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HEALTH POLICY COMMISSION

M.G.L. pt. Part I, tit. Title II, ch. c. 6D
in effect

M.G.L. c. 6D, § 1 Definitions

c. 6D, § 1. Definitions Section 1. As used in this chapter, the following words shall, unless the context clearly requires otherwise, have the following meanings:— ''Actual costs'', all direct and indirect costs incurred by a hospital or a community health center in providing medically necessary care and treatment to its patients, determined under with generally accepted accounting principles. ''Acute hospital'', the teaching hospital of the University of Massachusetts Medical School and any hospital licensed under section 51 of chapter 111 and which contains a majority of medical-surgical, pediatric, obstetric and maternity beds, as defined by the department of public health. ''Accountable care organization'' or ''ACO'', a provider organization certified under section 15. ''ACO participant'', a health care provider that either integrates or contracts with an ACO to provide services to ACO patients. ''ACO patient'', an individual who chooses or is attributed to an ACO for medical and behavioral health care, for whom such services are paid by the payer to the ACO. ''After-hours care'', services provided in the office during regularly scheduled evening, weekend or holiday office hours, in addition to basic service. ''Allowed amount'', the contractually agreed upon amount paid by a payer to a health care provider for health care services provided to an insured. ''Alternative payment contract'', any contract between a provider or provider organization and a health care payer payer which utilizes alternative payment methodologies. ''Alternative payment methodologies or methods'', methods of payment that are not solely based on fee-for-service reimbursements; provided that, ''alternative payment methodologies'' may include, but shall not be limited to, shared savings arrangement, bundled payments and global payments; provided further, that ''alternative payment methodologies'' may include fee-for-service payments, which are settled or reconciled with a bundled or global payment. ''Carrier'', an insurer licensed or otherwise authorized to transact accident or health insurance under chapter 175; a nonprofit hospital service corporation organized under chapter 176A; a nonprofit medical service corporation organized under chapter 176B; a health maintenance organization organized under chapter 176G; and an organization entering into a preferred provider arrangement under chapter 176I; provided, that this shall not include an employer purchasing coverage or acting on behalf of its employees or the employees of 1 or more subsidiaries or affiliated corporations of the employer; provided that, unless otherwise noted, the term ''carrier'' shall not include any entity to the extent it offers a policy, certificate or contract that provides coverage solely for dental care services or visions care services. ''Center'', the center for health information and analysis established under chapter 12C. ''Charge'', the uniform price for specific services within a revenue center of a hospital. ''Child'', a person who is under 18 years of age. ''Community health centers'', health centers operating in conformance with the requirements of Section 330 of United States Public Law 95–626 and shall include all community health centers which file cost reports as requested by the commission. ''Commission'', health policy commission established by section 2. ''Comprehensive cancer center'', the hospital of any institution so designated by the national cancer institute under the authority of 42 U.S.C. sections 408(a) and 408(b) organized solely for the treatment of cancer, and offered exemption from the medicare diagnosis related group payment system under 42 C.F.R. 405.475(f). ''Dependent'', the spouse and children of any employee if such persons would qualify for dependent status under the Internal Revenue Code or for whom a support order could be granted under chapters 208, 209 or 209C. ''Disproportionate share hospital'', any acute hospital that exhibits a payer mix where a minimum of 63 per cent of the acute hospital's gross patient service revenue is attributable to Title XVIII and Title XIX of the Federal Social Security Act, other government payors and free care. ''Emergency services'', medically necessary health care services provided to an individual with an emergency medical condition. ''Employee'', a person who performs services primarily in the commonwealth for remuneration for a commonwealth employer. A person who is self-employed shall not be deemed to be an employee. ''Employer'', an employer as defined in section 1 of chapter 151A. ''Executive director'', the executive director of the health policy commission. ''Executive office'', executive office of health and human services. ''Facility'', a licensed institution providing health care services or a health care setting, including, but not limited to, hospitals and other licensed inpatient centers, ambulatory surgical or treatment centers, skilled nursing centers, residential treatment centers, diagnostic, laboratory and imaging centers, and rehabilitation and other therapeutic health settings. ''Fee-for-service'', a payment mechanism in which all reimbursable health care activity is described and categorized into discreet and separate units of service and each provider is separately reimbursed for each discrete service rendered to a patient. ''Fiscal year'', the 12 month period during which a hospital keeps its accounts and which ends in the calendar year by which it is identified. ''Generic drug'', a retail drug that is: (i) marketed or distributed pursuant to an abbreviated new drug application approved under 21 U.S.C. 355(j); (ii) an authorized generic drug as defined by 42 C.F.R. 447.502; (iii) a drug that entered the market before January 1, 1962 and was not originally marketed under a new drug application; or (iv) identified by the carrier as a generic drug based on available data resources such as Medi–Span. ''Global payment'', a payment arrangement where spending targets are established for a comprehensive set of health care services for the care that a defined population of patients may receive in a specified period of time. ''Governmental unit'', the commonwealth, any department, agency board or commission of the commonwealth, and any political subdivision of the commonwealth. ''Gross patient service revenue'', the total dollar amount of a hospital's charges for services rendered in a fiscal year. ''Gross state product'', the total annual output of the Massachusetts economy as measured by the U.S. Department of Commerce, Bureau of Economic Analysis, Gross Domestic Product by State series. ''Growth rate of potential gross state product'', the long-run average growth rate of the commonwealth's economy, excluding fluctuations due to the business cycle, as established under section 7H1/2 of chapter 29. ''Health benefit plan'', as defined in section 1 of chapter 176J. ''Health care cost growth benchmark,'' the projected annual percentage change in total health care expenditures in the commonwealth, as established in section 9. ''Health care entity'', a provider, provider organization or carrier. ''Health care provider'', a provider of medical or health services or any other person or organization that furnishes, bills or is paid for health care service delivery in the normal course of business. ''Health care real estate investment trust'', a real estate investment trust, as defined by 26 U.S.C section 856, whose assets consist of real property held in connection with the use or operations of a provider or provider organization. ''Health care resource'', any resource, whether personal or institutional in nature and whether owned or operated by any person, the commonwealth or political subdivision thereof, the principal purpose of which is to provide, or facilitate the provision of, services for the prevention, detection, diagnosis or treatment of those physical and mental conditions, which usually are the result of, or result in, disease, injury, deformity or pain; provided, however, that the term ''treatment'', as used in this definition, shall include custodial and rehabilitative care incident to infirmity, developmental disability or old age. ''Health care services'', supplies, care and services of medical, behavioral health, substance use disorder, mental health, surgical, optometric, dental, podiatric, chiropractic, psychiatric, therapeutic, diagnostic, preventative, rehabilitative, supportive or geriatric nature including, but not limited to, inpatient and outpatient acute hospital care and services; services provided by a community health center home health and hospice care provider, or by a sanatorium, as included in the definition of ''hospital'' in Title XVIII of the federal Social Security Act, and treatment and care compatible with such services or by a health maintenance organization. ''Health disparities'', preventable differences in the burden of disease, injury, violence or opportunities to achieve optimal health that are experienced by socially disadvantaged populations. ''Health equity'', the state in which a health system offers the infrastructure, facilities, services, geographic coverage, affordability and all other relevant features, conditions and capabilities that will provide all people with the opportunity and reasonable expectation that they can reach their full health potential and well-being and are not disadvantaged in access to health care by their race, ethnicity, language, disability, age, gender, gender identity, sexual orientation, social class, intersections among these communities or identities, or their socially determined circumstances. ''Health insurance company'', a company, as defined in section 1 of chapter 175, which engages in the business of health insurance. ''Health insurance plan'', the medicare program or an individual or group contract or other plan providing coverage of health care services and which is issued by a health insurance company, a hospital service corporation, a medical service corporation or a health maintenance organization. ''Health maintenance organization'', a company which provides or arranges for the provision of health care services to enrolled members in exchange primarily for a prepaid per capita or aggregate fixed sum as further defined in section 1 of chapter 176G. ''Health status adjusted total medical expenses'', the total cost of care for the patient population associated with a provider group based on allowed claims for all categories of medical expenses and all non-claims related payments to providers, adjusted by health status, and expressed on a per member per month basis, as calculated under section 8 of chapter 12C. ''Hospital'', any hospital licensed under section 51 of chapter 111, the teaching hospital of the University of Massachusetts Medical School and any psychiatric facility licensed under section 19 of chapter 19. ''Hospital service corporation'', a corporation established to operate a nonprofit hospital service plan as provided in chapter 176A. ''Management services organization'', a corporation that provides management or administrative services to a provider or provider organization for compensation. ''Medicaid program'', the medical assistance program administered by the office of Medicaid under chapter 118E and under Title XIX of the Federal Social Security Act or any successor statute. ''Medical assistance program'', the medicaid program, the Veterans Administration health and hospital programs and any other medical assistance program operated by a governmental unit for persons categorically eligible for such program. ''Medical service corporation'', a corporation established for the purpose of operating a nonprofit medical service plan as provided in chapter 176B. ''Medicare program'', the medical insurance program established by Title XVIII of the Federal Social Security Act. ''Net cost of private health insurance'', the difference between health premiums earned and benefits incurred, which shall consist of: (i) all categories of administrative expenditures, as included in medical loss ratio regulations promulgated by the division of insurance; (ii) net additions to reserves; (iii) rate credits and dividends; and (iv) profits or losses, or as otherwise defined by regulations promulgated by the center under chapter 12C. ''Non-acute hospital'', any hospital which is not an acute hospital. ''Patient'', any natural person receiving health care services from a hospital. ''Patient-centered medical home'', a model of health care delivery designed to provide a patient with a single point of coordination for all their health care, including primary, specialty, post-acute and chronic care, which is (i) patient-centered; (ii) comprehensive, integrated and continuous; and (iii) delivered by a team of health care professionals to manage a patient's care, reduce fragmentation and improve patient outcomes. ''Patient decision aid'', an interactive, written or audio-visual tool that provides a balanced presentation of the condition and treatment or screening options, benefits and harms, with attention to the patient's preferences and values. ''Payer'', any entity, other than an individual, that pays providers for the provision of health care services; provided, however, that ''payer'' shall include both governmental and private entities; and provided further, that ''payer'' shall include self-insured plans to the extent allowed under the Employee Retirement Income Security Act of 1974. ''Performance improvement plan,'' a plan submitted to the commission by a carrier, a provider or a provider organization under section 10. ''Performance incentive payment'' or ''pay-for-performance'', an amount paid to a provider by a payer for achieving certain quality measures as defined in this chapter. ''Performance penalty'', a reduction in the payments made by a payer to a provider for failing to achieve certain quality measures as defined in this chapter. ''Pharmaceutical manufacturing company'', an entity engaged in the: (i) production, preparation, propagation, compounding, conversion or processing of prescription drugs, directly or indirectly, by extraction from substances of natural origin, independently by means of chemical synthesis or by a combination of extraction and chemical synthesis; or (ii) packaging, repackaging, labeling, relabeling or distribution of prescription drugs; provided, however, that ''pharmaceutical manufacturing company'' shall not include a hospital licensed under section 51 of chapter 111, a wholesale drug distributor licensed under section 36B of chapter 112 or a retail pharmacist registered under section 39 of said chapter 112. ''Pharmacy benefit manager'', as defined in section 1 of chapter 176Y. ''Physician'', a medical or osteopathic doctor licensed to practice medicine in the commonwealth. ''Primary care physician'', a physician who has a primary specialty designation of internal medicine, general practice, family practice, pediatric practice or geriatric practice. ''Primary care provider'', a health care professional qualified to provide general medical care for common health care problems, who supervises, coordinates, prescribes or otherwise provides or proposes health care services, initiates referrals for specialist care and maintains continuity of care within the scope of practice. ''Private equity company'', any company that collects capital investments from individuals or entities and purchases, as a parent company or through another entity that the company completely or partially owns or controls, a direct or indirect ownership share of a provider, provider organization or management services organization; provided, however, that ''private equity company'' shall not include venture capital firms exclusively funding startups or other early-stage businesses. ''Private health care payer'', (i) a carrier authorized to transact accident and health insurance under chapter 175, (ii) a nonprofit hospital service corporation licensed under chapter 176A, (iii) a nonprofit medical service corporation licensed under chapter 176B, (iv) a dental service corporation organized under chapter 176E, (v) an optometric service corporation organized under chapter 176F, (vi) a self-insured plan, to the extent allowable under federal law governing health care provided by employers to employees, or (vii) a health maintenance organization licensed under chapter 176G. ''Provider'', any person, corporation, partnership, governmental unit, state institution or any other entity qualified under the laws of the commonwealth to perform or provide health care services. ''Provider organization'', any corporation, partnership, business trust, association or organized group of persons, which is in the business of health care delivery or management, whether incorporated or not that represents 1 or more health care providers in contracting with carriers for the payments of heath care services; provided, that ''provider organization'' shall include, but not be limited to, physician organizations, physician-hospital organizations, independent practice associations, provider networks, accountable care organizations and any other organization that contracts with carriers for payment for health care services. ''Public health care payer'', the Medicaid program established in chapter 118E; any carrier or other entity that contracts with the office of Medicaid to pay for or arrange the purchase of health care services on behalf of individuals enrolled in health coverage programs under Titles XIX or XXI of the Social Security Act, including prepaid health plans subject to section 28 of chapter 47 of the acts of 1997; the group insurance commission established pursuant to chapter 32A; and any city or town with a population of more than 60,000 that has adopted chapter 32B. ''Quality measures'', the standard quality measure set as defined by the center under section 14 of chapter 12C. ''Registered provider organization'', a provider organization that has been registered under this chapter. ''Relative prices'', the contractually negotiated amounts paid to providers by each private and public carrier for health care services, including non-claims related payments and expressed in the aggregate relative to the payer's network-wide average amount paid to providers, as calculated under section 10 of chapter 12C. ''Resident'', a person living in the commonwealth, as defined by the commission by regulation; provided, however, that such regulation shall not define a resident as a person who moved into the commonwealth for the sole purpose of securing health insurance under this chapter; provided further, that confinement of a person in a nursing home, hospital or other medical institution shall not, in and of itself, suffice to qualify such person as a resident. ''Risk-bearing provider organization'', a provider organization that manages the treatment of a group of patients and bears the downside risk according to the terms of an alternate payment contract. ''Secretary'', the secretary of health and human services. ''Self-employed'', a person who, at common law, is not considered to be an employee and whose primary source of income is derived from the pursuit of a bona fide business. ''Self-insurance health plan'', a plan which provides health benefits to the employees of a business, which is not a health insurance plan, and in which the business is liable for the actual costs of the health care services provided by the plan and administrative costs. ''Self-insured group'', a self-insured or self-funded employer group health plan. ''Shared decision-making'', a process in which the health care provider and patient or patient's representative discuss the patient's condition or disease, the treatment options available for that condition or disease, the benefits and harms of each treatment option, information on the limits of scientific knowledge on patient outcomes from the treatment options, and the patient's values and preferences for treatment, and if available for said condition or disease, with the use of a patient decision aid. ''Significant equity investor'', (i) any private equity company with a financial interest in a provider, provider organization or management services organization; or (ii) an investor, group of investors or other entity with a direct or indirect possession of equity in the capital, stock or profits totaling more than 10 per cent of a provider, provider organization or management services organization; provided, however, that ''significant equity investor'' shall not include venture capital firms exclusively funding startups or other early-stage businesses. ''State institution'', any hospital, sanatorium, infirmary, clinic and other such facility owned, operated or administered by the commonwealth, which furnishes general health supplies, care or rehabilitative services and accommodations. ''Surcharge payor'', an individual or entity that pays for or arranges for the purchase of health care services provided by acute hospitals and ambulatory surgical center services provided by ambulatory surgical centers; provided, however, that the term ''surcharge payor'' shall include a managed care organization; and provided further, that ''surcharge payor'' shall not include Title XVIII and Title XIX programs and their beneficiaries or recipients, other governmental programs of public assistance and their beneficiaries or recipients and the workers' compensation program established under chapter 152. ''Third party administrator'', an entity that administers payments for health care services on behalf of a client in exchange for an administrative fee. ''Title XIX'', Title XIX of the Federal Social Security Act, 42 U.S.C. 1396 et seq., or any successor statute enacted into federal law for the same purposes as Title XIX. ''Total health care expenditures'', the annual per capita sum of all health care expenditures in the commonwealth from public and private sources, including: (i) all categories of medical expenses and all non-claims related payments to providers, as included in the health status adjusted total medical expenses reported by the center under subsection (d) of section 8 of chapter 12C; (ii) all patient cost-sharing amounts, such as, deductibles and copayments; and (iv) the net cost of private health insurance, or as otherwise defined in regulations promulgated by the center.

