Minnesota Statutes
Chapter 62Q — Health Plan Companies
Section 62Q.525 — Coverage For Off-label Drug Use.

Subdivision 1. Scope of coverage. This section applies to all health plans, including the coverages described in section 62A.011, subdivision 3, clauses (7) and (10), that are issued or renewed to a Minnesota resident.
Subd. 2. Definitions. (a) For purposes of this section, the terms defined in this subdivision have the meanings given them.
(b) "Medical literature" means articles from major peer reviewed medical journals that have recognized the drug or combination of drugs' safety and effectiveness for treatment of the indication for which it has been prescribed. Each article shall meet the uniform requirements for manuscripts submitted to biomedical journals established by the International Committee of Medical Journal Editors or be published in a journal specified by the United States Secretary of Health and Human Services pursuant to United States Code, title 42, section 1395x, paragraph (t), clause (2), item (B), as amended, as acceptable peer review medical literature. Each article must use generally acceptable scientific standards and must not use case reports to satisfy this criterion.
(c) "Off-label use of drugs" means when drugs are prescribed for treatments other than those stated in the labeling approved by the federal Food and Drug Administration.
(d) "Standard reference compendia" means any authoritative compendia as identified by the Medicare program for use in the determination of a medically accepted indication of drugs and biologicals used off-label.
Subd. 3. Required coverage. (a) Every type of coverage included in subdivision 1 that provides coverage for drugs may not exclude coverage of a drug for the treatment of cancer on the ground that the drug has not been approved by the federal Food and Drug Administration for the treatment of cancer if the drug is recognized for treatment of cancer in one of the standard reference compendia or in one article in the medical literature, as defined in subdivision 2.
(b) Coverage of a drug required by this subdivision includes coverage of medically necessary services directly related to and required for appropriate administration of the drug.
(c) Coverage required by this subdivision does not include coverage of a drug not listed on the formulary of the coverage included in subdivision 1.
(d) Coverage of a drug required under this subdivision must not be subject to any co-payment, coinsurance, deductible, or other enrollee cost-sharing greater than the coverage included in subdivision 1 applies to other drugs.
(e) The commissioner of commerce or health, as appropriate, may direct a person that issues coverage included in subdivision 1 to make payments required by this section.
Subd. 4. Construction. This section must not be construed to:
(1) alter existing law limiting the coverage of drugs that have not been approved by the federal Food and Drug Administration;
(2) require coverage for any drug when the federal Food and Drug Administration has determined its use to be contraindicated;
(3) require coverage for experimental drugs not otherwise approved for any indication by the federal Food and Drug Administration; or
(4) reduce or limit coverage for off-label use of drugs otherwise required by law or contract.
1998 c 301 s 1; 2009 c 159 s 3

Structure Minnesota Statutes

Minnesota Statutes

Chapters 59A - 79A — Insurance

Chapter 62Q — Health Plan Companies

Section 62Q.01 — Definitions.

Section 62Q.02 — Applicability Of Chapter.

Section 62Q.021 — Federal Act; Compliance Required.

Section 62Q.025 — High Deductible Health Plans.

Section 62Q.03 — Process For Risk Adjustment System.

Section 62Q.075 — Local Public Accountability And Collaboration Plan.

Section 62Q.096 — Credentialing Of Providers.

Section 62Q.097 — Requirements For Timely Provider Credentialing.

Section 62Q.101 — Evaluation Of Provider Performance.

Section 62Q.1055 — Chemical Dependency.

Section 62Q.106 — Dispute Resolution By Commissioner.

Section 62Q.107 — Prohibited Provision; Judicial Review.

Section 62Q.12 — Denial Of Access.

Section 62Q.121 — Licensure Of Medical Directors.

Section 62Q.135 — Contracting For Chemical Dependency Services.

Section 62Q.137 — Chemical Dependency Treatment; Coverage.

Section 62Q.14 — Restrictions On Enrollee Services.

Section 62Q.145 — Abortion And Scope Of Practice.

Section 62Q.16 — Midmonth Termination Prohibited.

Section 62Q.165 — Universal Coverage.

Section 62Q.17 — Voluntary Purchasing Pools.

Section 62Q.18 — Portability Of Coverage.

Section 62Q.181 — Written Certification Of Coverage.

Section 62Q.184 — Step Therapy Override.

