.16  service to the enrollee for an ongoing course of treatment and 
  5.17  the enrollee meets one of the following conditions: 
  5.18     (1) has a life-threatening physical condition or mental 
  5.19  condition; 
  5.20     (2) has a physical or mental disability, a chronic health 
  5.21  care condition in an acute phase of the condition, or mental 
  5.22  retardation or other related condition; 
  5.23     (3) has entered the second trimester of pregnancy prior to 
  5.24  the time of enrollment; 
  5.25     (4) is receiving culturally appropriate services and the 
  5.26  health plan company does not have a provider in its preferred 
  5.27  provider network with special expertise in the delivery of these 
  5.28  culturally appropriate services within the time and distance 
  5.29  requirements of section 62D.124, subdivision 1; or 
  5.30     (5) does not speak English and the health plan company does 
  5.31  not have a provider or interpreter in its preferred provider 
  5.32  network that speaks the language spoken by the enrollee within 
  5.33  the time and distance requirements of section 62D.124, 
  5.34  subdivision 1.  At the request of the enrollee coverage for the 
  5.35  services provided by the terminating provider shall continue 
  5.36  until the end of the treatment or 180 days, whichever is shorter 
  6.1   except in the case of a terminally ill hospice eligible enrollee.
  6.2      (c) If the contract termination was for cause, enrollees 
  6.3   must be notified of the change and transferred to participating 
  6.4   providers in a timely manner so that health care services remain 
  6.5   available and accessible to the affected enrollees.  The health 
  6.6   plan company is not required to refer an enrollee back to the 
  6.7   terminating provider if the termination was for cause. 
  6.8      Subd. 2.  [CHANGE IN HEALTH PLANS.] (a) The A health plan 
  6.9   company shall prepare a written plan that provides a process for 
  6.10  provide coverage determinations for continuity of care for a new 
  6.11  enrollees with special needs, special risks, or other special 
  6.12  circumstances, such as cultural or language barriers, enrollee 
  6.13  who request requests continuity of care with their the 
  6.14  enrollee's former provider for up to 120 days.  The written plan 
  6.15  must explain the criteria that will be used for determining 
  6.16  special needs cases, and how continuity of care will be 
  6.17  provided. for up to 180 days if at the time of enrollment the 
  6.18  enrollee is receiving an ongoing course of treatment from the 
  6.19  former provider and the enrollee meets one of the conditions 
  6.20  described in subdivision 1, paragraph (b).  
  6.21     (b) This subdivision applies only to group coverage and 
  6.22  continuation and conversion coverage, and applies only to 
  6.23  changes in health plans made by the employer. 
  6.24     Subd. 2a.  [LIMITATIONS.] (a) Subdivisions 1 and 2 apply 
  6.25  only if the enrollee's health care provider agrees to: 
  6.26     (1) accept as payment in full the health plan company's 
  6.27  reimbursement rate for in-network providers for the same or 
  6.28  similar service; 
  6.29     (2) adhere to the health plan company's preauthorization 
  6.30  requirements; and 
  6.31     (3) provide the health plan company with all necessary 
  6.32  medical information related to the care provided to the enrollee.
  6.33     (b) Nothing in this section requires a health plan company 
  6.34  to provide coverage for a health care service or treatment that 
  6.35  is not covered under the enrollee's health plan.  
  6.36     Subd. 3.  [DISCLOSURES DISCLOSURE.] The written plans 
  7.1   required under this section must be made available upon request 
  7.2   to enrollees or prospective enrollees.  Information regarding an 
  7.3   enrollee's rights under this section must be included in member 
  7.4   contracts or certificates of coverage and must be provided by a 
  7.5   health plan company upon request of an enrollee or prospective 
  7.6   enrollee.  
  7.7      Sec. 5.  Minnesota Statutes 1998, section 62Q.58, is 
  7.8   amended to read: 
  7.9      62Q.58 [ACCESS TO SPECIALTY CARE.] 
  7.10     Subdivision 1.  [STANDING REFERRAL.] A health plan company 
  7.11  shall establish a procedure by which an enrollee may apply 
  7.12  for and, if appropriate, receive a standing referral to a health 
  7.13  care provider who is a specialist if a referral to a specialist 
  7.14  is required for coverage.  This procedure for a standing 
  7.15  referral must specify the necessary criteria and conditions, 
  7.16  which must be met in order for an enrollee to obtain a standing 
  7.17  referral managed care review and approval an enrollee must 
  7.18  obtain before such a standing referral is permitted. 
  7.19     Subd. 1a.  [MANDATORY STANDING REFERRAL.] An enrollee who 
  7.20  requests a standing referral to a specialist qualified to treat 
  7.21  the specific condition described in clauses (1) to (3) must be 
  7.22  given a standing referral to such a specialist if the enrollee 
  7.23  meets any of the following conditions:  
  7.24     (1) has a life-threatening physical condition or mental 
  7.25  condition; 
  7.26     (2) has a physical or mental disability, a chronic health 
  7.27  care condition in an acute phase of the condition, or mental 
  7.28  retardation or other related conditions; or 
  7.29     (3) has entered the second trimester of pregnancy and the 
  7.30  pregnancy has been assessed by the health plan company as high 
  7.31  risk.  
