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OREGON HEALTH AUTHORITY,
PUBLIC HEALTH DIVISION

 

DIVISION 35

HOSPICE PROGRAM LICENSURE

333-035-0045

Purpose

These rules establish the authority of the Oregon Health Authority, Public Health Division to license hospice programs in order to ensure the health and safety of individuals who are experiencing the last phases of life.

Stat. Auth.: ORS 443.860
Stats. Implemented: ORS 443.860
Hist.: PH 19-2010, f. 8-30-10, cert. ef. 9-1-10

333-035-0050

Definitions

As used in OAR chapter 333, division 35, the following definitions apply:

(1) "Accreditation" means a designation by an accrediting organization that a hospice program has met standards that have been developed to indicate a quality program.

(2) “Administrator” means a person responsible for the administrative functions and operation of the hospice program.

(3) “CMS” means Centers for Medicare and Medicaid Services.

(4) “Certification” means a state agency's official recommendations and findings to CMS regarding a hospice program's compliance with federal CMS regulations.

(5) "Conditions of Participation" mean the applicable federal regulations that hospice programs are required to comply with in order to participate in the federal Medicare and Medicaid programs.

(6) "Division" means the Public Health Division of the Oregon Health Authority.

(7) "Hospice aide" has the same meaning as nurse's aide.

(8) "Hospice program" means a coordinated program of home and inpatient care, available 24 hours a day, that utilizes an interdisciplinary team of personnel trained to provide palliative and supportive services to a patient-family unit experiencing a life threatening disease with a limited medical prognosis. A hospice program is an institution for purposes of ORS 146.100.

(9) "Hospice services" means items and services provided to a patient-family unit by a hospice program or by other individuals or community agencies under a consulting or contractual arrangement with a hospice program. Hospice services include home care, inpatient care for acute pain and symptom management or respite, and bereavement services provided to meet the physical, psychosocial, emotional, spiritual and other special needs of a patient-family unit during the final stages of illness, dying and the bereavement period.

(10) "Interdisciplinary team" means a group of individuals working together in a coordinated manner to provide hospice care. An interdisciplinary team includes, but is not limited to, the patient-family unit, the patient's attending physician or clinician and one or more of the following hospice program personnel:

(a) Physician;

(b) Nurse practitioner;

(c) Nurse;

(d) Nurse's aide;

(e) Occupational therapist;

(f) Physical therapist;

(g) Trained lay volunteer;

(h) Clergy or spiritual counselor; or

(i) Credentialed mental health professional such as psychiatrist, psychologist, psychiatric nurse or social worker.

(11) "Medicare Certification Number" means the unique identification number, also referred to as the Medicare Provider Number, assigned to a qualifying hospice program by CMS.

(12) “Nurse’s Aide” means a person certified as a nursing assistant under ORS 678.442 who has received special hospice training in accordance with CMS Conditions of Participation.

(13) "Patient-family unit" includes an individual who has a life threatening disease with a limited prognosis and all others sharing housing, common ancestry or a common personal commitment with the individual.

(14) "Person" includes individuals, organizations and groups of organizations.

(15) "Survey" means an inspection of an applicant for a hospice program license or a hospice program to determine the extent to which the applicant or hospice program is in compliance with state hospice program statutes, these rules and CMS Conditions of Participation.

Stat. Auth.: ORS 443.860
Stats Implemented: ORS 443.850
Hist.: PH 19-2010, f. 8-30-10, cert. ef. 9-1-10

333-035-0055

Licensing and Fees

(1) A person may not establish, conduct or maintain a hospice program providing hospice services, or hold itself out to the public as a hospice program, without obtaining a license from the Division.

(2) A person may apply to operate a hospice program by submitting a complete application on a form prescribed by the Division, accompanied by a fee of $750. An application that is incomplete or that is not accompanied by the correct fee will be returned to the person applying.

(3) In order for a license application to be considered complete, it shall include, but is not limited to:

(a) Business name;

(b) Medicare Certification Number (Medicare Provider Number)(if applicable);

(c) Primary and multiple locations (if any);

(d) Tax status;

(e) Ownership category (e.g. corporation, partnership, sole proprietorship);

(f) Physical and mailing addresses;

(g) Owner information;

(h) Descriptions of services;

(i) Staffing levels; and

(j) Average daily census.

(4) The Division shall conduct an initial survey prior to licensure.

(5) In lieu of an initial survey required under section (4) of this rule, the Division may accept a CMS certification or a survey conducted within the previous three years by an accrediting organization approved by the Division.

