Bill Text: IA SF404 | 2017-2018 | 87th General Assembly | Introduced

Iowa Senate Bill 404 (Prior Session Legislation)

NOTE: There are more recent revisions of this legislation. Read Latest Draft
Bill Title: A bill for an act relating to the use of experimental treatments for patients with a terminal illness. (Formerly SSB 1115.) Effective 7-1-17.

Spectrum: Committee Bill

Status: (Passed) 2017-05-11 - Signed by Governor. S.J. 1135. [SF404 Detail]

Download: Iowa-2017-SF404-Introduced.html

Senate File 404 - Introduced




                                 SENATE FILE       
                                 BY  COMMITTEE ON COMMERCE

                                 (SUCCESSOR TO SSB
                                     1115)

                                      A BILL FOR

  1 An Act relating to the use of experimental treatments for
  2    patients with a terminal illness.
  3 BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA:
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PAG LIN



  1  1    Section 1.  NEW SECTION.  144E.1  Title.
  1  2    This chapter shall be known and may be cited as the "Right
  1  3 to Try Act".
  1  4    Sec. 2.  NEW SECTION.  144E.2  Definitions.
  1  5    As used in this chapter:
  1  6    1.  "Eligible patient" means an individual who meets all of
  1  7 the following conditions:
  1  8    a.  Has a terminal illness, attested to by the patient's
  1  9 treating physician.
  1 10    b.  Has considered and rejected or has tried and failed to
  1 11 respond to all other treatment options approved by the United
  1 12 States food and drug administration.
  1 13    c.  Has received a recommendation from the individual's
  1 14 physician for an investigational drug, biological product, or
  1 15 device.
  1 16    d.  Has given written informed consent for the use of the
  1 17 investigational drug, biological product, or device.
  1 18    e.  Has documentation from the individual's physician that
  1 19 the individual meets the requirements of this subsection.
  1 20    2.  "Investigational drug, biological product, or device"
  1 21 means a drug, biological product, or device that has
  1 22 successfully completed phase 1 of a United States food and drug
  1 23 administration=approved clinical trial but has not yet been
  1 24 approved for general use by the United States food and drug
  1 25 administration and remains under investigation in a United
  1 26 States food and drug administration=approved clinical trial.
  1 27    3.  "Terminal illness" means a progressive disease or medical
  1 28 or surgical condition that entails significant functional
  1 29 impairment, that is not considered by a treating physician to
  1 30 be reversible even with administration of treatments approved
  1 31 by the United States food and drug administration, and that,
  1 32 without life=sustaining procedures, will result in death.
  1 33    4.  "Written informed consent" means a written document that
  1 34 is signed by the patient, a parent of a minor patient, or a
  1 35 legal guardian or other legal representative of the patient and
  2  1 attested to by the patient's treating physician and a witness
  2  2 and that includes all of the following:
  2  3    a.  An explanation of the products and treatments approved by
  2  4 the United States food and drug administration for the disease
  2  5 or condition from which the patient suffers.
  2  6    b.  An attestation that the patient concurs with the
  2  7 patient's treating physician in believing that all products
  2  8 and treatments approved by the United States food and drug
  2  9 administration are unlikely to prolong the patient's life.
  2 10    c.  Clear identification of the specific proposed
  2 11 investigational drug, biological product, or device that the
  2 12 patient is seeking to use.
  2 13    d.  A description of the best and worst potential outcomes
  2 14 of using the investigational drug, biological product, or
  2 15 device and a realistic description of the most likely outcome.
  2 16 The description shall include the possibility that new,
  2 17 unanticipated, different, or worse symptoms might result
  2 18 and that death could be hastened by use of the proposed
  2 19 investigational drug, biological product, or device. The
  2 20 description shall be based on the treating physician's
  2 21 knowledge of the proposed investigational drug, biological
  2 22 product, or device in conjunction with an awareness of the
  2 23 patient's condition.
  2 24    e.  A statement that the patient's health plan or third=party
  2 25 administrator and provider are not obligated to pay for any
  2 26 care or treatments consequent to the use of the investigational
  2 27 drug, biological product, or device, unless they are
  2 28 specifically required to do so by law or contract.
  2 29    f.  A statement that the patient's eligibility for hospice
  2 30 care may be withdrawn if the patient begins curative treatment
  2 31 with the investigational drug, biological product, or device
  2 32 and that care may be reinstated if this treatment ends and the
  2 33 patient meets hospice eligibility requirements.
  2 34    g.  A statement that the patient understands that the
  2 35 patient is liable for all expenses consequent to the use of
  3  1 the investigational drug, biological product, or device and
  3  2 that this liability extends to the patient's estate unless
  3  3 a contract between the patient and the manufacturer of the
  3  4 investigational drug, biological product, or device states
  3  5 otherwise.
  3  6    Sec. 3.  NEW SECTION.  144E.3  Manufacturer rights.
  3  7    1.  A manufacturer of an investigational drug, biological
  3  8 product, or device may make available and an eligible patient
  3  9 may request the manufacturer's investigational drug, biological
  3 10 product, or device under this chapter. This chapter does not
  3 11 require a manufacturer of an investigational drug, biological
  3 12 product, or device to provide or otherwise make available the
  3 13 investigational drug, biological product, or device to an
  3 14 eligible patient.
  3 15    2.  A manufacturer described in subsection 1 may do any of
  3 16 the following:
  3 17    a.  Provide an investigational drug, biological product, or
  3 18 device to an eligible patient without receiving compensation.
  3 19    b.  Require an eligible patient to pay the costs of, or the
  3 20 costs associated with, the manufacture of the investigational