M.G.L. c. 6D, § 2 Health policy commission; governing board; members; duties and powers; annual report

c. 6D, § 2. Health policy commission; governing board; members; duties and powers; annual report Section 2. (a) There shall be established within the executive office for administration and finance, but not under its control, a state agency known as the health policy commission. The commission shall be an independent public entity not subject to the supervision and control of any other executive office, department, commission, board, bureau, agency or political subdivision of the commonwealth. (b)(1) There shall be a board, with duties and powers established by this chapter, which shall govern the commission. The board shall consist of 11 members: 1 of whom shall be the secretary of health and human services, or a designee; 1 of whom shall be the commissioner of insurance, or a designee; 6 of whom shall be appointed by the governor, 1 of whom shall serve as chairperson, 1 of whom shall be selected from a list of 3 nominees submitted by the president of the senate and 1 of whom shall be selected from a list of 3 nominees submitted by the speaker of the house or representatives; and 3 of whom shall be appointed by the attorney general. All appointed members shall serve for a term of 5 years, but a person appointed to fill a vacancy shall serve only for the remainder of the unexpired term. An appointed member of the board shall be eligible for reappointment; provided, however, that no appointed member shall hold full or part-time employment in the executive branch of state government. The board shall annually elect 1 of its members to serve as vice-chairperson. Each member of the board shall be a resident of the commonwealth. (2) The person appointed by the governor to serve as chairperson shall have demonstrated expertise in health care administration, finance and management at a senior level. The second person appointed by the governor, shall have demonstrated expertise in representing hospitals or hospital health systems. The third person appointed by the governor shall have demonstrated expertise in health plan administration and finance. The fourth person appointed by the governor shall be a registered nurse with expertise in the delivery of care and development and utilization of innovative treatments in the practice of patient care. The fifth person appointed by the governor, from the list of nominees submitted by the president of the senate, shall have demonstrated expertise in representing the health care workforce as a leader in a labor organization. The sixth person appointed by the governor, from the list of nominees submitted by the speaker of the house of representatives, shall have demonstrated expertise in health care innovation, including pharmaceuticals, biotechnology or medical devices. The first person appointed by the attorney general shall be a health economist. The second person appointed by the attorney general shall have demonstrated expertise in health care consumer advocacy. The third person appointed by the attorney general shall have expertise in behavioral health, substance use disorder, mental health services and mental health reimbursement systems. (c) Six members of the board shall constitute a quorum, and the affirmative vote of 6 members of the board shall be necessary and sufficient for any action taken by the board. No vacancy in the membership of the board shall impair the right of a quorum to exercise all the rights and duties of the commission. The appointed members of the board shall receive a stipend in an amount not more than 10 per cent of the salary of the secretary of administration and finance under section 4 of chapter 7; provided, however, that the chairperson shall receive a stipend in an amount not more than 12 per cent of the salary of the secretary of administration and finance under said section 4 of said chapter 7. The secretary of health and human services and the commissioner of insurance, or their designees, shall not receive a stipend for their service as board members. A member of the board shall not be employed by, a consultant to, a member of the board of directors of, affiliated with, have a financial stake in or otherwise be a representative of a health care entity while serving on the board. (d) Any action of the commission may take effect immediately and need not be published or posted unless otherwise provided by law. Meetings of the commission shall be subject to sections 18 to 25, inclusive, of chapter 30A; provided however that said sections shall not apply to any meeting of members of the commission serving ex officio in the exercise of their duties as officers of the commonwealth if no matters relating to the official business of the commission are discussed and decided at the meeting. The commission shall be subject to all other provisions of said chapter 30A, and records pertaining to the administration of the commission shall be subject to section 42 of chapter 30 and section 10 of chapter 66. All moneys of the commission shall be considered to be public funds for purposes of chapter 12A. Except as otherwise provided in this section, the operations of the commission shall be subject to chapter 268A and chapter 268B. The commission shall not be required to obtain the approval of any other officer or employee of any executive agency in connection with the collection or analysis of any information; nor shall the commission be required, prior to publication, to obtain the approval of any other officer or employee of any executive agency with respect to the substance of any reports which the commission has prepared under this chapter. (e) The board shall appoint an executive director by a majority vote. The executive director shall supervise the administrative affairs and general management and operations of the commission and also serve as secretary of the commission, ex officio. The executive director shall receive a salary commensurate with the duties of the office. The executive director may appoint other officers and employees of the commission necessary to the functioning of the commission. The executive director shall not be required to obtain the approval of any other executive agency in connection with appointment of employees. Sections 9A, 45, 46 and 46C of chapter 30, chapter 31 and chapter 150E shall not apply to the executive director of the commission. Sections 45, 46 and 46C of chapter 30 shall not apply to any employee of the commission. The executive director may establish personnel regulations for the officers and employees of the commission. The executive director shall file an annual personnel report not later than the first Wednesday in February with the senate and house committees on ways and means containing the job classifications, duties and salary of each officer and employee within the center together with personnel regulations applicable to said officers and employees. The executive director shall file amendments to such report with the senate and house committees on ways and means whenever any changes become effective. The executive director shall, with the approval of the board: (i) plan, direct, coordinate and execute administrative functions in conformity with the policies and directives of the board; (ii) employ professional and clerical staff as necessary; (iii) report to the board on all operations under their control and supervision; (iv) prepare an annual budget and manage the administrative expenses of the commission; and (v) undertake any other activities necessary to implement the powers and duties under this chapter. The board may approve the use of funds from the Healthcare Payment Reform Fund to support the annual budget of the commission, in addition to funds from any other source and any funds appropriated therefor by the general court. The commission shall not be required to obtain the approval of any other executive agency in connection with the development and administration of its annual budget. (f) Chapter 268A shall apply to all board members, except that the commission may purchase from, sell to, borrow from, contract with or otherwise deal with any organization in which any board member is in anyway interested or involved; provided, however, that such interest or involvement shall be disclosed in advance to the board and recorded in the minutes of the proceedings of the board; and provided further, that no member shall be deemed to have violated section 4 of said chapter 268A because of such member's receipt of such member's usual and regular compensation from such member's employer during the time in which the member participates in the activities of the board. (g) The executive director shall appoint and may remove such agents and subordinate officers as the executive director may consider necessary and may establish such subdivisions within the commission as the excutive director considers appropriate to fulfill the purposes under this chapter,. The commission shall adopt and amend rules and regulations, underh chapter 30A, for the administration of its duties and powers and to effectuate this chapter.

M.G.L. c. 6D, § 2A Confidentiality of nonpublic clinical, financial, strategic or operational documents

c. 6D, § 2A. Confidentiality of nonpublic clinical, financial, strategic or operational documents Section 2A. The commission shall keep confidential all nonpublic clinical, financial, strategic or operational documents or information provided or reported to the commission in connection with any care delivery or quality improvement process or performance improvement plan activities authorized under section 7, 10, 14 or 15 of this chapter or under section 2GGGG of chapter 29 and shall not disclose the information or documents to any person without the consent of the payer or provider providing or reporting the information or documents under said section 7, 10, 14 or 15 of this chapter or under said section 2GGGG of said chapter 29, except in summary form in evaluative reports of such activities or when the commission believes that such disclosure should be made in the public interest after taking into account any privacy, trade secret or anticompetitive considerations. The confidential information and documents shall not be public records and shall be exempt from disclosure under clause Twenty sixth of section 7 of chapter 4 or section 10 of chapter 66.

M.G.L. c. 6D, § 3 Board powers and duties

c. 6D, § 3. Board powers and duties Section 3. For the purposes of this chapter, the board shall be authorized and empowered as follows: (a) to develop a plan of operation for the commission. The plan of operation shall include, but not be limited to: (1) implementation of procedures for operations of the commission; and (2) implementation of procedures for communications with the executive director; (b) to make, amend and repeal rules and regulations for the management of its affairs; (c) to make contracts and execute all instruments necessary or convenient for the carrying on of its business; (d) to acquire, own, hold, dispose of and encumber personal property and to lease real property in the exercise of its powers and the performance of its duties; (e) to seek and receive any grant funding from the federal government, departments or agencies of the commonwealth, and private foundations; (f) to enter into and execute instruments in connection with agreements or transactions with any federal, state or municipal agency or other public institution or with any private individual, partnership, firm, corporation, association or other entity, including contracts with professional service firms as may be necessary in its judgment, and to fix their compensation; (g) to maintain a prudent level of reserve funds to protect the solvency of any trust funds under the operation and control of the commission; (h) to enter into interdepartmental agreements with any other state agencies the board considers necessary to implement this chapter. (i) to adopt an official seal and alter the same; (j) to sue and be sued in its own name, plead and be impleaded; (k) to establish lines of credit, and establish 1 or more cash and investment accounts to receive payments for services rendered, appropriations from the commonwealth and for all other business activity granted by this chapter except to the extent otherwise limited by any applicable provision of the Employee Retirement Income Security Act of 1974; and (l) to approve the use of its trademarks, brand names, seals, logos and similar instruments by participating carriers, employers or organizations.

