HB 5456

substitute for
House BILL NO. 5456
A bill to create a hyperbaric oxygen therapy grant program
and pilot program for providing treatment to veterans with traumatic brain
injuries or post-traumatic stress disorder; to provide for the powers and
duties of certain state governmental officers and entities; and to require the
promulgation of rules.
the peoplE of the state of michigan enact:
Sec. 1. This act may be cited as the "hyperbaric oxygen
therapy pilot program act".
Sec.
2. As used in this act:
(a) "Accreditation" means
a safety or operational review performed by a recognized accrediting
organization that conducts evaluations of hyperbaric chamber operations,
facility practices, or safety protocols using standards consistent with recognized
hyperbaric safety principles.
(b) "Chamber attendant"
means an individual with training provided by a recognized accrediting
organization who is responsible for direct care and supervision of a patient
receiving hyperbaric oxygen therapy, including operating and monitoring
equipment in accordance with manufacturer, facility, state, and federal
guidelines.
(c) "Department"
means the department of health and human services.
(d) "Eligible veteran"
means an individual who meets all of the following criteria:
(i) Is
a veteran as that term is defined in section 1 of 1965 PA 190, MCL 35.61.
(ii)
Is diagnosed with a traumatic brain injury or post-traumatic stress disorder.
(iii)
Is a resident of this state.
(e) "510(k) clearance"
means premarket clearance under section 510(k) of the federal food, drug, and
cosmetic act of 1938, 21 USC 360(k).
(f) "Fund" means
the hyperbaric oxygen therapy fund created in section 3 of the hyperbaric oxygen therapy fund act.
(g) "Grant program" means
the hyperbaric oxygen therapy grant program created in section 3.
(h) "Hard-shelled hyperbaric
chamber" means a rigid pressure vessel that meets both of the following
requirements:
(i) Is
constructed in accordance with ASME PVHO-1 and has an ASME PVHO-1 stamp.
(ii) Has
510(k) clearance from the United States Food and Drug Administration for its
intended use, or meets other federally recognized pressure-vessel engineering
standards.
(i) "Hyperbaric oxygen therapy" means treatment
delivered under increased atmospheric pressure, with or without supplemental
oxygen, and prescribed by a physician, physician's assistant, or nurse
practitioner.
(j) "Nurse practitioner"
means an individual who is licensed as a registered professional nurse under
part 172 of the public health code, 1978 PA 368, MCL 333.17201 to 333.17242,
who has been granted a specialty certification as a nurse practitioner by the
Michigan board of nursing under section 17210 of the public health code, 1978
PA 368, MCL 333.17210.
(k) "Physician" means a
physician who is licensed under part 170 or part 175 of the public health code,
1978 PA 368, MCL 333.17001 to 333.17097 and 333.17501 to 333.17556.
(l)
"Physician's assistant" means a physician's assistant who is licensed
under part 170 or part 175 of the public health code, 1978 PA 368, MCL
333.17001 to 333.17097 and 333.17501 to 333.17556.
(m) "Pilot program"
means the hyperbaric oxygen therapy pilot
program established under section 5.
(n) "Provider" means a
provider of hyperbaric oxygen therapy.
(o) "Recognized accrediting
organization" means any of the following:
(i)
American College of Hyperbaric Medicine.
(ii) International
Board of Undersea Medicine.
(iii) International
Hyperbaric Association.
(iv) National
Board of Diving and Hyperbaric Medical Technology.
(v) Undersea
and Hyperbaric Medical Society.
(p) "Safety director" means
a certified individual designated by a provider to perform duties including,
but not limited to, overseeing chamber safety procedures, conducting operator
training, performing daily safety checks, and ensuring emergency protocol
compliance.
(q) "Soft-shelled hyperbaric
chamber" means a flexible or soft-sided chamber holding valid 510(k) clearance
from the United States Food and Drug Administration for its intended use.
(r) "Treatment
plan" means a hyperbaric oxygen therapy treatment
plan.
Sec. 3. (1) As part of the pilot program, the department shall create
and operate a hyperbaric oxygen therapy grant program. The department
may make grants under this section only to a
provider chosen by the department under section 5 to assist the provider in
providing and paying the costs of hyperbaric
oxygen therapy and related diagnostic testing, including, but not
limited to, Automated Neuropsychological Assessment Metrics procedures, to
eligible veterans
under the pilot program. All providers that
receive a grant under this section must offer hyperbaric oxygen therapy at no
cost to eligible veterans as provided in section 5.
(2) The department shall not make a grant under this section until after the department has established the pilot program and promulgated the
rules required by section 5.
(3) The department shall not make a grant under this section after the pilot program ends.
(4) By not later than 12 months
after the effective date of this act, the department shall promulgate
rules to implement this section under the
administrative procedures act of 1969, 1969 PA 306, MCL 24.201 to 24.328, that
must address only the following for grants
under this section:
(a) Application procedures.
(b) Eligibility criteria subject to
section 5.
(c) Selection procedures subject to
section 5.
(d) A consideration of the extent to which a provider has used
assistance available from other assistance programs before the department makes
a grant under this section to the provider. However, a grant must not be denied or delayed solely on
the basis that assistance available from other programs has not been used.
