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Health Insurance Coverage For Cancer Clinical Trials

Regulation
Friday, August 5, 2005
Reg-H-2005-3

File attachments: 

http://www.dfr.vermont.gov/sites/default/files/H_2005_03_Cancer_Clinical_Trials.pdf

Regulation H-2005-03

HEALTH INSURANCE COVERAGE FOR CANCER CLINICAL TRIALS

Section 1. Purpose and Authority

This regulation is issued pursuant to the authority of the Commissioner of the Department of Banking, Insurance, Securities and Health Care Administration under 8 V.S.A. § 15 and 8 V.S.A. § 4088b to issue rules and regulations requiring that health benefit plans provide coverage for routine costs for patients who participate in approved cancer clinical trials.

Section 2. Applicability and Scope

This rule applies to any health insurance policy or health benefit plan in effect on March 1, 2002 and to any such plan offered, issued, or renewed on or after March 1, 2002 in Vermont by a health insurer as defined in 18 V.S.A.§ 9402(7), and to cancer care providers as defined in subsection 3(B) of this regulation. This rule applies to the Vermont Agency of Human Services through its Vermont Medicaid program in the same manner as insurers defined in 18 V.S.A. § 9402(7). The scope of this rule is limited to the coverage of costs for routine patient care services for patients who participate in approved cancer clinical trials as defined in subsection 3(A) of this regulation that are conducted under the auspices of cancer care providers as defined in subsection 3(B) of this regulation.

Section 3. Definitions

A. “Approved cancer clinical trial” means an organized, systematic, scientific study of therapies, tests, or other clinical interventions for purposes of treatment, palliation, or prevention of cancer in human beings. The approved cancer clinical trial must seek to answer a credible and specific medical or scientific question for the purpose of advancing cancer care and:

1. is conducted by a cancer care provider as defined in subsection 3 (B) of this regulation;

2. is conducted by a facility and personnel capable of conducting such a trial by virtue of experience, training and volume of patients treated to maintain expertise;

3. enrolls only those patients for whom there is no clearly superior, non-investigational treatment alternative to the cancer clinical trial and the available clinical or preclinical data provide a reasonable expectation that the treatment obtained in the cancer clinical trial will be at least as effective as the non-investigational alternative;

4. is conducted only after obtaining fully informed, written consent from the patient or the patient's legally authorized representative in a manner that is consistent with current legal and ethical standards and requirements; and

5. is conducted under the auspices of a peer-reviewed protocol that has been approved by one of the following entities:

a. one of the National Institutes of Health (“NIH”);

b. an NIH-affiliated cooperative group that is a formal network of facilities that collaborate on research projects and have an established NIH-approved peer review program operating within the group;

c. the FDA in the form of an investigational new drug application or exemption; or

d. the federal departments of Veterans Affairs or Defense.

B. “Cancer care provider” means the following: the Vermont Cancer Center at Fletcher Allen Health Care, the Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center, and a Vermont hospital and its affiliated, qualified Vermont cancer care providers administering approved cancer clinical trials.

C. “Commissioner” means the commissioner of the Vermont Department of Banking, Insurance, Securities and Health Care Administration.

D. “Department” means the Vermont Department of Banking, Insurance, Securities and Health Care Administration.

E. “Division” means the Division of Health Care Administration of the Department of Banking, Insurance, Securities and Health Care Administration.

F. “Health benefit plan” means any health insurance policy or health benefit plan offered by a health insurer as defined in 18 V.S.A.§ 9402(7).

G. “Health insurer” means any health insurance company, nonprofit hospital and medical service corporation, managed care organizations, and, to the extent permitted by federal law, any administrator of an insured, self-insured, or publicly funded health care benefit plan offered by public and private entities.