Section 62Q.1841 — Prohibition On Use Of Step Therapy For Metastatic Cancer.

Section 62Q.185 — Guaranteed Renewability; Large Employer Group.

Section 62Q.186 — Prohibition On Rescissions Of Health Plans.

Section 62Q.188 — Flexible Benefits Plans.

Section 62Q.19 — Essential Community Providers.

Section 62Q.22 — Health Care Services Prepaid Option.

Section 62Q.23 — General Services.

Section 62Q.32 — Local Ombudsperson.

Section 62Q.33 — Local Government Public Health Functions.

Section 62Q.37 — Audits Conducted By Independent Organization.

Section 62Q.43 — Geographic Access.

Section 62Q.45 — Coverage For Out-of-area Primary Care.

Section 62Q.46 — Preventive Items And Services.

Section 62Q.47 — Alcoholism, Mental Health, And Chemical Dependency Services.

Section 62Q.471 — Exclusion For Suicide Attempts Prohibited.

Section 62Q.472 — Screening And Testing For Opioids.

Section 62Q.48 — Cost-sharing In Prescription Insulin Drugs.

Section 62Q.49 — Enrollee Cost Sharing; Negotiated Provider Payments.

Section 62Q.50 — Prostate Cancer Screening.

Section 62Q.51 — Point-of-service Option.

Section 62Q.52 — Direct Access To Obstetric And Gynecologic Services.

Section 62Q.521 — Postnatal Care.

Section 62Q.525 — Coverage For Off-label Drug Use.

Section 62Q.526 — Coverage For Participation In Approved Clinical Trials.

Section 62Q.527 — Nonformulary Antipsychotic Drugs; Required Coverage.

Section 62Q.528 — Drug Coverage In Emergency Situations.

Section 62Q.529 — Coverage For Drugs Prescribed And Dispensed By Pharmacies.

Section 62Q.53 — Mental Health Coverage; Medically Necessary Care.

Section 62Q.535 — Coverage For Court-ordered Mental Health Services.

Section 62Q.54 — Referrals For Residents Of Health Care Facilities.

Section 62Q.545 — Coverage Of Home Care Nursing.

Section 62Q.55 — Emergency Services.

Section 62Q.556 — Unauthorized Provider Services.

Section 62Q.56 — Continuity Of Care.

Section 62Q.57 — Designation Of Primary Care Provider.

Section 62Q.58 — Access To Specialty Care.

Section 62Q.645 — Efficiency Reports And Distribution Of Information.

Section 62Q.65 — Access To Provider Discounts.

Section 62Q.66 — Durable Medical Equipment Coverage.

Section 62Q.67 — Disclosure Of Covered Durable Medical Equipment.

Section 62Q.675 — Hearing Aids; Persons 18 Or Younger.

Section 62Q.676 — Medication Therapy Management.

Section 62Q.677 — Lifetime And Annual Limits.

Section 62Q.678 — Dependent Child Notice.

Section 62Q.68 — Definitions.

Section 62Q.69 — Complaint Resolution.

Section 62Q.70 — Appeal Of The Complaint Decision.

Section 62Q.71 — Notice To Enrollees.

Section 62Q.72 — Record Keeping; Reporting.

Section 62Q.73 — External Review Of Adverse Determinations.

Section 62Q.731 — Appeal From Adverse Determination.

Section 62Q.732 — Citation.

Section 62Q.733 — Definitions.

Section 62Q.734 — Exemption.

Section 62Q.735 — Provider Contracting Procedures.

Section 62Q.736 — Payment Rates.

Section 62Q.737 — Service Code Changes.

Section 62Q.739 — Unilateral Terms Prohibited.

Section 62Q.74 — Network Shadow Contracting.

Section 62Q.746 — Access To Certain Information Regarding Providers.

Section 62Q.75 — Prompt Payment Required.

Section 62Q.751 — Collecting Deductibles And Coinsurance.

Section 62Q.76 — Definitions.

Section 62Q.77 — Terms Of Coverage Disclosure.

Section 62Q.78 — Dental Benefit Plan Requirements.

Section 62Q.79 — Limitations.

Section 62Q.80 — Community-based Health Care Coverage Program.

Section 62Q.81 — Essential Health Benefit Package Requirements.

Section 62Q.82 — Benefits And Coverage Explanation.