(e) Department oversight and verification of the use of grant
money.
Sec. 5. (1) The department, in consultation with the
department of military and veterans affairs, shall
establish a hyperbaric oxygen therapy pilot
program to assist each provider that the department approves to provide
hyperbaric oxygen therapy and related diagnostic
testing to eligible veterans. The pilot
program must end 3 years after the first session of
hyperbaric oxygen therapy is administered under the program.
(2) The department shall issue a request for proposals within
this state to provide hyperbaric oxygen therapy to
eligible veterans. In
determining the providers that will participate in the pilot program, the
department shall prioritize existing providers in this state that meet all of
the following criteria:
(a) Have a medical director who is a
licensed medical professional who can prescribe oxygen who provides medical
oversight of all hyperbaric oxygen therapy delivered. The medical director must
be certified in hyperbaric medicine with a minimum certification of a 40-hour
introduction to hyperbaric medicine clinician course.
(b) Have a safety director on-site
to oversee trained chamber attendants.
(c) Follow established treatment
protocols for using hyperbaric oxygen therapy to treat traumatic brain injuries
and post-traumatic stress disorder.
(3) An eligible veteran is eligible for hyperbaric oxygen therapy under the pilot
program if the event that caused the traumatic brain injury or
post-traumatic stress disorder meets both of the
following:
(a) Is documented as a
service-connected disability by the United States Department of Veterans
Affairs.
(b) Is documented by a physician.
(4) By not later than 12 months
after the effective date of this act, the department, after consulting with the department of military and veterans affairs, shall promulgate
rules to implement this section under the
administrative procedures act of 1969, 1969 PA 306, MCL 24.201 to 24.328, that
must include standards for only the following:
(a) Confirmation by a
provider that an eligible veteran is a veteran eligible for participation in the pilot
program by showing 1 of the following forms as
applicable:
(i) DD214.
(ii) NGB-22.
(iii) DD256.
(b) Determination by the department
that a provider is eligible to participate in the pilot program with a
hard-shelled hyperbaric chamber, including meeting all of the following
requirements:
(i)
Each hard-shelled hyperbaric chamber must be constructed in accordance with
ASME PVHO-1 and have 510(k) clearance from the United States Food and Drug
Administration for its intended use.
(ii) Each
hard-shelled hyperbaric chamber must be operated and maintained in accordance
with manufacturer guidelines and specifications.
(iii)
Providers must maintain easily accessible records of all of the following:
(A) Each hard-shelled hyperbaric
chamber's ASME "U" stamp certification, data plate information, and
clinical and operating manual.
(B) Proof that a designated safety
director is on-site during hyperbaric oxygen therapy services.
(C) Documentation that the provider
has a medical director responsible for the oversight of the facility's
hyperbaric operations.
(D) Written policies for management
of the hyperbaric facility, including, but not limited to, general operational
procedures, emergency procedures, and documentation and maintenance of the
equipment that must be accessible to physicians and staff in the workplace,
reviewed by all staff at least annually, and revised periodically.
(iv)
Providers shall obtain accreditation for each hard-shelled chamber from a
recognized accreditation organization.
(v)
Providers shall undergo an independent safety audit not less than every 3 years
by a recognized accrediting organization or a reviewer with experience
evaluating hyperbaric chamber operations or safety practices.
(c) Determination by the department
that a provider is eligible to participate in the pilot program with a
soft-shelled hyperbaric chamber, including that the provider meets the
following requirements:
(i)
Each soft-shelled hyperbaric chamber must have 510(k) clearance from the United
States Food and Drug Administration for its intended use.
(ii) Each
soft-shelled hyperbaric chamber must be operated and maintained in accordance
with manufacturer guidelines and specifications.
(iii)
The oxygen concentration within each soft-shelled chamber and room in which the
soft-shelled chamber operates must not exceed 23.5% oxygen.
(iv) Providers
must maintain easily accessible records of all of the following:
(A) Each soft-shelled chamber's serial
number, clinical and operating manual, and proof of 510(k) clearance from the
United States Food and Drug Administration.
(B) Proof that a designated safety
director is on-site during hyperbaric oxygen therapy services.
(C) Documentation that the provider
has a medical director responsible for the oversight of the facility's hyperbaric
operations.
(D) Written policies for management
of the hyperbaric facility, including, but not limited to, general operational
procedures, emergency procedures, and documentation and maintenance of the
equipment that must be accessible to physicians and staff in the workplace,
reviewed by all staff at least annually, and revised periodically.
(v) Providers
shall obtain accreditation for each soft-shelled chamber from a recognized
accreditation organization.
(vi)
Providers operating soft-shelled chambers shall undergo an independent safety
audit not less than every 3 years by a recognized accreditation organization or
reviewer with experience evaluating hyperbaric chamber operations or safety
practices.