(6) A hospice program licensed in Washington, Idaho or California must be licensed in Oregon in order to provide care in Oregon within a 60 mile radius of the parent agency in the other state. A hospice program licensed in these other states shall pay the required fee and the Division:

(a) Shall conduct a licensing survey; or

(b) May accept a CMS certification or a survey conducted within the previous three years by an accrediting organization approved by the Division.

(7) The Division may waive the mileage guideline in section (6) of this rule if the parent hospice program proposes to provide hospice services to an underserved area of the state and adequately demonstrates the ability to manage and control the services.

(8) The Division shall issue a license to an applicant that has the necessary qualifications, meets all requirements established by the Division, meets the CMS Conditions of Participation for hospice programs found in 42 CFR Part 418, and has paid the fee.

(9) A license issued under this section is valid for one year and is not transferable.

(10) A licensee may apply for renewal of a license by completing a renewal application on a form prescribed by the Division and submission of a $750 renewal fee. The Division shall renew a license if the licensee is in compliance with ORS 443.850 through 443.869, these rules, and CMS Conditions of Participation, 42 CFR Part 418.

(11) The Division may permit a hospice program providing care at multiple locations, to operate under one license for all locations, if:

(a) All locations are operating under the same Medicare Certification Number;

(b) The multiple location provides the same full range of care and services that is required by the hospice program issued the Medicare Certification Number; and

(c) The locations are located within a 60 mile radius of the parent hospice program applying for licensure.

(12) The Division may waive the mileage guideline in subsection (11)(c) of this rule if the parent hospice program proposes to provide hospice services to an underserved area of the state and adequately demonstrates the ability to manage and control the services.

(13) An applicant or licensee may be required by CMS to obtain a survey by a CMS deemed accrediting organization in addition to any survey conducted by the Division under section (4) of this rule or OAR 333-035-0075.

Stat. Auth.: ORS 443.860
Stats. Implemented: ORS 443.860
Hist.: PH 19-2010, f. 8-30-10, cert. ef. 9-1-10

333-035-0060

Criminal Background Checks

(1) Except as provided in section (7) of this rule, a hospice program must obtain a criminal background check for the following prior to employment, entering into a contract, or permitting a volunteer to have direct patient contact and every three years thereafter:

(a) Hospice program employees;

(b) Individuals who contract with the hospice program and who have direct patient contact or access to patient records; and

(c) Volunteers who have direct patient contact or access to patient records.

(2) A hospice program must have written policies and procedures for conducting criminal background checks in accordance with section (1) of this rule including a description of criminal convictions that disqualifies an individual from being employed, contracted with or working as a volunteer.

(3) If the criminal background check or other information obtained by a hospice program indicates an employee, contractor or volunteer has been convicted of a crime against a person or property that reasonably raises questions about the ability of that individual to safely provide services or care, the hospice program shall notify the individual in writing that they have been found unfit to be employed, contracted with or to be a volunteer.

(4) If an individual has been found unfit in accordance with section (3) of this rule, the hospice program shall provide that individual with information on how to appeal to the source of the criminal background check if the individual believes the records are in error.

(5) A hospice program shall keep the information obtained from criminal background checks confidential and use it solely to determine an individual’s eligibility to be employed, contracted with or to be a volunteer.

(6) A hospice program shall require the individuals described in subsection (1)(a) through (c) of this rule to report within 10 days:

(a) Any criminal conviction;

(b) Any arrest, indictment, or charge for a sexual offense or property crime; and

(c) Any disciplinary action taken by a health professional regulatory board or agency.

(7) An individual licensed by a health professional regulatory board as defined in ORS 676.160 is not subject to the criminal background checks described in section (1) of this rule.

(8) A hospice program shall have policies and procedures that ensure the entities it contracts with have conducted criminal background checks for individuals that will have direct contact with the hospice program's patients or access to hospice program patient records.

Stat. Auth.: ORS 443.860
Stats. Implemented: ORS 443.860
Hist.: PH 19-2010, f. 8-30-10, cert. ef. 9-1-10

333-035-0065

Complaints

(1) Any person may make a complaint verbally or in writing to the Division regarding an allegation as to the care or services provided by a hospice program or violations of any hospice program laws or regulations.

(2) The identity of a person making a complaint will be kept confidential.

(3) An investigation will be carried out as soon as practicable after the receipt of a complaint in accordance with OAR 333-035-0070.

(4) If the complaint involves an allegation of criminal conduct or an allegation that is within the jurisdiction of another local, state, or federal agency, the Division will refer the matter to that agency.

