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Chapter 16     Entire Code

1 - STATE PUBLIC HEALTH SYSTEM

1A - UNIFORM CREDENTIALING FOR HEAL

1B - SKILLED NURSING FACILITIES FOR

1C - HEALTH CARE PROVIDER TRANSPARE

2 - LOCAL BOARDS OF HEALTH

2A - ALTERNATIVE METHOD OF ORGANIZI

2B - FAMILY PLANNING AND CHILD SPAC

2C - HOME HEALTH SERVICES

2D - CERTIFICATE OF NEED

2E - BIRTHING CENTERS

2F - PARENTAL NOTIFICATION OF ABORT

2G - SPECIAL SUPPLEMENTARY FOOD PRO

2H - PRIMARY CARE SUPPORT PROGRAM

2I - WOMEN'S RIGHT TO KNOW ACT

2J - PREVENTIVE CARE PILOT PROGRAM

2K - PROGRAMS OF ALL-INCLUSIVE CARE

2L - PROVIDER SPONSORED NETWORKS

2M - THE PAIN-CAPABLE UNBORN CHILD

2N - NEONATAL ABSTINENCE CENTERS

2O - UNBORN CHILD PROTECTION FROM D

3 - PREVENTION AND CONTROL OF COMMU

3A - REPOSITORY OF INFORMATION ON M

3B - PERTUSSIS

3C - AIDS-RELATED MEDICAL TESTING A

3D - TUBERCULOSIS TESTING, CONTROL,

4 - SEXUALLY TRANSMITTED DISEASES

4A - PRENATAL EXAMINATION

4B - AUTOPSIES ON BODIES OF DECEASE

4C - EMERGENCY MEDICAL SERVICES ACT

4D - AUTOMATED EXTERNAL DEFIBRILLAT

4E - UNIFORM MATERNAL SCREENING ACT

4F - EXPEDITED PARTNER THERAPY

5 - VITAL STATISTICS

5A - CANCER CONTROL

5B - HOSPITALS AND SIMILAR INSTITUT

5C - NURSING HOMES

5D - ASSISTED LIVING RESIDENCES

5E - REGISTRATION AND INSPECTION OF

5F - HEALTH CARE FINANCIAL DISCLOSU

5G - OPEN HOSPITAL PROCEEDINGS

5H - CHRONIC PAIN CLINIC LICENSING

5I - HOSPICE LICENSURE ACT

5J - CLINICAL LABORATORIES QUALITY

5K - EARLY INTERVENTION SERVICES FO

5L - LONG-TERM CARE OMBUDSMAN PROGR

5M - OSTEOPOROSIS PREVENTION EDUCAT

5N - RESIDENTIAL CARE COMMUNITIES

5O - MEDICATION ADMINISTRATION BY U

5P - SENIOR SERVICES

5Q - THE JAMES "TIGER" MO

5R - THE ALZHEIMER'S SPECIAL CARE S

5S - OLDER WEST VIRGINIANS ACT

5T - OFFICE OF DRUG CONTROL POLICY

5U - ARTHRITIS PREVENTION EDUCATION

5V - EMERGENCY MEDICAL SERVICES RET

5W - WEST VIRGINIA OFFICIAL PRESCRI

5X - CAREGIVER ADVISE, RECORD AND E

5Y - MEDICATION-ASSISTED TREATMENT

5Z - COALITION FOR DIABETES MANAGEM

6 - HOTELS AND RESTAURANTS

7 - PURE FOOD AND DRUGS

8 - ELECTROLOGISTS

8A - NARCOTIC DRUGS

8B - DANGEROUS DRUGS ACT

9 - OFFENSES GENERALLY

9A - TOBACCO USAGE RESTRICTIONS

9B - IMPLEMENTING TOBACCO MASTER SE

9C - STATE TOBACCO GROWERS' SETTLEM

9D - ENFORCEMENT OF STATUTES IMPLEM

9E - DELIVERY SALES OF TOBACCO

9F - COUNTERFEIT CIGARETTES

10 - UNIFORM DETERMINATION OF DEAT

11 - SEXUAL STERILIZATION

12 - SANITARY DISTRICTS FOR SEWAGE

13 - SEWAGE WORKS AND STORMWATER W

13A - PUBLIC SERVICE DISTRICTS

13B - COMMUNITY IMPROVEMENT ACT

13C - DRINKING WATER TREATMENT REV

13D - REGIONAL WATER AND WASTEWATE

13E - COMMUNITY ENHANCEMENT ACT

14 - BARBERS AND COSMETOLOGISTS

15 - STATE HOUSING LAW

16 - HOUSING COOPERATION LAW

17 - NATIONAL DEFENSE HOUSING

18 - SLUM CLEARANCE

19 - ANATOMICAL GIFT ACT

20 - AIR POLLUTION CONTROL

21 - BLOOD DONATIONS

22 - DETECTION AND CONTROL OF PHEN

22A - TESTING OF NEWBORN INFANTS F

22B - BIRTH SCORE PROGRAM

23 - TRANSFUSION OF BLOOD; TRANSPL

24 - STATE HEMOPHILIA PROGRAM

25 - DETECTION OF TUBERCULOSIS, HI

26 - WEST VIRGINIA SOLID WASTE MAN

27 - STORAGE AND DISPOSAL OF RADIO

27A - BAN ON CONSTRUCTION OF NUCLE

28 - ASSISTANCE TO KOREAN AND VIET

29 - HEALTH CARE RECORDS

29A - WEST VIRGINIA HOSPITAL FINAN

29B - HEALTH CARE AUTHORITY

29C - INDIGENT CARE

29D - STATE HEALTH CARE

29E - LEGISLATIVE OVERSIGHT COMMIS

29F - UNINSURED AND UNDERINSURED P

29G - WEST VIRGINIA HEALTH INFORMA

29H - INTERAGENCY HEALTH COUNCIL

29I - WEST VIRGINIA HEALTH CARE AU

30 - WEST VIRGINIA HEALTH CARE DEC