H. “Medically-necessary care” means health care services including diagnostic testing, preventive services and aftercare appropriate, in terms of type, amount, frequency, level, setting, and duration to the member’s diagnosis or condition. Medically-necessary care must be consistent with generally accepted practice parameters as recognized by health care providers in the same or similar general specialty as typically treat or manage the diagnosis or condition, and

1. help restore or maintain the member’s health; or

2. prevent deterioration of or palliate the member’s condition; or

3. prevent the reasonably likely onset of a health problem or detect an incipient problem.

I. “Routine patient care services” means those health care services for which a health insurer subject to this regulation is otherwise responsible under the patient’s health benefit plan, including any medically necessary health care service that is incurred as a result of the treatment being provided to the patient for the purposes of the approved cancer clinical trial. Routine patient care services include any physician service, diagnostic or laboratory test, hospitalization, or other service provided to the patient during the course of treatment in the approved cancer clinical trial for a condition or one of its complications or for a complication of the treatment provided during the approved cancer clinical trial which is consistent with the usual and customary standard of care and would be covered even if the patient were not enrolled in an approved cancer clinical trial. Routine patient care services do not include the following items:

1. The costs of investigational new drugs that have not been approved for market for any indication by the U.S. Food and Drug Administration (“FDA”) or the costs of any drug being studied under an FDA-approved investigational new drug exemption for the purpose of expanding the drug’s labeled indications;

 

2. The costs of non-health care services that may be required as a result of the treatment being provided for the purposes of the approved cancer clinical trial;

3. The costs of services that are clearly inconsistent with widely accepted and established regional or national standards of care for a particular diagnosis and performed specifically to meet the requirements of the approved cancer clinical trial;

4. the costs of any tests or services performed specifically to meet the needs of the approved cancer clinical trial protocol;

5. the costs of running the approved cancer clinical trial and collecting and analyzing data;

6. the costs associated with managing the research associated with the approved clinical trial;

7. costs for non-investigational treatments or services that would not otherwise be covered under the patient's health benefit plan; or

8. any product or service paid for or supplied by the trial sponsor.

Section 4. Services Required to Be Covered

All health insurance policies or health benefit plans in effect on March 1, 2002 and all such plans offered, issued, or renewed on or after March 1, 2002 in Vermont by a health insurer as defined in 18 V.S.A.§ 9402(7) and this regulation shall provide coverage for the costs of routine patient care services for patients who participate in all four types of approved cancer clinical trials (Phases I, II, III, and IV) that are conducted under the auspices of cancer care providers. Such costs shall be covered in a manner that is otherwise consistent with the terms of the patient’s health benefit plan, the health insurer’s contract with the cancer care provider and applicable state and federal law.

Section 5. Specific Responsibilities of Cancer Care Providers

A. Upon enrolling a patient into an approved cancer clinical trial, the cancer care provider shall provide the patient’s health insurer(s) and the patient with information that clearly identifies what services provided to the patient are being done solely to meet the needs of the approved cancer clinical trial protocol, and thus are not the responsibility of the health plan to cover and reimburse.

B. A copy of the document(s) evidencing the fully informed, written consent of the patient or the patient's legally authorized representative shall be made available to the patient’s health insurer upon request.

Section 6. Reporting Requirements

On or before July 1, 2004, the Office of Vermont Health Access and the four health insurers with the largest number of covered lives in Vermont on the effective date of this regulation shall submit to the Division data and analysis pertaining to the financial impact of the clinical trial pilot program required by 8 V.S.A. § 4088b on health care insurance premiums based on specifications provided by the Division.

Section 7. Severability

If any provision of this regulation or the application thereof to any person or circumstance is for any reason held to be invalid, the remainder of the regulation and the application of such provisions to other persons or circumstances shall not be affected thereby.

 

Section 8. Effective Date and Date of Expiration

The effective date of this regulation is August 5, 2005.