Stat. Auth.: ORS 443.860
Stats. Implemented: ORS 443.860
Hist.: PH 19-2010, f. 8-30-10, cert. ef. 9-1-10

333-035-0070

Investigations

(1) As soon as practicable after receiving a complaint, taking into consideration the nature of the complaint, Division staff may begin an investigation.

(2) A hospice program shall permit Division staff access to any location from which it is operating its program or providing services during an investigation.

(3) An investigation may include but is not limited to:

(a) Interviews of the complainant, patients of the hospice program, patient family members, witnesses, hospice program management and staff;

(b) On-site observations of patients and staff performance; and

(c) Review of documents and records.

(4) Except as otherwise specified in 42 CFR ¦ 401, Subpart B, the Division shall draft an investigation report and may make publicly available a copy of that report that does not contain any information that could lead to the identification of the complainant, a patient, or any other information that is confidential under state law.

Stat. Auth.: ORS 443.860
Stats. Implemented: ORS 443.860
Hist.: PH 19-2010, f. 8-30-10, cert. ef. 9-1-10

333-035-0075

Surveys

(1) The Division shall, in addition to any investigations conducted under OAR 333-035-0070, conduct at least one survey of each hospice program every three years and at such other times as the Division deems necessary.

(2) In lieu of a survey required under section (1) of this rule, the Division may:

(a) Accept certification by a federal agency; or

(b) Accept a survey performed by an accrediting organization approved by the Division under OAR 333-035-0100, and conducted within the last three years.

(3) A hospice program shall permit Division staff access to any location from which it is operating its program or providing services during a survey.

(4) A survey may include but is not limited to:

(a) Interviews of patients, patient family members, hospice program management and staff;

(b) On-site observations of patients and staff performance;

(c) Review of documents and records; and

(d) Patient audits.

(5) A hospice program shall make all requested documents and records available to the surveyor for review and copying.

(6) Following a survey, Division staff may conduct an exit conference with the hospice program administrator or his or her designee. During the exit conference Division staff shall:

(a) Inform the hospice program representative of the preliminary findings of the inspection; and

(b) Give the person a reasonable opportunity to submit additional facts or other information to the surveyor in response to those findings.

(7) Following the survey, Division staff shall prepare and provide the hospice program administrator or his or her designee specific and timely written notice of the findings.

(8) If the findings result in a referral to another regulatory agency, Division staff shall submit the applicable information to that referral agency for its review and determination of appropriate action.

(9) If no deficiencies are found during a survey, the Division shall issue written findings to the hospice program administrator indicating that fact.

(10) If the surveyor's written notice of findings indicates that the agency was in compliance with hospice program licensing laws and no deficiencies were cited, the agency administrator or administrator's designee shall sign the written notice and return it to the Division.

(11) If deficiencies are found, the Division shall take informal or formal enforcement action in compliance with OAR 333-035-0085 or 333-035-0090.

Stat. Auth.: ORS 443.860
Stats. Implemented: ORS 443.860
Hist.: PH 19-2010, f. 8-30-10, cert. ef. 9-1-10

333-035-0080

Violations

In addition to non-compliance with any hospice program licensing law or CMS Conditions of Participation, it is a violation to:

(1) Refuse to cooperate with an investigation or survey, including but not limited to failure to permit Division staff access to the hospice program, its documents or records;

(2) Fail to implement an approved plan of correction;

(3) Fail to comply with all applicable laws, lawful ordinances and rules relating to safety from fire;

(4) Refuse or fail to comply with an order issued by the Division;

(5) Refuse or fail to pay a civil penalty;

(6) Fail to comply with rules governing the storage of records following the closure of a hospice program; or

(7) Fail to obtain a license.

Stat. Auth.: ORS 443.860
Stats. Implemented: ORS 443.860
Hist.: PH 19-2010, f. 8-30-10, cert. ef. 9-1-10

333-035-0085

Informal Enforcement

(1) If during an investigation or survey Division staff document violations of hospice program licensing laws or conditions of participation, the Division may issue a statement of deficiencies that cites the law alleged to have been violated and the facts supporting the allegation.

(2) A signed plan of correction must be received by the Division within 10 business days from the date the statement of deficiencies was mailed to the hospice program. A signed plan of correction will not be used by the Division as an admission of the violations alleged in the statement of deficiencies.

(3) A hospice program shall correct all deficiencies within 45 days from the date of the exit conference, unless an extension of time is requested from the Division. A request for such an extension shall be submitted in writing and must accompany the plan of correction.

