BILL REQ. #:  H-1675.2 

Read first time 02/08/2007.   Referred to Committee on Health Care & Wellness.

     AN ACT Relating to activities to support the certificate of need program; amending RCW 70.38.015, 70.38.025, 70.38.095, 70.38.115, 70.38.125, and 70.38.135; adding new sections to chapter 70.38 RCW; and creating a new section.

BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF WASHINGTON:

Sec. 1   RCW 70.38.015 and 1989 1st ex.s. c 9 s 601 are each amended to read as follows:
     It is declared to be the public policy of this state:
     (1) That health planning to promote, maintain, and assure the health of all citizens in the state, to provide accessible health services, health manpower, health facilities, and other resources while controlling excessive increases in costs, and to recognize prevention as a high priority in health programs, is essential to the health, safety, and welfare of the people of the state. Health planning should be responsive to changing health and social needs and conditions. Involvement in health planning from both consumers and providers throughout the state should be encouraged;
     (2) That the development of health services and resources, including the construction, modernization, and conversion of health facilities, should be accomplished in a planned, orderly fashion, consistent with identified priorities and without unnecessary duplication or fragmentation. The certificate of need program is a component of a health planning regulatory process that:
     (a) Balances consideration of:
     (i) Access to quality care at a reasonable cost for all residents;
     (ii) Optimal use of existing health care resources;
     (iii) Fostering expenditure control; and
     (iv) Avoidance of unnecessary duplication of health care facilities and services;
     (b) Supports improved health care outcomes by:
     (i) Basing decisions on the best available evidence and information; and
     (ii) Continuously monitoring compliance;
     (c) Is accountable for maintaining the resources necessary for high quality decisions that are timely and consistent;
     (d) Utilizes detailed criteria, standards, and need methodologies, both general and specific to particular facilities and services, that are updated regularly and that are complementary to the statewide health resources strategy; and
     (e) Is conducted in a transparent and accountable manner;
     (3) That the development and ongoing maintenance of adequate health care information, statistics and projections of need for health facilities and services ((is)) are essential to ((effective health planning and resources development)) supporting the review and monitoring of specified health care facilities and services regulated by the certificate of need program;
     (4) That the development of ((nonregulatory)) other approaches to health care ((cost containment should be)) expenditure control are considered, including the strengthening of ((price)) competition((; and
     (5) That health planning should be concerned with public health and health care financing, access, and quality, recognizing their close interrelationship and emphasizing cost control of health services, including cost-effectiveness and cost-benefit analysis)).