30A - MEDICAL POWER OF ATTORNEY

30B - HEALTH CARE SURROGATE ACT

30C - DO NOT RESUSCITATE ACT

31 - COMMUNITY RIGHT TO KNOW

32 - ASBESTOS ABATEMENT

33 - BREAST AND CERVICAL CANCER PR

34 - LICENSURE OF RADON MITIGATORS

35 - LEAD ABATEMENT

36 - NEEDLESTICK INJURY PREVENTION

37 - BODY PIERCING STUDIO BUSINESS

38 - TATTOO STUDIO BUSINESS

39 - PATIENT SAFETY ACT

40 - STATEWIDE BIRTH DEFECTS INFOR

41 - ORAL HEALTH IMPROVEMENT ACT

42 - COMPREHENSIVE BEHAVIORAL HEAL

43 - ENGINE COOLANT AND ANTIFREEZE

44 - THE PULSE OXIMETRY NEWBORN TE

45 - TANNING FACILITIES

46 - ACCESS TO OPIOID ANTAGONISTS

47 - ALCOHOL AND DRUG OVERDOSE PRE

48 - WEST VIRGINIA ABLE ACT

49 - WEST VIRGINIA CLEARANCE FOR A

50 - EPINEPHRINE AUTO-INJECTOR AVA

51 - RIGHT TO TRY ACT
    16 - 51 - 1
    16 - 51 - 2
    16 - 51 - 3
    16 - 51 - 4
    16 - 51 - 5
    16 - 51 - 6
    16 - 51 - 7
    16 - 51 - 8

52 - COALITION FOR RESPONSIBLE PAI

53 - ESTABLISHING ADDITIONAL SUBST

CHAPTER 16. PUBLIC HEALTH.

ARTICLE 51. RIGHT TO TRY ACT.

§16-51-1.  Short title.

This article shall be known and may be cited as the Ben Price Right to Try Act.

§16-51-2.  Legislative findings.

(a) The Legislature finds and declares that:

(1) The process of approval for investigational drugs, biological products and devices in the United States protects future patients from premature, ineffective and unsafe medications and treatments over the long run, but the process often takes many years;

(2) Patients who have a terminal illness do not have the luxury of waiting until an investigational drug, biological product or device receives final approval from the United States Food and Drug Administration;

(3) Patients who have a terminal illness have a fundamental right to attempt to pursue the preservation of their own lives by accessing available investigational drugs, biological products and devices;

(4) The use of available investigational drugs, biological products and devices is a decision that should be made by the patient with a terminal illness in consultation with the patient’s health care provider and the patient’s health care team, if applicable; and

(5) The decision to use an investigational drug, biological product or device should be made with full awareness of the potential risks, benefits and consequences to the patient and the patient’s family.

(b) It is the intent of the Legislature to allow for terminally ill patients to use potentially life-saving or pain-relieving investigational drugs, biological products and devices.

§16-51-3.  Definitions.

For the purposes of this article:

(1) “Eligible patient” means a person who has:

(A) A terminal illness attested to by the patient’s treating physician;

(B) Considered all other treatment options currently approved by the United States Food and Drug Administration;

(C) Been unable to participate in a clinical trial for the terminal illness within one hundred miles of the patient’s home address for the terminal illness, or not been accepted to the clinical trial within one week of completion of the clinical trial application process;

(D) Received a recommendation from his or her physician for an investigational drug, biological product or device;

(E) Given written, informed consent for the use of the investigational drug, biological product or device or, if the patient is a minor or lacks the mental capacity to provide informed consent, a parent or legal guardian has given written, informed consent on the patient’s behalf; and

(F) Documentation from his or her physician that he or she meets the requirements of this subdivision.