M.G.L. c. 6D, § 3A Office for pharmaceutical policy and analysis

c. 6D, § 3A. Office for pharmaceutical policy and analysis Section 3A. (a) There shall be within the commission an office for pharmaceutical policy and analysis. The office shall: (i) analyze pharmaceutical spending data and information collected by the commission and other agencies of the commonwealth pursuant to subsection (b); (ii) produce reports and analyses of trends related to the access, affordability of and spending on pharmaceutical drugs in the commonwealth pursuant to subsection (c); (iii) analyze records related to pharmaceutical pricing disclosed to the commission pursuant to section 8A and assist the commission in identifying proposed supplemental rebates for eligible drugs under said section 8A; and (iv) advise the general court and state agencies on matters related to pharmaceutical drug policy. (b) The office shall analyze pharmaceutical spending data collected by the commission and other agencies of the commonwealth, including pharmaceutical spending data collected by the center under sections 8 to 10A, inclusive, of chapter 12C, and pharmaceutical spending data available through publicly available sources. As part of its analysis, the office shall conduct an annual survey of payers on pharmaceutical access and plan design, including tiering, cost-sharing and other utilization management techniques employed by payers; provided, however, that any confidential data shall not be a public record and shall be exempt from disclosure pursuant to clause Twenty-sixth of section 7 of chapter 4 and section 10 of chapter 66. (c)(1) The office shall produce an annual report on trends related to access, affordability and spending on pharmaceutical drugs in the commonwealth and other reports from time to time. The annual report shall address such trends and underlying factors for pharmaceutical drug spending, including an analysis of trends in: (i) prices and utilization; (ii) drugs or categories of drugs with the highest impact on spending; (iii) patient out-of-pocket spending; and (iv) access and affordability issues for patients with rare diseases and chronic diseases; provided, however, that any analysis pursuant to section 8A of a drug prescribed to treat a rare disease, or that is otherwise designated as a first-in-class drug, shall be conducted pursuant to paragraph (3). The report shall include any recommendations for strategies to mitigate pharmaceutical spending growth, promote affordability and enhance pharmaceutical access. (2) The annual report shall be based on factors, including, but not limited to: (i) drug pricing; (ii) the impact of aggregate manufacturer rebates, discounts and other price concessions on net drug pricing; (iii) patient cost-sharing such as deductibles, coinsurance, copayments or similar charges paid by patients for drugs; (iv) the impact of aggregate rebates, discounts and other price concessions on such cost-sharing; and (v) the impact of utilization management techniques on pharmaceutical access employed by payers, including tiering, prior authorization and step therapy. The annual report shall be informed by: (A) the office's analysis of information provided at the annual cost trends hearing by providers, provider organizations and payers; (B) data collected by the center under sections 8 to 10A, inclusive, of chapter 12C; and (C) any other information available to the commission that is necessary to fulfill its duties under this section, as further defined in regulations promulgated by the commission. (3) The office shall consult with the rare disease advisory council established pursuant to section 241 of chapter 111 and other stakeholders as determined by the office for any analysis the office performs pursuant to section 8A of a drug that is prescribed to treat a rare disease or is otherwise designated as a first-in-class drug by the United States Food and Drug Administration's Center for Drug Evaluation and Research. Such analysis shall include: (i) the disease treated by the drug; (ii) the severity of disease treated by the drug; (iii) the unmet medical need associated with the disease treated by the drug; (iv) the impact of particular coverage, cost-sharing, tiering, utilization management, prior authorization, medication therapy management or other utilization management policies on access to the drug and on patients' adherence to the treatment regimen prescribed or otherwise recommended by their health care provider; (v) an assessment of the benefits and risks of the drug for patients; (vi) whether patients who need treatment from or a consultation with a rare disease specialist or a specialist in the disease being treated by the first-in-class drug have adequate access and, if not, what factors are causing the limited access; and (vii) the demographic and the clinical description of patient populations. (4) Annually, but in no event later than September 1, the report shall be submitted to the house and senate committees on ways and means and the joint committee on health care financing and shall be published and made available to the public. (d) The office shall analyze records related to pharmaceutical pricing disclosed to the commission pursuant to section 8A and assist the commission in identifying proposed supplemental rebates for eligible drugs under said section 8A. The office's analysis of such records shall consider: (i) the effectiveness of the drug in treating the conditions for which it is prescribed; (ii) improvements to a patient's health, quality of life or overall health outcomes; and (iii) the likelihood that use of the drug will reduce the need for other medical care, including hospitalization. (e) The office may consult with external experts or other third-party entities when the office lacks the specific scientific, medical or technical expertise necessary for the performance of its responsibilities under this section; provided, however, that the commission shall disclose when such external expert or third-party entity contributes to its analysis and reporting and the identity of such external expert or third-party entity.

M.G.L. c. 6D, § 4 Advisory council

c. 6D, § 4. Advisory council Section 4. There shall be an advisory council to the commission. The council shall advise on the overall operation and policy of the commission. The council shall be chosen by the executive director and shall reflect a broad distribution of diverse perspectives on the health care system, including health care professionals, educational institutions, consumer representatives, medical device manufacturers, representatives of the biotechnology industry, pharmaceutical manufacturing companies, pharmacy benefit managers, providers, provider organizations, labor organizations and public and private payers.

M.G.L. c. 6D, § 5 Monitoring of health care delivery and payment system

c. 6D, § 5. Monitoring of health care delivery and payment system Section 5. The commission shall monitor the reform of the health care delivery and payment system in the commonwealth under this chapter. The commission shall: (i) set health care cost growth goals for the commonwealth; (ii) enhance the transparency of provider organizations; (iii) monitor the development of ACOs and patient-centered medical homes; (iv) monitor the adoption of alternative payment methodologies; (v) foster innovative health care delivery and payment models that lower health care cost growth while improving the quality of patient care; (vi) monitor and review the impact of changes within the health care marketplace; (vii) monitor the location and distribution of health care services and health care resources; and (viii) protect patient access to necessary health care services. The commission shall establish goals that are intended to reduce health care disparities in racial, ethnic and disabled communities and in doing so shall seek to incorporate the recommendations of the health disparities council and the office of health equity.

M.G.L. c. 6D, § 6 Payment by acute hospital or ambulatory surgical center for estimated expenses of commission

c. 6D, § 6. Payment by acute hospital or ambulatory surgical center for estimated expenses of commission Section 6. (a) For the purposes of this section, ''non-hospital provider organization'' shall mean a provider organization required to register under section 11 that is: (i) a non-hospital-based physician practice with not less than $500,000,000 in annual gross patient service revenue; (ii) a clinical laboratory; (iii) an imaging facility; or (iv) a network of affiliated urgent care centers. (b) Each acute hospital, ambulatory surgical center, non-hospital provider organization, pharmaceutical manufacturing company and pharmacy benefit manager shall pay to the commonwealth an amount for the estimated expenses of the commission. (c) The assessed amount for acute hospitals, ambulatory surgical centers and non-hospital provider organizations shall be not less than 30 per cent nor more than 40 per cent of the amount appropriated by the general court for the expenses of the commission minus amounts collected from: (i) filing fees; (ii) fees and charges generated by the commission; and (iii) federal matching revenues received for these expenses or received retroactively for expenses of predecessor agencies; provided, however, that, to the maximum extent permissible under federal law, non-hospital provider organizations shall be assessed not less than 3 per cent nor more than 8 per cent of the total assessed amount for acute hospitals, ambulatory surgical centers and non-hospital provider organizations. Each acute hospital, ambulatory surgical center and non-hospital provider organization shall pay such assessed amount multiplied by the ratio of the acute hospital's, ambulatory surgical center's or non-hospital provider organization's gross patient service revenues to the total gross patient service revenues of all such hospitals, ambulatory surgical centers and non-hospital provider organizations. Each acute hospital, ambulatory surgical center and non-hospital provider organization shall make a preliminary payment to the commission on October 1 of each year in an amount equal to 1/2 of the previous year's total assessment. Thereafter, each acute hospital, ambulatory surgical center and non-hospital provider organization shall pay, within 30 days' notice from the commission, the balance of the total assessment for the current year based upon its most current projected gross patient service revenue. The commission shall subsequently adjust the assessment for any variation in actual and estimated expenses of the commission and for changes in acute hospital, ambulatory surgical center and non-hospital provider organization gross patient service revenue. Such estimated and actual expenses shall include an amount equal to the cost of fringe benefits and indirect expenses, as established by the comptroller under section 5D of chapter 29. In the event of late payment by any such acute hospital, ambulatory surgical center or non-hospital provider organization, the treasurer shall advance the amount of due and unpaid funds to the commission prior to the receipt of such monies in anticipation of such revenues up to the amount authorized in the then current budget attributable to such assessments and the commission shall reimburse the treasurer for such advances upon receipt of such revenues. This section shall not apply to any state institution or to any acute hospital which is operated by a city or town. (d) To the maximum extent permissible under federal law, and provided that such assessment will not result in any reduction of federal financial participation in Medicaid, the assessed amount for pharmaceutical manufacturing companies shall be not less than 5 per cent nor more than 10 per cent of the amount appropriated by the general court for the expenses of the commission minus amounts collected from: (i) filing fees; (ii) fees and charges generated by the commission; and (iii) federal matching revenues received for these expenses or received retroactively for expenses of predecessor agencies. Each pharmaceutical manufacturing company shall pay such assessed amount multiplied by the ratio of MassHealth's net spending for the manufacturer's prescription drugs used in the MassHealth rebate program to MassHealth's total pharmacy spending. (e) To the maximum extent permissible under federal law, and provided that such assessment will not result in any reduction of federal financial participation in Medicaid, the assessed amount for pharmacy benefit managers shall be not less than 5 per cent nor more than 10 per cent of the amount appropriated by the general court for the expenses of the commission minus amounts collected from: (i) filing fees; (ii) fees and charges generated by the commission; and (iii) federal matching revenues received for these expenses or received retroactively for expenses of predecessor agencies. Each pharmacy benefit manager shall pay such assessed amount multiplied by the ratio of the claims paid by the pharmacy benefit manager attributed to residents of the commonwealth for whom it manages pharmaceutical benefits on behalf of carriers to the total of all such claims paid by all pharmacy benefit managers attributed to residents of the commonwealth for whom they manage pharmaceutical benefits on behalf of carriers. (f) Each pharmaceutical manufacturing company and each pharmacy benefit manager shall make a preliminary payment to the commission annually on October 1 in an amount equal to 1/2 of the previous year's total assessment. Thereafter, each pharmaceutical manufacturing company and each pharmacy benefit manager shall pay, within 30 days of receiving notice from the commission, the balance of the total assessment for the current year as determined by the commission.