Sec. 2   RCW 70.38.025 and 2000 c 175 s 22 are each amended to read as follows:
     When used in this chapter, the terms defined in this section shall have the meanings indicated.
     (1) "Affected party" means an interested person who:
     (a) Is located or resides in the applicant's health service area;
     (b) Testified at a public hearing or submitted written information; and
     (c) Requested in writing to be informed of the department's decision.
     (2) "Board of health" means the state board of health created pursuant to chapter 43.20 RCW.
     (((2))) (3) "Capital expenditure" is an expenditure, including a force account expenditure (i.e., an expenditure for a construction project undertaken by a nursing home facility as its own contractor) which, under generally accepted accounting principles, is not properly chargeable as an expense of operation or maintenance. Where a person makes an acquisition under lease or comparable arrangement, or through donation, which would have required review if the acquisition had been made by purchase, such expenditure shall be deemed a capital expenditure. Capital expenditures include donations of equipment or facilities to a nursing home facility which if acquired directly by such facility would be subject to certificate of need review under the provisions of this chapter and transfer of equipment or facilities for less than fair market value if a transfer of the equipment or facilities at fair market value would be subject to such review. The cost of any studies, surveys, designs, plans, working drawings, specifications, and other activities essential to the acquisition, improvement, expansion, or replacement of any plant or equipment with respect to which such expenditure is made shall be included in determining the amount of the expenditure.
     (((3))) (4) "Continuing care retirement community" means an entity which provides shelter and services under continuing care contracts with its members and which sponsors or includes a health care facility or a health service. A "continuing care contract" means a contract to provide a person, for the duration of that person's life or for a term in excess of one year, shelter along with nursing, medical, health-related, or personal care services, which is conditioned upon the transfer of property, the payment of an entrance fee to the provider of such services, or the payment of periodic charges for the care and services involved. A continuing care contract is not excluded from this definition because the contract is mutually terminable or because shelter and services are not provided at the same location.
     (((4))) (5) "Department" means the department of health.
     (((5))) (6) "Expenditure minimum" means, for the purposes of the certificate of need program, one million dollars adjusted by the department by rule to reflect changes in the United States department of commerce composite construction cost index; or a lesser amount required by federal law and established by the department by rule.
     (((6))) (7) "Health care facility" means hospices, hospice care centers, hospitals, psychiatric hospitals, nursing homes, kidney disease treatment centers, ambulatory surgical facilities, and home health agencies, and includes such facilities when owned and operated by a political subdivision or instrumentality of the state and such other facilities as required by federal law and implementing regulations, but does not include any health facility or institution conducted by and for those who rely exclusively upon treatment by prayer or spiritual means in accordance with the creed or tenets of any well-recognized church or religious denomination, or any health facility or institution operated for the exclusive care of members of a convent as defined in RCW 84.36.800 or rectory, monastery, or other institution operated for the care of members of the clergy. In addition, the term does not include any nonprofit hospital: (a) Which is operated exclusively to provide health care services for children; (b) which does not charge fees for such services; and (c) if not contrary to federal law as necessary to the receipt of federal funds by the state.
     (((7))) (8) "Health maintenance organization" means a public or private organization, organized under the laws of the state, which:
     (a) Is a qualified health maintenance organization under Title XIII, section 1310(d) of the Public Health Services Act; or
     (b)(i) Provides or otherwise makes available to enrolled participants health care services, including at least the following basic health care services: Usual physician services, hospitalization, laboratory, X-ray, emergency, and preventive services, and out-of-area coverage; (ii) is compensated (except for copayments) for the provision of the basic health care services listed in (b)(i) to enrolled participants by a payment which is paid on a periodic basis without regard to the date the health care services are provided and which is fixed without regard to the frequency, extent, or kind of health service actually provided; and (iii) provides physicians' services primarily (A) directly through physicians who are either employees or partners of such organization, or (B) through arrangements with individual physicians or one or more groups of physicians (organized on a group practice or individual practice basis).
     (((8))) (9) "Health services" means clinically related (i.e., preventive, diagnostic, curative, rehabilitative, or palliative) services and includes alcoholism, drug abuse, and mental health services and as defined in federal law.
     (((9))) (10) "Health service area" means a geographic region appropriate for effective health planning which includes a broad range of health services.
     (((10))) (11) "Person" means an individual, a trust or estate, a partnership, a corporation (including associations, joint stock companies, and insurance companies), the state, or a political subdivision or instrumentality of the state, including a municipal corporation or a hospital district.
     (((11))) (12) "Provider" generally means a health care professional or an organization, institution, or other entity providing health care but the precise definition for this term shall be established by rule of the department, consistent with federal law.
     (((12))) (13) "Public health" means the level of well-being of the general population; those actions in a community necessary to preserve, protect, and promote the health of the people for which government is responsible; and the governmental system developed to guarantee the preservation of the health of the people.
     (((13))) (14) "Secretary" means the secretary of health or the secretary's designee.
     (((14))) (15) "Tertiary health service" means a specialized service that meets complicated medical needs of people and requires sufficient patient volume to optimize provider effectiveness, quality of service, and improved outcomes of care.
     (((15))) (16) "Hospital" means any health care institution which is required to qualify for a license under RCW 70.41.020(((2))) (4); or as a psychiatric hospital under chapter 71.12 RCW.