(2) “Eligible patient” does not include a person being treated as an inpatient in a hospital licensed or certified pursuant to article five-b, chapter sixteen of this code.

(3) “Investigational drug, biological product or device” means a drug, biological product or device that has successfully completed phase one of a clinical trial but has not yet been approved for general use by the United States Food and Drug Administration.

(4) “Terminal illness” means a disease that, without life-sustaining procedures, will soon result in death or a state of permanent unconsciousness from which recovery is unlikely.

(5) “Written, informed consent” means a written document signed by the patient and attested to by the patient’s physician and a witness that, at a minimum:

(A) Explains the currently approved products and treatments for the disease or condition from which the patient suffers;

(B) Attests to the fact that the patient concurs with his or her physician in believing that all currently approved and conventionally recognized treatments are unlikely to prolong the patient’s life;

(C) Clearly identifies the specific proposed investigational drug, biological product or device that the patient is seeking to use;

(D) Describes the potentially best and worst outcomes of using the investigational drug, biological product or device with a realistic description of the most likely outcome, including the possibility that new, unanticipated, different or worse symptoms might result and that death could be hastened by the proposed treatment based on the physician’s knowledge of the proposed treatment in conjunction with an awareness of the patient’s condition;

(E) Makes clear that the patient’s health insurer and provider may not be obligated to pay for any care or treatments consequent to the use of the investigational drug, biological product or device;

(F) Makes clear that the patient’s eligibility for hospice care may be withdrawn if the patient begins curative treatment and care may be reinstated if the curative treatment ends and the patient meets hospice eligibility requirements;

(G) Makes clear that in-home health care may be denied if treatment begins; and

(H) States that the patient understands that he or she may be liable for all expenses consequent to the use of the investigational drug, biological product or device, and that this liability extends to the patient’s estate, unless a contract between the patient and the manufacturer of the drug, biological product or device states otherwise.

§16-51-4.  Drug manufacturers; availability of investigational drugs, biological products or devices; costs; insurance coverage.

(a) A manufacturer of an investigational drug, biological product or device may make available the manufacturer’s investigational drug, biological product or device to eligible patients pursuant to this article. This article does not require that a manufacturer make available an investigational drug, biological product or device to an eligible patient.

(b) A manufacturer may:

(1) Provide an investigational drug, biological product or device to an eligible patient without receiving compensation; or

(2) Require an eligible patient to pay the costs of, or the costs associated with, the manufacture of the investigational drug, biological product or device.

(c) Nothing in this article expands the coverage required by article fifteen, chapter thirty-three of this code.

(d) A health insurance carrier may, but is not required by this article to, provide coverage for the cost of an investigational drug, biological product or device.

(e) An insurer may deny coverage to an eligible patient from the time the eligible patient begins use of the investigational drug, biologic product or device through a period not to exceed six months from the time the investigational drug, biologic product or device is no longer used by the eligible patient; except that coverage may not be denied for a preexisting condition and for coverage for benefits which commenced prior to the time the eligible patient begins use of such drug, biologic product or device.

(f) If a patient dies while being treated by an investigational drug, biological product or device, the patient’s heirs and estate are not liable for any outstanding debt related to the treatment or lack of insurance due to the treatment.

§16-51-5.  Action against health care providers license or Medicare certification prohibited.

Notwithstanding any other law, a licensing board may not revoke, fail to renew, suspend or take any action against a health care provider’s license issued pursuant to chapter thirty of this code based solely on the health care provider’s recommendations to an eligible patient regarding access to or treatment with an investigational drug, biological product or device as long as the recommendations are consistent with medical standards of care.  Action against a health care provider’s Medicare certification based solely on the health care provider’s recommendation that a patient have access to an investigational drug, biological product or device is prohibited.

§16-51-6.  Access to investigational drugs, biological products and devices.

An official, employee or agent of this state shall not block or attempt to block an eligible patient’s access to an investigational drug, biological product or device.  Counseling, advice or a recommendation consistent with medical standards of care from a licensed health care provider is not a violation of this section.

§16-51-7.  No cause of action created.

This article does not create a private cause of action against a manufacturer of an investigational drug, biological product or device, against a health care provider as defined in section two, article seven-b, chapter fifty-five of this Code, or against any other person or entity involved in the care of an eligible patient using the investigational drug, biological product or device, for any harm done to the eligible patient resulting from the investigational drug, biological product or device, so long as the manufacturer, health care provider, or other person or entity is complying in good faith with the terms of this article.

§16-51-8.  Effect on health care coverage.

Nothing in this article affects the mandatory health care coverage for participation in clinical trials pursuant to section two, article twenty-five-f, chapter thirty-three of this code.

Note: WV Code updated with legislation passed through the 2017 Regular Session
The West Virginia Code Online is an unofficial copy of the annotated WV Code, provided as a convenience. It has NOT been edited for publication, and is not in any way official or authoritative.


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