M.G.L. c. 6D, § 7 Administration of the Healthcare Payment Reform Fund; competitive process for development of health care payment and service delivery models; annual report

c. 6D, § 7. Administration of the Healthcare Payment Reform Fund; competitive process for development of health care payment and service delivery models; annual report Section 7. (a) The commission, in consultation with the advisory council, shall administer the Healthcare Payment Reform Fund, established under section 100 of chapter 194 of the acts of 2011. The fund shall be used for the following purposes: (1) to support the activities of the commission; and (2) to foster innovation in health care payment and service delivery. (b) The commission shall establish a competitive process for health care entities to develop, implement or evaluate promising models in health care payment and health care service delivery. Assistance from the commission may take the form of incentives, grants, technical assistance, evaluation assistance or partnerships, as determined by the commission. (c) Prior to making a request for proposals under subsection (b), the commission shall solicit ideas for health care payment and service reforms directly from providers, provider organizations, carriers, research institutions, health professionals, public institutions of higher education, community-based organizations and private-public partnerships, or any combination thereof. The commission shall review health care payment and service delivery models so submitted and shall seek input from other relevant stakeholders in evaluating their potential. (d) The commission shall consider proposals that achieve 1 or more of the following goals: (i) to support safety-net provider and disproportionate share hospital participation in new payment and health care payment and service delivery models; (ii) to support the successful implementation of performance improvement plans by health care entities under subsection (c) of section 10; (iii) to support cooperative efforts between representatives of employees and management that are focused on controlling costs and improving the quality of care through workforce engagement; (iv) to support the evaluation of mobile health and connected health technologies to improve health outcomes among under-served patients with chronic diseases; (v) to develop the capacity to safely and effectively treat chronic, common and complex diseases in rural and underserved areas and to monitor outcomes of those treatments; (vi) advance health equity; and (vii) any other goals as determined by the commission. (e) All approved activities funded through the Healthcare Payment Reform Fund shall support the commonwealth's efforts to meet the health care cost growth benchmark established under section 9, and shall include measurable outcomes in both cost reduction and quality improvement. (f) To the maximum extent feasible, the commission shall seek to coordinate expenditures from the Healthcare Payment Reform Fund with other public expenditures from the Prevention and Wellness Trust Fund, the E–Health Institute Fund, the Massachusetts Health Information Exchange Fund, the Distressed Hospital Trust Fund, the Health Care Workforce Transformation Trust Fund, the executive office of health and human services, any funding available through the Medicare program and the CMS Innovation Center, established under the federal Patient Protection and Affordable Care Act and any funding expended under the Delivery System Transformation Initiative Master Plan and hospital-specific plans approved in the MassHealth section 1115 demonstration waiver. (g) Activities funded through the Healthcare Payment Reform Fund that demonstrate measurable success in improving care or reducing costs shall be shared with other providers, provider organizations and payers as model programs which may be voluntarily adopted by such other health care entities. The commission may also incorporate any successful models and practices into its standards for ACO certification under section 15 and for alternative payment methodologies established for state-funded programs. (h) The commission shall, annually on or before January 31, report on expenditures from the Healthcare Payment Reform Fund. The report shall include, but not be limited to: (i) the revenue credited to the fund; (ii) the amount of fund expenditures attributable to the administrative costs of the commission; (iii) an itemized list of the funds expended through the competitive process and a description of the grantee activities; and (iv) the results of the evaluation of the effectiveness of the activities funded through grants. The report shall be provided to the chairs of the house and senate committees on ways and means and the joint committee on health care financing and shall be posted on the commission's website.

M.G.L. c. 6D, § 8 Public hearings; witnesses; annual report

c. 6D, § 8. Public hearings; witnesses; annual report Section 8. (a) Not later than October 1 of every year, the commission shall hold public hearings based on the report submitted by the center for health information and analysis under section 16 of chapter 12C comparing the growth in total health care expenditures to the health care cost growth benchmark for the previous calendar year. The hearings shall examine the costs, prices and cost trends of health care providers, provider organizations, private and public health care payers, pharmaceutical manufacturing companies and pharmacy benefit managers and any relevant impact of significant equity investors, health care real estate investment trusts, management services organizations on such costs, prices and cost trends, with particular attention to factors that contribute to cost growth within the commonwealth's health care system and trends in annual primary care and behavioral health expenditures. (b) The attorney general may intervene in such hearings. (c) Public notice of any hearing shall be provided at least 60 days in advance. (d) The commission shall identify as witnesses for the public hearing a representative sample of providers, provider organizations, payers, significant equity investors, health care real estate investment trusts, management services organizations, pharmaceutical manufacturing companies, pharmacy benefit managers and others, including: (i) at least 3 academic medical centers, including the 2 acute hospitals with the highest level of net patient service revenue; (ii) at least 3 disproportionate share hospitals, including the 2 hospitals whose largest per cent of gross patient service revenue is attributable to Title XVIII and XIX of the federal Social Security Act or other governmental payers; (iii) community hospitals from at least 3 separate regions of the commonwealth; (iv) freestanding ambulatory surgical centers from at least 3 separate regions of the commonwealth; (v) community health centers from at least 3 separate regions of the commonwealth; (vi) the 5 private health care payers with the highest enrollments in the commonwealth; (vii) any managed care organization that provides health benefits under Title XIX; (viii) the group insurance commission; (ix) at least 3 municipalities that have adopted chapter 32B; (x) at least 4 provider organizations which shall be from diverse geographic regions of the commonwealth, at least 2 of which shall be certified as accountable care organizations and 1 of which shall be certified as a model ACO; (xi) any significant equity investor, health care real estate investment trust or management services organization associated with a provider or provider organization; (xii) a representative from the division of insurance; (xiii) the executive director of the commonwealth health insurance connector authority; (xiv) the assistant secretary for MassHealth; (xv) not less than 2 representatives of the pharmacy benefit management industry; (xvi) not less than 3 representatives of pharmaceutical manufacturing companies, 1 of whom shall be a representative of a publicly traded company that manufactures specialty drugs, 1 of whom shall be a representative of a company that manufacturers generic drugs and 1 of whom shall be a representative of a company that has been in existence for fewer than 10 years; and (xvii) any witness identified by the attorney general or the center. The commission shall also request testimony from officials representing the federal Centers for Medicare and Medicaid Services. (e) Witnesses shall provide testimony under oath and subject to examination and cross examination by the commission, the executive director of the center and the attorney general at the public hearing in a manner and form to be determined by the commission, including, but not limited to: (i) in the case of providers and provider organizations, testimony concerning payment systems, care delivery models, payer mix, cost structures, administrative and labor costs, capital and technology cost, adequacy of public payer reimbursement levels, reserve levels, utilization trends, relative price, quality improvement and care-coordination strategies, investments in health information technology, the relation of private payer reimbursement levels to public payer reimbursements for similar services, efforts to improve the efficiency of the delivery system, efforts to reduce the inappropriate or duplicative use of technology and the impact of price transparency on prices; (ii) in the case of private and public payers, testimony concerning factors underlying premium cost and rate increases, the relation of reserves to premium costs, efforts by the payer to reduce the use of fee-for-service payment mechanisms, the payer's efforts to develop benefit design, network design and payment policies that enhance product affordability and encourage efficient use of health resources and technology including utilization of alternative payment methodologies, efforts by the payer to increase consumer access to health care information, efforts by the payer to promote the standardization of administrative practices, the impact of price transparency on prices and any other matters as determined by the commission; (iii) in the case of the assistant secretary for MassHealth, testimony concerning the structure, benefits, eligibility, caseload and financing of MassHealth and other Medicaid programs administered by the office of Medicaid or in partnership with other state and federal agencies and the agency's activities to align or redesign those programs in order to encourage the development of more integrated and efficient health care delivery systems; (iv) in the case of pharmacy benefit managers and pharmaceutical manufacturing companies, testimony concerning factors underlying prescription drug costs and price increases, the impact of aggregate manufacturer rebates, discounts and other price concessions on net pricing; provided, however, that such testimony shall be suitable for public release and not likely to compromise the financial, competitive or proprietary nature of any information or data; and (v) in the case of significant equity investors, health care real estate investment trusts or management services organization associated with a provider or provider organization, testimony concerning health outcomes, prices charged to insurers and patients, staffing levels, clinical workflow, financial stability and ownership structure of an associated provider or provider organization, dividends paid out to investors, compensation including, but not limited to, base salaries, incentives, bonuses, stock options, deferred compensations, benefits and contingent payments to officers, managers and directors of provider organizations in the commonwealth acquired, owned or managed, in whole or in part, by said significant equity investors, health care real estate investment trusts or management services organizations. The commission shall solicit testimony from any payer which has been identified by the center's annual report under subsection (a) of section 16 of chapter 12C as (1) paying providers more than 10 per cent above or more than 10 per cent below the average relative price or (2) entering into alternative payment contracts that vary by more than 10 per cent. Any payer identified by the center's report shall explain the extent of price variation between the payer's participating providers and describe any efforts to reduce such price variation. (f) In the event that the center's annual report under subsection (a) of section 16 of chapter 12C finds that the percentage change in total health care expenditures exceeded the health care cost benchmark in the previous calendar year, the commission may identify additional witnesses for the public hearing. Witnesses shall provide testimony subject to examination and cross examination by the commission, the executive director of the center and attorney general at the public hearing in a manner and form to be determined by the commission, including, but not limited to: (i) testimony concerning unanticipated events that may have impacted the total health care cost expenditures, including, but not limited to, a public health crisis such as an outbreak of a disease, a public safety event or a natural disaster; (ii) testimony concerning trends in patient acuity, complexity or utilization of services; (iii) testimony concerning trends in input cost structures, including, but not limited to, the introduction of new pharmaceuticals, medical devices and other health technologies; (iv) testimony concerning the cost of providing certain specialty services, including, but not limited to, the provision of health care to children, cancer-related health care and medical education; (v) testimony related to unanticipated administrative costs for carriers, including, but not limited to, costs related to information technology, administrative simplification efforts, labor costs and transparency efforts; (vi) testimony related to costs due the implementation of state or federal legislation or government regulation; and (vii) any other factors that may have led to excessive health care cost growth. (g) The commission shall compile an annual report concerning spending trends, including primary care and behavioral health expenditures, and the underlying factors influencing said spending trends. The report shall be based on the commission's analysis of information provided at the hearings by witnesses, providers, provider organizations and payers, registration data collected pursuant to section 11, data collected or analyzed by the center pursuant to sections 8 to 10A, inclusive, of chapter 12C and any other available information that the commission considers necessary to fulfill its duties under this section, as defined in regulations promulgated by the commission. The report shall be submitted to the house and senate committees on ways and means and the joint committee on health care financing and shall be published and available to the public not later than December 31 of each year. The report shall include recommendations for strategies to increase the efficiency of the health care system and promote affordability for individuals and families, recommendations on the specific spending trends that impede the commonwealth's ability to meet the health care cost growth benchmark and draft legislation necessary to implement said recommendations.

M.G.L. c. 6D, § 8A Pharmaceutical drug pricing; manufacturer disclosure of pricing information; determination of supplemental rebate, proposed value or reasonableness of pricing of a drug

c. 6D, § 8A. Pharmaceutical drug pricing; manufacturer disclosure of pricing information; determination of supplemental rebate, proposed value or reasonableness of pricing of a drug Section 8A. (a) As used in this section, the following word shall, unless the context clearly requires otherwise, have the following meaning: ''Manufacturer'', an entity that manufactures a pharmaceutical drug covered by MassHealth. (b) The commission may require a manufacturer specified in subsection (c) to disclose to the commission within a reasonable time information relating to the manufacturer's pricing of that drug, on a standard reporting form developed by the commission with the input of the manufacturers, which includes but shall not be limited to, the following: (1) A schedule of the drug's wholesale acquisition cost increases over the previous five calendar years; (2) The manufacturer's aggregate, company-level research and development and other relevant capital expenditures, including facility construction, for the most recent year for which final audited data are available; (3) A written, narrative description, suitable for public release, of factors that contributed to reported changes in wholesale acquisition cost during the previous five calendar years; and (4) Any other information that the manufacturer wishes to provide to the commission. Based on the records furnished, the commission may identify a proposed supplemental rebate, in consultation with the executive office, for a prescribed drug specified in subsection (c); provided that the proposed supplemental rebate may be based on a proposed value of the drug; and provided further, that the commission shall consider any proposed supplemental rebate framework or other information provided to the commission under subsection (g) of section 12A of chapter 118E. The commission may request additional relevant information that it deems necessary to identify a proposed supplemental rebate or proposed value of the drug. (c) A manufacturer of the following prescribed drugs shall comply with the requirements set forth in this section: a drug for which the executive office was unable to successfully conclude supplemental rebate negotiations with the manufacturer under subsections (b) and (c) of section 12A of chapter 118E, and for which the commission has received notice from the executive office under subsection (g) of said section 12A of said chapter 118E. (d) Records disclosed by a manufacturer under this section shall: (i) be accompanied by an attestation that all information provided is true and correct; (ii) not be public records under section 7 of chapter 4 or chapter 66; and (iii) remain confidential; provided, however, that the commission may produce reports summarizing any findings; provided that any such report shall not be in a form that identifies specific prices charged for or rebate amounts associated with drugs by a manufacturer, or in a manner that is likely to compromise the financial, competitive or proprietary nature of the information. (e) If, after review of any records furnished to the commission under subsection (b), the commission determines that the manufacturer's pricing of the drug is potentially unreasonable or excessive in relation to the commission's proposed value under subsection (b), the commission shall, with 30 days' advance notice to the manufacturer, request that the manufacturer provide further information related to the pricing of the prescribed drug and the manufacturer's justification for the pricing. In addition to the manufacturer, the commission may identify other relevant parties including but not limited to patients, providers, provider organizations and payers who may provide information to the commission. (f) Any information, analyses or reports regarding a particular drug reviewed or used in identifying the supplemental rebate or assessing the proposed value of the drug shall be provided to the manufacturer for review and input. The commission shall consider any clarifications or data provided by the manufacturer with respect to its drug. The commission may not base its determination on the supplemental rebate, the proposed value or the reasonableness of the drug pricing, solely on the analysis or research of an outside third party. (g) If the commission relies upon a third party to provide cost-effectiveness analysis or research related to the proposed value, such analysis or research shall also provide, but not be limited in scope to, (i) a description of the methodologies and models used in its analysis; (ii) any assumptions and potential limitations of research findings in the context of the results; and (iii) outcomes for affected subpopulations that utilize the drug. (h) Not later than 60 days after receiving information from the manufacturer, as required under subsection (b) or (e), the commission shall issue a determination on whether the manufacturer's pricing of a drug subject to the supplemental rebate negotiation that resulted in the provision of notice under section 12A of chapter 118E is unreasonable or excessive in relation to the commission's proposed value of the drug. (i) If the manufacturer fails to timely comply with the commission's request for records under subsections (b) or (e), or otherwise knowingly obstructs the commission's ability to issue its determination under subsection (h), including, but not limited to, providing incomplete, false or misleading information, the commission may impose appropriate sanctions against the manufacturer, including reasonable monetary penalties not to exceed $500,000, in each instance. The commission shall seek to promote compliance with this section and shall only impose a civil penalty on the manufacturer as a last resort. (j) The commission shall adopt any written policies, procedures or regulations the commission determines necessary to implement this section.