Sec. 3   RCW 70.38.095 and 2005 c 274 s 332 are each amended to read as follows:
     ((Public accessibility to records shall be accorded by health systems agencies pursuant to Public Law 93-641 and chapter 42.56 RCW. A health systems agency shall be considered a "public agency" for the sole purpose of complying with the public records act, chapter 42.56 RCW.))
     The department shall adopt policies for informing affected parties and the interested public of certificate of need activities through postal mailings, electronic mailings, or web site notification, as appropriate to the activity. The policy shall, at a minimum, include means for providing reasonable notification for distributing information related to: Applications; the status of the department's activities related to applications under consideration; determinations of nonreviewability; findings and decisions of the department; the status of appeals of findings and decisions of the department; and the monitoring status of approved projects. The policy shall include a searchable repository of recent and historical certificate of need decisions.

Sec. 4   RCW 70.38.115 and 1996 c 178 s 22 are each amended to read as follows:
     (1) Certificates of need shall be issued, denied, suspended, or revoked by the designee of the secretary in accord with the provisions of this chapter and rules of the department ((which)) that develop and publish review criteria and standards and establish review procedures ((and criteria for the certificate of need program)).
     (2) Criteria for the review of certificate of need applications, except as provided in subsection (3) of this section for health maintenance organizations, shall include but not be limited to consideration of the following:
     (a) The need that the population served or to be served by such services has for such services based on current utilization data, evidence related to appropriate utilization, and utilization trends;
     (b) The availability of less costly or more effective alternative methods of providing such services;
     (c) The financial feasibility and the probable impact of the proposal on the cost of and charges for providing health services in the community to be served, including the impact on the current health system infrastructure and ability of existing providers to serve the underinsured and uninsured;
     (d) In the case of health services to be provided((,)):
     (i) The availability of alternative uses of project resources for the provision of other health services((,));
     (ii) The extent to which such proposed services will be accessible to all residents of the area to be served((,)); and
     (iii) ((the need for and the availability in the community of services and facilities for osteopathic physicians and surgeons and allopathic physicians and their patients.)) The ((department shall consider the application in terms of its)) impact on existing and proposed institutional and other educational training programs for ((doctors of osteopathic medicine and surgery and medicine)) health care providers at the student, internship, and residency training levels;
     (e) In the case of a construction project, the costs and methods of the proposed construction, including the cost and methods of energy provision, and the probable impact of the ((construction)) project ((reviewed)) (i) on the cost of providing ((health)) services by the ((person proposing such construction project)) applicant and (ii) on the cost ((and charges to the public)) of providing ((health)) services by other ((persons)) entities;
     (f) The special needs and circumstances of ((osteopathic hospitals, nonallopathic services and)) children's hospitals;
     (g) Improvements or innovations in the financing and delivery of health services ((which)) that foster cost containment ((and serve to promote quality assurance and)), improved health outcomes, cost-effectiveness, and promote quality;
     (h) ((In the case of)) For proposed health services ((proposed to be provided)), a comparison of the efficiency and appropriateness of the use of similar existing services and facilities ((similar to those proposed));
     (i) ((In the case of)) For existing services or facilities, the quality of care provided by such services or facilities in the past;
     (j) In the case of hospitals ((certificate of need applications)), whether the ((hospital)) applicant meets or exceeds the regional average level of charity care, as determined by the secretary((; and)), and whether the applicant has adopted policies in excess of the charity care and reporting requirement of RCW 70.170.060;
     (k) ((In the case of)) For nursing home applications:
     (i) The availability of other nursing home beds in the planning area to be served; and
     (ii) The availability of other services in the community to be served. Data used to determine the availability of other services will include but not be limited to data provided by the department of social and health services;
     (l) For certificate of need regulated services other than hospitals, whether the applicant will provide charity care consistent with a minimal community standard developed by the department with provider participation for each regulated service;
     (m) The availability of appropriate health care providers to deliver the proposed service; and
     (n) Whether the applicant agrees to provide services to medicaid and medicare enrollees and agrees not to discriminate against medicaid and medicare enrollees based upon their coverage.
     (3) A certificate of need application of a health maintenance organization or a health care facility which is controlled, directly or indirectly, by a health maintenance organization, shall be approved by the department if the department finds:
     (a) Approval of such application is required to meet the needs of the members of the health maintenance organization and of the new members which such organization can reasonably be expected to enroll; and
     (b) The health maintenance organization is unable to provide, through services or facilities which can reasonably be expected to be available to the organization, its health services in a reasonable and cost-effective manner which is consistent with the basic method of operation of the organization and which makes such services available on a long-term basis through physicians and other health professionals associated with it.
     A health care facility, or any part thereof, with respect to which a certificate of need was issued under this subsection may not be sold or leased and a controlling interest in such facility or in a lease of such facility may not be acquired unless the department issues a certificate of need approving the sale, acquisition, or lease.
     (4) ((Until the final expiration of the state health plan as provided under RCW 70.38.919, the decision of the department on a certificate of need application shall be consistent with the state health plan in effect, except in emergency circumstances which pose a threat to the public health.)) The department ((in making its final decision)) may issue a conditional certificate of need if it finds that the project is justified only under specific circumstances. The conditions shall directly relate to the project being reviewed. The conditions may be ((released)) eliminated if it can be substantiated that the conditions are no longer valid and the ((release)) elimination of such conditions would be consistent with the purposes of this chapter.