  3 21 drug, biological product, or device.
  3 22    Sec. 4.  NEW SECTION.  144E.4  Treatment coverage.
  3 23    1.  This chapter does not expand the coverage required of an
  3 24 insurer under Title XIII, subtitle 1.
  3 25    2.  A health plan, third=party administrator, or
  3 26 governmental agency may provide coverage for the cost of an
  3 27 investigational drug, biological product, or device, or the
  3 28 cost of services related to the use of an investigational drug,
  3 29 biological product, or device under this chapter.
  3 30    3.  This chapter does not require any governmental agency
  3 31 to pay costs associated with the use, care, or treatment of a
  3 32 patient with an investigational drug, biological product, or
  3 33 device.
  3 34    4.  This chapter does not require a hospital licensed under
  3 35 chapter 135B or other health care facility to provide new or
  4  1 additional services.
  4  2    Sec. 5.  NEW SECTION.  144E.5  Heirs not liable for treatment
  4  3 debts.
  4  4    If a patient dies while being treated by an investigational
  4  5 drug, biological product, or device, the patient's heirs are
  4  6 not liable for any outstanding debt related to the treatment
  4  7 or lack of insurance due to the treatment, unless otherwise
  4  8 required by law.
  4  9    Sec. 6.  NEW SECTION.  144E.6  Provider recourse.
  4 10    1.  To the extent consistent with state law, the board of
  4 11 medicine created under chapter 147 shall not revoke, fail
  4 12 to renew, suspend, or take any action against a physician's
  4 13 license based solely on the physician's recommendations to
  4 14 an eligible patient regarding access to or treatment with an
  4 15 investigational drug, biological product, or device.
  4 16    2.  To the extent consistent with federal law, an entity
  4 17 responsible for Medicare certification shall not take action
  4 18 against a physician's Medicare certification based solely on
  4 19 the physician's recommendation that a patient have access to an
  4 20 investigational drug, biological product, or device.
  4 21    Sec. 7.  NEW SECTION.  144E.7  State interference.
  4 22    An official, employee, or agent of this state shall not
  4 23 block or attempt to block an eligible patient's access to
  4 24 an investigational drug, biological product, or device.
  4 25 Counseling, advice, or a recommendation consistent with medical
  4 26 standards of care from a licensed physician is not a violation
  4 27 of this section.
  4 28    Sec. 8.  NEW SECTION.  144E.8  Private cause of action.
  4 29    1.  This chapter shall not create a private cause of
  4 30 action against a manufacturer of an investigational drug,
  4 31 biological product, or device or against any other person
  4 32 or entity involved in the care of an eligible patient using
  4 33 the investigational drug, biological product, or device
  4 34 for any harm done to the eligible patient resulting from
  4 35 the investigational drug, biological product, or device, if
  5  1 the manufacturer or other person or entity is complying in
  5  2 good faith with the terms of this chapter and has exercised
  5  3 reasonable care.
  5  4    2.  This chapter shall not affect any mandatory health care
  5  5 coverage for participation in clinical trials under Title XIII,
  5  6 subtitle 1.
  5  7                           EXPLANATION
  5  8 The inclusion of this explanation does not constitute agreement with
  5  9 the explanation's substance by the members of the general assembly.
  5 10    This bill, titled the "Right to Try Act", permits
  5 11 manufacturers of investigational drugs, biological products, or
  5 12 devices to make available, and eligible patients with terminal
  5 13 illnesses to attempt treatment with, an investigational
  5 14 drug, biological product, or device as long as they provided
  5 15 written informed consent. The bill defines the terms "eligible
  5 16 patient", "terminal illness", "investigational drug, biological
  5 17 product, or device", and "written informed consent".
  5 18    Under the bill, an eligible patient's physician must
  5 19 acknowledge that the patient's illness is terminal and
  5 20 recommend the patient try an investigational drug, biological
  5 21 product, or device. The patient's written informed consent
  5 22 must acknowledge that treatments currently approved by the
  5 23 United Stated food and drug administration are unlikely to
  5 24 prolong the patient's life. It must identify the specific
  5 25 treatment sought and the potential best, worst, and expected
  5 26 results from the treatment. It must acknowledge that the
  5 27 patient's insurance is not required to pay for the treatment
  5 28 and that any hospice service may refuse to accept the patient
  5 29 after receiving the treatment. It must also acknowledge
  5 30 that expenses will be credited to the patient, including the
  5 31 patient's estate, unless an agreement with the manufacturer of
  5 32 an investigational drug, biological product, or device states
  5 33 otherwise. If the patient dies during treatment, the patient's
  5 34 heirs are not liable for any remaining debts unless otherwise
  5 35 required by law.
  6  1 The manufacturer of an investigational drug, biological
  6  2 product, or device may charge an eligible patient or provide
  6  3 the treatment free of charge. Governmental entities are
  6  4 not required to pay costs associated with the use, care,
  6  5 or treatment of a patient with an investigational drug,
  6  6 biological product, or device. The bill does not require
  6  7 hospitals licensed under Code chapter 135B or other health care
  6  8 facilities to provide new or additional services.
  6  9    Consistent with existing law, the board of medicine shall
  6 10 not take an adverse action against a physician's license solely
  6 11 for recommending an investigational drug, biological product,
  6 12 or device for the physician's eligible patient. The bill does
  6 13 not create a new private cause of action against any person or
  6 14 entity involved in the care of an eligible patient using the
  6 15 investigational drug, biological product, or device for any
  6 16 harm done to the patient resulting from the treatment if the
  6 17 person or entity is complying in good faith with the terms of
  6 18 the bill and has exercised reasonable care.
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