M.G.L. c. 6D, § 9 Health care cost growth benchmark; modification

c. 6D, § 9. Health care cost growth benchmark; modification Section 9. (a) Not later than April 15 of every year, the board shall establish a health care cost growth benchmark for the average growth in total health care expenditures in the commonwealth for the next calendar year. The commission shall establish procedures to prominently publish the annual health care cost growth benchmark on the commission's website. (b) The commission shall establish the annual health care cost growth benchmark as follows: (1) For calendar years 2013 through 2017, the health care cost growth benchmark shall be equal to the growth rate of potential gross state product established under section 7H1/2 of chapter 29; provided, however, that the growth rate of potential gross state product for calendar year 2013 shall be 3.6 per cent. (2) For calendar years 2018 through 2022, the health care cost growth benchmark shall be equal to the growth rate of potential gross state product established under said section 7H1/2 of said chapter 29, minus 0.5 per cent. (3) For calendar years 2023 and beyond, the health care cost growth benchmark shall be equal to the growth rate of potential gross state product established under said section 7H1/2 of said chapter 29. (c) For calendar years 2018 through 2022, if the commission determines that an adjustment in the health care cost growth benchmark is reasonably warranted, having first considered any testimony at the public hearing as required under subsection (f), the board of the commission may modify the health care cost growth benchmark such that the health care cost growth benchmark shall be set at an amount between minus 0.5 per cent of the growth of the potential gross state product and an amount equal to the growth of the potential gross state product. (d) For calendar years 2018 through 2022, on or after January 15 but not later than January 31 of the second year of a biennial session of the general court, the board shall submit notice of its intention to modify the health care cost growth benchmark under subsection (c) to the joint committee on health care financing. Within 30 days of such filing, the joint committee shall hold a public hearing on the board's proposed modification to the health care cost growth benchmark. The joint committee shall report its findings to the general court together with any necessary legislation, including its recommendation, within 30 days of the public hearing and provide a copy of its findings and legislation to the board. If the general court does not enact legislation with respect to the board's recommended modification to the health care cost growth benchmark within 45 days of the public hearing, the board's modification to the health care cost growth benchmark shall take effect. (e) For calendar years 2023 through 2032, if the commission determines that an adjustment in the health care cost growth benchmark is reasonably warranted, having first considered any testimony at a public hearing as required under subsection (f), the board of the commission may recommend a modification of the health care cost growth benchmark, in any amount as determined by the commission. On or after January 15 but not later than January 31 of the second year of a biennial session of the general court, the board shall submit notice of its recommendation for any modification to the joint committee on health care financing. Within 30 days of such filing, the joint committee may hold a public hearing on the board's proposed modification to the health care cost growth benchmark. The joint committee may report its findings, to the general court together with legislation, including its recommendation on whether to affirm or reject the board's recommendation, within 30 days of the public hearing and provide a copy of its findings and proposed legislation to the board. (f) Prior to making any recommended modification to the health care cost growth benchmark under subsections (c), (d) and (e), the board shall hold a public hearing on any such recommended modification. The public hearing shall be based on the report submitted by the center under section 16 of chapter 12C comparing the growth in total health care expenditures to the health care cost growth benchmark for the previous calendar year, any other data provided by the center and such other pertinent information or data as may be available to the board. The hearings shall examine health care provider, provider organization, pharmacy benefit manager, pharmaceutical manufacturing company and private and public health care payer costs, prices and cost trends, with particular attention to factors that contribute to cost growth within the commonwealth's health care system, and whether, based on the testimony, information and data, a modification in the health care cost growth benchmark is appropriate. The commission shall provide public notice of such hearing at least 45 days prior to the date of the hearing, including notice to the joint committee on health care financing. The joint committee on health care financing may participate in the hearing. The commission shall identify as witnesses for the public hearing a representative sample of providers, provider organizations, pharmacy benefit managers, pharmaceutical manufacturing companies, payers and such other interested parties as the commission may determine. Any other interested parties may testify at the hearing. (g) Any recommendation of the commission to modify the health care cost growth benchmark under subsections (d) or (e) shall be approved by a two thirds vote of the board.

M.G.L. c. 6D, § 10 Notice to health care entities exceeding health care cost growth benchmark; performance improvement plan; waiver; penalty for failure to comply

c. 6D, § 10. Notice to health care entities exceeding health care cost growth benchmark; performance improvement plan; waiver; penalty for failure to comply Section 10. (a) For the purposes of this section, ''health care entity'' shall mean a clinic, hospital, ambulatory surgical center, physician organization, accountable care organization or payer; provided, however, that physician contracting units with a patient panel of 15,000 or fewer, or which represents providers who collectively receive less than $25,000,000 in annual net patient service revenue from carriers shall be exempt. (b) The commission shall provide notice to all health care entities that have been identified by the center under section 18 of chapter 12C as exceeding the health care cost growth benchmark for any given year. Such notice shall state that the center may analyze the cost growth of individual health care entities and, beginning in calendar year 2016, the commission may require certain actions, as established in this section, from health care entities so identified. (c) For calendar year 2015, if the commission finds, based on the center's annual report, the commission's annual cost trend hearings or any other pertinent information, that the average percentage change in cumulative total health care expenditures from 2013 to 2014 exceeded the average health care cost growth benchmark from 2013 to 2014, and in order to support the state's efforts to meet future health care cost growth benchmarks, as established in section 9, the commission shall establish procedures to assist health care entities to improve efficiency and reduce cost growth by requiring certain health care entities to file and implement a performance improvement plan. Beginning in calendar year 2016, if the commission finds, based on the center's annual report, the commission's annual cost trend hearings or any other pertinent information, that the percentage change in total health care expenditures exceeded the health care cost growth benchmark in the previous calendar year, and in order to support the state's efforts to meet future health care cost growth benchmarks, as established in said section 9, the commission shall establish procedures to assist health care entities to improve efficiency and reduce cost growth by requiring certain health care entities to file and implement a performance improvement plan. (d) In addition to the notice provided under subsection (b), the commission may require any health care entity that is identified by ther center under section 16 of chapter 12C as exceeding the health care cost growth benchmark established under section 9 to file a performance improvement plan with the commission. The commission shall provide written notice to such health care entity that they are required to file a performance improvement plan. Within 45 days of receipt of such written notice, the health care entity shall either: (1) file a performance improvement plan with the commission; or (2) file an application with the commission to waive or extend the requirement to file a performance improvement plan. (e) The health care entity may file any documentation or supporting evidence with the commission to support the health care entity's application to waive or extend the requirement to file a performance improvement plan. The commission shall require the health care entity to submit any other relevant information it deems necessary in considering the waiver or extension application; provided, however, that such information shall be made public at the discretion of the commission. (f) The commission may waive or delay the requirement for a health care entity to file a performance improvement plan in response to a waiver or extension request filed under subsection (b) in light of all information received from the health care entity, based on a consideration of the following factors: (1) the costs, price and utilization trends of the health care entity over time, and any demonstrated improvement to reduce health status total medical expenses; (2) any ongoing strategies or investments that the health care entity is implementing to improve future long-term efficiency and reduce cost growth; (3) whether the factors that led to increased costs for the health care entity can reasonably be considered to be unanticipated and outside of the control of the entity. Such factors may include, but shall not be limited to, age and other health status adjusted factors and other cost inputs such as pharmaceutical expenses and medical device expenses; (4) the overall financial condition of the health care entity; (5) a significant difference between the growth rate of potential gross state product and the growth rate of actual gross state product, as determined under section 7H1/2 of chapter 29; and (6) any other factors the commission considers relevant. (h) If the commission declines to waive or extend the requirement for the health care entity to file a performance improvement plan, the commission shall provide written notice to the health care entity that its application for a waiver or extension was denied and the health care entity shall file a performance improvement plan. (i) A health care entity shall file a performance improvement plan: (1) within 45 days of receipt of a notice under subsection (c); (2) if the health care entity has requested a waiver or extension, within 45 days of receipt of a notice that such waiver or extension has been denied; or (3) if the health care entity is granted an extension, on the date given on such extension. The performance improvement plan shall be generated by the health care entity and shall identify the causes of the entity's cost growth and shall include, but not be limited to, specific strategies, adjustments and action steps the entity proposes to implement to improve cost performance. The proposed performance improvement plan shall include specific identifiable and measurable expected outcomes and a timetable for implementation. The timetable for a performance improvement plan shall not exceed 18 months. (j) The commission shall approve any performance improvement plan that it determines is reasonably likely to address the underlying cause of the entity's cost growth and has a reasonable expectation for successful implementation. (k) If the board determines that the performance improvement plan is unacceptable or incomplete, the commission may provide consultation on the criteria that have not been met and may allow an additional time period, up to 30 calendar days, for resubmission; provided, however, that all aspects of the performance improvement plan shall be proposed by the health care entity and the commission shall not require specific elements for approval. (l) Upon approval of the proposed performance improvement plan, the commission shall notify the health care entity to begin immediate implementation of the performance improvement plan. Public notice shall be provided by the commission on its website, identifying that the health care entity is implementing a performance improvement plan. All health care entities implementing an approved performance improvement plan shall be subject to additional reporting requirements and compliance monitoring, as determined by the commission. The commission shall provide assistance to the health care entity in the successful implementation of the performance improvement plan. (m) All health care entities shall, in good faith, work to implement the performance improvement plan. At any point during the implementation of the performance improvement plan the health care entity may file amendments to the performance improvement plan, subject to approval of the commission. (n) At the conclusion of the timetable established in the performance improvement plan, the health care entity shall report to the commission regarding the outcome of the performance improvement plan. If the performance improvement plan was found to be unsuccessful, the commission shall either: (i) extend the implementation timetable of the existing performance improvement plan; (ii) approve amendments to the performance improvement plan as proposed by the health care entity; (iii) require the health care entity to submit a new performance improvement plan under subsection (c) or (iv) waive or delay the requirement to file any additional performance improvement plans. (o) Upon the successful completion of the performance improvement plan, the identity of the health care entity shall be removed from the commission's website. (p) The commission may submit a recommendation for proposed legislation to the joint committee on health care financing if the commission determines that further legislative authority is needed to achieve the health care quality and spending sustainability objectives of this act, assist health care entities with the implementation of performance improvement plans or otherwise ensure compliance with the provisions of this section. (q) If the commission determines that a health care entity has: (i) willfully neglected to file a performance improvement plan with the commission within 45 days as required under subsection (d); (ii) failed to file an acceptable performance improvement plan in good faith with the commission; (iii) failed to implement the performance improvement plan in good faith; or (iv) knowingly failed to provide information required by this section to the commission or that knowingly falsifies the same, the commission may assess a civil penalty to the health care entity of not more than $500,000. The commission shall seek to promote compliance with this section and shall only impose a civil penalty as a last resort. (r) The commission shall promulgate regulations necessary to implement this section; provided, however, that notice of any proposed regulations shall be filed with the joint committee on state administration and regulatory oversight and the joint committee on health care financing at least 180 days before adoption. or third-party administrators shall be excluded from this definition.