Civil Unions

Regulation
Monday, January 1, 2001
Reg-H-2000-01-IH

File attachments: 

http://www.dfr.vermont.gov/sites/default/files/REG-I-2000-01-IH_0.pdf

Regulation 2000-01-IH Civil Unions

Section 1 Purpose

This regulation is promulgated to prohibit insurers from unfairly discriminating between married couples and parties to a civil union regarding the offering of insurance policies and contracts. In accordance with this Regulation, insurers shall make insurance policies and contracts that are currently available to married couples, spouses, and their families available to civil union couples, parties to a civil union, and their families.

Section 2 Authority

This regulation is issued pursuant to the authority of the Commissioner to promulgate regulations. 8 V.S.A. '75. The regulation is based on the legislative prohibition on unfair discrimination against the parties to a civil union. See 8 V.S.A. '4724(7)(E).

Section 3 Applicability and Scope

(a) This regulation applies to any person transacting the business of insurance in the state of Vermont, as defined under 8 V.S.A. '3368(b).

(b) Except as expressly provided herein, this regulation applies to all insurance policies and contracts solicited, delivered, issued, or renewed in the state of Vermont.

(c) This regulation shall not be construed to affect the ability of a fraternal benefit society to determine the admission of its members as provided under 8 V.S.A. '4464 or to determine the scope of beneficiaries in accordance with 8 V.S.A. '4477(a). Further, this regulation shall not apply to a fraternal benefit society that has been established and is operating for charitable and educational purposes and which is operated, supervised or controlled by or in connection with a religious organization where compliance with this regulation would violate the society's free exercise of religion, as guaranteed by the First Amendment to the Constitution of the United States or by Chapter I, Article 3rd, of the Constitution of the State of Vermont.

Section 4 Definitions

(a) "Civil Union" shall mean a civil union established pursuant to 15 V.S.A. chapter 23 and 18 V.S.A. chapter 106.

(b) "Commissioner" shall mean the Commissioner of the Vermont Department of Banking, Insurance, Securities and Health Care Administration.

(c) "Department" shall mean the Vermont Department of Banking, Insurance, Securities and Health Care Administration.

(d) "Insurance policy" or "Insurance contract" shall mean any contract of insurance, indemnity, medical, dental, optometric, or hospital service, suretyship, or annuity, issued, proposed for issuance, or intended for issuance, by any insurer.

(e) "Insurer" shall mean any individual, corporation, association, partnership, reciprocal exchange, inter-insurer, Lloyds insurer, fraternal benefit society, hospital or medical service corporation, health maintenance organization, managed care organization, mental health review agent and any other legal entity engaged in the business of insurance, including agents, brokers, appraisers, and adjusters. For the purposes of this regulation, insurer shall also include third party administrators and other agents and contractors of persons engaged in the business of insurance in Vermont.

(f) "Party to a civil union" shall mean a person who has established a civil union.

Section 5 Interpretation of Department Regulations

Pursuant to 15 V.S.A. '1204, parties to a civil union and civil union couples shall be included in any definition or use of the terms "marriage," "spouse," "family," "immediate family," "dependent," "next of kin," and any other terms that denote a marital or spousal relationship, as those terms are used throughout the Department's regulations.

Section 6 Coverage Standards for Civil Unions

(a) Insurance contracts and policies offered by insurers to married couples, spouses, and their families shall also be offered to civil union couples, parties to a civil union, and their families. Except as specifically provided herein, all insurance contracts and policies shall provide coverage to parties to a civil union and their families that is equivalent to coverage provided to married persons and their families. At the request of a civil union party, insurers shall endorse or amend any such policy or contract to include policy or contract language which is consistent with this regulation. As provided in Section 7(c) all policies and contracts shall be amended or endorsed between January 1, 2001 and December 31, 2001.

(b) Effective January 1, 2001, any party to a civil union wishing to change his or her insurance contract or policy into a joint contract or policy shall be entitled to make that change to the extent a married person would be allowed to change his or her policy, without incurring any penalty as the result of such change. Any such change may be subject to standard and routine underwriting of the party to be added to the policy or contract.