     (5) Criteria adopted for review in accordance with subsection (2) of this section may vary according to the purpose for which the particular review is being conducted or the type of health service reviewed.
     (6) The department shall specify information to be required for certificate of need applications. Within fifteen days of receipt of the application, the department shall request additional information considered necessary to the application or start the review process. Applicants may decline to submit requested information through written notice to the department, in which case review starts on the date of receipt of the notice. Applications may be denied or limited because of failure to submit required and necessary information.
     (7) Concurrent review is for the purpose of comparative analysis and evaluation of competing or similar projects in order to determine which of the projects may best meet identified needs. Categories of projects subject to concurrent review include at least new health care facilities, new services, and expansion of existing health care facilities. The department shall specify time periods for the submission of applications for certificates of need subject to concurrent review, which shall not exceed ninety days. Review of concurrent applications shall start fifteen days after the conclusion of the time period for submission of applications subject to concurrent review. Concurrent review periods shall be limited to one hundred fifty days, except as provided for in rules adopted by the department authorizing and limiting amendment during the course of the review, or for an unresolved pivotal issue declared by the department.
     (8) Review periods for certificate of need applications other than those subject to concurrent review shall be limited to ninety days. Review periods may be extended up to thirty days if needed by a review agency, and for unresolved pivotal issues the department may extend up to an additional thirty days. A review may be extended in any case if the applicant agrees to the extension.
     (9) The department or its designee, shall conduct a public hearing on a certificate of need application if requested unless the review is expedited or subject to emergency review. The department by rule shall specify the period of time within which a public hearing must be requested and requirements related to public notice of the hearing, procedures, recordkeeping and related matters.
     (10)(a) Any applicant ((denied a certificate of need or whose certificate of need has been suspended or revoked)) or affected party that disagrees with an action of or a failure to act by the department with respect to a project regulated by this chapter, including the denial or suspension or revocation of a certificate of need, has the right to an adjudicative proceeding. The proceeding is governed by chapter 34.05 RCW, the Administrative Procedure Act.
     (b) Any health care facility or health maintenance organization that: (i) Provides services similar to the services provided by the applicant and under review pursuant to this subsection; (ii) is located within the applicant's health service area; and (iii) testified or submitted evidence at a public hearing held pursuant to subsection (9) of this section, shall be provided an opportunity to present oral or written testimony and argument in a proceeding under this subsection: PROVIDED, That the health care facility or health maintenance organization had, in writing, requested to be informed of the department's decisions.
     (c) If the department desires to settle with the applicant prior to the conclusion of the adjudicative proceeding, the department shall so inform the health care facility or health maintenance organization and afford them an opportunity to comment, in advance, on the proposed settlement.
     (11) An amended certificate of need shall be required for the following modifications of an approved project:
     (a) A new service requiring review under this chapter;
     (b) An expansion of a service subject to review beyond that originally approved;
     (c) An increase in bed capacity;
     (d) A significant reduction in the scope of a nursing home project without a commensurate reduction in the cost of the nursing home project, or a cost increase (as represented in bids on a nursing home construction project or final cost estimates acceptable to the person to whom the certificate of need was issued) if the total of such increases exceeds twelve percent or fifty thousand dollars, whichever is greater, over the maximum capital expenditure approved. The review of reductions or cost increases shall be restricted to the continued conformance of the nursing home project with the review criteria pertaining to financial feasibility and cost containment.
     (12) An application for a certificate of need for a nursing home capital expenditure which is determined by the department to be required to eliminate or prevent imminent safety hazards or correct violations of applicable licensure and accreditation standards shall be approved.
     (13)(a) Replacement of existing nursing home beds in the same planning area by an existing licensee who has operated the beds for at least one year shall not require a certificate of need under this chapter. The licensee shall give written notice of its intent to replace the existing nursing home beds to the department and shall provide the department with information as may be required pursuant to rule. Replacement of the beds by a party other than the licensee is subject to certificate of need review under this chapter, except as otherwise permitted by subsection (14) of this section.
     (b) When an entire nursing home ceases operation, the licensee or any other party who has secured an interest in the beds may reserve his or her interest in the beds for eight years or until a certificate of need to replace them is issued, whichever occurs first. However, the nursing home, licensee, or any other party who has secured an interest in the beds must give notice of its intent to retain the beds to the department of health no later than thirty days after the effective date of the facility's closure. Certificate of need review shall be required for any party who has reserved the nursing home beds except that the need criteria shall be deemed met when the applicant is the licensee who had operated the beds for at least one year, who has operated the beds for at least one year immediately preceding the reservation of the beds, and who is replacing the beds in the same planning area.
     (14) In the event that a licensee, who has provided the department with notice of his or her intent to replace nursing home beds under subsection (13)(a) of this section, engages in unprofessional conduct or becomes unable to practice with reasonable skill and safety by reason of mental or physical condition, pursuant to chapter 18.130 RCW, or dies, the building owner shall be permitted to complete the nursing home bed replacement project, provided the building owner has secured an interest in the beds.