M.G.L. c. 6D, § 11 Registration program for provider organizations; division of insurance risk certificate

c. 6D, § 11. Registration program for provider organizations; division of insurance risk certificate Section 11. (a) The commission shall develop and administer a registration program for provider organizations. A provider organization shall be registered for a term of 2 years and renewable under like terms. The commission shall coordinate with state agencies including, but not limited to, the center, the division of insurance, the executive office of health and human services, the office of Medicaid and the department of public health to minimize duplicative reporting requirements. The commission may enter interagency service agreements to perform these functions including but not limited to the sharing of data collected. The commission, in consultation with the center, shall promulgate such regulations as may be necessary to ensure the uniform reporting of data collected under this section. (b) The commission shall require that all provider organizations report the following information for registration and renewal: (i) organizational charts showing the ownership, governance and operational structure of the provider organization, including any clinical affiliations, parent entities, corporate affiliates, significant equity investors, health care real estate investment trusts, management services organizations, and community advisory boards; (ii) the number of affiliated health care professional full-time equivalents and the number of professionals affiliated with or employed by the organization; (iii) the name and address of licensed facilities; and (iv) such other information as the commission considers appropriate. (c) Upon receiving an application for registration, the commission may, within 30 days, require an applicant to provide additional information to complete or supplement the filing. The commission shall determine whether an application is complete within 45 days of receipt of the application and any supplementary information. The commission shall provide the applicant with a written notice that provider organization's registration is complete and provide a copy of the completed registration materials to the division of insurance. The commission may assess a reasonable registration or administrative fee on the registration of provider organizations to support the commission's operations and administration. (d) The commission shall support the division of insurance in its review of risk-bearing provider organizations under chapter 176U and the center in its efforts to collect and analyze data. The commission shall promulgate regulations setting forth a process for provider organizations to submit proposed changes to its structure. (e) A risk bearing provider organization shall provide the commission with a division of insurance risk certificate under chapter 176U. The commission may suspend, revoke or refuse to renew a risk-bearing provider organization's registration for failure to proffer a risk certificate.

M.G.L. c. 6D, § 12 Negotiation of network contracts by unregistered provider or provider organization prohibited

c. 6D, § 12. Negotiation of network contracts by unregistered provider or provider organization prohibited Section 12. (a) No provider or provider organization may negotiate network contracts with any carrier or third-party administrator except for a provider or provider organizations which are registered under this chapter and regulations promulgated under this chapter; provided, however, that nothing in this chapter shall require a provider or provider organization with a patient panel of 15,000 or fewer or which represents providers who collectively receive, less than $25,000,000 in annual net patient service revenue from payers to be registered if such provider or provider is not a risk-bearing provider organization. (b) Nothing in this chapter shall require a carrier to negotiate a network contract with a registered provider organization or with a registered provider or provider organization for all providers that are part of, or represented by, a registered provider organization.

M.G.L. c. 6D, § 13 Notice of material changes to operations or governance structure of provider or provider organization; cost and market impact review

c. 6D, § 13. Notice of material changes to operations or governance structure of provider or provider organization; cost and market impact review Section 13. (a) Every provider or provider organization shall, before making any material change to its operations or governance structure, submit notice to the commission, the center and the attorney general of such change, not fewer than 60 days before the date of the proposed change. Material changes shall include, but not be limited to: (i) significant expansions in a provider or provider organization's capacity; (ii) a corporate merger, acquisition or affiliation of a provider or provider organization and a carrier; (iii) mergers or acquisitions of hospitals or hospital systems; (iv) acquisition of insolvent provider organizations; (v) transactions involving a significant equity investor which result in a change of ownership or control of a provider or provider organization; (vi) significant acquisitions, sales or transfers of assets including, but not limited to, real estate sale lease-back arrangements; (vii) conversion of a provider or provider organization from a non-profit entity to a for-profit entity; and (viii) mergers or acquisitions of provider organizations which will result in a provider organization having a dominant market share in a given service or region. Within 30 days of receipt of a completed notice filed under the commission's regulations, the commission shall conduct a preliminary review to determine whether the material change is likely to result in a significant impact on the commonwealth's ability to meet the health care cost growth benchmark established in section 9, or on the competitive market. If the commission finds that the material change is likely to have a significant impact on the commonwealth's ability to meet the health care cost growth benchmark, or on the competitive market, the commission may conduct a cost and market impact review under this section. (b) In addition to the grounds for a cost and market impact review set forth in subsection (a), if the commission finds, based on the center's annual report under section 16 of chapter 12C, that the percentage change in total health care expenditures exceeded the health care cost growth benchmark in the previous calendar year, the commission may conduct a cost and market impact review of any provider organization identified by the center under section 18 of said chapter 12C. (c)(1) The commission shall initiate a cost and market impact review by sending the provider or provider organization notice of a cost and market impact review, which shall explain the basis for the review and the particular factors that the commission seeks to examine through the review. The provider or provider organization shall submit to the commission, within 21 days of the commission's notice, a written response to the notice, including, but not limited to, any information or documents sought by the commission that are described in the commission's notice. The commission may require that any provider, provider organization, significant equity investor, or other party involved in a given transaction submit documents and information in connection with a notice of material change or a cost and market impact review under this section. The commission shall keep confidential all nonpublic information and documents obtained under this section and shall not disclose the information or documents to any person without the consent of the provider or payer that produced the information or documents, except in a preliminary report or final report under this section if the commission believes that such disclosure should be made in the public interest after taking into account any privacy, trade secret or anti-competitive considerations. The confidential information and documents shall not be public records and shall be exempt from disclosure under clause Twenty-sixth of section 7 of chapter 4 or section 10 of chapter 66. (2) For any material change involving a significant equity investor, the commission may specify certain information required to be submitted as part of the notice, including, but not limited to, information regarding the significant equity investor's capital structure, general financial condition, ownership and management structure and audited financial statements. (3) The commission may also require, for a period of 5 years following the completion of a material change, that any provider or provider organization submit data and information necessary for the commission to assess the post-transaction impacts of a material change. (d) A cost and market impact review may examine factors relating to the provider or provider organization's business and its relative market position, including, but not limited to: (i) the provider or provider organization's size and market share within its primary service areas by major service category, and within its dispersed service areas; (ii) the provider or provider organization's prices for services, including its relative price compared to other providers for the same services in the same market; (iii) the provider or provider organization's health status adjusted total medical expense, including its health status adjusted total medical expense compared to similar providers; (iv) the quality of the services provided by the provider or provider organization, including patient experience; (v) provider cost and cost trends in comparison to total health care expenditures statewide; (vi) the availability and accessibility of services similar to those provided, or proposed to be provided, through the provider or provider organization within its primary service areas and dispersed service areas; (vii) the provider or provider organization's impact on competing options for the delivery of health care services within its primary service areas and dispersed service areas including, if applicable, the impact on existing service providers of a provider or provider organization's expansion, affiliation, merger or acquisition, to enter a primary or dispersed service area in which it did not previously operate; (viii) the methods used by the provider or provider organization to attract patient volume and to recruit or acquire health care professionals or facilities; (ix) the role of the provider or provider organization in serving at-risk, underserved and government payer patient populations, including those with behavioral, substance use disorder and mental health conditions, within its primary service areas and dispersed service areas; (x) the role of the provider or provider organization in providing low margin or negative margin services within its primary service areas and dispersed service areas; (xi) consumer concerns, including but not limited to, complaints or other allegations that the provider or provider organization has engaged in any unfair method of competition or any unfair or deceptive act or practice; (xii) the size and market share of any corporate affiliates or significant equity investors of the provider or provider organization; (xiii) the inventory of health care resources maintained by the department of public health, pursuant to section 25A of chapter 111; (xiv) any related data or reports from the office of health resource planning, established in section 22; and (xv) any other factors that the commission determines to be in the public interest. (e) The commission shall make factual findings and issue a preliminary report on the cost and market impact review. In the report, the commission shall identify any provider or provider organization that meets all of the following criteria: (i) the provider or provider organization has, or likely will have as a result of the proposed material change, a dominant market share for the services it provides; (ii) the provider or provider organization charges, or likely will charge as a result of the proposed material change, prices for services that are materially higher than the median prices charged by comparable providers for the same services in the same market; and (iii) the provider or provider organization has, or likely will have as a result of the proposed material change, a health status adjusted total medical expense that is materially higher than the median total medical expense of comparable providers in the same market. (f) Within 30 days after issuance of a preliminary report, the provider or provider organization may respond in writing to the findings in the report. The commission shall then issue its final report. The commission shall refer to the attorney general its report on any provider or provider organization that meets all 3 criteria under subsection (e). The commission shall issue its final report on the cost and market impact review within 185 days from the date that the provider or provider organization has submitted a completed notice to the commission; provided, that the provider or provider organization has certified substantial compliance with the commission's requests for data and information pursuant to subsection (c) within 21 days of the commission's notice, or by a later date set by mutual agreement of the provider or provider organization and the commission. (g) Nothing in this section shall prohibit a proposed material change under subsection (a); provided, however, that any proposed material change shall not be completed: (i) until at least 30 days after the commission has issued its final report; or (ii) if the attorney general brings an action under chapter 93A or any other law related to the material change, while such action is pending and prior to a final judgment being issued by a court of competent jurisdiction, whichever is later. (h) When the commission, under subsection (f), refers a report on a provider or provider organization to the attorney general, the attorney general may: (i) conduct an investigation to determine whether the provider or provider organization engaged in unfair methods of competition or anti-competitive behavior in violation of chapter 93A or any other law; (ii) report to the commission in writing the findings of the investigation and a conclusion as to whether the provider or provider organization engaged in unfair methods of competition or anti-competitive behavior in violation of chapter 93A or any other law; and (iii) if appropriate, take action under chapter 93A or any other law to protect consumers in the health care market. The commission's final report may be evidence in any such action. (i) Nothing in this section shall limit the authority of the attorney general to protect consumers in the health care market under any other law. (j) The commission shall adopt regulations for conducting cost and market impact reviews and for administering this section. These regulations shall include definitions of material change and non-material change, primary service areas, dispersed service areas, dominant market share, materially higher prices and materially higher health status adjusted total medical expenses, and any other terms as necessary to provide market participants with appropriate notice. These regulations may identify filing thresholds in connection with this section; provided, however, that any financial threshold identified by the commission shall be adjusted annually based on any inflation index established by the United States Department of Health and Human Services or similarly reliable national index, as set forth by the commission. All regulations promulgated by the commission shall comply with chapter 30A. (k) Nothing in this section shall limit the application of other laws or regulations that may be applicable to a provider or provider organization, including laws and regulations governing insurance. (l) Upon issuance of its final report pursuant to subsection (f), the commission shall provide a copy of said final report to the department of public health. The final report shall be included in the written record and considered by the department of public health during its review of an application for determination of need and considered where relevant in connection with licensure or other regulatory actions involving the provider or provider organization.