(c) Insurers shall not use the fact that an applicant or an insured is a party to a civil union as a means to include sexual orientation in the underwriting process or in the determination of insurability. Use of sexual orientation as an underwriting standard or practice or as an eligibility requirement constitutes an unfair trade practice that is prohibited under 8 V.S.A. '4724(7).

(d) Nothing in this regulation shall be construed to prohibit insurers from setting rates for insurance in accordance with reasonable classifications based on relevant actuarial data or actual cost experience. However, preferential rates or discounts offered to married persons that are not based on relevant actuarial data or actual cost experience, such as rates and discounts which reflect administrative cost savings for the insurer or are used as a marketing tool by insurers, shall also be made equally available to the parties to a civil union.

(e) The existence of a civil union shall automatically create for each party to a civil union an insurable interest in the other party. Both parties in a civil union shall also automatically have an insurable interest in any child for whom one party in a civil union becomes the natural parent, as that term is used in 15 V.S.A. '1204(f), during the term of a civil union.

(f) An insurer shall not require any party to a civil union to produce proof of the existence of a valid civil union if that insurer does not also require married persons to produce proof of the existence of a valid marriage. Insurers may require an applicant to produce proof of the existence of a valid civil union only where the insurer would also require proof of the existence of a valid marriage under the same circumstances.

(g) Insurers are not required to provide a benefit available to a married person to a party to a civil union, or amend an insurance policy or contract of a party to a civil union when application of federal law prohibits such action or limits the benefit to married persons. Where an insurer declines to provide a benefit to, or amend an insurance contract of, a party to a civil union because of the application of federal law, the insurer shall notify the party to a civil union of the declination and the specific reason for the declination.

Section 7. Form Filings

(a) All forms filed on or after the effective date of this regulation shall comply with this regulation.

(b) All forms filed prior to the effective date of this regulation but not approved before January 1, 2001 shall, if approved, receive approval conditioned upon the inclusion of an appropriate endorsement that brings the policy or contract into compliance with this regulation.

(c) All forms currently on file and approved by the Department shall be amended or endorsed to bring the policy or contract into compliance with this regulation. Such amendment or endorsement shall be included in all policies and contracts issued or renewed on or after January 1, 2001. All contracts and policies that do not contain a renewal date shall be amended or endorsed to bring the policy or contract into compliance with this regulation on the first anniversary of the policy effective date following January 1, 2001. For example, a life insurance policy issued on March 1, 1965 or March 1, 1975 shall be amended or endorsed on or before March 1, 2001. For good cause shown, the Commissioner may extend these deadlines but not beyond December 31, 2001.

Section 8. Severability

If any provision of this regulation or the application thereof to any person or circumstance is for any reason held to be invalid, the remainder of the regulation and the application of such provisions to other persons or circumstances shall not be affected thereby.

Section 9. Effective Date

This regulation shall be effective January 1, 2001.

Coverage for Diagnosis and Treatment of Autism Spectrum Disorders, 8 V.S.A. § 4088i

Bulletin
Wednesday, April 20, 2011
Health Care Bulletin #133

File attachments: 

http://www.dfr.vermont.gov/sites/default/files/health-care-bulletin-133.pdf

Reminder to health insurance plans of the coverage mandated by 8 V.S.A. § 4088i

Southwestern Vermont Medical Center Fiscal Year 2009 Budget Performance

Order
Monday, March 21, 2011
Docket No. 09-074-H

File attachments: 

http://www.dfr.vermont.gov/sites/default/files/Stipulation%20and%20Consent%20Order.pdf

Nature of the Proceedings:  Stipulation and Consent Order

Date Issued:  March 21, 2011
Violation: Failure to comply with the budget established by the Commissioner
Action Taken: The Stipulation and Consent Order requires the implementation of procedures to ensure ongoing compliance.

