E2SHB 2575 -
By Committee on Ways & Means
ADOPTED 03/03/2006
Strike everything after the enacting clause and insert the following:
"NEW SECTION. Sec. 1 A new section is added to chapter 70.14 RCW
to read as follows:
(1) "Administrator" means the administrator of the Washington state
health care authority under chapter 41.05 RCW.
(2) "Advisory group" means a group established under section
4(2)(c) of this act.
(3) "Committee" means the health technology clinical committee
established under section 2 of this act.
(4) "Coverage determination" means a determination of the
circumstances, if any, under which a health technology will be included
as a covered benefit in a state purchased health care program.
(5) "Health technology" means medical and surgical devices and
procedures, medical equipment, and diagnostic tests. Health
technologies does not include prescription drugs governed by RCW
70.14.050.
(6) "Participating agency" means the department of social and
health services, the state health care authority, and the department of
labor and industries.
(7) "Reimbursement determination" means a determination to provide
or deny reimbursement for a health technology included as a covered
benefit in a specific circumstance for an individual patient who is
eligible to receive health care services from the state purchased
health care program making the determination.
NEW SECTION. Sec. 2 A new section is added to chapter 70.14 RCW
to read as follows:
(a) Six practicing physicians licensed under chapter 18.57 or 18.71
RCW; and
(b) Five other practicing licensed health professionals who use
health technology in their scope of practice.
At least two members of the committee must have professional
experience treating women, children, elderly persons, and people with
diverse ethnic and racial backgrounds.
(2) Members of the committee:
(a) Shall not contract with or be employed by a health technology
manufacturer or a participating agency during their term or for
eighteen months before their appointment. As a condition of
appointment, each person shall agree to the terms and conditions
imposed by the administrator regarding conflicts of interest;
(b) Are immune from civil liability for any official acts performed
in good faith as members of the committee; and
(c) Shall be compensated for participation in the work of the
committee in accordance with a personal services contract to be
executed after appointment and before commencement of activities
related to the work of the committee.
(3) Meetings of the committee and any advisory group are subject to
chapter 42.30 RCW, the open public meetings act, including RCW
42.30.110(1)(l), which authorizes an executive session during a regular
or special meeting to consider proprietary or confidential nonpublished
information.
(4) Neither the committee nor any advisory group is an agency for
purposes of chapter 34.05 RCW.
(5) The health care authority shall provide administrative support
to the committee and any advisory group, and may adopt rules governing
their operation.
NEW SECTION. Sec. 3 A new section is added to chapter 70.14 RCW
to read as follows:
(a) There are concerns about its safety, efficacy, or cost-effectiveness, especially relative to existing alternatives, or
significant variations in its use;
(b) Actual or expected state expenditures are high, due to demand
for the technology, its cost, or both; and
(c) There is adequate evidence available to conduct the complete
review.
(2) A health technology for which the committee has made a
determination under section 4 of this act shall be considered for
rereview at least once every eighteen months, beginning the date the
determination is made. The administrator, in consultation with
participating agencies and the committee, shall select the technology
for rereview if he or she decides that evidence has since become
available that could change a previous determination. Upon rereview,
consideration shall be given only to evidence made available since the
previous determination.
(3) Pursuant to a petition submitted by an interested party, the
health technology clinical committee may select health technologies for
review that have not otherwise been selected by the administrator under
subsection (1) or (2) of this section.
(4) Upon the selection of a health technology for review, the
administrator shall contract for a systematic evidence-based assessment
of the technology's safety, efficacy, and cost-effectiveness. The
contract shall:
(a) Be with an evidence-based practice center designated as such by
the federal agency for health care research and quality, or other
appropriate entity;
(b) Require the assessment be initiated no sooner than thirty days
after notice of the selection of the health technology for review is
posted on the internet under section 7 of this act;
(c) Require, in addition to other information considered as part of
the assessment, consideration of: (i) Safety, health outcome, and cost
data submitted by a participating agency; and (ii) evidence submitted
by any interested party; and
(d) Require the assessment to: (i) Give the greatest weight to the
evidence determined, based on objective indicators, to be the most
valid and reliable, considering the nature and source of the evidence,
the empirical characteristic of the studies or trials upon which the
evidence is based, and the consistency of the outcome with comparable
studies; and (ii) take into account any unique impacts of the
technology on specific populations based upon factors such as sex, age,
ethnicity, race, or disability.
NEW SECTION. Sec. 4 A new section is added to chapter 70.14 RCW
to read as follows:
(2) In making a determination under subsection (1) of this section,
the committee:
(a) Shall consider, in an open and transparent process, evidence
regarding the safety, efficacy, and cost-effectiveness of the
technology as set forth in the systematic assessment conducted under
section 3(4) of this act;
(b) Shall provide an opportunity for public comment; and
(c) May establish ad hoc temporary advisory groups if specialized
expertise is needed to review a particular health technology or group
of health technologies, or to seek input from enrollees or clients of
state purchased health care programs. Advisory group members are
immune from civil liability for any official act performed in good
faith as a member of the group. As a condition of appointment, each
person shall agree to the terms and conditions imposed by the
administrator regarding conflicts of interest.