(4) The Division shall determine if a written plan of correction is acceptable. If the plan of correction is not acceptable to the Division, the Division shall notify the hospice program administrator in writing and request that the plan of correction be modified and resubmitted no later than 10 working days from the date the letter of non-acceptance was mailed to the administrator.

(5) If the hospice program does not come into compliance by the date of correction reflected on the plan of correction or 45 days from date of the exit conference, whichever is sooner, the Division may propose to deny, suspend, or revoke the hospice program license, or impose civil penalties.

Stat. Auth.: ORS 443.860
Stats. Implemented: ORS 443.860
Hist.: PH 19-2010, f. 8-30-10, cert. ef. 9-1-10

333-035-0090

Formal Enforcement

(1) If during an investigation or survey Division staff document a substantial failure to comply with hospice program licensing laws or conditions of participation, or if a hospice program fails to pay a civil penalty imposed under ORS 443.869, the Division may issue a Notice of Proposed Suspension or Notice of Proposed Revocation in accordance with ORS 183.411 through 183.470.

(2) The Division may issue a Notice of Imposition of Civil Penalty for violations of hospice program licensing laws.

(3) At any time the Division may issue a Notice of Emergency License Suspension under ORS 183.430(2).

(4) If the Division revokes a hospice program license, the order shall specify when, if ever, the hospice program may reapply for a license.

Stat. Auth.: ORS 443.860
Stats. Implemented: ORS 443.860
Hist.: PH 19-2010, f. 8-30-10, cert. ef. 9-1-10

333-035-0095

Civil Penalties

(1) In addition to any other liability or penalty provided by law, the Division may impose a civil penalty of $1,000 per day, up to $10,000 in any 30-day period, for any of the following:

(a) Violation of any of the terms or conditions of a license issued under these rules;

(b) Violation of any of these rules or an order issued by the Division to a hospice program licensed under these rules;

(c) Violation of any final order of the director that pertains specifically to a hospice program owned or operated by the person incurring the penalty; or

(d) Violation of ORS 443.860 or of rules adopted under ORS 443.860.

(2) In determining the amount of a civil penalty the Division shall consider whether:

(a) The Division made repeated attempts to obtain compliance;

(b) There is a history of noncompliance with hospice program licensing laws;

(c) The violation poses a serious risk to the public's health;

(d) The person or licensee gained financially from the noncompliance; and

(e) There are mitigating factors, such as a person or licensee's cooperation with an investigation or actions to come into compliance.

(3) The Division shall document its consideration of the factors in section (2) of this rule.

(4) Each day a violation continues is an additional violation.

(5) Civil penalties under this section shall be imposed in the manner provided by ORS 183.745.

Stat. Auth.: ORS 443.860
Stats. Implemented: ORS 443.869
Hist.: PH 19-2010, f. 8-30-10, cert. ef. 9-1-10

333-035-0100

Approval of Accrediting Organizations

(1) An accrediting organization must request approval by the Division to accredit hospice programs in Oregon.

(2) An accrediting organization shall request approval in writing and shall provide, at a minimum:

(a) Evidence that it is recognized as a deemed accrediting organization by CMS; or

(b) Documentation of program policies and procedures that the accreditation meets standards and conditions established for hospice programs by CMS;

(c) Accreditation history; and

(d) References from a minimum of two hospice programs currently receiving services from the organization.

(3) If the Division finds that an accrediting organization’s qualifications are equal to or exceed state licensing requirements in Oregon, the Division will enter into an agreement with the accrediting organization permitting it to accredit hospice programs in Oregon.

(4) CMS will not accept accreditation by an organization that is not a deemed organization by CMS, for purposes of CMS certification.

Stat. Auth.: ORS 443.860
Stats. Implemented: ORS 443.860
Hist.: PH 19-2010, f. 8-30-10, cert. ef. 9-1-10

333-035-0105

Applicability of Rules

(1) A hospice program already in operation on September 1, 2010 shall apply to the Division for a license and pay the applicable fee by October 1, 2010.

(2) The Division shall allow a hospice program already in operation on September 1, 2010, three months from its date of application before an on-site inspection is conducted, in order to allow a hospice program to come into compliance with these rules.

(3) A hospice program already in operation on September 1, 2010 shall conduct criminal background checks in accordance with OAR 333-035-0060 prior to September 1, 2012.

Stat. Auth: ORS 443.860
Stats. Implemented: ORS 443.860
Hist.: PH 19-2010, f. 8-30-10, cert. ef. 9-1-10

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