Sec. 5   RCW 70.38.125 and 1989 1st ex.s. c 9 s 606 are each amended to read as follows:
     (1) A certificate of need shall be valid for two years. One six-month extension may be made if it can be substantiated that substantial and continuing progress toward commencement of the project has been made as defined by regulations to be adopted pursuant to this chapter.
     (2) A project for which a certificate of need has been issued shall be commenced during the validity period for the certificate of need.
     (3) The department shall monitor the approved projects to assure conformance with certificates of need that have been issued. Rules and regulations adopted shall specify when changes in the project require reevaluation of the project. The department may require applicants to submit periodic progress reports on approved projects or other information as may be necessary to effectuate its monitoring responsibilities.
     (4) The secretary, in the case of a new health facility, shall not issue any license unless and until a prior certificate of need shall have been issued by the department for the offering or development of such new health facility.
     (((5) Any person who engages in any undertaking which requires certificate of need review without first having received from the department either a certificate of need or an exception granted in accordance with this chapter shall be liable to the state in an amount not to exceed one hundred dollars a day for each day of such unauthorized offering or development. Such amounts of money shall be recoverable in an action brought by the attorney general on behalf of the state in the superior court of any county in which the unauthorized undertaking occurred. Any amounts of money so recovered by the attorney general shall be deposited in the state general fund.
     (6) The department may bring any action to enjoin a violation or the threatened violation of the provisions of this chapter or any rules and regulations adopted pursuant to this chapter, or may bring any legal proceeding authorized by law, including but not limited to the special proceedings authorized in Title 7 RCW, in the superior court in the county in which such violation occurs or is about to occur, or in the superior court of Thurston county.))

NEW SECTION.  Sec. 6   A new section is added to chapter 70.38 RCW to read as follows:
     (1) Upon completion of a project, the department shall continue to monitor the operation of the project and the provision of the approved service for five years to assure that the project complies with the terms and conditions of the certificate, including the population served, medicare beneficiaries and medical assistance program clients served, levels of charity care provided, utilization and volume standards applicable to tertiary services, special conditions and representations associated with the approval of the project, and other items relevant to the project.
     (2) The department shall adopt rules, with the participation of providers, to establish the responsibilities of certificate recipients to assist the department in regular monitoring of completed projects, and penalties for failure to assist.
     (3) Other agencies having data relevant to the department's postcompletion monitoring activities shall cooperate with the department in sharing such information.
     (4) The department shall establish a reasonable fee for postcompletion monitoring activities.