Health Care Bulletin #132

Bulletin
Tuesday, February 15, 2011
Health Care Bulletin #132

File attachments: 

http://www.dfr.vermont.gov/sites/default/files/Bulletin_HCA_132.pdf

This bulletin explains the Department's position concerning Section 3.2(G)(4)e of Rule H-2009-03.

Regence Bluecross Blueshield of Utah

Order
Monday, November 22, 2010
Docket No. 10-102-H

File attachments: 

http://www.dfr.vermont.gov/sites/default/files/Order-10-102-H.pdf

Aetna Insurance Company

Order
Friday, October 29, 2010
Docket No. 10-059-H

File attachments: 

http://www.dfr.vermont.gov/sites/default/files/Order-10-059-H.pdf

Nature of the Proceedings:

Stipulation and Consent Order

Violation:

Failure to comply with forms filed with the Commissioner in violation of 8 V.S.A. § 4723 by reason of 8 V.S.A 4724 (19). (Vermont Insurance Trade Practices Act)

Action taken:

Administrative penalty payment of $125,000.00.
Payment of the Department’s costs of $13,280.00

Reliance Standard Life Insurance Company

Order
Thursday, October 7, 2010
Docket No. 10-020-H

File attachments: 

http://www.dfr.vermont.gov/sites/default/files/Order-10-020-H.pdf
Nature of the Proceedings:
Stipulation and Consent Order
 
Violation:
Failure to comply with forms filed with the Commissioner in violation of 8 V.S.A. § 4723 by reason of 8 V.S.A 4724 (19). (Vermont Insurance Trade Practices Act)
 
Action taken:
Administrative penalty payment of $100,000.00.
Payment of the Department’s costs of $2,313.00

MVP Health Insurance

Order
Monday, October 4, 2010
Docket No. 10-0098-H

File attachments: 

http://www.dfr.vermont.gov/sites/default/files/Order-10-0098-H.pdf

Stipulation and Consent Order

Failure to fully and/or timely submit required health care claims data, eligibility data, provider files and other information relating to health care services provided to Vermont residents, pursuant to the authority in 18 V.S.A. 9410(g) and Regulation H-2008-001 (VHCURES).
 
Payment of an administrative penalty of Seventy Five Thousand ($75,000) Dollars
 

Hospital Community Reports

Regulation
Monday, August 30, 2010
Reg-H-2009-05

File attachments: 

http://www.dfr.vermont.gov/sites/default/files/REG-H-2009-05.pdf

Regulation H-2009-05

HOSPITAL COMMUNITY REPORTS.

Section 1. General Provisions.

Authority . This regulation is promulgated by the Department of Banking, Insurance, Securities and Health Care Administration under the authority of 18 V.S.A. § 9405b, 18 V.S.A. § 1919 and 8 V.S.A. § 15.

Purpose . Section 9405b of Title 18 requires each hospital licensed pursuant to Chapter 43 of Title 18 to publish and provide to the Commissioner and the Public Oversight Commission annual hospital community reports in standard format. The purpose of this regulation is to establish the standard format for such reports, as well as the contents, which must include: (1) measures of quality, including process and outcome measures; (2) measures of patient safety; (3) measures of hospital-acquired infections; (4) measures of the hospital’s financial health; (5) a summary of the hospital’s budget; (6) measures that provide information for comparison of charges for higher volume services; (7) a description of the hospital’s process for achieving openness, inclusiveness and meaningful public participation in strategic planning and decision-making; (8) the hospital’s consumer complaint resolution process; (9) information concerning recent or current quality improvement and patient safety projects; (10) a description of identified health care needs strategic initiatives, capital expenditure plans and a depreciation schedule for existing facilities; (11) information on membership and governing body qualifications; and (12) information on nurse staffing.

 

Definitions.

As used in this regulation:

(A) “Annual Reporting Manual” means the manual issued by the Department under Section 3(C) of this regulation.

(B) “Benchmark” means an attribute or achievement that serves as a standard for other providers or institutions to emulate. Benchmarks differ from other standard of care goals in that they derive from empiric data – specifically, performance or outcomes data.