M.G.L. c. 6D, § 14 Standards of certification for patient-centered medical homes; coordination of care; quality standards

c. 6D, § 14. Standards of certification for patient-centered medical homes; coordination of care; quality standards Section 14. (a) By January 1, 2014, the commission, in consultation with the office of Medicaid, shall develop and implement standards of certification for patient-centered medical homes. In developing these standards, the commission shall consider existing standards by the National Committee for Quality Assurance or other independent accrediting and medical home organizations. The standards developed by the commission shall be based on the following criteria: (1) enhancing access to routine care, urgent care and clinical advice though means such as implementing shared appointments, open scheduling and after-hours care; (2) enabling utilization of a range of qualified health care professionals, including dedicated care coordinators, which may include, but not be limited to, nurse practitioners, physician assistants and social workers, in a manner that enables providers to practice to the fullest extent of their license; (3) encouraging shared decision-making for preference-sensitive conditions such as chronic back pain, early stage of breast and prostate cancers, hip osteoarthritis, and cataracts; provided that shared decision-making shall be conducted on, but not be limited to, long-term care and supports and palliative care; and (4) ensuring that patient-centered medical homes develop and maintain appropriate comprehensive care plans for their patients with complex or chronic conditions, including an assessment of health risks and chronic conditions. (5) such other criteria as the commission deems appropriate. In developing these standards, the commission shall consult with national and local organizations working on medical home models, relevant state agencies, health plans, physicians, nurse practitioners, behavioral health providers, hospitals, social workers, other health care providers and consumers. Furthermore, the commission shall consult with the department of public health to maximize opportunities for administrative simplification and regulatory consistency. (b) Nothing in this section shall be construed as prohibiting a primary care provider, behavioral health provider or specialty care provider from being certified as a patient-centered medical home; provided, that such providers meet the standards set by the commission in accordance with this section or are recognized by the National Committee for Quality Assurance as a patient-centered medical home. (c) Certification as a patient-centered medical home is voluntary. Primary care providers, behavioral health providers and specialty care providers certified by the commission as a patient-centered medical home shall renew their certification every 2 years under like terms. (d) A primary care provider or specialty care provider certified as a patient-centered medical home shall have the ability to assess and provide or arrange for, and coordinate care with, mental health and substance abuse services, to the extent determined by the commission. A behavioral health provider or specialty care provider certified as a patient-centered medical home shall have the ability to assess and provide or arrange for, and coordinate care with, primary care services, to the extent determined by the commission. (e) By July 1, 2014, the commission, in consultation with the office of Medicaid, shall establish a patient-centered medical home training for patient-centered medical homes to learn the core competencies of the patient-centered medical home model. The commission may require participation in such training as a condition of certification. (f) For continued certification by the commission under this section, the commission may establish and monitor specific quality standards. Such quality standards shall be developed with reference to the standard quality measure set established by section 14 of chapter 12C. (g) In providing after-hours care, a patient-centered medical home may enter into a cooperative agreement with another patient-centered medical home, primary care practice, limited service clinic, as defined by the department of public health, Medicare-certified home health agency for those patients that receive home-health services, or urgent care center to provide after-hours care for their patients. (h) The commission shall develop a model payment system for patient-centered medical homes certified under this section or recognized by the National Committee for Quality Assurance as a patient-centered medical home. In developing the model payment system, the commission shall consider, but not be limited to, per-patient payments, payment levels based on care-complexity, and payments for care coordination, clinical management, quality performance and shared savings. Development of the model patient-centered medical home payment system shall be completed by January 1, 2014. (i) Payers may make patient-centered medical home payments to network providers certified as a patient-centered medical home under this section or recognized by the National Committee for Quality Assurance as a patient-centered medical home, or equivalent. Payers may use the model payment system developed by the commission or any other medical home payment system the carrier deems appropriate. (j) The commission shall develop and distribute a directory of key existing referral systems and resources that can assist patients in obtaining housing, food, transportation, child care, elder services, long-term care services, peer services and other community-based services. This directory shall be made available to patient-centered medical homes in order to connect patients to services in their community. (k) Nothing in this section shall preclude the continuation of existing patient-centered medical homes or medical home programs currently operating or under development.

M.G.L. c. 6D, § 15 Certification as accountable care organization (ACO); standards

c. 6D, § 15. Certification as accountable care organization (ACO); standards Section 15. (a) The commission shall establish a process for certain registered provider organizations to be certified as accountable care organizations, herein referred to as ACOs; provided that no provider organization is required to become an ACO. The ACO shall be certified for a term of 2 years and renewable under like terms. The purpose of the ACO certification process shall be to encourage the adoption of integrated delivery care systems in the commonwealth for the purpose of cost containment, quality improvement and patient protection. The commission shall create a common application form for provider organizations that wish to apply to the commission. Within 30 days of an application submission, the commission may require the applicant to provide additional information. (b) The commission shall establish minimum standards for certified ACOs. A certified ACO shall: (i) be organized or registered as a separate legal entity from its ACO participants; (ii) have a governance structure that includes an administrative officer, a medical officer, and patient or consumer representation; (iii) receive reimbursements or compensation from alternative payment methodologies; (iv) have functional capabilities to coordinate financial payments amongst its providers; (v) have significant implementation of interoperable health information technology, as determined by the commission, for the purposes of care delivery coordination and population management; (vi) develop and file an internal appeals plan as required for risk-bearing provider organizations under section 24 of chapter 176O; provided, that said plan shall be approved by the office of patient protection; provided further, that the plan shall be a part of a membership packet for newly enrolled individuals; (vii) provide medically necessary services across the care continuum including behavioral and physical health services, as determined by the commission through regulations, internally or through contractual agreements; provided, that any medically necessary service that is not internally available shall be provided to a patient through services outside the ACO; (viii) implement systems that allow ACO participants to report the pricing of services, as defined by the commission through regulations; further provided that ACO participants shall have the ability to provide patients with relevant price information when contemplating their care and potential referrals; (ix) obtain a risk certificate from the division of insurance under chapter 176U; and (x) shall engage patients in shared decision-making, including, but not limited to, shared-decision making on palliative care and long-term care services and supports. (c) The commission may establish additional standards for an ACO. In developing additional standards for ACO certification, the commission shall consider the following goals for ACOs: (1) to reduce the growth of health status adjusted total medical expenses over time, consistent with the state's efforts to meet the health care cost growth benchmark established under section 9; (2) to improve the quality of health services provided, as measured by the statewide quality measure set and other appropriate measures, as established by the commission; (3) to ensure patient access to health care services across the care continuum, including, but not limited to, access to: preventive and primary care services; emergency services; hospitalization services; ambulatory patient services; mental health, substance use disorder and behavioral health services; access to specialty care units, including, but are not limited to, burn, coronary care, cancer care, including the services of a comprehensive cancer center, neonatal care, post-obstetric and post operative recovery care, pulmonary care, renal dialysis and surgical, including trauma and intensive care units; pediatric services; obstetrics and gynecology services; diagnostic imaging and screening services; clinical laboratory and pathology services; maternity and newborn care services and related mental health outcomes; radiation therapy and treatment services; skilled nursing facilities; family planning services; home health services; treatment and prevention services for alcohol and other drug abuse; pain management, including non-opioid and non-pharmaceutical pain management; breakthrough technologies and treatments; allied health services including, but not limited to, advance practice nurses, optometric care, direct access to chiropractic services and physical therapy, occupational therapists, dental care, midwifery services, and end-of-life care services, including hospice and palliative care; and establishing mechanisms to protect patient provider choice, including parameters for out-of-ACO arrangements; (4) to promote alternative payment methodologies consistent with the standards developed by the commission and the adoption of payment incentives that improve quality and care coordination, including, but not limited to, incentives to reduce avoidable hospitalizations, avoidable readmissions, adverse events and unnecessary emergency room visits; incentives to reduce racial, ethnic and linguistic health disparities in the patient population; and in all cases ensuring that alternative payment methodologies do not create any incentive to deny or limit medically necessary care, especially for patients with high risk factors or multiple health conditions; (5) to improve access to certain primary care services, including, but not limited to, by having a demonstrated primary care and care coordination capacity and a minimum number of practices engaged in becoming patient centered medical homes including certified patient centered medical homes; (6) to improve access to health care services and quality of care for vulnerable populations including, but not limited to, children, the elderly, low-income individuals, individuals with disabilities, individuals with chronic illnesses, including chronic pain, and racial and ethnic minorities, including demonstrating an ability to provide culturally and linguistically appropriate care, patient education and outreach provided by community health workers. (7) to promote the integration of mental health, substance use disorder and behavioral health services with primary care services including, but not limited to, the establishment of behavioral health medical homes, recovery coaching and peer support and services provided by peer support workers, certified peer specialists and licensed alcohol and drug counselors; (8) to promote patient-centeredness by, including, but not limited to, establishing mechanisms to conduct patient outreach and education on the necessity and benefits of care coordination, including group visits and chronic disease self-management programs; demonstrating an ability to effectively involve patients in care transitions to improve the continuity and quality of care across settings, with case manager follow up; demonstrating an ability to engage and activate patients at home, through methods such as home visits or telemedicine, to improve self-management; establishing mechanisms to evaluate patient satisfaction with the access and quality of their care; establishing mechanisms between payers and the provider organization such that any shared savings between the provider and the payer shall contain a mechanism to return a percentage of the savings to the ACO patients; and establishing mechanisms to protect patient provider choice, including parameters for accessing care outside of the ACO; (9) to adopt certain health information technology, data analysis functions and performance management programs, including, but not limited to, the ability to aggregate and analyze clinical data; the ability to electronically exchange patient summary records across providers who are ACO participants and other providers in the community to ensure continuity of care; the ability to provide access to multi-payer claims data and performance reports and the ability to share performance feedback on a timely basis with participating providers; the ability to enable the beneficiary access to electronic health information, provided that the patient has provided consent; and the utilization of a proven performance management program, including, but not limited to, participation in the 2011and 2012 Health Care Criteria for Performance Excellence as developed in conjunction with the Baldrige Criteria for Performance Excellence administered by the National Institutes of Standards and Technology of the United States Department of Commerce; (10) to demonstrate excellence in the area of managing chronic disease and care coordination, as managed by a physician, nurse practitioner, registered nurse, physician assistant or social worker, and as evidenced by the success of previous or existing care coordination, pay for performance, patient centered medical home, quality improvement or health outcomes improvement initiatives, including, but not limited to, a demonstrated commitment to reducing avoidable hospitalizations, adverse events and unnecessary emergency room visits; (11) to promote protocols for provider integration, both with providers within and outside of the provider organization, including, but not limited to, clinical integration of the medical director of the laboratory, accredited or certified under the federal Clinical Laboratory Improvements Act of 1988, providing these services to the organization; (12) to promote community-based wellness programs and community health workers, consistent with efforts funded by the department of public health through the Prevention and Wellness Trust Fund established in section 2G of chapter 111 and to promote other activities that integrate community public health interventions with an emphasis on the social determinants of health and which have been proven to improve health; (13) to promote the health and well being of children, including, but not limited to, improving access to pediatric care, providing access to mental and behavioral health services for children, developing and improving pediatric quality measures, developing and improving on pediatric risk adjustments. (14) to promote worker training programs and skills training opportunities for employees of the provider organization, consistent with efforts funded by the secretary of labor and workforce development through the Health Care Workforce Transformation Trust Fund; (15) to adopt certain governance structure standards, including standards related to financial conflicts of interest and transparency; and (16) any other requirements the commission considers necessary. (d) The commission shall update the standards for certification as an ACO at least every 2 years, or at such other times as the commission determines necessary. The commission shall not deny an ACO certification based solely on the geographic location or size of the provider organization. (e) The commission shall create a designation process for Model ACOs only to be conferred on ACOs that have demonstrated excellence in adopting the best practices for quality improvement, cost containment and patient protections, as determined by the commission. In developing this standard of excellence, the commission shall review the standards set forth in subsection (c). (f) All ACOs shall publish the standards used by the ACO to determine which providers of free-standing ancillary services shall be approved to provide services to ACO patients. Free-standing ancillary services shall include, but shall not be limited to, durable medical equipment services, laboratory services, imaging services, dialysis centers, and services provided by free-standing diagnostic, non-hospital surgery centers. A provider of these services shall be informed in writing by the ACO of the standards by which they were accepted or rejected as an approved provider of these free-standing ancillary services for ACO patients. The commission shall create a review process for aggrieved providers under this subsection that are denied approval by an ACO as a provider of free-standing ancillary services for ACO patients. For such process, the commission may review the following: (1) a comparison of the costs of services between an aggrieved provider and the costs of services provided within the ACO; (2) a comparison of the quality of services between an aggrieved provider and the quality of services provided within the ACO; (3) a comparison of the efficiency of services between an aggrieved provider and efficiency of services provided within the ACO; and (4) the extent to which the aggrieved provider meets the published standards used by the ACO to determine inclusion as an approved provider for ACO patients. (g) The commission shall promulgate any necessary regulations to administer this section. In promulgating such regulations, the regulations shall, to the extent applicable and feasible, be consistent with federal law, regulations, demonstrations and rules governing accountable care organizations and shared savings programs.