  7.32     Subd. 2.  [COORDINATION OF SERVICES.] A primary care 
  7.33  provider or primary care group shall remain responsible for 
  7.34  coordinating the care of an enrollee who has received a standing 
  7.35  referral to a specialist.  The specialist shall not make any 
  7.36  secondary referrals related to primary care services without 
  8.1   prior approval by the primary care provider or primary care 
  8.2   group.  However, An enrollee with a standing referral to a 
  8.3   specialist may request primary care services from that 
  8.4   specialist that the specialist become the enrollee's primary 
  8.5   care provider and manage all medical care appropriate to the 
  8.6   enrollee.  The specialist, in agreement with the enrollee and 
  8.7   primary care provider or primary care group, may elect to 
  8.8   provide primary care services to that the enrollee, authorize 
  8.9   tests and services, and make secondary referrals according to 
  8.10  procedures established by the health plan company.  
  8.11     Subd. 3.  [DISCLOSURE.] Information regarding referral 
  8.12  procedures under this section, including the application process 
  8.13  and criteria and conditions for a standing referral, must be 
  8.14  included in member contracts or certificates of coverage and 
  8.15  must be provided to an enrollee or prospective enrollee by a 
  8.16  health plan company upon request. 
  8.17     Subd. 4.  [REFERRAL.] (a) If a standing referral is 
  8.18  authorized under subdivision 1, or is mandatory under 
  8.19  subdivision 1a, the health plan company must provide a referral 
  8.20  to an appropriate participating specialist who is available and 
  8.21  accessible to provide the treatment, or to a nonparticipating 
  8.22  specialist if the health plan company does not have an 
  8.23  appropriate participating specialist that is available and 
  8.24  accessible to treat the enrollee's condition or disease. 
  8.25     (b) If an enrollee receives services from a 
  8.26  nonparticipating specialist because a participating specialist 
  8.27  is not available, services shall be provided at no additional 
  8.28  cost to the enrollee beyond what the enrollee would otherwise 
  8.29  pay for services received from a participating specialist. 
  8.30     Subd. 5.  [DEFINITION OF SPECIALIST.] For purposes of this 
  8.31  section, "specialist" means, with respect to a condition or 
  8.32  disease, a health care provider, or health care facility that 
  8.33  has adequate expertise through appropriate training and 
  8.34  practical clinical experience, including appropriate pediatric 
  8.35  expertise in the case of a child, to provide high-quality care 
  8.36  in treating the unique condition or disease of the particular 
  9.1   patient. 
  9.2      Sec. 6.  [62Q.75] [MEDICAL CLINICAL TRIALS.] 
  9.3      Subdivision 1.  [DEFINITIONS.] For purposes of this 
  9.4   section, "patient cost" means the cost of routine patient care 
  9.5   for items and services furnished in connection with 
  9.6   participation in a clinical trial.  Patient cost does not 
  9.7   include: 
  9.8      (1) the cost of an investigational drug or device; 
  9.9      (2) the cost of a non-health care service that an enrollee 
  9.10  may be required to receive as a result of treatment being 
  9.11  provided for the purposes of a clinical trial; 
  9.12     (3) costs associated with managing the research associated 
  9.13  with a clinical trial; 
  9.14     (4) costs that would not be covered under the enrollee's 
  9.15  health plan; or 
  9.16     (5) costs of a health care service provided by a provider 
  9.17  outside the health plan company's provider network available to 
  9.18  the enrollee. 
  9.19     Subd. 2.  [COVERAGE REQUIRED.] A health plan company shall 
  9.20  provide coverage for patient costs incurred by an enrollee in a 
  9.21  clinical trial for the treatment of a life-threatening condition 
  9.22  or prevention, early detection, and treatment of cancer if: 
  9.23     (1) the treatment is being provided or the studies are 
  9.24  being conducted in a phase II, phase III, or phase IV clinical 
  9.25  trial for cancer, or the treatment is being provided in a phase 
  9.26  II, phase III, or phase IV clinical trial for any other 
  9.27  life-threatening condition; 
  9.28     (2) the treatment is being provided in a clinical trial 
  9.29  approved by: 
  9.30     (i) the National Institute of Health; 
  9.31     (ii) a cooperative group or center of the National 
  9.32  Institute of Health; 
  9.33     (iii) the federal Food and Drug Administration in the form 
  9.34  of an investigational new drug application; 
  9.35     (iv) the federal Department of Veterans Affairs; 
  9.36     (v) the federal Department of Defense; or 
 10.1      (vi) a qualified research entity that meets the criteria 
 10.2   for the center of the National Institute of Health support grant 
 10.3   eligibility; 
 10.4      (3) the proposed treatment has been reviewed and approved 
 10.5   by a qualified institutional review board; and 
 10.6      (4) the facility and personnel providing the treatment are 
 10.7   providing treatment within their scope of practice, experience, 
 10.8   and training. 
 10.9      Sec. 7.  [QUALITY OF PATIENT CARE.] 
 10.10     The commissioner of health, in consultation with the health 
 10.11  care professional and provider organizations, shall develop and 
 10.12  submit to the legislature by February 1, 2001, a plan for the 
 10.13  collection of data on the quality of patient care provided in 
 10.14  hospitals, outpatient surgical centers, and medical clinics.  In 
 10.15  developing the plan, the commissioner shall consider the 
 10.16  collection of data on variables sensitive to both nursing care 
 10.17  and medical care, such as infection rate, medication errors, 
 10.18  skin breakdown, and patient injuries.  The plan must address the 
 10.19  release of this data in a useful form to the public.  
 10.20     Sec. 8.  [EFFECTIVE DATE.] 
 10.21     Sections 3 and 4 are effective January 1, 2001.  Section 5 
 10.22  is effective for all new policies, contracts, or health benefit 
 10.23  plans issued or renewed on or after January 1, 2001.  Section 6 
 10.24  is effective the day following final enactment.