NEW SECTION.  Sec. 7   A new section is added to chapter 70.38 RCW to read as follows:
     (1) In any case in which the department finds that there has been a failure or refusal to comply with the requirements of this chapter, the standards or rules adopted pursuant to this chapter, or the terms and conditions of an approved certificate of need, the department is authorized to suspend, revoke, or modify a certificate of need for an approved project or impose other appropriate penalties, including fines, not to exceed ten thousand dollars per violation, and moratoria on future certificate of need applications for a specified period of time, not to exceed two years. The department shall establish procedures for the notification to the recipient of a certificate of need of an adverse action against a certificate of need and to provide the right to an adjudicative proceeding. Upon the issuance of an adverse action for a violation of this section, the department shall notify any agency that may have issued a license for the project that an action has been taken and the nature of the violation. If the licensing agency determines that the underlying facts constitute a violation of any licensing provisions, the licensing agency may take appropriate disciplinary action within its authority.
     (2) Any person who engages in any undertaking which requires certificate of need review without first having received from the department either a certificate of need or an exception granted in accordance with this chapter is liable to the state in an amount not to exceed one hundred dollars a day for each day of such unauthorized offering or development. Such amounts of money are recoverable in an action brought by the attorney general on behalf of the state in the superior court of any county in which the unauthorized undertaking occurred. Any amounts of money so recovered by the attorney general shall be deposited in the state general fund.
     (3) The department may bring any action to enjoin a violation or the threatened violation of the provisions of this chapter or any rules adopted pursuant to this chapter, or may bring any legal proceeding authorized by law, including but not limited to the special proceedings authorized in Title 7 RCW, in the superior court in the county in which such violation occurs or is about to occur, or in the superior court of Thurston county.
     (4) The legislature finds that the practices covered by this act are matters vitally affecting the public interest for the purpose of applying the consumer protection act, chapter 19.86 RCW. A violation of this act is not reasonable in relation to the development and preservation of business and is an unfair or deceptive act in trade or commerce and an unfair method of competition for the purpose of applying the consumer protection act, chapter 19.86 RCW.

Sec. 8   RCW 70.38.135 and 1989 1st ex.s. c 9 s 607 are each amended to read as follows:
     The secretary shall have authority to:
     (1) Provide when needed temporary or intermittent services of experts or consultants or organizations thereof, by contract, when such services are to be performed on a part time or fee-for-service basis;
     (2) Make or cause to be made such on-site surveys of health care or medical facilities as may be necessary for the administration of the certificate of need program, including any monitoring activities conducted pursuant to this chapter;
     (3) Upon review of recommendations, if any, from the board of health:
     (a) Promulgate rules under which health care facilities providers doing business within the state shall submit to the department such data related to health and health care as the department finds necessary to the performance of its functions under this chapter;
     (b) Promulgate rules pertaining to the maintenance and operation of medical facilities which receive federal assistance under the provisions of Title XVI;
     (c) Promulgate rules in implementation of the provisions of this chapter, including the establishment of procedures for public hearings for predecisions and post-decisions on applications for certificate of need;
     (d) Promulgate rules providing circumstances and procedures of expedited certificate of need review if there has not been a significant change in existing health facilities of the same type or in the need for such health facilities and services;
     (4) Grant allocated state funds to qualified entities, as defined by the department, to fund not more than seventy-five percent of the costs of regional planning activities, excluding costs related to review of applications for certificates of need, provided for in this chapter or approved by the department; and
     (5) Contract with and provide reasonable reimbursement for qualified entities to assist in determinations of certificates of need.

NEW SECTION.  Sec. 9   The criteria in RCW 70.38.115 apply to any applications for a certificate of need submitted after the effective date of this act.