M.G.L. c. 6D, § 16 Office of patient protection; powers and duties; external review system

c. 6D, § 16. Office of patient protection; powers and duties; external review system Section 16. (a) There is hereby established within the commission an office of patient protection. The office shall:— (1) have the authority to administer and enforce the standards and procedures established by sections 13, 14, 15 and 16 of chapter 176O. The commission shall promulgate such regulations to enforce this section. Such regulations shall protect the confidentiality of any information about a carrier or utilization review organization, as defined in said chapter 176O, which, in the opinion of the office, and in consultation with the division of insurance, is proprietary in nature and is not in the public interest to disclose. Utilization review criteria, medical necessity criteria and protocols shall be made available upon request to the office and the division of insurance; provided, however, that licensed, proprietary criteria and protocols purchased by a carrier shall not be public records and shall be exempt from disclosure pursuant to clause Twenty-sixth of section 7 of chapter 4 and section 10 of chapter 66. Utilization review criteria, medical necessity criteria and protocols shall be made available to the public at no charge; provided, however, that licensed, proprietary criteria purchased by a carrier or utilization review organization shall not be made available to the public, but such licensed, proprietary criteria relevant to particular treatments and services shall be provided to insureds, prospective insureds and health care providers upon request. The regulations authorized by this section shall be consistent with, and not duplicate or overlap with, regulations promulgated by the bureau of managed care established in the division of insurance pursuant to said chapter 176O; (2) make managed care information collected by the office readily accessible to consumers on the commission's website. The information shall, at a minimum, include (i) a chart, prepared by the office, comparing the information obtained on premium revenue expended for health care services as provided under paragraph (3) of subsection (b) of section 7 of chapter 176O, for the most recent year for which information is available, and (ii) data collected under paragraph (c); (3) assist consumers with questions or concerns relating to managed care, including, but not limited to, exercising the grievance and appeals rights established by sections 13 and 14 of said chapter 176O; (4) monitor quality-related health insurance plan information relating to managed care practices; (5) regulate the establishment and functions of review panels established by section 14 of chapter 176O; (6) periodically advise the commission, the commissioner of insurance, the managed care oversight board, established by section 16D of chapter 6A, the joint committee on health care financing and the joint committee on financial services on actions, including legislation, which may improve the quality of managed care health insurance plans; (7) administer and grant enrollment waivers under paragraph (4) of subsection (a) of section 4 of chapter 176J; provided, however, that the office of patient protection may grant a waiver to an eligible individual who certifies, under penalty of perjury, that such individual did not intentionally forego enrollment into coverage for which the individual is eligible and that is at least actuarially equivalent to minimum creditable coverage; provided further, that the office shall establish, by regulation, standards and procedures for enrollment waivers; and (8) establish, by regulation, procedures and rules relating to appeals by consumers aggrieved by restrictions on patient choice, denials of services or quality of care resulting from any final action of an ACO, and to conduct hearings and issue rulings on appeals brought by ACO consumers that are not otherwise properly heard through the consumer's payer or provider. (b) The commission shall establish an external review system for the review of grievances submitted by or on behalf of insureds of carriers under section 14 of chapter 176O, including a process for identifying and referring matters to the division of insurance and the office of the attorney general for review of compliance with state and federal mental health and substance use disorder parity laws. The commission shall establish an external review process for the review of grievances submitted by or on behalf of ACO patients and shall specify the maximum amount of time for the completion of a determination and review after a grievance is submitted. The commission shall establish expedited review procedures applicable to emergency situations, as defined by regulation promulgated by the division.

M.G.L. c. 6D, § 17 Annual report; audits

c. 6D, § 17. Annual report; audits Section 17. The commission shall keep an accurate account of all its activities and of all its receipts and expenditures and shall annually make a report thereof as of the end of its fiscal year to its board, to the governor, to the general court, and to the state auditor, such reports to be in a form prescribed by the board, with the written approval of the auditor. The auditor may investigate the affairs of the commission, may severally examine the properties and records of the commission, and may prescribe methods of accounting and of rendering of periodic reports in relation to projects undertaken by the commission. The commission shall be subject to an audit by the state auditor, in accordance with generally accepted government auditing standards, once every 3 years or as often as the state auditor determines is necessary.

M.G.L. c. 6D, § 18 Adoption of regulations to implement chapter 6D

c. 6D, § 18. Adoption of regulations to implement chapter 6D Section 18. The commission may adopt regulations to implement this chapter.

M.G.L. c. 6D, § 20 Pediatric behavioral health planning report

c. 6D, § 20. Pediatric behavioral health planning report Section 20. Every 3 years, the commission, in collaboration with the department of public health, the department of mental health and the department of developmental services, shall prepare a pediatric behavioral health planning report analyzing the status of pediatric behavioral health in the commonwealth. The report shall include, but not be limited to: (i) a review of data from the online portal established in section 16P of chapter 6A and the reports submitted to the commission pursuant to subsection (f) of said section 16P of said chapter 6A; (ii) an analysis of the availability of pediatric acute psychiatric beds, crisis stabilization unit beds, community-based acute treatment beds, intensive community-based acute treatment beds, continuing care unit beds and post-hospitalization residential beds, broken down by geographic region and by sub-specialty, and an identification of any service limitations; (iii) an analysis of the capacity of the pediatric behavioral health workforce to respond to the acute behavioral health needs of children and adolescents across the commonwealth; (iv) any statutory, regulatory or operational factors that may impact pediatric boarding under said section 16P of said chapter 6A; and (v) any other information deemed relevant by the commission. The report shall be published on the commission's website.

M.G.L. c. 6D, § 21 Standard release form for exchange of confidential mental health and substance use disorder information

c. 6D, § 21. Standard release form for exchange of confidential mental health and substance use disorder information Section 21. The commission shall develop a standard release form for exchanging confidential mental health and substance use disorder information. The standard release form shall be available in electronic and paper format and shall be accepted and used by all public and private agencies, departments, corporations, provider organizations and licensed professionals involved with the medical or behavioral health treatment of an individual experiencing mental illness, serious emotional disturbance or substance use disorder. The commission shall promulgate regulations for the proper use of the standard release form that shall comply with federal and state laws relating to the protection of individually identifiable health information.

M.G.L. c. 6D, § 22 Office for health resource planning; state health resource plan; assessments of health care resource supply, distribution and capacity

c. 6D, § 22. Office for health resource planning; state health resource plan; assessments of health care resource supply, distribution and capacity Section 22. (a)(1) There shall be within the commission an office for health resource planning. The office shall develop a state health resource plan to identify: (i) the anticipated needs of the commonwealth for health care services, providers, programs and facilities; (ii) the existing health care resources, providers, programs and facilities available to meet those needs; (iii) the projected resources, including the health care workforce, necessary to meet those anticipated needs; (iv) recommendations for the appropriate supply and distribution of resources, workforce, programs, capacities, technologies and services on a statewide and regional basis; (v) the priorities for addressing those needs; and (vi) recommendations for any further legislative, regulatory or other state action to assist the commonwealth in achieving the recommendations identified in the plan. (2) The state health resource plan developed by the office shall be a forecast of anticipated demand, production, supply and distribution of health care resources on a state-wide and regional basis during a 5–year planning period, and shall include the location, distribution and nature of all health care resources in the commonwealth, including: (i) acute care units; (ii) non-acute care units; (iii) specialty care units, including, but not limited to, burn, coronary care, cancer care, neonatal care, post-obstetric and post-operative recovery care, pulmonary care, rare diseases care, renal dialysis and surgical, including trauma and intensive care units; (iv) skilled nursing facilities; (v) assisted living facilities; (vi) long-term care facilities; (vii) ambulatory surgical centers; (viii) office-based surgical centers; (ix) urgent care centers; (x) home health; (xi) adult and pediatric behavioral health and mental health services and supports; (xii) substance use disorder treatment and recovery services; (xiii) emergency care; (xiv) ambulatory care services; (xv) primary care resources; (xvi) pediatric care services; (xvii) pharmacy and pharmacological services; (xviii) family planning services; (xix) obstetrics and gynecology and maternal health services; (xx) allied health services including, but not limited to, optometric care, chiropractic services, oral health care and midwifery services; (xxi) federally qualified health centers and free clinics; (xxii) numbers of technologies or equipment defined as innovative services or new technologies by the department of public health pursuant to section 25C of chapter 111; (xxiii) hospice and palliative care service; (xxiv) health screening and early intervention services; and (xxv) any other service or resource identified by the office. (3) The goal of the state health resource plan shall be to promote the appropriate and equitable distribution of health care resources across geographic regions of the commonwealth based on the needs of the population on a statewide basis and the needs of particular geographic and demographic groups The recommendations shall support, at a minimum, the commonwealth's goals of: (i) maintaining and improving the quality of and access to health care services; (ii) ensuring a stable and adequate health care workforce; (iii) meeting the health care cost growth benchmark established pursuant to section 9; (iv) supporting innovative health care delivery and alternative payment models as identified by the commission; (v) avoiding unnecessary duplication of health care resources; (vi) advancing health equity and addressing health disparities; (vii) integrating oral health, mental health, behavioral health and substance use disorder treatment services with overall medical care; (viii) aligning housing, health care and home care to improve overall health outcomes and reduce costs; (ix) tracking trends in utilization and promoting the best standards of care; and (x) ensuring equitable access to health care resources across geographic regions of the commonwealth. (b)(1) In addition to the state health resource plan, the office may conduct focused assessments of health care resource supply, distribution and capacity in relation to projected need. Each assessment shall be conducted in consultation with the board, the advisory council established pursuant to section 4 and other state agencies as appropriate, including, but not limited to, the executive office, the executive office of economic development, the board of higher education, the department of public health, the department of mental health, the office of Medicaid, the division of insurance, the center for health information and analysis, the Massachusetts Life Sciences Center, the executive office of elder affairs, the board of registration in medicine, the bureau of health professions licensure and the office of health equity established under section 16AA of chapter 6A. All such agencies shall provide data and information necessary for the office to conduct the assessment. The office shall consider available state and national data and academic research on health service supply and need and relevant community health needs assessments by non-profit hospitals and other organizations and other individual and community statements of need. (2) Each focused assessment may present findings that include, but are not limited to: (i) the extent to which supply, distribution and capacity of a given health care resource aligns with projected need at the statewide or regional level; (ii) health system factors driving any documented health disparities; (iii) services or providers, including in a specific geographic area, that are critical to the proper functioning of the health care system; (iv) estimates of where and how many additional units of service would be needed in the state or in a specific geographic area to meet projected need; (v) an analysis of health care workforce needs; (vi) identification of barriers impacting accessibility of available health care resources by specific populations; and (vii) legislative, regulatory or other policy recommendations to address the drivers of health disparities, access barriers and areas of misalignment of need and supply, distribution and capacity. (c) The office shall provide direction to the department of public health to establish and maintain on a current basis an inventory of all such health care resources together with all other reasonably pertinent information concerning such resources. Agencies of the commonwealth that license, register, regulate or otherwise collect cost, quality or other data concerning health care resources shall cooperate with the office and the department of public health in coordinating such data and information collected pursuant to this section and section 25A of chapter 111. The inventory compiled pursuant to this section and said section 25A of said chapter 111 and all related information shall be maintained in a form usable by the general public and shall constitute a public record; provided, however, that any item of information which is confidential or privileged in nature under any other law shall not be regarded as a public record pursuant to this section. (d) In developing the state health resource plan, the office shall conduct no fewer than 1 annual public hearing seeking input on the development of the plan and any focused assessment under development, and shall give interested persons an opportunity to submit their views orally and in writing. In addition, the office may create and maintain a website to allow members of the public to submit comments electronically and review comments submitted by others. (e) The office shall publish analyses, reports and interpretations of information collected pursuant to this section to promote awareness of the distribution and nature of health care resources in the commonwealth. (f) Annually, not later than January 1, the office shall file a report with the joint committee on health care financing concerning the activities of the office in general and, in particular, describing the progress to date in developing the state health resource plan and any focused assessment produced to date or under development, and recommending such further legislative action as it considers appropriate. (g) Nothing in this section shall be construed to impose caps on health care resources in the commonwealth or a particular region in the commonwealth.

M.G.L. c. 6D, § 23 Evaluation and reporting of the impact of various sections of the general laws on the effects of capping co-payments on health care costs

c. 6D, § 23. Evaluation and reporting of the impact of various sections of the general laws on the effects of capping co-payments on health care costs Section 23. Every 2 years, the commission, in consultation with the center, the group insurance commission, the office of Medicaid and the division of insurance, shall evaluate the impact of section 17Z of chapter 32A, section 10Z of chapter 118E, section 47CCC of chapter 175, section 8DDD of chapter 176A, section 4DDD of chapter 176B and section 4VV of chapter 176G on the effects of capping co-payments on health care costs, including premiums, pharmaceutical spending, aggregate rebates, cost-sharing, drug treatment utilization and adherence, incidence of related acute events and health equity. Biennially, not later than November 30, the commission shall file a report of its findings with the clerks of the house of representatives and senate, the chairs of the joint committee on public health, the chairs of the joint committee on health care financing and the chairs of house and senate committees on ways and means.
Source: Massachusetts General Court (malegislature.gov)URL: https://malegislature.gov/Laws/GeneralLaws/PartI/TitleII/Chapter6DFetched: 10/20/2026

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