(C) “Charge” means the amount, in U.S. dollars, that a hospital invoices a purchaser or patient, as the case may be, for a particular service or combination of services performed by the hospital prior to the application of any discounts, reductions or mark-downs that may ultimately affect the amount the purchaser or patient, as the case may be, is obligated to pay for the performance of such service(s).

(D) “Commissioner” means the Commissioner of the Department of Banking, Insurance, Securities and Health Care Administration.

(E) “Department” means the Department of Banking, Insurance, Securities and Health Care Administration.

(F) “Hospital” means each hospital licensed under Chapter 43 of Title 18.

(G) “Public Oversight Commission” means the commission established pursuant to 18 V.S.A. § 9407(a).

(H) “Reliability” means the consistency of a measure. A reliable measure of quality should produce consistent results when repeated in the same population and setting, even when assessed by different people at different times. Any variation in a quality measure should reflect a true change in quality and not errors produced by the measurement itself. Such inconsistencies and errors occur when trying to measure quality in rare events (e.g., mortality), a small number of events (e.g., small hospitals may conduct very few of a specific procedure), or restricted samples of events (e.g., counting occurrence of an event over a relatively short period of time). Quality measures should be repeated periodically, and any changes in the measures should reflect a true change in quality.

(I) “Validity” means the accuracy of a measure, so that a specific quality indicator measures what it is intended to measure. Reliability is a prerequisite to validity, but does not guarantee a valid measure. The validity of a quality measure is assessed by whether it makes sense logically and clinically, correlates well with other measures of the same aspects of quality, and captures the meaningful aspects of quality. Quality measures should be linked to significant processes or outcomes of care as demonstrated by established scientific studies.

Section 2. Responsibilities of Hospitals

(A) Each hospital is responsible for publishing a community report by June 1 of each year. Such report shall contain the contents outlined in Section 4 of this regulation and in the Department’s hospital community reports reporting manual, to be issued annually under Section 3 of this regulation. Each hospital shall publish its community report on its website, making paper copies available on request, and shall provide to the Commissioner and all members of the Public Oversight Commission the URL website address of its report. All community reports shall be available in electronic format or such other format as the Commissioner may reasonably require from time to time.

(B) Each hospital shall hold at least one public hearing annually to permit community members to comment on its report, and shall provide notice of the hearing(s) in a newspaper of general circulation in the service area or areas of the hospital. The Department will provide guidance, in writing, to the hospitals regarding any specific hearing notice requirements, either through the annual reporting manual or otherwise.

Section 3. Responsibilities of Department

(A) The Department may convene one or more advisory committees from time to time to make recommendations to the Commissioner regarding quality, patient safety, nurse staffing, infection and financial measures; parameters for presenting qualitative information; and report format.

(B) Measures for each annual community report will be selected and communicated to the hospitals in a manner that allows reasonable time for hospitals to prepare for data collection and address budgeting and data systems needs. In any event, measures that do not require new data collection processes shall be selected and communicated to hospitals at least six (6) months prior to the scheduled publication date of the applicable community report and measures for which hospitals do not otherwise collect data according to the specifications adopted by the Commissioner shall be communicated to the hospitals by the Department at least four (4) months prior to the inception date for data collection with respect to such measures.

(C) The Commissioner’s final decision on community report content and format shall be communicated to hospitals in an annual reporting manual for hospital community reports to be distributed by the Department to hospitals on or before March 15 for the community report to be published by June 1 of that same year. The reporting manual shall contain, at a minimum, a list of quantitative measures; the methodology for collecting and analyzing data for each measure; specifications for the uniform format referenced in Section 5 of this regulation; parameters for presenting quantitative and qualitative information; and common explanatory language to be used in each community report.

(D) Annually, the Department shall establish on its public website a link to each individual hospital’s website where the hospital’s community report is published, and shall develop and publish on its public website a report that allows consumers to compare hospitals for quality and financial indicators.