(3) Determinations of the committee under subsection (1) of this
section shall be consistent with decisions made under the federal
medicare program and in expert treatment guidelines, including those
from specialty physician organizations and patient advocacy
organizations, unless the committee concludes, based on its review of
the systematic assessment, that substantial evidence regarding the
safety, efficacy, and cost-effectiveness of the technology supports a
contrary determination.
NEW SECTION. Sec. 5 A new section is added to chapter 70.14 RCW
to read as follows:
(a) The determination conflicts with an applicable federal statute
or regulation, or applicable state statute; or
(b) Reimbursement is provided under an agency policy regarding
experimental or investigational treatment, services under a clinical
investigation approved by an institutional review board, or health
technologies that have a humanitarian device exemption from the federal
food and drug administration.
(2) For a health technology not selected for review under section
3 of this act, a participating agency may use its existing statutory
and administrative authority to make coverage and reimbursement
determinations. Such determinations shall be shared among agencies,
with a goal of maximizing each agency's understanding of the basis for
the other's decisions and providing opportunities for agency
collaboration.
(3) A health technology not included as a covered benefit under a
state purchased health care program pursuant to a determination of the
health technology clinical committee under section 4 of this act, or
for which a condition of coverage established by the committee is not
met, shall not be subject to a determination in the case of an
individual patient as to whether it is medically necessary, or proper
and necessary treatment.
(4) Nothing in this act diminishes an individual's right under
existing law to appeal an action or decision of a participating agency
regarding a state purchased health care program. Appeals shall be
governed by state and federal law applicable to participating agency
decisions.
NEW SECTION. Sec. 6 A new section is added to chapter 70.14 RCW
to read as follows:
NEW SECTION. Sec. 7 A new section is added to chapter 70.14 RCW
to read as follows:
(a) Notification when a health technology is selected for review
under section 3 of this act, indicating when the review will be
initiated and how an interested party may submit evidence, or provide
public comment, for consideration during the review;
(b) Notification of any determination made by the committee under
section 4(1) of this act, its effective date, and an explanation of the
basis for the determination; and
(c) Access to the systematic assessment completed under section
3(4) of this act, and reports completed under subsection (2) of this
section.
(2) Participating agencies shall develop methods to report on the
implementation of this section and sections 1 through 6 of this act
with respect to health care outcomes, frequency of exceptions, cost
outcomes, and other matters deemed appropriate by the administrator.
Sec. 8 RCW 41.05.013 and 2005 c 462 s 3 are each amended to read
as follows:
(1) The authority shall coordinate state agency efforts to develop
and implement uniform policies across state purchased health care
programs that will ensure prudent, cost-effective health services
purchasing, maximize efficiencies in administration of state purchased
health care programs, improve the quality of care provided through
state purchased health care programs, and reduce administrative burdens
on health care providers participating in state purchased health care
programs. The policies adopted should be based, to the extent
possible, upon the best available scientific and medical evidence and
shall endeavor to address:
(a) Methods of formal assessment, such as a health technology
assessment under sections 1 through 7 of this act. Consideration of
the best available scientific evidence does not preclude consideration
of experimental or investigational treatment or services under a
clinical investigation approved by an institutional review board;
(b) Monitoring of health outcomes, adverse events, quality, and
cost-effectiveness of health services;
(c) Development of a common definition of medical necessity; and
(d) Exploration of common strategies for disease management and
demand management programs, including asthma, diabetes, heart disease,
and similar common chronic diseases. Strategies to be explored include
individual asthma management plans. On January 1, 2007, and January 1,
2009, the authority shall issue a status report to the legislature
summarizing any results it attains in exploring and coordinating
strategies for asthma, diabetes, heart disease, and other chronic
diseases.
(2) The administrator may invite health care provider
organizations, carriers, other health care purchasers, and consumers to
participate in efforts undertaken under this section.
(3) For the purposes of this section "best available scientific and
medical evidence" means the best available clinical evidence derived
from systematic research.
NEW SECTION. Sec. 9 A new section is added to chapter 70.14 RCW
to read as follows:
Sections 1 through 7 of this act and RCW 41.05.013 do not apply to
state purchased health care services that are purchased from or through
health carriers as defined in RCW 48.43.005.
NEW SECTION. Sec. 10 Captions used in this act are not any part
of the law.
NEW SECTION. Sec. 11 If any part of this act is found to be in
conflict with federal requirements that are a prescribed condition to
the allocation of federal funds to the state, the conflicting part of
this act is inoperative solely to the extent of the conflict and with
respect to the agencies directly affected, and this finding does not
affect the operation of the remainder of this act in its application to
the agencies concerned. Rules adopted under this act must meet federal
requirements that are a necessary condition to the receipt of federal
funds by the state."
E2SHB 2575 -
By Committee on Ways & Means
ADOPTED 03/03/2006
On page 1, line 2 of the title, after "program;" strike the remainder of the title and insert "amending RCW 41.05.013; adding new sections to chapter 70.14 RCW; and creating new sections."
EFFECT: Clarifies the language and substantially reorganizes the bill. Substantive changes include: (1) Limiting the number of assessments done in the program's first two years of operation; (2) allowing interested parties to petition to have a technology reviewed; (3) explicitly allowing any advisory groups to include enrollees in state health care programs; (4) requiring the clinical committee to follow decisions made under Medicare unless evidence supports a contrary determination; (5) directing the HCA administrator to establish an appeals process; (6) removing a legislative oversight committee.