(d) Treatment plan
requirements, including all of the following:
(i)
That a provider must submit to the department,
before providing hyperbaric oxygen therapy to an eligible veteran, a treatment plan that includes
all of the following:
(A) A prescription from a physician,
physician's assistant, or nurse practitioner. Each patient must be evaluated
and cleared by a physician, physician's assistant, or nurse practitioner before
receiving hyperbaric oxygen therapy for the first time and any time the patient
has a major change in the patient's health status.
(B) Verification by the provider that the eligible veteran is eligible under subdivision (a) for participation in the pilot program and
voluntarily accepts treatment through the pilot program.
(C) An estimate of the cost of the eligible
veteran's hyperbaric oxygen therapy.
(D) Any other information required by the department.
(ii)
A requirement that both of the following must occur after the department receives a proposed
treatment plan from a provider:
(A) Approval or disapproval by the department of the treatment plan within
10 business days.
(B) Notice to the provider of approval or disapproval of the
treatment plan within 15 business days.
(iii)
Contingent on the availability of sufficient
funding in the fund, approval of each treatment plan that meets the
requirements established by the department under this section.
(iv)
The sources of funding for the estimated cost of hyperbaric
oxygen therapy for each eligible veteran
whose treatment plan is approved under this section.
(e) Criteria for approval of
payment for hyperbaric oxygen therapy that has
been verified by the department to have been provided under a treatment plan
approved under subdivision (d), including both
of the following:
(i)
Whether a drug or device used in the treatment plan has
been approved for any purpose by the United States Food
and Drug Administration.
(ii)
A verification that an eligible veteran
received the hyperbaric oxygen therapy as
demonstrated through billing documentation from the provider, or attendance
documentation signed by the provider and the eligible
veteran attesting to the receipt of the hyperbaric
oxygen therapy.
(f) Confidentiality of all
individually identifiable patient information of an
eligible veteran.
(5) A provider shall not bill an
eligible veteran for any service provided under the pilot program. A
provider shall bill the pilot program and be paid at cost out of a grant made to the provider
under the grant program at a rate agreed to between the provider and the
department, which may be the current state or federal Centers for Medicare and
Medicaid Services rates, but must not be more than the following amounts:
(a) For a hard-shelled hyperbaric
chamber, not more than $250.00 per dive and not more than $10,000.00 for a full
session of 40 dives.
(b) For a soft-shelled hyperbaric
chamber, not more than $175.00 per dive and not more than $7,000.00 for a full
session of 40 dives.
(6) Each provider must administer Automated
Neuropsychological Assessment Metrics procedures following the general
guidelines of the American Psychological Association for the distribution and
administration of psychological tests. Automated Neuropsychological Assessment
Metrics procedures must be administered before treatment, halfway through treatment
after 20 dives, and after the completion of a treatment of 40 dives. Automated
Neuropsychological Assessment Metrics procedures may be administered by trained
proctors under the supervision of individuals with training in psychological
testing principles and test administration procedures. Results must be
interpreted by qualified medical professionals such as clinical psychologists,
neuropsychologists, or physicians with training in psychological testing
principles, test administration procedures, and clinical test interpretation.
(7) An eligible veteran must provide
written informed consent to receive hyperbaric oxygen therapy under the pilot
program, subject to all of the following:
(a) At a minimum, the written
informed consent must include all of the following:
(i) An
explanation of the products used and treatments given for the traumatic brain
injury or post-traumatic stress disorder from which the veteran suffers.
(ii) A
description of the best and worst potential outcomes of using hyperbaric oxygen
therapy and a realistic description of the most likely outcomes. Both of the
following apply to the description of potential outcomes:
(A) Must include the possibility
that new, unanticipated, different, or worse symptoms may result and that the
proposed treatment may hasten death.
(B) Must be based on the treating
provider's knowledge of the proposed treatment in conjunction with an awareness
of the veteran's condition.
(b) The written informed consent
must be signed by the eligible veteran and attested to by the treating
provider.
Sec.
7. (1) Each provider shall file a quarterly status report concerning the
services performed by the provider under the pilot program with the department
and the department of military and veterans affairs
that must include separate results for treatments using hard shell chambers,
soft shell chambers with supplemental oxygen, and soft shell chambers without
supplemental oxygen.
(2) By not later than 1 year after the
pilot program begins and each year after until the pilot program ends,
the department, in
consultation with the department of military
and veterans affairs, shall prepare an annual report
and submit it to the governor and the chairpersons of the senate and the house
of representatives standing committees on military and veterans affairs. The reports required under this subsection must be made
available on the department's website and contain, at
a minimum, all of the following information for the pilot program for the
applicable reporting period:
(a) An evaluation of the
effectiveness of the pilot program.
(b) The number of eligible veterans
that participated.
(c) The number of providers that
participated.
(d) Separate results for treatments
using hard shell chambers, soft shell chambers with supplemental oxygen, and
soft shell chambers without supplemental oxygen.
(3) In addition to the reports
required under subsection (2), by not later than 6 months after the pilot
program ends, the department shall prepare and submit a final cumulative report
in the same manner as the report required under subsection (2), containing the
information described in subsection (2) for the entire duration of the pilot
program.
Enacting section 1.
This act does not take effect unless House Bill No. 5457 of the 103rd
Legislature is enacted into law.