(E) Periodically, the Department shall evaluate the hospital community reports. Such evaluation may include website traffic reports, consumer feedback, hospital and Department efforts to publicize and provide access to the reports to consumers, and hospital and Department resources required to produce the hospital community reports.

 

Section 4. Community Report Contents

(A) Quality, patient safety, nurse staffing and infection rate measures. In order to identify quality, patient safety, nurse staffing and infection rate measures for hospitals to include in their annual community reports, the Department may consult with national and state organizations, including but not limited to:

1. The Centers for Medicare and Medicaid Services (CMS);

2. The Joint Commission, formerly The Joint Commission on Accreditation of Healthcare Organizations;

3. The Agency for Healthcare Research and Quality (AHRQ);

4. The Vermont Program for Quality in Health Care (VPQHC);

5. The National Quality Forum (NQF);

6. The Institute for Healthcare Improvement (IHI);

7. The Northeast Health Care Quality Foundation;

8. The Institute of Medicine (IOM);

9. The Healthcare Infection Control Practices Advisory Committee (HICPAC);

10. The Centers for Disease Control and Prevention (CDC);

11. The National Association of Health Data Organizations (NAHDO);

12. The American Nurses Association’s National Database of Nursing Quality Indicators (NDNQI); and

13. The Leapfrog Group.

The Department may require hospitals to include patient experience of care survey data for inpatient and/or outpatient hospital services in their community reports as a measure of hospital quality.

The Department, after receiving recommendations from the Commissioner of Health pursuant to 18 V.S.A. § 1919, shall evaluate measures of reportable adverse events for inclusion in the hospital community reports.

The Department shall consider relevant criteria in evaluating potential measures for inclusion in the community reports, including but not limited to:

1. Reliability;

2. Validity;

3. Basis in scientific evidence;

4. National consensus;

5. Availability of relevant, reliable and valid external benchmarks;

6. Well-developed specifications;

7. Importance to consumers;

8. Adequacy of case numbers; and

9. Cost of data collection.

The Department may require hospitals to report measures by payer, race, gender, socioeconomic status, or other variables indicative of equity in treatment or access. In addition, the Department may require hospitals to report only on measures for which there are enough cases to make reporting reliable. The Department, in consultation with experts in quality measurement, will determine what constitutes adequate case numbers for public reporting.

(B) Description of hospital’s strategic planning and decision-making processes and the hospital’s identified health care needs strategic initiatives . Each community report shall describe the hospital’s processes for strategic planning and decision-making and the hospital’s strategic initiatives, including but not limited to:

1. A summary description of the hospital’s process for achieving openness, inclusiveness and meaningful public participation in its strategic planning, decision-making and identification of health care needs. Such description shall include:

a. the manner in which the hospital has incorporated meaningful public participation into its strategic planning, decision-making and identification of health care needs in its service area;

b. a listing of the activities that are available for public participation (e.g., volunteer opportunities, regional or community partnerships, public meetings, community events, interviews with key community leaders, surveys, and/or focus groups); and

c. contact information, including but not limited to the department(s), telephone numbers, e-mail addresses, fax numbers and postal addresses at the hospital for consumers to use if interested in learning about public participation events; website references may also be included;

2. A description of at least three initiatives that the hospital is undertaking or plans to undertake to meet hospital service area needs identified through the hospital’s strategic planning process, including key quantitative or qualitative indicators, if available;

3. The summary and description of the items covered in 1 and 2 in previous community reports should be updated annually, if changes have occurred and if the hospital’s service area’s identified needs have changed; and

4. A description of where and how consumers may obtain detailed information about, or a copy of, the hospital’s strategic plan, its one- and four-year capital expenditure plan and a depreciation schedule for existing facilities.

 

(C) Summary of the hospital’s consumer complaint resolution process. Each community report shall describe the hospital’s consumer complaint resolution process, including but not limited to:

1. A description of the complaint resolution process, including how to register a complaint;

2. Contact information, including but not limited to telephone numbers, e-mail addresses, fax numbers and postal addresses for the hospital employee(s) responsible for the implementation of the complaint resolution process; and

3. Contact information, including but not limited to telephone numbers, e-mail addresses, fax numbers and postal addresses for the Vermont Department of Health in order to register a complaint against a hospital.

(D) Information concerning recently completed or ongoing quality improvement and patient safety projects. Each community report shall provide descriptions of new quality improvement and patient safety projects, or projects that have had significant activity with reportable milestones and/or results within the previous two years, including but not limited to:

1. A summary of at least three significant projects, including at least one clinical quality improvement and one patient safety project. The summary shall include:

 

a. Project name, time frame and description;

 

b. A description of the problem the project sought to solve or address, including how the problem was identified, and supporting data;

c. Project goals, with appropriate measures;

d. A description of the intervention(s); and

e. A discussion of the evaluation process, and results if available;

2. Contact information, including but not limited to telephone numbers, e-mail addresses, fax numbers and postal addresses for the hospital quality improvement department through which consumers may obtain more information; and

3. Contact information for the Vermont Program for Quality in Health Care, if relevant.

(E) Information on hospital governance, schedule of hospital’s governing body meetings and opportunity for public participation. Each community report shall provide a description of the hospital’s governance, including but not limited to:

1. Membership and governing body qualifications;

2. List of current governing body members;

3. Information on how to obtain a schedule of governing body meetings, and how to obtain information on when the meetings are open for public access and public comment; and

4. Contact information, including but not limited to telephone numbers, e-mail addresses, fax numbers and postal addresses for the hospital department that can provide more information on hospital governance, including schedules and agendas of meetings, and information on obtaining a copy of the hospital’s annual report.

(F) Measures of the hospital’s financial health and budget information. Each community report shall include measures indicative of the hospital’s financial health and a summary of the hospital’s budget. Measures relating to the hospital’s financial health shall include comparisons to appropriate national and/or other benchmarks for efficient operation and fiscal health and shall be derived from the hospital budget and budget-to-actual information submitted annually to the Department pursuant to Rule 7.000 (Unified Health Care Budget).

1. Hospital Finances. Each community report shall provide a description of the hospital’s finances, including but not limited to ratios, statistics and indicators relating to liquidity, cash flow, productivity, surplus, charges and payer mix. Such ratios, statistics and indicators shall represent both actual results and projections for subsequent budget years and shall be presented against at least one national peer, regional peer or Vermont peer group data, or against one bond rating agency’s comparable rating.

2. Hospital Budget. Each community report shall provide a summary of the hospital’s budget, including revenue by payer and quantification of cost shifting to private payers, and shall use formats, graphic data displays, data sources and common explanatory language approved by the Department. The Department reserves the right to review and approve the data from each hospital to ensure accuracy and consistency with the requirements outlined in the annual reporting manual prior to the publication of the community report. Minimum content and presentation requirements for summary hospital budget information, including one-year and four-year capital expenditure plans and depreciation expenses, shall be detailed in the annual reporting manual.

(G) Information on hospital pricing. Each community report shall include a comparison of charges for higher volume health care services, such services to be determined by the Commissioner and to include an array of hospital and/or physician services. Presentation requirements for the comparison of charges data shall be detailed in the annual reporting manual.

Section 5. Community Report Format

Each community report shall be provided in a uniform format to allow for comparison among hospitals. The uniform format will be outlined in the applicable annual reporting manual for hospital community reports. The reporting manual shall specify, at a minimum, a common website design; a common menu page; and the required hospital-specific information.


Section 6. Severability

If any provision of this regulation or its applicability to any person or circumstance is held invalid by a court, the remainder of this regulation or the applicability of the provision to other persons or circumstances shall not be affected.

 

Section 7. Effective Date

This regulation shall take effect on August 30, 2010.

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